IFUs: Essential weapons against infections

IFUs: Essential weapons against infections

INSIDE...Instrument innovation marathon

Data standards roller coasterCrisis planning call-to-arms

Skin prep’s defensive line

CLINICAL INTELLIGENCE FOR SUPPLY CHAIN LEADERSHIP®

www.hpnonline.com

March 2016 • Vol. 40 No. 3$7.00

HEALTHCAREHEALTHCAREHEALTHCAREHEALTHCAREHEALTHCAREHEALTHCAREPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASING ®EWSEWSEWSEWSEWSEWS

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March 2016 • HEALTHCARE PURCHASING NEWS • hpnonline.com2

SPECIAL FOCUS6 Newswire/Fast Stats

10 SUPPLY DATA STANDARDS: H EALTHCARE’S ENDURING ROLLER COASTER RIDEAmid the twists and turns, ups and downs and loop-the-loops, the healthcare industry is making progress but it just can’t agree on the breadth, depth and speed.

INFECTION PREVENTION14 PROPER SKIN PREP DEFENDS AGAINST SSIs

Some of the latest products and techniques can reduce incidents and long-term costs. Skin Prep Product Spotlights ................19

14 Prevention Update

CS CONNECTION20 IFUS POISED FOR STANDARDS EVOLUTION, REVOLUTION

Manufacturer instructions for use are being targeted as weapons against processing-related infectious outbreaks.

20 Instrumental News26 Self-Study Series

Standards, sterilization and quality controlRaising the standard of care for fl exible endoscopesby Jason Bean

30 CS Solutions Keeping sterile sets dry, the 25-pound trayby Ray Taurasi

32 IAHCSMM ViewpointWhat TJC, CMS surveyors are focusing on in CSby Rose Seavey

OPERATING ROOM34 THE RACE TO KEEP PACE WITH TECHNOLOGY IN TODAY’S OR

Surgical instrument innovation demands all players have the right information at their fi ngertips.

PRODUCTS & SERVICES 40 CRISES CALL FOR CLEAN, CRISP PLANNING PRAGMATISM

When a crisis erupts it can strike fear, loathing and strife in the hearts of clinicians and administrators alike, but mental and operational clutter should be scrapped.

40 New Technology 43 Having My Say

Responding to a disaster in sterile processingby Jo M. Wood

EXPERT EXCLUSIVES4 Fast Foreward44 People & Opinions

Did you wash your hands? Ask less and do more: selecting the right hand-hygiene monitoring systemby Hosniyeh Bagheri, Janis Ober, Jason Burnham and Sudhanshu Gakhar

44 Worth Repeating46 Standard Practices

The Supply Chain link to the Triple Aimby Karen Conway

48 Back Talk Creating patient-centered Supply Chain a healthy prescription by Dee Donatelli

47 Advertiser Index/Classifi ed

March 2016 • Volume 40, No. 3

10

20

34

40

IN THIS ISSUE...

14

HEALTHCAREPURCHASING EWSN

Cover photo courtesy Sanford Medical Center Fargo

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Copyright 2016 by KSR Publishing Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopy, recording, or any information storage-and-retrieval system, without permission in writing from the publisher. Healthcare Purchasing News is a registered trademark used herein under license.Offi ce of publication: Periodicals Postage Paid at Sarasota, FL 34242 and at additional mailing offi ces. Postmaster: Send address changes to: Healthcare Purchasing News, P.O. Box 17517, Sarasota, FL 34276-9801.

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EDITORIALPublisher/Executive Editor Kristine Russell [email protected] Senior Editor Rick Dana Barlow [email protected] Managing Editor Valerie J. Dimond [email protected] (941) 927-9345, ext. 202 Contributing Editors Kara Nadeau [email protected] Susan Cantrell [email protected]

ADVERTISING SALES East Coast Blake and Michelle Holton (407) 971-6286 Midwest Donna Boatman-Riley (815) 393-4624 West Coast Blake and Michelle Holton (407) 971-6286

ADVERTISING & ART PRODUCTIONAd Contracts Manager Tiffany Coffman (941) 927-9345, ext. 203 Graphic Design Tracy Arendt MAILING LIST RENTALS Laura Moulton (941) 927-9345, ext. 201

CORPORATE President Kristine Russell Healthcare Purchasing News (ISSN: 1098-3716) is published monthly by KSR Publishing Inc., 2477 Stickney Point Road, Suite 315B, Sarasota, FL 34231, Phone: (941) 927-9345, Fax: (941) 927-9588, www.hpnonline.com, Business hours: 8:00 a.m.-5:00 p.m. EST.

EDITORIAL ADVISORY BOARDJoe Colonna, Vice President, Supply Chain, Piedmont Healthcare, Atlanta, GA; Karen Conway, Executive Director, Industry Relations, GHX, Louisville, CO; Michele De Meo, CRCST, (Ret.); Dee Donatelli, RN, CMRP, CVAHP, Navigant, Wichita, KS; Mary Beth Lang, Vice President, HC Pharmacy and SCM Commercial Services, UPMC, Pittsburgh, PA; John Mateka, FAHRMM, Executive Director of Supply Chain Operations, Greenville (SC) Health System; Melanie Miller, RN, CNOR, CSPDM, Consultant, CA; Dennis Orthman, Senior Director, Strategic Marketplace Initiative (SMI); Jean Sargent, CMRP, FAHRMM, Vice President, Healthcare Strategy and Implementation, USDM Life Sciences, Santa Barbara, CA; Rose Seavey, RN, BS, MBA, CNOR, ACSP, Seavey Healthcare Consulting Inc.; Richard W. Schule, MBA, BS, FAST, CST, FCS, CRCST, CHMMC, CIS, CHL, AGTS, Director, Clinical Education, STERIS Corporation; Robert Simpson, CMRP, President and CEO, LeeSar Regional Service Center and Cooperative Services of Florida, Fort Myers, FL; Barbara Strain, Director, Value Management, University of Virginia Health System, Charlottesville, VA; Deborah Petretich Templeton, R Ph., MHA, Chief of Care Support Services, Geisinger Health System, Danville, PA; Ray Taurasi, Eastern Regional Director of Clinical Sales and Services, Healthmark Industries; Brian Viele, R.N., BSN, CCRN, Director, ICU/ BHU/Clinical Consultants/Inpatient Cardiopulmonary, Mid Coast Hospital, Brunswick, ME

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CHANGE OF ADDRESSSubscribers: For change of address, send your old and new addresses to Healthcare Purchasing News, 2477 Stickney Point Road, Suite 315B, Sara-sota, FL 34231. Fax: (941) 927-9588, Email: [email protected]. Allow 4 to 6 weeks for correction. All other inquiries, call Tiffany Coffman at (941) 927-9345, ext. 203.

FAST FOREWARDBlot the blightLeave a mark, not a stain.

Admittedly, that lead statement remains a personal motto that extends into the professional realm.

Unfortunately, not everyone shares or practices it on a universal basis.

For the last 25 years, opinion columns such as this one served as my creative outlet alternately to advocate, criticize, evangelize and even satirize supply chain behaviors, operations and viewpoints. Designed and intended merely to provoke thoughts, some column topics and treatments can ignite misplaced emotional distress and misdirected occupational duress — especially if a topic and the way it’s portrayed by one observer’s words hits too close to home and pokes or taps the internal guilt-o-meter.

Borrowing unabashedly the title of Jay McInerney’s famous 1992 novel, I’m disap-pointed to touch upon yet another case of “Brightness Falls” in this industry.

Every few years, as if by clockwork, a healthcare supply chain leader, manager or front-line professional succumbs to a temptation that invariably leads to scandal. These incidents span ignorance and negligence to outright malfeasance and felonious behaviors. Some might argue a fi ne line delineates morals from ethics, and both from legalities. But this isn’t an exercise to parse words and play with the boundaries of truth.

Whether you’re a dogmatic, orthodox absolutist or a compassionate, but somewhat logical pragmatist and anything in between or outside of those psychological jurisdic-tions, you surely agree on one thing: Whenever one of your own falls, it hurts everyone continuing onward.

Take the trite notion of one bad apple doesn’t spoil the bunch. However, we all know that’s a fallacy. If you leave a bad anything in close contact with anything else it will infect everything. Clinicians can vouch for that in this era of outbreaks and pandemics with oddly sounding, but famously memorable names. Granted, such infection may not be guaranteed. What IS guaranteed, however, are tarnished reputations as well as ill-informed and uninformed opinions spreading vitriol quickly and seamlessly in this era of instant media saturation.

Once the bile spreads, it takes a long time to scrub away. In fact, time does not heal old wounds; it just gives you the opportunity to cover up the wound with a scab, followed by an emotional paint job. Maybe what you do with your time determines how thoroughly and how well the wound heals.

Armchair psychotherapy aside, healthcare supply chain leaders, managers and front-line professionals should not use a colleague’s disgraceful exit as a convenient excuse to criticize or look down their noses at others. Committing contract signing mistakes, falling for sales rep strategic and tactical seduction techniques, setting up ghost and patronage payroll schemes as well as dummy/shell corporations to move ill-gotten stock, stealing products and reusing products on patients, or even lording your ego, fame or narcissis-tic, self-indulgent behaviors over co-workers, remain completely unacceptable actions.

When this blight occurs, it should motivate all of us to stop, sit back and examine ourselves. Each one of us represents selected components of an entire industry, which in and of itself, remains a component of a much larger industry that serves society at large.

Amid the specter of criminal and uncivil behavior that may be lurking in someone else’s life right now reading these words, it’s fascinating — but also discouraging — to see the infrequent topic of “Purchasing Law and Occupational Ethics” as a routine educational seminar. And when it does show up on a conference docket, too few attend. Perhaps this industry feels it knows right from wrong. It should. But knowing is not the same as doing — especially if the short-term results seem so blindingly bright that you don’t notice the long-term blight that follows when you’re eventually caught and exposed.

We can do better. We must do better. We need to do better. Together. Individually.



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FAST STATS NEWSWIRE

FDA Draft Guidance on UDI: Policy on national health related item codes assigned to devicesThe Food and Drug Administration (FDA) released a draft guidance document, “En-forcement Policy on National Health Related Item Code and National Drug Code Num-bers Assigned to Devices; Draft Guidance for Industry and Food and Drug Adminis-tration Staff.”

Medical devices currently available through a pharmacy and potentially eligible for reimbursement from payers are gener-ally labeled with an 11-digit reimbursement number. This is typically a National Health Related Item Code (NHRIC) or National Drug Code (NDC) number.

The Unique Device Identifi cation System fi nal rule (UDI Rule) includes a provision (21 CFR 801.57) that rescinds any NHRIC or NDC number assigned to a medical device.

If a device is required to bear a UDI on its label, any NHRIC or NDC number as-signed to that device is rescinded and may no longer be on the device label or on any device package on the compliance date established by the FDA in conjunction with the UDI Rule.

If a device is not required to bear a UDI on its label, any NHRIC or NDC number assigned to that device is rescinded as of September 24, 2018, and may no longer be on the device label or on any device package.

When fi nalized, this draft guidance will describe the Agency’s intent not to enforce before September 24, 2021, the prohibition against providing NHRIC or NDC numbers on device labels and packages, with respect to class III devices, devices licensed under the Public Health Services (PHS) Act, class II devices, and implantable, life-supporting or life-sustaining devices, manufactured and labeled prior to September 24, 2018. In the draft guidance, the Agency is also propos-ing to extend the deadline to request use of FDA-issued labeler codes under a system for the issuance of unique device identifi ers (UDIs) to September 24, 2018 (an extension from the 2014 deadline).

While implementing UDI requirements according to the scheduled UDI compliance dates is important to achieving the UDI Rule objectives in a timely manner, it is not the FDA’s intent to disrupt existing reim-bursement, supply chain, and procurement processes, or to potentially interfere with patients’ access to treatment. Additional time is appropriate for stakeholders to make changes to ensure that these processes will not depend on NHRIC and NDC numbers.

Visit FDA for the guidance: www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm484092.pdf.

UDIs & EHRs — the ins & outs of medical device data Implantable medical devices are essential to quality healthcare, yet questions abound about their real world performance. Better data can help physicians (and their patients) make decisions about which device to use, and what to do if something goes wrong, while hospitals can better source and track these high cost items.

The FDA’s Unique Device Identifi cation (UDI) rule and Meaningful Use regulations are aimed at increasing visibility around use and performance of implantable de-vices. The benefi ts of UDI are widespread — from greater supply chain effi ciencies to comparative effectiveness research. Yet, to realize these benefi ts, hospitals and health-care systems need to populate EHRs with accurate product data and then access data on product usage to ascertain effectiveness.

A panel of experts will discuss what hospitals must do to comply with new regulations, changes in Meaningful Use re-quirements, and the value of UDI-generated research to support value-based healthcare.

Confi rmed speakers include:• Andrew Gettinger, MD, Chief Medical

Information Offi cer, Offi ce of the National Coordinator for Health IT

• Ben Moscovitch, Offi cer, Medical Devices, The Pew Charitable TrustsPlease join us at HIMSS Supply Chain

Management Special Interest Group meeting Wednesday, March 2, from 10-11:00 a.m. in Delfi no 4001. Email [email protected] for more information.

Amerinet is now Intalere Amerinet announced January 20, 2016 a new brand identity, Intalere, and an evolved mission which focuses on elevating the operational health of America’s healthcare providers by designing tailored, smart solu-tions that deliver optimal cost, quality and clinical outcomes.

“The name, Intalere, derives from a Latin word that means ‘to nourish,’” said Brent Johnson, Intalere president and CEO. “It signifi es our vision of being the essential part-ner for operational excellence in healthcare through customized solutions that address customers’ individual needs by assisting in managing their entire non-labor spend, pro-viding innovative technologies, products and services, and leveraging the best practices of a provider-led model.

Amerinet has built a reputation through its 27-year history of timeliness, and being knowledgeable and responsive to member needs. Intalere is now uniquely positioned to become the innovation leader in the indus-try, based on this exceptional tradition, now combined with Intermountain Healthcare’s

ZIKAZIKAZIKAZIKAZIKAZIKAZIKAZIKAZIKA

26countries and territories in the Americas are dealing with local Zika virus transmission.

50 laboratory-confi rmed cases of the Zika virus

have been confi rmed among U.S. travelers by the Centers for Disease Control and Prevention

between Dec. 2015 and Feb. 5, 2016.

$1.8 BILLION in emergency funding was requested of

Congress by President Obama in response to the Zika virus.

$1.48 BILLIONwould support the Department of Health and

Human Services (HHS).

$200 MILLION would fund vaccine research and diagnostics, which includes funding for the NIH to advance the scientifi c understanding of the virus and

funding for the FDA to support Zika virus medical product development.

$210 MILLION would be earmarked for other HHS activities including the development of an “Urgent and Emerging Threat Fund” in the event that Zika

mosquito population migrates to the U.S.

$250 MILLIONin additional funding was requested to

provide more Federal assistance to support health services for pregnant women at risk of infection or diagnosed with Zika virus and for children with microcephaly, and other health

care costs.

Source: The White House; Centers for Disease Control and Prevention.

1603-Newswire.indd 6 2/11/2016 8:34:50 AM

Our name is new, but we’re not. Vizient™ combines the strengths of VHA®, UHC® and Novation®, three trusted leaders, to form the nation’s largest member-owned health care services company. Through our networks, we connect members with opportunities to learn, improve and build together. Through the power of numbers, we deliver brilliant, data-driven resources and insights to where they’re needed most: the frontlines of today’s dynamic health care ecosystem.

Find out how we help you solve your financial, operational and quality of care needs. And allow you to focus on what you do best: deliver exceptional, cost-effective care.

Advancing brilliant connections™

We’re here to connect you to an even better quality of care.

Visit us at vizientinc.com ©2016 Vizient, Inc. All rights reserved.


1603-Vizient.indd 7 2/9/2016 3:02:52 PM

March 2016 • HEALTHCARE PuRCHAsing nEWs • hpnonline.com8

nEWsWiREnationally-recognized supply chain expertise and innovation in technology, process improve-ment, and evidence-based clinical and business best practices.

“Intalere’s innovative solutions are designed to reduce costs, enable data driven strategies and improve performance for the products that healthcare providers need for optimal patient care today and in the future,” said Johnson.

Intalere’s core strategic business drivers include:•Value-addedservicesbeyondcontracting•Robust,comprehensiveportfoliowithbest

pricing and discounts to meet needs across the business

•Innovative technologies and easy-to-useanalytic tools

•Acommittedportfolioproductwithbestpricing

•Responsiveandagilecustomerservice•Scalabilitytomeetspecificdemandsofmem-

ber organizationsVisitwww.intalere.comtolearnmore.

Zika virus resources for Essential HospitalsZikavirus,namedforitsEastAfricapointoforigin,aUgandanforest,wasfirstidentifiedin1947 and did not appear in humans until 1952. Occurrences of the diseases had been limited until an outbreak in Brazil emerged in spring 2015.Sincethattime,thevirushasinfectedatleast 1 million people in more than 30 countries, includingtheUnitedStates.

The World Health Organization (WHO) has warnedthatthediseaseis“spreadingexplo-sively” in theAmericasandcould infectasmany as 4 million people by the end of 2016. Based on this estimate, WHO declared a public health emergency Feb. 1.

The Zika virus is spread to people primarily throughthebiteofaninfectedAedesspeciesmosquito. Its most common symptoms — fever, rash, joint pain, and conjunctivitis — generally aremildandlastfromafewdaystoaweek.Onlyoneinfivepeopleinfectedwiththevirusdevelopsymptoms,andthosewhodousuallydon’t get sick enough to require hospitalization.

But of much greater concern is the link be-tweenZikavirusandmicrocephaly,abirthdefect characterized by an irregularly small head.Researchersalsobelieve theremaybealinkbetweenZikaandsubsequentcasesofGuillain-Barré syndrome.America’sEssentialHospitalshasestablished

this resource page for its member hospitals and otherswithaninterestinthisemerginghealthcrisis.Essentialhospitalsprovideasignificantvolume of public health and emergency pre-paredness services and stand ready to support the nation’s response to Zika. VisitAmerica’sEssentialsHospitalsathttp://

essentialhospitals.org/policy/zika-resources-for-essential-hospitals for the article. HPn

1603-Newswire.indd 8 2/11/2016 1:45:19 PM

Services and Solutions for the Endoscopy Suite. Managing inventory for the endoscopy suite is an important task, but when the burden falls on clinicians, is that really time well spent? While this problem is common, Boston Scientifi c offers a solution that is custom. It’s how we helped a major northeast academic medical center get their clinicians back to taking care of patients. As the challenge of optimizing patient care while managing effi ciencies and costs grows, our ADVANTICS™ Innovative Healthcare Solutions provides a new and collaborative way to meet your needs. Because as healthcare provider needs change, it’s our mission to fi nd new and better ways to support them.

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sPECiAL FoCus

in the hospitality, manufacturing and re-tail industries it may be hard to imagine conducting business without supply data

standards.After all, these industries move product so

frequently in the 21st century that they must be connected to their suppliers and service com-panies up and down their supply chains just to satisfy market demand. In fact, many cor-porate organizations within these industries have been using bar-coded Universal Product Code (UPC) labels since the mid-1970s to track and trace products and services with varying degrees of success.

The healthcare industry, however, which also moves product frequently, particularly in crisis situations, and deals more invasively in human lives, remains a work in progress — since the mid-1970s.

Healthcare Purchasing News has explored and chronicled the bumpy emergence of electronic information systems and supply data standards since its inception in the late 1970s. If you check HPN coverage in print and online during the last four decades you’ll likely spot several common themes gurgling to the surface in the roller coaster ride toward adoption and implementation progress.

Most prevalent among the common themes is the finger pointing between suppliers and providers. Who makes the first move and drives this? Who pays for adoption and im-plementation? These questions are followed by the requisite response: Not me! From there, debates focused on which standards to use and by whom? Will software companies make it easy and relatively painless to use? How will suppliers protect the competitive advantages and attributes of their products versus the providers’ latent desire to compare all products freely and fully to aid in contract and pricing negotiations?

Amid the twists and turns, ups and downs and loop-the-loops, a number of companies vying to carry the torch have sprouted then withered, fading into the backstory of healthcare’s ongoing struggle to plod onward for supply data standards. Meanwhile, tech-nology tries to keep pace with the fits and starts, and government regulations try to nudge the industry forward, stopping short of draconian edicts with stiff penalties for non-compliance.

Supply data standards: Healthcare’s enduring roller coaster rideby Rick Dana Barlow

If providers and suppliers can agree on one thing when it comes to supply data standards progress, it’s that the healthcare industry is making progress. They just can’t agree on the breadth, depth and speed.

Checking the progress-o-meterGauging the success of supply data standards adoption and implementation efforts during the last year compared to five years ago is a lot like checking the applause meter monitoring the audience reactions to a young stand-up comedian. The needle bounces around as the jokes ebb and flow, some funny, some not so much.

Observers, by and large, grant higher marks to suppliers than to providers, even as a few providers emit flashes of brilliance along the way.

“Suppliers have made significant progress in adopting data standards over the last year as compared to five years ago,” said Greg Bylo, Vice President, Healthcare, GS1 US. In fact, he attributed supplier perfor-mance to the Food and Drug Administration’s Unique Device Identification (UDI) regulations and the yearly deadlines specified by the FDA. Suppliers face the next key milestone on September 24 with the balance of Class II devices being covered and then Sept. 24, 2018, for Class I de-vices. Bylo added they expect these deadlines to drive further adoption.

Yet Bylo expressed less generosity with providers.

“Hospital Providers, on the other hand, have not, in general, adopted data standards as rapidly compared to five years ago,” Bylo said. “Where significant progress has been made with providers is with organizations that see the intrinsic value [that] will result from adopting the standards.” Bylo cited or-ganizations such as Franciscan Missionaries of Our Lady (FMOL) and those facilities that are part of the Healthcare Transformation Group as examples of standards adopters, reaping the benefits of their decisions.

“[They] are seeing real value in their sup-ply chain business processes,” Bylo said. “The value proposition for data standards is increased process efficiency. The savings from

an efficiency project, such as a UDI project, can be challenging to measure. However, we are working with industry to accomplish that task.”

Bylo acknowledged that hospital providers have “other burning issues” they need to ad-dress and “may be perceived as a higher prior-ity right now.” Examples include Meaningful Use 2 and the ONC Electronic Health Record (EHR) requirement.

“We continue to work with providers under the GS1 Healthcare US initiative to help them understand the value of data standards,” he added.

Jay Crowley, formerly the FDA’s point man on supply data standards, echoed the leaps suppliers have made as adoption of medical device identification standards has been “very high within the last year or so.” Crowley, who moved to the private sector as Vice President, UDI Services and Solutions, USDM Life Sciences, attributed supplier response to the UDI regulation.

Yet Crowley voiced cautious optimism about overall progress. “It is unknown at this point whether that adoption is appropriate and usable by downstream trading partners,” he told HPN. “It is largely an open loop sys-tem. No feedback is provided to the suppliers about the allocation and marking of devices.”

Dennis Black, Director, e-Business, BD’s Solutions Group for the U.S. Region, shared just how open-ended the standards land-scape has been for decades. Black should know because BD was one of the first movers in the supply data standards movement decades ago and earliest healthcare product suppliers to start the conversion process.

“Prior to the FDA UDI rule in 2013, the use of supply chain data standards for product identification was completely voluntary,” Black recalled. “After the FDA UDI rule was announced in 2013, virtually all medical device manufacturers started implementing data standards, while healthcare provider adoption has been much slower. Although BD and some other medical device manufacturers

Greg Bylo

Jay Crowley

Dennis Black

1603-SF-SupplyDataStandards.indd 10 2/9/2016 1:49:54 PM

hpnonline.com • HEALTHCARE PuRCHAsing nEWs • March 2016 11

sPECiAL FoCusimplemented data standards decades ago, many other device manufacturers didn’t start using data standards until FDA began study-ing the topic of UDI.”

But Black gave providers some props. “A quick review of the data in the FDA [Global UDI Database], or a walk through a hospital store room will quickly validate that medical device manufacturers are making tremendous progress implementing data standards,” he continued. “Providers are being given the critical mass of data standard use needed to effectively enhance their material manage-ment operations.”

Deborah Petretich Templeton, Chief, Care Support Services, Geisinger Health System, a prominent member of the Healthcare Transformation Group, also credited provider efforts during the last five years, due in part to education and information access.

“The FDA ruling on UDI requirements for suppliers has caused more information to be available than had been previously. There are providers that continue to integrate the available information in to their systems, the growth of which drives new learnings in to how to improve seamless transacting/exchange of the information. Also, there is more clinical interest in what the standards can do to improve information that not only gets in to the electronic medical records, but that can also be supplied on medi-cal claims forms to provide a 360-degree view of the patient and product.”

In context, the government require-ments seem to have jump-started prog-ress — at least on one side, agreed Paul Helmering, Vice President of Information and Technology Solutions, Resource Optimization & Innovation (ROi).

“With the final ruling is-sued, the release of FDA’s GUDID database, and the compliance dates reached for Class III and implant-able, life-supporting and life-sustaining medical devices, supplier adoption is occurring,” Helmering said. “Provider adoption, on the other hand, does not have these drivers and has not made significant progress.”

The abundance “master data” creates a new wrinkle that may complicate matters for some facilities, according to Chris Chandler, PharmD, Vice President, Healthcare Services and Solutions, USDM Life Sciences. This “master data management” approach seeks to link information derived from the item master, chargemaster and electronic health records, among others.

Under current healthcare reform initiatives, Chandler noted a “growing appetite for this new wealth of master data for patient safety” but that providers may feel a bit too bridled.

“A major constraint is the mix of allowable standards for use by suppliers to meet FDA’s UDI regulation, requiring familiarity with multiple [automatic identification and data capture] methods to begin relating the UDI in procure-ment and clinical data sources,” she said. “The recent availability of FDA’s GUDID can assist as a product look-up tool, however it also requires a minimum dataset of knowledge and is not easily downloadable for use in healthcare provider systems.”

As a former hospital supply chain executive and a current supply data standards advocate and evangelist, Jean Sargent notched front-line experience in adoption and implementation efforts as well as seen first-hand provider ef-forts through the educational seminars she conducts. With her knowledge and experi-ence of administrative trench warfare, she cut providers some slack.

“I believe there is much more awareness on the providers,” Sargent indicated. “I also believe that as this is a paradigm shift, many do not know how to get started addressing adoption and implementation and who to turn to for support within their organizations.”

Chalk it up to drawn-out impatience, accord-ing to David Reed, Vice President, Healthcare Business Solutions and Operations, and Corporate Compliance Officer, Cook Medical Inc.

“For those of us who are passionate about data stan-dards, the transition may never feel like it’s happening fast enough,” Reed observed. “But that’s because there are a lot of moving parts in implementation. Providers need to modify their internal processes in order to be able to consume the data. Suppliers need to put UDIs on their products. And then the two parties need to transact with each other using UDIs.

“Today, more progress is being made be-cause there’s an expectation that suppliers will have UDIs on their products,” Reed contin-ued. “We are seeing disparate systems work together, and once that happens, we can collect data and evaluate those data. Five years ago I would say that a small number of healthcare professionals were working on adoption, but more of them were working on it a year ago, and even more are working on it today.”

William Mosser, Vice President, Materials Management, Franciscan Missionaries of Our Lady Health System, offered a more sobering assessment, hinting that perhaps the provider community needs a swift kick in the pants to wake up and accelerate their efforts. In fact, his organization is developing the “FMOLHS GS1 U.S. Data Standards Master Process Implementation Plan,” a handy 58-page guide and comprehensive playbook, based on their experience, for healthcare organizations to use. (See related story online.) Think of it as a proverbial boot polisher.

“We’ve seen some good progress, but frankly, not enough,” Mosser told HPN. “Our supplier community has stepped up and of-fered to work with us in a number of areas and, for the most part, seems committed to data standards. But our provider community is still lagging behind. We’ve been discussing this subject since the old EHCR initiative in the mid-90s. So the subject matter isn’t new, or something we don’t understand within the supply chain. But until recently, the broader provider community hasn’t experienced that ‘burning platform’ to drive change.

“We’re gaining a better understanding of the expectations from the FDA, ONC and CMS Meaningful Use,” Mosser continued. “All have implications of lower reimbursements and/or fines associated with performance based reimbursement and regulatory non-compliance. The mere suggestion of lower revenue is guiding us to a focus on the actual cost of providing care and we’re seeing more interest on the parts of the Finance and Senior Operations leadership on the provider side.”

Futurecasting fateTo date, much of the discussion around supply data standards adoption and implementation centered on what’s wrong, what can or should solve what’s wrong and why this all should be taken seriously — or at least given a higher perch on the administrative priority list, tied closely to clinical, financial and operational outcomes.

Just like any typical 12-step program, sup-pliers and providers alike needed to admit their supply chain process rumbles along with problems, identify those problems, then identify probable solutions to those problems using available technology and make process improvements. When the smoke clears, they could record what happened and share their experiences with others so that they learn.

Despite the slow but growing number of providers taking the supply data stan-dards plunge during the last decade alone, too few have shared their experiences

Deborah Petretich

Templeton

William Mosser

Paul Helmering

Jean Sargent

David Reed

Chris Chandler

Page 12


sPECiAL FoCuscomprehensively — that is, beyond hitting the high and low points for promotional and prognosticative purposes, observers admit. (See sidebar: Where are those case studies, examples and icons to connect the dots?)

But ideally, what would a UDI-empowered, EHR-enriched, collectively reformed health-care industry look like? With supply data standards universally accepted, adopted and implemented so that virtually all data and information were linked ubiquitously, and both humans and machines alike readily and easily could access data and information on demand, how might that inspire marveling minds salivating to pursue improvement?

Chandler predicted a “master data manage-ment” scenario whereby all of the “master” systems, including the item master, procedure master and chargemaster can share the same product identifier for both patient safety and a closed-loop system to improve charge capture. “Imagine the scenario of real-time adverse event alerts flowing through health-care provider systems, preventing the use of a recalled device and allowing affected patients to be contacted from the information in their EHR.”

It’s not so far-fetched, is it?Is the industry poised for an “Internet of

Things” or “Internet of People” revolution?Believe it, Templeton urged.“In looking to the future, one must recognize

that the Internet of Things will eventually become the Internet of Everything,” she said. “Keeping this in mind, we recognize that the value becomes the platform from which you operate and not necessarily the product you use. The value will not come from the number of things you have, but from the connections between people, process, data and things. Change then becomes instant, not just con-stant, and essentially every company becomes a technology company. In order to drive this type of connectivity, things like having standards will drive our ability to exchange information in ways that will be necessary to meet new demand.

“We need to be able to link today’s disparate information sources in to a continuous flow of the most trusted information we can deliver to our healthcare providers to enable them to deliver the best care and for the supply chain to be the most efficient and effective to support economic viability of systems in the future,” she continued.

For example, Templeton envisioned if the UDI could be connected from point of manufacture, through point of implant and then tied to an insurance claim, the ordering and performance of the implant could then be processed and measured in ways that are hard to do today.

“Drugs are being developed to contain micro-sensor tracking to allow adherence

monitoring, and eventually could be tied to triggers for reorder, a much tighter indicator of a demand signal than we have today,” she said. “Without standard language to identify the what and where of things being trans-acted, we will be severely limited in how we can take advantage of what technology will allow us to do.”

The end game about this is — and should be — patient safety, according to Bylo.

“If UDI were fully implemented the impact would be substantial, including having the ability to trace an implant serial number to the patient it was used in and also trace it to the original manufacturer with a batch number or serial number in which it was made, creating a full end-to-end traceability capability,” he said. “The other real benefit is significant improvement in transactional efficiency leading to less effort and time for everyone in the supply chain in managing materials.”

Bylo pictured complete UDI adoption and use looking something like this: As the clini-cian implants a device into the patient the de-vice identification and patient data would be entered into the electronic health record and linked to billing. With the transaction data captured in the operating room the computer then would trigger an inventory update from usable stock and issue a replenishment order, which would send a signal to the planner/buyer to replenish the device. The distribu-tor or manufacturer also would receive an electronic prompt to replenish stock at the provider to an established inventory level.

“This would reduce overall inventory re-quirements in the end-to-end supply chain, reducing inventory carrying costs would financially impact the bottom line of every organization in the supply chain,” Bylo said. “Additionally, if a recall occurred, the manufacturer would be easily able to pin point where each device was used, easing the impact of a recall on everyone in the supply chain. A recall today creates many redundant activities for every player in the supply chain which consumes resources, time and money.”

Ideally, UDI will create a “truly integrated supply chain,” according to Helmering. “Currently, every point of communication between parties and every transition in processes through the value chain has errors and inefficiencies caused by the inability to accurately identify product and unit of mea-sure,” he said. “Processes such as price man-agement, spend analytics, demand planning, ordering, invoicing, inventory management, distribution, returns, point-of-use scanning, charge coding and claims processing will become integrated and seamless through UDI’s ability to enable accurate identification and exchange of data.”

The end-to-end traceability of a product from manufacturer through to the hospital, patient and payer for billing is a real pos-sibility, Sargent noted.

“This will require an overarching master data management strategy that incorporates the UDI flow through all systems, thus al-lowing analytics to a level which we do not see today,” she added.

Crowley noted he does not think it is very difficult or far-reaching to imagine the potential benefits of UDI.

“We really do not have to look any far-ther than the pharmaceutical space — with ubiquitous use of [National Drug Codes] and all the visibility and understanding that provides — or any one of the retail models,” he said. “UDI has some advantage in that it often includes production identifiers, so it will — at least for a short time — be ahead of some of the others. Even the more mundane use cases, such as documentation of device use/implantation in clinical information systems, inclusion of UDI in claims and reg-istries, use of UDI in adverse event reports and recalls, will fundamentally change the device ecosystem in ways that we cannot imagine.”

Healthcare’s history is rife with clinical and technological progress, according to Reed, and supply data standards should be added to that panoply.

“Many minimally invasive treatments that are commonplace today in healthcare didn’t exist 40 years ago,” he said. “The possibilities will be limitless as we continue to develop sensors that allow us to monitor ourselves in a simple way. An example might be a pill box that measures when a patient takes medication. Or a device could monitor a diabetic’s blood sugar for them innocuously. Imagine a device that could tell you that your aortic stenosis is increas-ing. Those types of things become possible.

“In many ways, the practice of medicine has been an art form, even though it’s based on science,” Reed continued. “Five physi-cians might do the same procedure or treat the same disease, but they might all do that in different ways. As we bring data to physi-cians, we will increase the chances that they can make better decisions about how they do their work. But without data, predictive analytics aren’t possible. In the foreseeable future, providers will find it incredibly valu-able to know what products were used, if they were effective, and if they provided a good outcome for patients.” HPn

Visit www.hpnonline.com/inside/2016-03/1603-SF-sidebars.html for the online features “Where are those case studies, examples and icons to connect the dots?” and “Supply data standards not about chasing windmills.”

1603-SF-SupplyDataStandards.indd 12 2/8/2016 2:29:18 PM

cookmedical.com

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Prevention uPdate infECTion PREvEnTion

H ealthcare-associated infections (HAIs) account for a large portion of the harms caused by healthcare

and are associated with high costs,” stated a report by Zimlichman et al.1 Whereas the editor’s note accompanying this study stated, “The reason to prevent healthcare-associated infections is to save lives, not costs,” the study clearly connected saving costs with saving lives. “Better evaluation of these infections could help providers and payers to justify investing in prevention,” the authors noted.

The costs of HAIs, an astounding figure of approximately $10 billion per year in the United States alone,1 may very well provide the motivation for healthcare administration to make it a priority to decrease HAIs. Although qual-ity patient care is the foremost priority, to administration, few things carry as much weight as does money. When the Centers for Medicare and Medicaid stopped pay-ing for HAIs in 2009, and private insur-ers began following suit, it definitely hit where it hurt.

One of the top, and most costly, HAIs is surgical-site infection (SSI). The Zimli-chman study estimated that each SSI case costs an average of $20,785.1 If the SSI is caused by methicillin-resistant Staphy-lococcus aureus, the costs can be higher.1 Studies such as this, allowing hospital administration to compare the cost of avoiding infections versus the cost of re-sponding to infections, are an important step in the right direction. If reducing infection to reduce costs also saves lives in the process, who can complain? It is a win-win situation.

Skin-prep selection criteriaNipping it in the bud may be the ideal approach for handling SSIs. Preparing skin for surgery is the initial and vital first step. Kimberly Prinsen, RN, MSN, Technical Service Specialist, 3M Infection

Prevention, Perioperative Division, talked to Healthcare Purchasing News about the importance of effective preoperative skin preparation. “The surgical skin prep is a critical step in reducing the risk of an SSI for patients undergoing surgery. Because all commonly used patient skin preps meet the Food and Drug Administration

(FDA) criteria for immediate microbial kill and persistent antimicrobial activity, it’s important to look at other factors that may affect performance when choosing a prep for each surgical patient.”

Prinsen offered specific advice on skin-prep selection criteria. “Selection of a patient prep is based on multiple factors, including patient allergies and sensitivi-ties, age of the patient, location and type of procedure, anticipated amount of fluid or blood exposure to the surgical site, and surgeon preference. Once these are evalu-ated, the prep choice also should consider the following: ease of application, ability to immobilize bacteria on the skin, ef-fectiveness of prep after blood and saline challenge, coverage area, and cost/value of each surgical prep.”

Noting that “Each patient requires a unique approach to skin antisepsis,” J. Hudson Garrett, Jr, PhD, MSN, MPH, Vice President, Clinical Affairs, PDI Inc., out-lined a few more factors to consider when matching appropriate skin-preparation products to patients. “It is important to ensure that the skin antiseptic chosen is broad-spectrum, FDA-approved, safe for the patient and the clinician, and demon-strates the ability to bind to the skin and

Proper skin prep defends against SSisProducts & techniques reduce incidents, costs

Hand hygiene compliance industry group formed to lead change for patient safetyTo create meaningful awareness of the patient safety risks and the economic burden to the U.S. healthcare system of outdated hand hygiene compliance measurement, eight U.S.-based hand-hygiene compliance solution providers have formed an alliance.

EHCO, the Electronic Hand-hygiene Compliance Organization, aims to lead and influence changes in hand-hygiene measurement policy and guide-lines at accreditation organizations, government agencies, health insurers, and hospitals. EHCO's focus is to improve hand hygiene compliance and, in turn, increase safety and reduce avoidable harm to patients and hospital staff.

While proper hand hygiene is critical to prevent-ing the transmission of many infections, compli-ance with hand hygiene guidelines is less than 50 percent globally. Until recently, the only way to measure how well healthcare workers performed hand hygiene was manual direct observation. With direct observation, individuals know they are being observed and adjust their behavior, a phenomenon known as the Hawthorne Effect, inflating a hospital's true compliance rate.

A hospital may think its hand hygiene compli-ance rate is 90 percent; but direct observation only accounts for 1.2 percent to 3.5 percent of all hand-hygiene events, leaving more than 96 percent of hand hygiene events undocumented and compliance rates highly overstated.

"Patient health and lives are being put at risk by outdated compliance measurement methods which often inflate actual hand hygiene rates by up to 300 percent," said Paul Alper, Chairman of EHCO and VP of Patient Safety Strategy, DebMed. "Patients are subjected to extended lengths of stay and unnecessary suffering as a result of HAIs, many of which could be prevented with proper hand hygiene. That is why the members of EHCO are uniting to drive change in US healthcare policy," Alper continued.

Only within the past few years has evidence-based electronic measurement of hand hygiene become widely available to accurately and continuously measure hand hygiene compliance in real-time and enable meaningful feedback to healthcare workers. While capturing 100 percent of hand hygiene behavior electronically gives hospital leaders in quality, patient safety, and infection control visibility to accurate and reliable rates, no policy guidelines or mandates exist. EHCO member companies believe that it is their responsibility to lead the change in the acceptable standard of care to improve public health and patient safety.

The companies engaged in EHCO include Airista, BioVigil, CenTrak, Clean Hands-Safe Hands, DebMed, Hill-Rom, Inc., SwipeSense, and Versus Technology.

Visit EHCO: www.ehcohealth.org/press-releases/hand-hygiene-compliance-industry-group-formed-to-lead-change-for-patient-safety.

by Susan Cantrell, ELS

Clorox Healthcare Nasal Antiseptic Swabs

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INFECTION PREVENTIONreduce microbial growth. To select broad-spectrum skin antiseptics, efficacy should be evaluated for common causative mi-crobial categories such as gram-positive and -negative bacteria, pathogenic fungi, and other pathogens.”

It is always advisable to be aware of guidelines, recommendations, and best practices. Colleen Glynn, Senior Market-ing Director of Surgical Businesses, BD,

referred to guidelines on skin prep, out-lining the basics. “Skin antisepsis guide-lines explain that standardized patient preparation should remove bioburden (e.g., soil and transient microorganisms) from skin, decrease resident microorgan-ism counts quickly while not irritating tissue, prevent regrowth and rebound of microorganisms, and have a persistent effect.”2,3

Application method makes a dif ferenceHow preoperative skin prepara-tions are applied can make a difference in eliminating pathogens effectively and in ensuring compliance. Prinsen explained why. “The application method for a prep is how a prep achieves its efficacy. It is necessary for staff to know and follow the nu-ances for each prep. Fol-lowing manufacturer’s instructions for use is critical not only to help reduce the risk of an SSI but also to ensure patient safety. Some surgical skin prepara-tions have different application methods based on the location of the body that is being prepped, e.g., a dry site (abdomen) versus a moist site (groin). 3M DuraPrep is applied in a single painted-on coat, with no variation for dry or moist sites. Taking the variability out of application method assists the clinician in being compliant with the instructions.”

Remember that tired old joke, “If all else fails, read the directions?” Instructions are there for a reason. “All antiseptics should be applied to the patient’s skin as directed in the manufacturer’s instructions for use,” said Garrett, PDI. “Some antiseptics are applied with concentric circles, whereas newer formulations, such as those contain-ing chlorhexidine gluconate, are applied in a back-and-forth motion.” Garrett explained that the back-and-forth applica-tion technique dislodges the transient fl ora found in the epidermis of the skin, which can cause SSIs.

Glynn explained in a nutshell why the method of product application merits attention. “An estimated eighty percent of skin fl ora reside in the fi rst fi ve layers of our outermost skin. When the skin is incised, the exposed tissues are at risk for contamination. Bacteria on patient skin is a leading cause of HAIs.”4

How they workPrinsen described 3M’s skin-prep solution, explaining how its formulation stops infec-tion in its tracks. “3M DuraPrep Surgical Solution [iodine povacrylex (0.7 percent available iodine) and isopropyl alcohol, 74 percent w/w] Patient Preoperative Skin Preparation is applied in a single painted coat. Iodine povacrylex contains a unique polymer that dries to a water-insoluble


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infECTion PREvEnTion

film. The film enables the prep to resist removal by blood and irrigating solutions, thus optimizing the persistent effect of iodine. The film also immobilizes bacteria remaining on the skin after prepping, helping to prevent bacteria migration into the surgical wound and enhancing incise drape adhesion.”

BD’s ChloraPrep formulation is two percent chlorhexidine gluconate and 70 percent isopropyl alcohol, fast-acting, broad-spectrum, and persistent. “The entire ChloraPrep portfolio is designed to reduce significantly bacteria on the skin that can cause infection, and it is appropri-ate for most minor and major procedures,” stated Glynn.

“By cleansing the surgical-site area with gentle back and forth motions, ChloraPrep penetrates into cracks and crevices on the skin, eliminating microbes in less-accessi-ble areas of the skin’s surface.”

Glynn continued, “ChloraPrep solution continues to be the only FDA-approved formulation of two percent chlorhexidine gluconate and seventy percent isopropyl alcohol (IPA) with a single-use applica-tor. It has appeared in more than 20 peer-

reviewed publications and been shown to outperform iodine-based products.”5,6

One of the studies Glynn referred to, by Ostrander et al, compared three skin-prep solutions on 125 consecutive foot and ankle surgeries. The study concluded: “The combination of chlorhexidine and al-cohol (ChloraPrep) was the most effective solution for eliminating potential wound contaminants from the forefoot prior to surgery.”6

PDI Inc., also offers a chlorhexidine glu-conate and isopropyl alcohol skin prep. Ease of use and a continued antimicrobial effect on the patient’s skin up to seven days with a single application are just two of its attractions. Garrett described how Prevan-tics differs from other similar products. “Prevantics is fully compliant with the current evidence-based recommendations from both the Centers for Disease Control and Prevention and the Association of PeriOperative Registered Nurses. Prevan-tics is the only 3.15 percent chlorhexidine gluconate/70 percent isopropyl alcohol, FDA-approved antiseptic available in the United States. The product is fully activated and ready for immediate use by the clinician, saving time and improving efficiency in the skin-antisepsis process. Prevantics tinctured formulation delivers the immediate efficacy provided by the isopropyl alcohol and also the sustained antimicrobial effect from the chlorhexidine gluconate. Prevantics is less expensive than other similar products, due to its intuitive and simple design.

“Prevantics has been used in many facili-ties to improve quality, reduce costs, and improve the overall patient experience,” stated Garrett. “Several recent published clinical studies have demonstrated its impact on reducing HAIs.”

Garrett relayed a study conducted and published by a community hospital in the Dallas-Fort Worth area, where Prevantics was implemented to reduce blood-culture contamination, a concern because contami-nated blood cultures can lead to patients being unnecessarily exposed to antibiotics. “This can result in significant risk for infec-tions with postoperative surgical patients,” noted Garrett. “As a result of the inter-vention, the facility’s contamination rate dropped from nine percent to just under three percent, well below the national aver-age for blood-culture contamination rates.”

Clorox Healthcare’s Nasal Antiseptic Swabs also may play a role in good an-tibiotic stewardship. Because the swabs can be used as an alternative in nasal

decolonization, and because bacteria have not developed resistance to povidone-iodine antiseptics, fewer antibiotics may be required.

Rosie D. Lyles, MD, MHA, MSc, Head of Clinical Affairs, Clorox Healthcare, explained, “Clorox Healthcare Nasal Antiseptic Swabs are pre-saturated, ready-to-use swabs that are used in patient nos-trils prior to surgery as part of a bundled intervention for patient decolonization, to help reduce the risk of postoperative SSIs. They are clinically shown to reduce 99.4 percent of Staphylococcus aureus at one hour, maintaining persistence through twelve hours. They are non-irritating and well-tolerated in the nares after 10 applica-tions. When used as part of preoperative or inpatient protocol, the swabs are proven to be a safe and effective alternative to anti-biotics for nasal decolonization, which can help enable antibiotic-stewardship plans, as there is no clinical evidence of bacteria developing resistance to povidone-iodine antiseptics.”

Lyles continued, “Nasal carriage of S aureus is a significant risk factor for de-veloping an SSI with S aureus,7 which is why effective nasal decolonization plays an important role as part of a bundled approach to reduce the risk of infection. However, there is growing evidence that nasal decolonization with antibiotics may contribute to bacterial resistance. Clorox Healthcare Nasal Antiseptic Swabs can safely and efficiently reduce S aureus in the nares without contributing to bacte-rial resistance, differentiating them from other nasal decolonization treatments with antibiotics such as mupirocin.”

Lyles also considered the importance of patient comfort and ease of use in applica-tion of the product. Naturally, if a product causes discomfort, or if it is difficult for the healthcare workers to apply, compli-ance can suffer. “Clorox Healthcare Nasal Antiseptic Swabs are applied to a patient’s nostrils by a healthcare provider one hour before surgery. This method of application increases the likelihood of compliance and reduces the risk of patient error. Patients have found the swabs comfortable during application and report an overall positive experience, with 96 percent of study partic-ipants reporting no discomfort throughout product application. Compliance and ease of use are important considerations when selecting a nasal decolonization method prior to surgery, because if a product is dif-ficult to use or uncomfortable for patients, it is less likely to be used effectively.” PDI Healthcare’s Prevantics products

ChloraPrep, from BD


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Referring to the high cost of treating SSIs, Lyles compared the cost of Clorox Healthcare Nasal Antiseptic Swabs to the cost of caring for a patient with a resistant strain of S aureus. “SSIs are the third most frequently reported HAI, are a source of signifi cant patient morbidity and mortality, and are extremely costly. The average per-patient cost for an SSI caused by resistant strains of S aureus can be as high as $60,000. Clorox Healthcare Nasal Antisep-tic Swabs are a cost-effective decolonization method, decolonizing the nose for less than the cost to screen for S aureus.” HPNReferences

1. Zimlichman E, Henderson D, Tamir O, et al. Health care-associated infections: a meta-analysis of cost and fi nancial impact on the US health care system. JAMA Intern Med. 2013;173(22):2039-2046.

2. Association of periOperative Registered Nurses. Recommended practices for preoperative patient skin antisepsis. Perioperative Standards and Recommended Practices. Denver, CO: AORN Inc. 2011.

3. Association for Professionals in Infection Control and Epidemiology Inc. Guide to the elimina-tion of orthopedic surgical site infections. Washington, DC: APIC; 2010. http://www.apic.org/Resource_/EliminationGuideForm/34e03612-d1e6-4214-a76b-e532c6fc3898/File/APIC-Ortho-Guide.pdf. Last accessed January 31, 2016.

4. Brown E, Wenzel RP, Hendley JO. Exploration of the microbial anatomy of normal human skin by using plasmid profi les of coagulase-negative staphylococci: search for the reservoir of resident skin fl ora. J Infect Dis. 1989;160(4):644-650.

5. Saltzman M, Nuber GW, Gryzlo SM, et al. Effi cacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am. 2009;91(8):1949-1953.

6. Ostrander RV, Botte MJ, Brage ME. Effi cacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am. 2005;87(5):980-985.

7. Kalmeijer MD, van Nieuwland-Bollen E, Bogaers-Hofman D, et al. Nasal carriage of Staphylococ-cus aureus is a major risk factor for surgical-site infections in orthopedic surgery. Infect Control Hosp Epidemiol. 2000;21(5):319-323.

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InstruMental news Cs ConnECTion

in response to processing-related infectious outbreaks last year, government agencies, in-dustry organizations, manufacturers, health-

care facilities and others have been diligently working to determine why they occurred and what can be done to prevent them in the future.

In October 2015, the Centers for Disease Con-trol and Prevention (CDC) and U.S. Food and Drug Administration (FDA) issued its latest alert to healthcare providers and facilities on the need to properly maintain, clean and disinfect or sterilize reusable medical devices. The agencies urged healthcare facilities to invest in central sterile/sterile processing (CS/SPD) staff training, implement regular audits of reprocessing steps, ensure adequate time for proper reprocessing, and involve CS/SPD and infection control staff in purchasing decisions.1

Healthcare Purchasing News reached out to experts from across the industry to gain their insights on how CS/SPD practices might be improved to prevent these types of outbreaks from reoccurring. The major themes that emerged were the need for improved instruc-tions for use (IFU) management, alignment of processes with industry standards (AAMI, AORN), CS/SPD staff education and training, better communication between the CS/SPD and other departments, and for healthcare facilities to ensure their CS/SPD staff has the time and resources they need to properly clean and steril-ize complex devices.

Purchasing decisionsAccording to Weston “Hank” Balch, CRCST, CIS, CHL, Director of Sterile Processing Opera-tions, Jewish Hospital & University of Louisville Hospital, infection prevention begins with the purchasing process. He urges healthcare or-ganizations to include CS/SPD professionals in the evaluation of new surgical equipment, stating:

“In many situations, pur-chasing decisions for new surgical equipment systems are made by supply chain or OR leadership with little consideration given to the CS processing requirements provided by the equipment manufacturer,” said Balch. “Facilities that are serious about guarding against a repeat of last year’s infection control challenges should strongly consider having CS representation on every new product committee, so that purchas-ing decisions can be made that take into account

IFus poised for standards evolution, revolution by Kara Nadeau

the full ownership costs of surgical instrumen-tation — namely, instrument plus appropriate processing equipment.”

Another area for consideration is the purchas-ing of equipment to process complex surgical devices, such as scopes. Balch explains how many CS/SPDs are operating with outdated equipment that is incapable of properly process-ing today’s instrumentation.

“Last year’s headlines confirmed what CS leaders around the country have known for some time,” said Balch. “Our problem is not that instru-ment manufacturing technology has outpaced the creation of equipment needed to clean these items, it’s that most facilities have been slow to adopt or unable to afford this next-generation processing equipment. Many departments are using yesterday’s tools to clean tomorrow’s scopes, and the result is broken processes.”

education and trainingThe October 2015, CDC/FDA health update em-phasized the need for training hospital personnel responsible for reprocessing medical devices. It was recommended that training be required and provided:

• Upon hire or prior to provision of services at the facility

• At least once a year• When new devices or protocols are intro-

duced, including changes in the manufacturer’s IFUs during a device’s lifecycle1

The CDC/FDA stated that healthcare facili-ties should require personnel to “demonstrate competency with device reprocessing prior to being allowed to perform reprocessing inde-pendently,” and “maintain current documenta-tion of trainings and competencies.” For those healthcare facilities hiring contractors for device reprocessing, “the facility should verify that the contractor has an appropriate training program and that the training program includes the spe-cific devices the healthcare facility uses.”1

“The majority of the press we heard last year was around the ERCP scope, and we know these are very complex and have numerous steps in reprocessing,” said Mark Duro, Director of Sterile Processing Operations for New England Baptist Hospital in Boston. “In some cases it may be necessary to increase the competency evaluation of staff as some of these scopes are so tedious to clean. Some devices, if too complex, maybe don’t

Weston Balch

Mark Duro

FDa clears Olympus tJF-Q180V duodenoscope with design modificationsThe Food and Drug Administration (FDA) cleared the Olympus TJF-Q180V duodenoscope with modifications to the device’s design and labeling intended to help reduce the risk of bacterial infec-tions. Olympus will voluntarily recall its original model currently being used in healthcare facilities and make the needed repair as quickly as possible.Olympus modified its design of the elevator channel sealing mechanism to create a tighter seal and reduce the potential for leakage of patient fluids and tissue into the closed elevator channel. Leakage into this channel could pose an infection risk to subsequent patients exposed to the contaminated device because the sealed area cannot be cleaned and disinfected between uses. The company also plans to conduct annual inspec-tions of each scope in use by facilities to identify any wear and tear on the elevator channel sealing mechanism or the presence of attached debris at the scope’s tip, which would require replacement of the potentially contaminated parts.

The company has submitted a 510(k) for the TJF-Q180V, and the FDA has determined that the model with the newly designed mechanism is substantially equivalent to previously cleared duodenoscopes.

In addition, Olympus is initiating a voluntary recall of the original TJF-Q180V model from healthcare facilities to replace the elevator channel sealing mechanism at the tip of the scope with a new sealing mechanism; the new mechanism is designed to reduce the risk of fluid leakage into the elevator channel. The company estimates it will be able to correct the mechanism in the approxi-mately 4,400 TJF-Q180V models currently used in healthcare facilities by August 2016.

While awaiting repair, healthare facilities may continue to use the Olympus TJF-Q180V, but they should meticulously follow the manufacturer’s reprocessing instructions.

FDa releases final guidance on devices labeled as sterileThe Food and Drug Administration (FDA) issued final guidance document, “Submission and Review of Sterility Information in Premarket Notification 510(k) Submissions for Devices Labeled as Sterile.” Its recommendations seek to ensure that manufac-turers incorporate adequate sterilization methods for 510(k) devices labeled as sterile and provide appropriate documentation and information to the FDA for premarket review for established and novel sterilization processes.

This final guidance also provides additional details about the pyrogenicity testing information that sponsors should include in a 510(k) submis-sion for certain sterile devices and those labeled as non-pyrogenic. Novel sterilization methods are newly developed and, therefore, have littlVisit the FDA for the guidance www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm109897.pdf.

1603-CS-RegulatoryAnalysisshort.indd 20 2/10/2016 3:16:59 PM

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CS CONNECTION

need to be on the market if they can’t be success-fully reprocessed.”

The critical role of IFUs Across the board those interviewed stressed the importance of manufacturer’s instructions for use (IFU) in proper instrument processing. They noted how CS/SPD professionals must have access to up-to-date IFUs that take into account real-world processing conditions. The October 2015 CDC/FDA update states: “Copies of manufacturers’ instructions for operating and reprocessing each type of reusable device should be readily available to staff and inspectors. This fi le should include instructions for use of chemi-cal disinfectants.”

“We know that it is possible for an inad-equately processed instrument or device to cause a surgical site infection (SSI),” said Cynthia Spry, MA, MS, RN, CNOR(E), CSPDT, an independent CS/SPD consultant. “Recent examples that have made headlines are inadequately processed duodenoscopes that led to a number of patient infections and, in some cases, death. More often however we do not know whether a contami-nated instrument was the cause of infection. Just knowing it is possible however, is reason to practice at the highest level possible.”

“The fi rst step is no short cuts when it comes to following the instructions for use,” she adds.

“The IFU is what the manufacturer has deter-mined is necessary to delivering a product that is safe for use in surgery. In essence, every time we take a short cut we are potentially putting a patient at risk. Knowing we have followed the IFU as written we can feel confi dent we have not contributed to a patient injury. This is the mark of a professional and what should help make sterile processing personnel sleep well at night .”

IFU accessibility Charles Hughes, Vice President of Infection Prevention and Consulting Services for Cantel Medical and the lead educator for Crosstex/SPSmedical, a Cantel Medical Company, en-courages healthcare organiza-tions to put into place policies and procedures where they will have the opportunity to review the written IFU prior to purchasing, borrowing or trialing any new reusable medical device.

“Hospitals should review all IFUs and confi rm there are no confl icts with their current reprocess-ing steps,” said Hughes. “If there is an issue, the hospital must secure the proper resources or must contact the device manufacturer and ask them to revalidate their IFUs to the hospital’s standard reprocessing procedures. Some device

manufacturers simply don’t know the chaos their IFUs cause reprocessing departments, and are willing to revalidate.”

IAHCSMM President David Jagrosse, CRCST, CHL, IFUs believes IFUs should be readily avail-able at all the touch points of the reprocessing cycle (e.g., point of use in the OR, decontamination, assembly). In his opinion, the most effective and accurate way to do this is by digitizing IFUs and using an asset manage-ment system (e.g., computer barcodes, tracking systems). He notes how this facilitates point-of-use access to the IFUs and also pictorial and video instruc-tion, if needed; rather than having everything committed to memory or paper.

“The most optimal system would include an asset management system that links to One-SOURCE or any online IFU reference library that updates and keeps the IFU,” Jagrosse adds. “This is especially valuable for loaners and con-signment instruments, and robust policies and procedures.”

IFU updates“The majority of IFUs we have currently have not been revised in years,” said Duro. “There have been so many advancements in technologies such as ultrasonic cleaners and washer disinfec-tors, as well as some of the non-fl exible general and orthopedic instrumentation. IFUs can play a major role but only if they are actually doable.”

“Take for example all that is going on with the fl exible endoscope market and reprocess-ing,” said IAHCSMM President-Elect Steven J. Adams BA, RN, CRCST, CHL, Manager of Sterile Processing/Anesthesia for Greater Baltimore Medical Center. “Although HLD has been an ac-ceptable practice for years for fl exible endoscopes — classifi ed as semi-critical devices by the CDC — recent outbreaks now have manufacturers of the scopes as well as sterilizer manufacturers thinking of ways to modify designs in order to perhaps one day sterilize fl exible endoscopes of many different varieties. Therefore, having an individual in the CS department dedicated to monitoring and keeping these IFUs up to date is crucial.”

According to Hughes, healthcare organiza-tions should establish policies and procedures that require device manufacturers to update the organization when changes are made to their current IFUs.

“Enforce all policy and procedures, especially when it comes to borrowed trays arriving on time and with IFUs,” said Hughes. “Additionally, confi rm that you have all your IFUs and if not, have your educator secure those that are miss-ing and/or outdated. In many cases, borrowed instruments — also referred to as loaners — come without validated IFUs, which means reprocess-ing must be delayed until the IFUs are provided.

Charles Hughes

David Jagrosse


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Cs ConnECTionWithout the IFU, the CS/SPD personnel have to guess how to properly reprocess the devices, which is a patient safety issue.”

To assure sterility of instrumentation, Hughes also suggests that the CS/SPD use Class 5 in-tegrators, which can provide an extra level of assurance when documenting the effectiveness of the sterilization cycle.

IFU improvementsProviding the CS/SPD access to updated IFUs isn’t enough according to Mar-cia Frieze, CEO, Case Medical Inc. The IFUs themselves must be written to meet the needs of the processing environment, taking into account industry best practices.

“Unfortunately, many IFUs are still unclear, inconclusive and simply wrong,” said Frieze. “Staff have been told to follow them blindly in some cases. This is a problem when an IFU simply does not take into consideration good common sense or even best practices clearly identified as guidelines or standards in AAMI and AORN documents. For example, using sterile water only and avoiding detergents, enzymatic cleaners in particular for reprocessing ophthalmic devices, or using germi-cides instead of cleaning and rinsing thoroughly after each use. In other words, quality control and IFUs require an ounce of common sense.”

Frieze compares the CS/SPD of a hospital to a manufacturing facility, noting how the CS/SPD is producing products that are required for the hospital’s customers — clinical depart-ments and their patients — particularly the OR where products are used in both invasive and minimally invasive surgery.

“Quality control and thorough review of manufacturer’s instructions is crucial to manu-facturing whether in a healthcare setting or a manufacturing facility,” said Frieze. Putting it simply, best practices are required to put out a qualified, reliable, reproducible product for future use.”

Sticking to StandardsIn addition to having access to manufacturer IFUs, Adams says it is essential for every member of a hospital’s CS/SPD department — not just the department’s manager — to have full access to the latest versions of the Association for the Ad-vancement of Medical Instrumentation (AAMI) and Association of periOperative Registered Nurses (AORN) standards and recommended practices. He notes that paper or electronic ver-sions are both fine, and the choice should be up to the manager. “It is crucial to let them know that it is impos-sible for any one person to be able to recite every individual standard while still performing their regular job duties. This is why we have these as reference manuals, so there is no shame in accessing and referring to these critical tools.”

Expert adviceRose Seavey, Owner of Seavey Healthcare Consulting LLC, believes every facility should have a reprocess-ing subject matter expert and that this individual should have the resources to stay current on all the latest standards recom-mendations and guidelines.

“They also need to make sure that they have all of the instructions for use for every piece of equipment, surgical instrument and chemicals that are used in reprocessing reusable medical devices,” said Seavey. “And that person needs to make sure that the frontline workers all understand and have access to those instructions for use.

“I also strongly feel that every facility should have a processing educator whose job is to make sure that every employee is competent with every job that they are assigned to when it comes to reprocessing reusable medical devices,” she adds.

Quality over quantityEven with access to IFUs and industry standards, a greater challenge is the nature of many CS/SPDs, where tight staffing and turn-around times combined with growing volumes of increasingly complex surgical instruments can force staff members to place quantity over quality.

The October 2015 CDC/FDA update states: “Healthcare facilities should allow adequate time for reprocessing to ensure adherence to all steps recommended by the device manufacturer, including drying, proper storage and transport of reprocessed devices. Considerations should be made regarding scheduling of procedures and supply of devices to ensure adequate time is allotted for reprocessing.”1

“We all have to be very honest from a CS/SPD perspective,” said Adams. “I believe the major-ity of facilities can state that they follow IFU on a daily basis. However, do we all really follow the IFU in a way that is intended and surveyed? To follow the IFU from start to finish takes time, and most CS departments do not have the luxury of time in order to follow every single step of an IFU perfectly.”

Given this situation, Adams urges CS/SPD managers to educate their C-suite on the critical-ity of following IFU perfectly and the real time and personnel resources it takes to perform these tasks flawlessly. He recommends managers per-form staffing assessments to determine whether the departments are appropriately staffed to accommodate hospital expectations.

Adams also recommends CS/SPD managers educate their staff on the importance of quality over quantity, noting that CS/SPD professionals still have to perform their very best in order to produce a high quality product no matter how well or poor their departments are staffed.

“It is wonderful to walk into a CS department and see completely full sterile storage shelves

and very few items, if any, left on staging racks ready to be assembled,” said Adams. “Having completely full sterile storage shelves is an OR director’s dream. However, if your CS staff members are rushing to get sets completed just for the sake of items being up sterile, are they really being processed at high quality?

“So what if you have every set you own sterile on the shelf ready to go if 25 percent of those sets are inaccurate or even still dirty? I would rather have 75 percent of the inventory sterile and ready to go and to give assurance that every sterile set is perfect. Always keep in mind - what if you were that patient on the table? Would you want a 100 percent chance of high quality or only 75 percent? The choice is ours.”

Communication and collaboration Greater communication and collaboration be-tween the CS/SPD and other departments, spe-cifically the OR, infection control, quality control and hospital leadership, was cited as a way to safeguard against processing-related infections.

“We are all aware that the media and pa-tients themselves have become increasingly concerned about how safe it is for themselves or their family members to go into healthcare facili-ties even for routine care,” said Frieze. “Many of us know people we care about who have gone into hospitals healthy and required readmission because of an infection they picked up during their stay — or even died. Yes, HAIs are caused by multiple drug-resistant microorganisms for the most part. However, there is much that can be done in cooperation with quality control and infection control practitioners to ensure that IFUs, hospital policies and procedures and best practices are followed, implemented and reviewed.”

Adams believes CS/SPD professionals should be willing to speak up about their departments’ shortcomings, admit where they are lacking and explain what they need to improve processes.

“There is not one CS department in existence that is perfect in any way. We all have something to learn and benefit by, just some of us need more than others. Speak up and ask for help, you may be surprised what you get in return. Just make sure you have strong, accurate supporting data to go along with your request. Not too many deci-sions are made in healthcare these days without strong supporting data and documentation.”

“I believe that the infection interventionist of the facility should work with the processing staff and do some routine assessments to make sure that the policies are being followed, the instruc-tions for use are being followed and that the staff have adequate time to reprocess in the correct way,” said Seavey. “These assessments should be documented and kept on file. Remember what gets monitored gets the attention and that helps for things to adequately get accomplished.” HPnReference

1. CDC/FDA Health Update: Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reus-able Medical Devices http://emergency.cdc.gov/han/han00383.asp.

Rose Seavey

Marcia Frieze



1603-CaseMedical.indd 25 2/11/2016 8:13:45 AM


SELF-STUDY SERIES Sponsored by

March 2016The self-study lesson on this central service topic was developed by STERIS. The lessons are administered by KSR Publishing Inc.

Earn CEUsThe series can assist readers in maintaining their CS certifi cation. After careful study of the lesson, complete the examination at the end of this sec-tion. Mail the complete examination and scoring fee to Healthcare Purchasing News for grading. We will notify you if you have a passing score of 70 percent or higher, and you will receive a certifi cate of completion within 30 days. Previous lessons are available on the Internet at www.hpnonline.com.

Certifi cationThe CBSPD (Certification Board for Sterile

Processing and Distribution) has pre-approved this in-service for one (1) contact hour for a period of fi ve (5) years from the date of original publication. Successful

completion of the lesson and post test must be documented by facility management and those records maintained by the individual until re-certifi cation is required. DO NOT SEND LESSON OR TEST TO CBSPD. For additional information regarding certifi cation contact CBSPD - 148 Main Street, Suite C-1, Lebanon, NJ 08833 • www.sterileprocessing.org.

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has pre-approved this in-service for 1.0 Continu-ing Education Credits for a period of three years, until March 31, 2019. The approval number for this lesson is HPN 160302.

For more information, direct any questions to Healthcare Purchasing News (941) 927-9345, ext. 202.

LEARNING OBJECTIVES1. Discuss the most current updates

to standards and guidelines for reprocessing duodenoscopes and other complex fl exible endoscopes.

2. Explain the stages, functions and quality control measures of liquid chemical sterilant processing.

3. Apply the key elements of a thorough quality control program, including process, product and people.

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This era of heightened infection risk has become a major challenge to healthcare providers, and no one is taking it lightly.

In the United States and around the world, concern is regularly expressed about the dan-gers of antibiotic-resistant, life-threatening healthcare-associated infections, and the need to reduce or eliminate them wherever possible. U.S. and international agencies meet regularly to discuss and gain consensus around the priori-ties for healthcare providers. By the time written reports, standards and guidelines are published, they refl ect the concern, research and input of many key healthcare stakeholders.

Sounding the alarm for fl exible endoscope reprocessing

In May 2015, the Center for Devices and Ra-diological Health of the U.S. Food and Drug Ad-ministration (FDA) hosted a Gastroenterology/Urology Devices Panel to discuss issues around duodenoscope and other complex endoscope reprocessing, which they felt did not provide a “reasonable assurance of safety.” Their report itemized areas for consideration by standards organizations, manufacturers and healthcare providers, including: making device design improvements that would assure effective reprocessing; paying more attention to main-tenance schedules to avoid functional damage to scopes, which poses a risk for patients; focusing on the importance of proper cleaning steps, staff training, equipment, and process monitoring; shifting duodenoscopes into the “critical” device category and moving scope reprocessing towards sterilization rather than disinfection; and making testing more robust by moving towards standardized microbiological sampling of processes and devices (although they acknowledged that faster methods must be developed to make this more practical).

On September 11, 2015, the Centers for Dis-ease Control and Prevention (CDC) issued a health advisory titled: “Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting and Sterilizing Reusable Medical Devices.” The advisory called for an expert assessment of each facility’s reprocess-ing procedures, to assure that all elements are included and that reprocessing is being done correctly and in accordance with written proce-dures and each medical device manufacturer’s

Standards, sterilization and quality controlRaising the standard of care for fl exible endoscopesby Jason Bean, BS, MBA

instructions for use (IFU). The alert also made recommendations concerning improving the documentation and delivery of training, making sure all manufacturers’ instructions for use are available, the regular auditing of procedures for compliance, allowing suffi cient time to perform all steps of a process, consulting reprocessing professionals for input before purchasing new equipment or devices, and following all IFU for equipment and device maintenance and repair.

In November 2015, the ECRI Institute (www.ecri.org) issued a report on The Top Ten Health Technology Hazards for 2016. Item number one on their list: “Inadequate Cleaning of Flexible Endo-scopes before Disinfection Can Spread Deadly Pathogens.” Although this is not news in the healthcare community, it refl ects a new level of urgency, importance and scrutiny. It also urges facilities to review what they have been doing up to this point and update any procedures that have not caught up with the latest best practices.

Applicable regulations, standards and guidelinesThere is a mountain of information available to healthcare providers to guide them in creating and updating their own endoscope reprocess-ing policies and procedures. The challenge is to prioritize the information so that it can help providers write compliant programs that follow the most current best practices. For endoscope reprocessing, the three authoritative levels of documentation are depicted in Table 1, top of next page.

The most currently relevant U.S. standards for processing reusable medical devices are: ANSI/AAMI ST79 and its four amendments (A1-A4, 2010 - 2013), which address the specifi cs of steam sterilization; ANSI/AAMI ST58, third edition, 2013, which addresses chemical sterilization and high-level disinfection; ANSI/AAMI ST41, fourth edition, 2010, which provides details on ethylene oxide (EO) sterilization; Society of Gas-troenterology Nurses and Associates (SGNA): Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes (2012); and ANSI/AAMI ST91, “The Comprehensive Guide to Flexible and Semi-rigid Endoscope Reprocessing in Health Care Facilities.” This last standard provides the most recent best practices for reprocessing thermosensitive fl exible endo-scopes in a manner that is safest for both person-

1603-CE-Steris.indd 26 2/8/2016 2:16:56 PM


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nel and patients. Although the standards differ in some respects, and some cover additional topics, all of them discuss work area design, personnel considerations, proper cleaning and preparation of devices, selecting the appropriate process and/or chemistries, using the process safely, device storage and/or transport, and quality control and improvement.

In addition to these, there are numerous guidelines available from professional and gov-ernmental agencies that provide detailed process and procedure recommendations to healthcare providers. The following documents are among the most relevant and useful at this time: CDC Guideline for Decontamination and Sterilization in Healthcare Facilities, (2008); ASGE/SHEA/SGNA/APIC: Multi-society guidelines on re-processing flexible gastrointestinal endoscopes (2011); SGNA Guidelines for Use of High Level Disinfectants and Sterilants for Reprocessing Flexible Gastrointestinal Endoscopes (2013); AORN Recommended Practices for Cleaning and Processing Flexible Endoscopes and En-doscope Accessories (2014); and AAMI TIR34: Water for the Reprocessing of Medical Devices (2014).

Moving the standard toward sterilizationCurrently, flexible endoscopes are reprocessed in a number of ways designed to achieve either

high-level disinfection or sterilization. A high-level disinfectant (HLD) is a product that, when used as directed, should inactivate all microbial pathogens, except large numbers of bacterial endospores. An HLD is often a liquid chemical sterilant that is being used for a shorter exposure time than is required to pass an FDA-defined spore inactivation test.

High-level disinfection requires controlled and correct use of the HLD, including proper rinsing. In fact, any liquid-based disinfection or sterilization process requires controlled, timed rinses with purified water to assure that scopes are not re-contaminated with microorganisms or chemicals commonly found in potable rinse wa-ter. AAMI TIR 34 provides valuable information on the biological and chemical contamination risks associated with potable water, and ways to assure the quality of rinse water for liquid disinfection and sterilization processes.

Sterilization is a validated process used to render an item free from viable microorganisms, including bacterial spores. The liquid chemical sterilant process uses a peracetic acid-based product that is validated to provide a micro-bial kill adequate to obtain FDA clearance for a device sterilization label claim. This means that the product has passed the required spore inactivation testing, and has demonstrated effec-tive liquid chemical sterilization of the intended types of medical devices in simulated use and in-use studies.

In order to align with the CDC Gastroenterol-ogy/Urology Devices Panel recommendation (that the healthcare community move toward sterilization as the standard of care for duo-denoscopes and other thermosensitive flexible endoscopes), facilities will need to evaluate the available low-temperature sterilization options and determine which are compatible with their particular devices. Each option has helpful and challenging aspects for reprocessing depart-ments. They are explained in Table 2, right.

Typically, a department needs more than one of these technologies in order to sterilize all the endoscopes they currently own. As new devices are evaluated for purchase, consideration should be given to how the new device will be steril-ized, so that where it makes sense or improves compliance, the department can work toward streamlining the inventory and the number of different sterilization systems being used.

essentials of liquid chemical sterilant processingEthylene oxide sterilizers have been in use for many decades, and hydrogen peroxide systems have been covered in recent literature, so this module will focus on the most recently cleared technology: the liquid chemical steril-ant processing system. The components of the cleared system include; the processor with interchangeable trays to accommodate differ-ent device types, a three-part water treatment

system, single-use sterilant cups for each cycle, and connectors designed for different types of critical and semi-critical endoscopes, including flexible multi-channel devices and endoscopic retrograde cholangiopancreatography (ERCP) scopes (see figure 1 on next page). Liquid chemi-cal sterilization with peracetic acid has a long history. In a 1998 study by MJ Alfa et al., titled, “Comparison of liquid chemical sterilization with peracetic acid and ethylene oxide steril-ization for long, narrow lumens,” the peracetic acid process was shown to be “more effective for sterilizing narrow flexible lumens in the presence of residual inorganic and organic soil. This effectiveness was achieved through a combination of organism wash-off and peracetic acid sterilant killing of organisms.”

Page 28TAbLe 2: TypeS of Low-TeMp STeriLizATion

ethylene oxide gas sterilizers

benefitsCompatible with some specific scope materials

challengesWill not condition without specific humidity and temperature levels

Hours-long cycle best suited for terminal sterilization

Aeration required

Endoscopes may require repair after 15-20 cycles

“Not routinely recommended” by FDA (Dr. William Maisel, FDA deputy director, chief scientist)

Hydrogen peroxide gas and plasma

benefitsCompatible with a large number of materials

Typical sterilization cycle is approx. 30 minutes

Processes some critical endoscopes

Some systems have claims for single and multiple-lumened devices, and for bronchoscopes

challengesNo existing system has a cleared claim to process flexible gastrointestinal scopes

Sterilization claims are for specific critical flexible endoscopes and specific lumen lengths and diameters – must consult manufacturer IFU for each device

Liquid chemical sterilization

benefitsOne system is cleared in the U.S. as a liquid chemical sterilant processing system (uses peracetic acid-based sterilant)

23-minute cycle time

Employs multi-stage water treatment system for extensively treated water for rinsing

challengesProcessed items cannot be stored – they must be used immediately

There is no drying cycle

Requires water supply

TAbLe 1: AuTHoriTATive LeveLS of docuMenTATion

reGuLATionS - Mandatory

Rules or directives made and maintained by an au-thority, such as the Occupational Safety and Health Administration (OSHA) or the Centers for Medicare & Medicaid Services (CMS)

Mandatory for the affected parties -- must be compli-ant in related policies and procedures

STAndArdS - voluntary/Mandatory

Provide requirements and specifications that can be used to assure consistency and fitness for a purpose

Maintained by national and international guidance bodies such as: International Organization for Standardization (ISO); Association for the Advance-ment of Medical Instrumentation (AAMI); American National Standards Institute (ANSI)

Although they are not typically mandatory, they can become so through an act of legislation, or if you claim compliance to them in your policies and procedures

GuideLineS, recoMMended prAcTiceS, TecHnicAL inforMATion reporTS - voluntary, with interpretation

Technical guidance, information or preferred proce-dures for a given practice or process

Examples: Association of periOperative Registered Nurses (AORN) recommended practices, or AAMI technical information reports (TIRs)

1603-CE-Steris.indd 27 2/8/2016 2:16:56 PM


sELf-sTudy sERiEs Sponsored by

This system was designed to align with nu-merous recommendations from current guid-ance. For example, it enables the user to treat duodenoscopes as critical devices regardless of their classification by applying a validated liquid chemical sterilant process to these de-vices and a growing number of other flex-ible endoscope models. In addition, guidance about rinse water quality has been addressed with a three-step treatment process involving pre-filtration, UV irradiation, and a second dual-layer 0.1-micron filtration to remove bacteria, fungi and protozoa. Also, to provide robust quality control for flexible endoscope reprocessing, numerous automated monitoring and documentation functions are built into the system to assure process integrity, and testing strips and biological tests have been designed for use in system cycles.

The key stages/functions in the liquid chemi-cal sterilant process, and their purposes, are:1. Device preparation: includes leak testing,

cleaning, and rinsing per the medical device manufacturer’s IFU. This removes all visible soils from device surfaces and facilitates the liquid sterilant process. Note: Drying is not required, which significantly reduces prep time.

2. Device placement: involves selecting the cor-rect support tray and appropriate connector, loading the device and tray into the processor, loading the sterilant cup, and placing a chemi-cal indicator in the chamber. This prepares all internal and external surfaces of the scope, including contact parts, for exposure to the flow of sterilant, and provides an independent quality control measure for the process.

3. Connections: involves aligning and locking the connector at all appropriate junctures of the specific scope, per the liquid chemical process manufacturer’s IFU. This prepares the scope for proper, complete sterilant flow during the cycle.

4. Sterilization: involves shutting and locking the lid and pressing the cycle activation but-ton. This initiates the 23-minute automated sterilant processing cycle, which includes:a. Filling and equilibration of the sealed

chamber

b. Six-minute exposure to the sterilant at 46- 55° C at a controlled flow and temperaturec. Two rinses with exten-sively treat water (via a three-step automated treatment process dur-ing the cycle)d. A filtered air purge, which removes most of the remaining liquid in the channels5. Quality control: nu-merous control functions and tools, including: au-

tomated time, temperature and concentration monitoring during the cycle; water treatment monitoring (a filter integrity test at the end of every cycle, and monitoring of the ultraviolet light dose); chemical indicators to assure the correct concentration of the sterilant; and spore test strips to demonstrate that the antimicrobial process has been applied. The system can also perform a diagnostic cycle as needed, to verify proper functions of the electromechanical systems.

6. Transport for patient use: Processed scopes are ready for immediate use after processing. Devices are transported in their trays to the site of use.As new endoscopes are developed, many are

undergoing individual laboratory and clinical testing in this liquid chemical sterilant process-ing system. Validation of each scope includes meeting specific regulatory requirements, demonstrating antimicrobial efficacy, confirm-ing connection and material compatibility, and verifying biocompatibility (lack of toxicity).

Improving quality controlA repeated call to action in recent guidance has been to improve the overall quality of every facility’s reprocessing functions. As stated in ANSI/AAMI ST91: 2015, “Quality control is usually thought of only as product and process monitoring. In its broadest sense, however, quality control involves continuous supervision of personnel performance and work practices, and ongoing verification of adherence to estab-lished policies and procedures...” The key to a robust and effective quality control plan is to monitor and verify process, product and people. The ANSI/AAMI ST 91 standard is a rich and detailed resource that healthcare professionals can use to establish thorough quality control policies, procedures and practices for flexible endoscope reprocessing.

In general, a thorough quality control plan should contain the following activities:• Create a written policy to stay current on all

applicable standards and guidelines. Watch for updates and areas of statement conflict to address

• Perform regular risk analyses. Ask these ques-tions:- Where are the risks in our facility?- What has been done to date to address

them?- Are there areas requiring continuous im-

provement?• Review the facility’s reprocessing policy,

including:- At the facility level: patient, personnel and

process safety, work area design, and es-sential requirements of the work

- At the individual department level: detailed work instructions on how to use all tools and equipment, and specific safety procedures

• Develop an effective staff training program that teaches all necessary skills and requires individuals to demonstrate their competence- Provide training for new staff and refreshers

for current personnel - Audit personnel practices periodically- Update practices and add training as new

equipment and devices enter the facility

Protect patients one scope at a timeProviders and patients continue to appreciate the value of minimally invasive therapies made possible by flexible endoscopes. New devices continue to enter the healthcare market at such a pace that it challenges providers to keep up. It’s time to slow down and rethink how these complex instruments are being managed and reprocessed in U.S. healthcare facilities, for the safety and benefit of everyone involved. Each device deserves the staff’s full attention and thorough understanding, and with improved policies, procedures and practices, this can be achieved. HPnReferences

1. Top 10 Health Technology Hazards for 2016: A Report from Health Devices, November 2015. www.ecri.org/2016hazards.

2. Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting and Sterilizing Reusable Medical Devices. http://emergency.cdc.gov/han/han00382.asp.

3. http://www.fda.gov/downloads/Advisory Committees/Commit-teesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCom-mittee/Gatroenterology-UrologyDevicesPanel/UCM446924.pdf.

4. MJ Alfa et al, Comparison of liquid chemical sterilization with per-acetic acid and ethylene oxide sterilization for long, narrow lumens. American J. of Inf. Cont., 1998 October;26(5): 469-77.

5. ANSI/AAMI ST91:2015, “The Comprehensive Guide to Flexible and Semi-Rigid Endoscope Reprocessing in Health Care Facilities,” pp. 35-39.

Jason D. Bean, BS, MBA, is the senior global product manager for endoscopy at STERIS Corporation. He began his career at STERIS as a microbiologist in the device testing group, where he spent more than five years conducting testing for FDA submissions. He then transitioned to a marketing career with an emphasis on low temperature sterilization modalities. Bean holds a BS in Biology with an emphasis on microbiology, from Lake Erie College in Painesville, Ohio, and a master of business administration also from Lake Erie College. He is a professional member of AORN and SGNA.

Figure 1

1603-CE-Steris.indd 28 2/8/2016 2:16:57 PM


Continuing eduCation test • MarCh 2016

Sponsored by sELf-sTudy sERiEs

Standards, sterilization and quality control

1. Three high-profile regulatory and guidance organizations issued warnings and concerns about flexible endoscope reprocessing that were discussed in this module. They were:a. FDA, OSHA, CDCb. AORN, CDC, AAMIc. CDC, FDA, ECRId. None of the above

2. Among the relevant standards related to reprocessing flexible endo-scopes, the most recent and specific document is:a. ANSI/AAMI ST79 b. ANSI/AAMI ST58c. ANSI/AAMI ST41d. ANSI/AAMI ST91

3. Guidelines, technical information reports and recommended practices are mandatory requirements.a. Trueb. False

4. The liquid chemical sterilant process uses a peracetic acid-based product that is validated to provide a microbial kill adequate to obtain FDA clear-ance for a medical device sterilization label claim. This means that:a. The product is a sterilantb. The product has demonstrated its effectiveness for liquid chemical steriliza-

tion in simulated use and in use with clinically used medical devices .c. a and bd. None of the above

5. The liquid chemical sterilant processing system was designed to align with numerous recommendations from current guidance, including:a. Improving rinse water qualityb. Improving quality controlc. Moving towards sterilization of flexible endoscopesd. None of the abovee. a, b and c

6. Validation of new endoscopes that undergo laboratory and clinical testing in the liquid chemical sterilant processing system includes:a. demonstrating antimicrobial efficacy and verifying biocompatibilityb. confirming connection and material compatibilityc. meeting specific regulatory requirementsd. All of the abovee. b and c

7. The key stages or functions in the liquid chemical sterilant process are:a. Leak testing, drying, loading the sterilant cup, closing the lid, starting the

cycleb. Testing the water, testing the chemistry, testing the filters, testing the

electromechanicsc. Device preparation, device placement, connection, sterilization, quality

control, transportd. None of the above

8. The 26-minute automated liquid sterilant processing cycle includes:a. Filling and equilibrationb. Six-minute exposure to the sterilant at 46-55° C at a controlled flow and

temperaturec. Two rinses with extensively treated water and a filtered air purged. A drying phasee. a, b, and c

9. Quality control involves continuous supervision of personnel performance and work practices, and ongoing verification of adherence to established policies and procedures.a. Trueb. False

10. The key to a robust and effective quality control plan is to monitor and verify process, product and people.a. Trueb. False

Circle the one correct answer:

request for scoringo I have enclosed the scoring fee of $10 for EACH test taken. (Payable to KSR Publishing Inc. We

regret that no refunds can be given. Multiple submissions may be submitted in bulk and paid with a single check for the bulk sum.)

Detach exam and return to:Continuing Education DivisionKSR Publishing Inc.2477 Stickney Point Road, Suite 315BSarasota, FL 34231PH: 941-927-9345 Fax: 941-927-9588

Please print or type. return this page only.

Name

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The approval number for this lesson is hPn 160302.

Presented by

1603-CE-Steris.indd 29 2/8/2016 2:16:58 PM


CS QUESTIONS • CS ANSWERSKeeping sterile sets dry; the 25-pound trayby Ray Taurasi

Q I work in an ambulatory surgical cen-ter and am responsible for operating

room (OR) staff education as well as quality assurance for the surgical processing and sterilization area. We have had recurring issues with some wetness in our sterilized instruments sets. My nurse manager has asked that I develop some brief educational sessions on some key causes and measures that can help minimize moisture in our sterile sets. This is not my forte. Could you please provide some advice and/or key points that you think I should include in my presentation? Also, I would like to put together a checklist that I could post to remind staff of the proper steps they need to take to avoid moisture.

A I suggest the following actions could help prevent the occur-rence of wetness in sterilized instruments sets and packages:

• Precondition the load by placing instruments inside the warm steam sterilizer with the door closed for 10 to 15 minutes before starting the cycle.

• Line instrument tray or basket with a cellulose tray liner.• Place a cellulose wicking material between the bottom of instru-

ment basket and packaging material or containment device.• Minimize density and metal mass divide sets containing exces-

sively heavy or dense instruments into two parts.• Do not use plastic paper peel pouches inside of wrapped or

containerized sets.• Do not overload sterilizer. • Minimize the use of plastic or non-absorbent packaging materials

or aids.• Properly position instruments in sets in a manner that will prevent

holding of moisture.• Be certain to clean the sterilizer chamber drain thoroughly, keep-

ing it free of lint and other debris.• Strive to keep the instrument set weight at no more than 25

pounds — heavy sets are diffi cult to dry without increasing dry time.

• Maintain a record of all wet loads or instruments sets: - Note load contents.- Identify wet sets and packages.- Note day and time of cycle.- Confi rm proper cycle parameters were achieved.- What were the results of sterilizer monitors, CI, BI, BD etc.? (This

information may be useful in identifying patterns in failure and corrective actions required.)

- Always follow the instructions for use (IFUs) of the medical device, sterilizer, containment and packaging manufacturers.

Q I understand that the instruments in a tray should not weigh more than a total

of 25 pounds. This, however, is not always something that can be realistically achieved. We even have some single instruments that in and of themselves weigh close to or more than 25 pounds. I have been an OR nurse for many years and sets heavier than 25 pounds have been used with no problems. I have monitored some of our heavier sets and instruments with multiple BIs, CIs and even culturing. Every test we have conducted has passed and we are confi dent that our sterilization process has been effective. So I see no problem with what we are doing. There is more to sterilization than a weight number. There is no way that every set can be no more than 25 pounds. Would you agree? What are we supposed to do?

A Both the Association of periOperative Registered Nurses (AORN) and the Association for the Advancement of Medi-

cal Instrumentation (AAMI) recommend that instrument sets and trays prepared for sterilization not exceed 25 pounds. This weight limit includes the combined weight of the instruments, tray, basket, containment device and packaging materials. You are correct in saying that there is a lot more to successful sterilization than just the weight of an instrument set but this recommended weight limit of 25 pounds is also about more than effective sterilization. There are employee safety issues associated with the 25-pound weight limit to consider as well. Excessive weight increases the risk of ergonomic injury to personnel lifting and handling these sets. Also, excessive instrument weights and metal mass are prone to moisture reten-tion and are a contributing factor to wetness in sterilized packages. Internal moisture can wick through package providing a conduit for contaminant penetration. There will obviously be times when it will be necessary to process and sterilize heavier instruments and sets. In these instances, measures should be taken to effectively manage this process for sterility assurance and worker safety. HPN

Ray Taurasi is Eastern Regional Director of Clinical Sales and Services for Healthmark Industries. His healthcare career spans over three decades as an Administrator, Educator, Technologist and Consultant. He is a member of AORN, AHA, SGNA, AAMI and a past president of IAHCSMM. Taurasi has been a faculty member of numerous colleges teaching in the divisions of business administration and health sciences.

SUBMIT YOUR QUESTIONSemail: [email protected]: (941) 927-9345 ext. 202

1603-CSssolutions2.indd 30 2/12/2016 10:06:50 AM

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1603-Healthmark.indd 31 2/9/2016 3:12:57 PM


IAHCSMM VIEWPOINTWhat TJC, CMS surveyors are focusing on in CSby Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT

Healthcare accreditation surveys, such as those conducted by The Joint Commission (TJC) or the

Centers for Medicare and Medicaid Services (CMS), are surveyor dependent. This means individual surveyors have their own way of conducting and focusing their onsite visits — and that often depends on each surveyor’s specifi c experience and expertise. Still, a major focal point of today’s surveys will likely be the reprocessing of reusable medical devices.

Today, surveyors look for risk reduction and process improvements relating to ster-ilization and high-level disinfection (HLD). Last September, hospitals, ambulatory surgery centers, clinics and doctors’ offi ces received a Health Alert from the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administra-tion (FDA).1

The two agencies strongly stated that; “Healthcare facilities should arrange for a healthcare professional with expertise in device reprocessing to immediately assess their reprocessing procedures. This assess-ment should ensure that reprocessing is done correctly, including allowing enough time for reprocessing personnel to follow all steps recommended by the device manufacturer.”

The CDC/FDA alert was a response to recent reports of patients at increased risk for infection due to lapses in basic cleaning, disinfection and sterilization of medical devices.1

Key areas on surveyors’ radarSurveyors will likely review how the facil-ity provides training to all who reprocess medical devices. This training should occur upon hire and at least once a year thereafter, and any time new devices or protocols are introduced. Surveyors will want to see the current documented competencies for all staff who perform any part of reprocessing (including immediate-use steam sterilization and HLD, anywhere it is performed in the organiza-tion). They often will ask if staff are certifi ed, as recommended in national guidelines and standards.2,3 Surveyors may also ask how

involved staff are with their professional associations.4

Surveyors want to ensure that facilities are using current evidence-based guidelines (EBG) and that staff orientation, training and competency are conducted by personnel who are considered a subject matter expert (SME).4 That trainer should have current education on EBG, be certifi ed, have expe-rience in all steps of reprocessing, and be involved in their professional organization. The SME should also collaborate with the Infection Prevention and Control (IPC) pro-fessional regarding policies and procedures, and ensure a traceable path to the patient and product identifi cation in the event of a recall.

Regulatory agencies and surveyors want to ensure facilities are following the manu-facturers’ instructions for use (IFU) for each type of reusable device, piece of equipment and/or chemical disinfectants used. They will want to see those IFUs readily avail-able to staff and inspectors.1 Organizations have been cited for lack of quality control, not following IFU and, therefore, not using validated conditions (e.g., concentration, exposure times, temperatures, etc.).

Departmental design is also assessed by surveyors. Over half the facilities surveyed by TJC have been cited for noncompliance related to the departmental design and the environment. Often, an engineer will be part of the survey team. Surveyors will possibly ask if staff know the required temperature and humidity parameters, how that informa-tion gets logged each day (paper or automa-tion) and what is the mandatory feedback if it goes out of compliance. They may inquire about risks relating to the utility systems, such as correct airfl ow. Staff should know if the airfl ow is positive or negative in each area and what they can do to maintain the appropriate pressure.

Managing risks related to hazardous materials is another area of concern. Eye-wash stations must be in the immediate area anywhere chemicals are used — and located within a 15-second travel time for staff. These stations should be plumbed and able to irrigate both eyes hands free for at least 15 minutes. The water should be tepid and the eyewash should have weekly inspections that are documented.

Surveyors may also review whether the facility allows adequate time for reprocess-ing to ensure adherence to all steps recom-mended by the device manufacturers’ IFU. The facility should consider scheduling of procedures and supply of devices to ensure adequate time is allotted for reprocessing. In the event of a recognized reprocessing error or failure, the organization should have policies and procedures outlining the necessary response.

Reprocessing activities, including main-tenance records for reprocessing equip-ment and records verifying high-level disinfectants were tested and replaced ap-propriately, should be documented and maintained according to the facility’s record retention policy.

Because each site visit will differ in terms of surveyor focus, the best way to ensure a good survey is to know and consistently fol-low the TJC or CMS accreditation standards. It’s also important to ensure staff are trained and educated according to current evidence based process guidelines, and work closely with the IPC professional and facilities staff/engineers to ensure the environment operates within standards. If these sugges-tions are followed, CS departments should pass a survey with fl ying colors. HPN

References

1. Centers for Disease Control and Prevention. Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfection, and Sterilizing Reusable Medical Devices. CDC Health Alert Network. Sept. 11, 2015.

2. Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section 4.

3. Association of periOperative Registered Nurses. 2015. AORN Guidelines and Tools for Sterile Processing.

4. Eiland JE. The Joint Commission presentation. 2014 IAHCSMM Annual Conference.

“Surveyors want to ensure that facilities are using current evidence-

based guidelines (EBG) and that staff orientation, training and competency are conducted by personnel who are considered a subject matter expert.”

1603-Viewpoint.indd 32 2/10/2016 11:49:21 AM

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1603-Midmark.indd 33 2/9/2016 3:11:35 PM


2016 SURGICAL INSTRUMENTS GUIDE

It’s probably safe to say that every facil-ity wants their surgeons to have the latest surgical tools and technologies

available — and so would every patient. To fi nd out what is new in the surgical instrument category, Healthcare Purchasing News invited a wide diversity of surgical instrument suppliers and industry experts to weigh in on what they think the current trends are and what we might expect going forward. Those who responded include: • Robert Edelstein, President, Millennium

Surgical Corp.• Paul Davison, Vice President, Research

and Development, Invuity• Dr. Hasan Alshemari, MD, President,

Alshemari Instruments• Barry Norlander, Global Marketing Man-

ager, Lead Management Division, Cook Medical

• Matt Smith, Marketing Manager, Health-mark Industries

• Keith Griffi s, Executive Director of Mar-keting, Surgical Endoscopy & Systems Integration, Olympus America Inc.

• Piet Hinoul, Franchise Medical Leader, Ethicon

• Melissa Graves, Associate Product Man-ager, Microline Surgical

HPN: In which surgical discipline would you say instrument innovation is progressing most rapidly right now?Edelstein: Laparoscopic instruments have been the focus of the most recent progres-sive advancements in the industry. New instrument patterns are resulting in smaller diameter instruments to facilitate smaller incisions and reduce patient trauma. Lap instruments are increasingly easier to clean and inspect. So many facilities are now turning to reusable instruments as a more cost-effective replacement for single-use.

Davison: Where we see the most opportu-nity is breast oncology and reconstruction.

The race to keep pace with technology in today’s ORSurgical instrument innovation demands all players have the right information.by Valerie J. Dimond

Each year, approximately 232,000 women in the U.S. will be diagnosed with breast cancer that requires surgery. Yet many are unaware that surgical scars can be a thing of the past, and there are now options that optimize clinical and cosmetic results. Pa-tient demand for less invasive procedures — including nipple sparing mastectomy and lumpectomy — will drive the need for technologies, like Invuity’s, that improve surgical safety, effi ciency and precision.

Alshemari : The powered surgical in-struments market witnessed considerable growth, primarily due to the rising volume of surgical procedures performed, the growth in the aging population, and high prevalence of chronic disorders across the globe. Innovative technological advance-ments in powered instruments are propel-ling market growth in surgical devices. The common theme as technology improves is that each surgical instrument is becoming lighter, more ergonomic and precise. These smart tools even have increased speed, ac-curacy and torque now, which let surgeons complete larger procedures with much less strain and discomfort. The “smart” trend is much more ergonomically friendly to the surgeon.

Griffi s: Advanced laparoscopy is advanc-ing most rapidly. With the advent of 3D, 4K, infra red, and other enhancement to technologies to improved diagnostic yield and treatment, it can be hard to keep up. Specifi c procedures include colorectal, bar-iatric, and thoracic where they are operating around sensitive anatomy and dealing with complex procedures and anatomy.

In what ways are surgical instruments becoming “smarter” and more intuitive? Davison: Lighting is a critical element of every open surgical procedure, and an area where surgical instruments are becoming more intuitive. Surgeons need to be able to see what they’re doing, which becomes

Invuity’s Eikon LT Illuminated Retrac-tor System: This system integrates Invuity’s Intelligent Photonics technol-ogy to improve visu-alization within deep, dark surgical cavities and increasingly small incisions. Surgeons use the system to

perform Hidden Scar Breast Cancer Surgery, an advanced approach to nipple sparing mastec-tomy or lumpectomy that reduces and hides visible scarring. Hospitals using the devices have saved between $580 and $2,000 and reduced anesthesia time by 31 minutes in bilateral nipple sparing mastectomy cases. Overall complication rates decreased, including a statistically signifi cant 70 percent reduction of epidermolysis (blistering or peeling of the skin or nipple-partial thickness).

Alshemari Instruments’ Vertical Needle Driver: The novel vertical needle holder allows the surgeon to apply sutures vertically, without hand twisting, in narrowed areas that would be diffi cult to reach with traditional needle drivers. The technique adds more accuracy and precision in suturing tissues in diffi cult conditions like long reaching areas or narrow spaces. The needle au-tomatically moves into an ideal position between two target points in a straight vertical rather than elliptical motion as in conventional needle drivers and can be applied in open, laparoscopic and microscopic surgeries.

Cook Medical’s Evolution RL controlled rotation dila-tor sheath set: This device comes in three sizes (9Fr, 11Fr and 13Fr) to aid in cardiac lead extraction procedures and provide clinicians with direct control capabilities that have not been previously available in extraction sheaths. It does not rely on tissue vaporization and the decagonal distal tip design and intricate braided inner sheath can help physi-cians in procedures where either minimally and/or highly calcifi ed binding lesions may be present.

1603-OR-SIGprod.indd 34 2/11/2016 2:41:59 PM

YOUR

IN SURGICAL EQUIPMENT

REPAIREQUIPMENT

REPAIREQUIPMENT

YOUR


REPAIR

YOUR


YOURYOURYOURYOUR

IN SURGICAL IN SURGICAL IN SURGICAL IN SURGICAL EQUIPMENT EQUIPMENT EQUIPMENT EQUIPMENT

TRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNERTRUSTED PARTNER


1603-MobileInstrument.indd 35 2/9/2016 3:10:42 PM


2016 SURGICAL INSTRUMENTS GUIDEmore diffi cult when operating within deep, dark cavities and ever-smaller incisions. Rather than having to follow the light, the light should come from inside the surgical cavity and stay in one place — that’s where Invuity comes in. Surgeons have told us that, before using our devices, they were operating with limited visibility. They’ve described the “before” as driving on a coun-try road with low beams, and the “after,” with Invuity products, as driving with their high beams on. They can see every ditch, crack or object on the road.

Hinoul: Procedural evolutions, and our surgeons’ preferred techniques, continue to shape and infl uence the innovation we bring to market. As with all our new prod-uct introductions, we always begin from a place of deep surgeon understanding and insight. Some of the ways in which we do this is through hands-on lab training, early prototype sharing, and ethnographic research. Our careful listening to users and reiterative testing of prototypes has resulted in meaningful innovation and advanced surgical instruments. Consider, for example, our innovations in bariatric and thoracic procedures, all of which are designed to provide solutions for surgeons’ clinical concerns.

It has been said that skill is not keeping up with some of today’s emerging technol-ogy — that there is a shortage of surgeons skilled enough to perform surgeries that require the latest hi-tech instruments. Do you agree?Davison: The next generation of surgeons are being trained on minimally invasive approaches and the latest technology from the get-go, but there can be a learning curve for surgeons trained in traditional open techniques. For example, even after cadaveric training, most surgeons need to perform 40 to 100 cases of anterior total hip arthroplasty (THA) to become comfortable with the procedure and to reduce their rate of complications down to the standard levels of experienced surgeons.

Surgeon skill and willingness to remain current on emerging technologies is critical — but it’s also up to companies to introduce technologies that are smarter and more intuitive to use. Emerging technologies should be easy to implement in the hospital OR setting, and require little to no modifi ca-tion of surgical technique. And, we believe there should be comprehensive training for surgeons who would like to enhance their experience with new technologies and new surgical approaches. In breast oncology and reconstruction surgery, for instance,

we introduced a training initiative and of-fer courses to help surgeons get hands-on experience with advanced approaches that reduce visible scars. Longer-term, we are also targeting courses in specialties like thyroid and gynecology.

Griffis : Compliance and government regulation has surely limited industries’ ability to educate surgeons post residency. This does pose a challenge for new tech-nologies. At this point, I don’t think we have suffered from this, but it does point to the societies who are trying to make an effort to reeducate their membership. That is a crucial element to new technology adoption in the future.

Hinoul: Rather than focus on the number of skilled surgeons, we think it’s important to ensure that surgeons have access to ap-propriate training programs so they can serve their patients most effectively, based on the latest science. Ethicon has invested in robust training programs for surgeons and allied health professionals. We train thousands of surgeons around the world every year on our latest technologies. How-ever, it’s not just a matter of implementing new innovation, but ensuring that surgeons have the right information and the right knowledge. We want the professionals using our products to understand the full value that a new technology or a new technique can deliver such as facilitating more effi cient procedures, and providing more effective treatments. Today we have technology that allows someone who is 10,000 miles away to see a case as it’s being performed. We think there are new, power-ful capabilities that can help us continue to raise standards of care in surgery and improve outcomes globally.

In what ways do you see value-based care delivery affecting surgical technology pur-chasing decisions?Alshemari: Prolonged surgical procedures increase the probability of surgical mistakes, the risk of infections, the patient waiting list and can add more cost on the healthcare system. Demand has sparked innovation, with one improvement after another aimed at providers who want to shorten the dura-tion of procedures, improve turnover time and enhance OR effi ciency, which promotes the delivery of high-quality, cost-effective healthcare.

Davison: With the drive toward value-based care, purchasing decision-makers will be asking key questions when assess-ing new technologies: Will it improve clini-cal outcomes and patient safety? Will it help surgeons perform better? Will it save time?

Millennium Surgical Corp’s Trocar Inci-sion Closure Device: This reusable version of the popular single-use Carter Thompson device pays for itself in less than eight uses when compared to the single-use device which typically sells for $125. The most popular of the three versions is the

Thumb Ring Syringe style, which is very close in design to the Carter Thompson. Surgeons also ap-preciate the solid feel of the stainless steel version.

Olympus ENDOEYE FLEX 3D: This device overcomes a major limitation of 2D surgery and improves the ability to suture, grasp tissue, and dissect more precisely. Olympus also offers intraop-erative endoscopy which utilizes a fl exible colono-scope or gastroscope to inspect anastomosis after procedures in the OR. When joining two tubular structures (e.g., colon) and using the Olympus IOE, surgeons are able to visually inspect the inside of the lumen prior to completing the procedure.

Ethicon ECHELON FLEX Powered Vascular Sta-pler: This powered vas-cular stapler is designed to provide unparalleled precision and stability for critical vessel transec-tions. The ECHELON FLEX Powered Vascular Stapler has the narrowest anvil of any stapler on the mar-ket, an articulating shaft and advanced placement tip that may allow for bet-ter visibility, navigation and precise placement during thoracic and other procedures, including VATS lobectomy (Video-Assisted Thoracoscopic Surgery) for lung cancer.

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Microline Surgical Re-New reposable lapa-roscopic instrument system: The ReNew system is different from other laparoscopic in-struments because it combines a reusable hand piece with dispos-able or reuseable tips. Hospitals can streamline their laparoscopic trays and reduce waste com-pared to fully disposable instruments. Microline also offers an extended warranty programs to protect the hospital’s investment and ensure years of device usage.

2016 SURGICAL INSTRUMENTS GUIDEminimally invasive or minimal access. But as surgeries become more complex due to smaller incisions, surgeons may be hesitant to expand minimal access procedures into new territories, despite the benefits for patient care. There’s a real opportunity to educate hospital purchasing decision-makers about technologies like intra-cavity illumination devices that give surgeons their vision back, enabling them to more confi dently perform complex procedures that are poised to become the standard of surgical care.

Norlander: Outcome based medicine is already here. Devices that meet or exceed existing clinical outcome measures while at the same time providing cost savings (both procedural and device unit) to medical in-stitutions are being selected as the devices of choice for use by healthcare providers within these institutions.

What key considerations should be on the table when evaluating new surgical technology/devices?Edelstein: Prices vary so shop around, even if a surgeon has stated a brand preference. Most instruments can be sourced from more than just the manufacturer. If you are purchasing from a GPO, verify that the cost you are quoted is competitive. In many cases, it isn’t. And include expertise and support from your vendor in your purchasing decision.

Norlander: Patient outcomes, compara-tive costs (both unit and procedural) to other devices, ease of training and clinical assimilation for clinician and staff, cost of ordering, timeliness of deliveries and ease of inventory management, and using new technology as a local B2C marketing op-portunity.

Graves: When hospitals evaluate new surgical devices, they should consider surgeon feedback, surgical outcomes and how this new device will impact their bot-tom line. Today’s healthcare is focused on reducing costs while maintaining and improving quality. With the implementa-tion of the Affordable Care Act, hospitals are feeling the pressure to reduce costs and therefore, looking to their surgeons to help relieve OR expenses. Surgeons and hospital administration must work together to purchase quality products that will help improve patient outcomes while also reducing costs.

How informed are patients about the lat-est surgical techniques and how much do they infl uence purchasing decisions and/or physician preference?

Edelstein: Patients associate the term “min-imally invasive” with a lack of scarring and reduced healing time. Surgeons are driven to meet those expectations. The demand of smaller profi le laparoscopic instruments, instruments that are easier to clean, and advancements in the area of trocar incision closure devices has been driven by those patient expectations.

Davison: Some patients may be well-versed on all of their available surgical options, and are asking their doctors about them. Others would not even think to ask and, thus, may not be offered the less inva-sive surgical options in the fi rst place. This is a prevalent concern in the breast cancer community, specifi cally, as surgery has major implications for a patient’s physical health, appearance and quality of life after surgery. Ultimately, we believe surgeons should continuously further their educa-tion on new surgical approaches and gain additional experience with new technolo-gies in order to help their patients make informed treatment decisions.

Griffi s: Patients drive many decisions for surgical equipment. There is the obvious scenario where patients choose a surgeon and facility based on reputation. We see this regularly with faculties who market our 3D technology. The second is patient satisfaction. When a patient is informed about the tools and techniques used, they may be more likely to rate a facility higher. Some hospitals use our new technologies such as 3D to educate new patients before procedures.This behavior will increase in the new healthcare environment. HPN

References

1. “U.S. Breast Cancer Statistics.” Breastcancer.org. May 11, 2015. Web. August 19, 2015.

2. Seng BE, Berend KR, Ajluni AF, Lombardi AV Jr: Anterior-Supine Minimally Invasive Total Hip Arthroplasty: Defi ning the Learning Curve. Orthop Clin North Am. 2009; 40: 343-350.

3. Masonis J, Thompson C, Odum S. Safe and Accurate: Learn-ing the Direct Anterior Total Hip Arthoplasty. Orthopedics Today. 2008; 31 (12 suppl 2).

4. Fehring TK, Mason JB. Catastrophi Complications of Minimally Invasive Hip Surgery: A Series of Three Cases. J Bone Joint Surg Am. 2005; 87-A: 711-714.

5. LIT 11922 Healthcare Consulting Firm: NSM Economic Find-ings, July 2015

6. LIT 12023 Retrospective Chart Review of Nipple Sparing Mas-tectomies With and Without an Enabling Intracavity Illumination and Visualization System, Beth Baughman DuPree MD, FACS, et al.

7. Ibid

8. The Joint Commission’s Sentinel Event Alert, Issue 51, “Pre-venting unintended retained foreign objects” October 17, 2013.

For the expanded version visit www.hpnon-line.com/inside/2016-03/1603-OR-SIG.html. For a listing of surgical instrument and ac-cessory vendors, visit www.hpnonline.com/inside/2016-03/1603-OR-SIG-list.pdf.

Healthmark Industries’ Transportation Iden-tifi cation Tag: These tags are for transporting materials considered a biohazard, while act-ing as an essential communication tool in the process. Designed for compliance with OSHA standard CFR 1910.1030, the Transportation Identifi cation Tag has one perforated tab, that says “CLEAN,” a tab that says “DIRTY” and a removable OSHA-approved “Biohazard Label” adhesive backing. There’s also has a check list for the surgical/procedure room/sterile processing team to ensure adequate delivery of the case cart or container in question.

And, will it help reduce costs? We foresee increased adoption of technologies that en-able minimally invasive procedures, which are on the uptick due to patient demand and an aging population. Although special-ized instrumentation for some procedures may come with increased costs, purchas-ing decision-makers should consider that over time the cost curve will be driven down if the technology enables surgeons to save time, reduce complications and allow patients to return home quicker. Today, up to 40 percent of surgeries are

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New TechNology PRoduCTs & sERviCEsFDA outlines cybersecurity recommendations for medical device manufacturersThe Food and Drug Administration (FDA) issued a draft guidance outlining important steps medi-cal device manufacturers should take to continu-ally address cybersecurity risks to keep patients safe and better protect the public health.

The draft guidance details the agency’s rec-ommendations for monitoring, identifying and addressing cybersecurity vulnerabilities in medi-cal devices once they have entered the market. Cybersecurity threats to medical devices are a growing concern. The exploitation of cyberse-curity vulnerabilities presents a potential risk to the safety and effectiveness of medical devices. While manufacturers can incorporate controls in the design of a product to help prevent these risks, it is essential that manufacturers also consider improvements during maintenance of devices, as the evolving nature of cyber threats means risks may arise throughout a device’s entire lifecycle.

“All medical devices that use software and are connected to hospital and healthcare organiza-tions’ networks have vulnerabilities; some we can proactively protect against, while others require vigilant monitoring and timely remediation,” said Suzanne Schwartz, M.D., M.B.A., associate director for science and strategic partnerships and acting director of emergency preparedness/operations and medical countermeasures in the FDA’s Center for Devices and Radiological Health.

The guidance outlines postmarket recom-mendations for medical device manufacturers, including the need to proactively plan for and to assess cybersecurity vulnerabilities; consistent with the FDA’s Quality System Regulation.

It also addresses the importance of informa-tion sharing via participation in an Information Sharing Analysis Organization (ISAO), a collab-orative group in which public and private-sector members share cybersecurity information. The draft guidance recommends that manufacturers should implement a structured and systematic comprehensive cybersecurity risk management program and respond in a timely fashion to identified vulnerabilities.

For the majority of cases, actions taken by manufacturers to address cybersecurity vulner-abilities and exploits are considered “cyberse-curity routine updates or patches,” for which the FDA does not require advance notification, additional premarket review or reporting under its regulations. For a small subset of cybersecurity vulnerabilities and exploits that may compromise the essential clinical performance of a device and present a reasonable probability of serious adverse health consequences or death, the FDA would require medical device manufacturers to notify the agency.

outbreak. Pandemic.When one erupts it can strike fear, loathing and strife in the hearts of

clinicians and administrators alike.On the front lines, doctors, nurses, infec-

tion preventionists and sterile processing professionals, along with environmental services, have to coordinate and launch both a defense against rapidly multiplying viral and bacterial invaders and an offense to ensure those microorganisms have no place to stick around.

In the back office, supply chain profession-als must marshal its troops to fortify those on the front lines, including lining up supplier deliveries and trade routes to satisfy — and even anticipate — demand.

Bottom line: If you’re not effectively or even adequately prepared to handle such an assault, you’re behind the eight-ball.

SARS, Ebola and Zika may surface over-seas, but the prospect of any of them reach-ing the United States can foment waves of internal panic and stress that can fester into public relations nightmares. Just ask those American facilities treating Ebola patients from Africa who were transported here in late 2014.

Closer to home late last year, a prominent American restaurant chain experienced such an overwhelming outbreak of E. coli and norovirus that at press time it still was on the verge of declaring a recovery before a skeptical and wary public.

Small things may create big damage, but big things can achieve the same.

Healthcare organizations also have to face natural disasters that can unleash destruc-tion, injuries and fatalities. Hurricanes on the East Coast. Tornadoes in the Midwest and Great Plains. Earthquakes and mudslides on the West Coast.

What to do? Can you prepare for some-thing that you don’t expect? How? And

crises call for clean, crisp planning pragmatism Mental, operational clutter should be consigned to the scrap heapby Rick Dana Barlow

how thoroughly if you don’t really know what to expect?

A panel discussion exploring crisis man-agement against the backdrop of the Ebola issue in late 2014 raised more than a dozen salient points and tips to follow in advance of the next crisis. Healthcare Purchasing News attended the session, but the executive speakers declined to be quoted, so their off-the-record insights have been paraphrased in context. HPN also reached out to other sources that experienced crisis manage-ment situations for additional comment on the record.

What are the key issues to resolve?

1. who’s in charge?Someone near or at the top generally must take the lead, even if specific responsibilities are delegated to others. They must establish a formal command center, too. You have to be structured, but flexible and fluid.

In fact, Jeff Hamilton, Regional Emergency Management Coordinator, Mercy, whose system managed through a devastating tornado a few years ago that destroyed a community hospital, called it an “inci-dent management system with a physical location.”

Further, Hamilton de-scribed five key leadership roles that require some ex-ecutive function. At the top is the “person in overall charge” or the incident commander. This usually is a vice president with a good understanding of the hospital and resource allocation issues, he indicated. Next is the “person in charge of tactics” or the opera-tions section. “All tasks during the incident should flow through that one source,” he noted. There needs to be a “person in charge of logistics,” who is responsible for obtaining resources, a “person in charge of

Jeff Hamilton

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PRODUCTS & SERVICES

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fi nance” and a “person in charge of plan-ning.” “[The latter] provides situational awareness so you don’t look at an incident only through your eyes but can see the whole picture,” he said.

“When Mercy and [Resource Optimization & Innovation] responded to the Joplin tor-nado crisis, we established several command centers — one was on the ground in the Joplin area to handle the immediate needs of individuals on the ground and another was in St. Louis to lead the supply effort, interfacing with our inventory management, distribution, and transportation colleagues within our own integrated supply chain as well as with the outside suppliers we needed to provide larger quantities (such as tetanus shots and bottled water) and emergency-specific supplies (such as mobile equipment and portable toilets),” said JoAnne Levy, Vice President of Supply Chain Operations, ROi, Mercy’s supply chain ser-vices organization. [Editor’s Note: Search HPN Online for “Mercy Joplin” and read the coverage from 2012 and 2013.]

2. Be able to communicate directions, news and updates to employees and staff fi rst, then patients, visitors, media and the public next.Communication is needed at all levels in all departments, but make sure to prevent too many people from making decisions — even with the right intentions — because it only will contribute to the chaos, fear and panic fueled by rumor.

“You need to appoint a public information offi cer who will write the communications plan for internal as well as media use,” Hamilton said. “All communication is ap-proved by the incident commander prior to distribution. Most hospitals or hospital systems have professionals with expertise in crisis communications who are familiar with internal messaging issues.”

And don’t forget about mobile phones.“In the Joplin tornado response, our abil-

ity to connect via cellular phone and text messages was invaluable as regular phone lines were not reliable,” Levy recalled. “All advance emergency response planning needs to include the physical means of com-munication on the assumption that regular communication means will be impaired.”

3. What about false alarms, misinformation and overreactions by patients, visitors, media and even suppliers?

Fear tends to drive a crisis. One solution may involve hiring a media fi rm to edu-cate and coach people on how to say things that won’t be taken out of context. For example, in the event of a highly contagious infectious outbreak, you may fi nd your vendors unwilling to park at your dock and unload cargo for fear of exposing their drivers.

A communications plan must include in-ternal messaging to minimize rumors, and also address social media issues, Hamilton insisted. “Huddles with managers and staff at frequent intervals are very effective in minimizing misinformation, and frequent messages from the command center to managers are also essential to minimizing rumors,” he added.

“During the Joplin tornado disaster re-sponse, ROi held daily briefi ngs with all of our involved co-workers in St. Louis,” Levy said. “It was critical that everyone was advised of the current status so that they could actively assist, cover the work of co-workers who are actively involved, and provide support to each other. Mercy and ROi also held numerous daily meetings by phone, each focused on particular issues and with relevant functional teams such as physical facility support, clinical leadership regarding patient needs, and on-the-ground supply chain personnel.”

4. Be able to move infected patients safely and securely through hallways and to other facilities on campus or across town, and provide visitors similar protection.Hospital infection prevention departments will defi ne the appropriate [personal protec-tive equipment] for patients and transport personnel,” Hamilton noted. “Logistics will ensure these resources are available, and the command center will defi ne allocation when resources are not suffi cient to match need.”

5. How do you handle the ease and speed of infectious transmission?You may need to turn your organization into a temporary living facility for your employ-ees and staff and any volunteers who want to help. Think of it as a “soft” lockdown for prevention and protection alike.

“Strict adherence to infection prevention protocols will markedly diminish the trans-fer of pathogens between people,” Hamilton insisted. “Pre-planning to identify air han-dling issues within buildings will also di-minish airborne transmission of pathogens.”

6. Lockdowns, yes, lockdowns must be swift and effi cient.“Controlling access is more than locking doors,” Hamilton noted. “Designated access points are essential. Indicators for lockdown, protocols and processes are essential. Hos-pital doors cannot be locked to exclude exit. They can only block entrance into the build-ing. Monitoring of a locked door is necessary to prevent it being held open by a misguided Good Samaritan. Encourage departments near exit doors to ‘adopt-the-door.’ Security will provide protocols for locking and moni-toring, the adopting department implements the protocol for their door.”

Levy stressed the security angle. “During the Joplin tornado disaster response, one of the fi rst matters that ROi had to attend to in addressing the immediate aftermath of the Joplin tornado was security around the Joplin hospital building, which was deemed unsafe,” she said. “Intruders and looters unfortunately saw the hospital and its contents as potentially valuable. Luckily, we were able to quickly secure the area and erect fencing that kept both the building and its contents safe from intruders and the public from entering an unsafe building.”

7. Inadequate governmental direction and support can pose a challenge.Timing, of course, is everything. In the case of the Ebola crisis, the federal guidelines for dealing with a pandemic were being revised and updated as everyone was learning how to deal with a real-life outbreak. Scoffed one executive who wished to remain anony-mous: “It’s a little late in the game when you’re in the middle of it.”

Still, the scale of the Ebola crisis extended far beyond what was expected. If anything, it woke up the healthcare industry that “anything can happen at any time,” observed another executive who wished to remain anonymous. “You prepare for the likely things but can’t prepare for that one-in-a-million thing. You just have to be ready.”

Hamilton, however, defended govern-mental agencies, such as the Centers for Disease Control and Prevention and the Federal Emergency Management Admin-

JoAnne Levy

dis·as·ternounA sudden event, such as an accident or a natural catastrophe, that causes great damage or loss of life.



PRoduCTs & sERviCEsistration. “Organizations such as the CDC are invaluable and routinely provide the best evidence-based recommendations,” he said. “Local hospital infectious disease specialists will exceed CDC recommenda-tions when appropriate for their hospital. [FEMA] has a massive amount of resources and services available, but they take a minimum of 72 to- 96 hours to be available to a community. Preplanning, inventory tracking and management, distribution and allocation are essential components of a hospital being able to be self-sustaining for at least 96 hours.”

Levy echoed support for a variety of au-thorities. “Early on during ROi’s response to the Joplin tornado, we realized the value of talking to, consulting with and collaborat-ing with local, state and national authorities on a variety of issues, including our plans, appropriate supplies, and necessary paper-work,” she said. “For instance, when Mercy caregivers on site in Joplin had to break into pharmacy cabinets to reach needed pain medications, we immediately alerted the Drug Enforcement Administration (DEA) to ensure they were aware of our emergency actions. Mercy and ROi worked closely with local authorities to coordinate our emer-gency response efforts and with national authorities such as FEMA to ensure that we were gathering all necessary paperwork to later establish emergency reimbursement claims.”

8. Product and equipment demand spikes, no matter how irrational, can be frustrating.Supply Chain, with clinical reinforcement and support, needs to determine the right quantity for certain products, as well as where to store them and how to get them quickly from the supplier — even if the product is sourced overseas, which opens up other key issues. The list may span tra-ditional and non-traditional items.

“Pre-planning to include studies that identified the equipment most likely to be used in common scenarios enables the identification of resources and deployment strategies to minimize resource shortages,” Hamilton noted. “Very early implementation of rationing strategies markedly reduces hoarding and misuse, which are components of demand spikes.”

9. Work with your suppliers to handle product order changes.Reliable vendors will be sympathetic and un-derstanding. True partners will go that extra mile to help source products. However, you may have to change vendors for a particular

product and rely on an overnight shipping service for quick logistical turnarounds.

“ROi’s strategy of establishing strategic supplier relationships was invaluable dur-ing the Joplin tornado response,” Levy said. “When the Joplin emergency arose, those suppliers were already knowledgeable about ROi’s and Mercy’s needs and were willing to step in to provide needed supplies and ser-vices. One supplier representative who had called upon Mercy’s Joplin facility even took it upon herself to personally drive a carload of supplies, including flashlights, into the Joplin area. Other suppliers provided extra products at humanitarian discounts and were exceedingly flexible, waiving normal purchase and payment requirements and shifting from their usual distribution chan-nels.”

10. Establish a basic marketbasket of products necessary to weather an outbreak, pandemic or natural disaster.In this case, Infection Prevention is Supply Chain’s closest friend as they can help deter-mine what is needed initially and quickly for many likely scenarios. In fact, peer-reviewed studies have demonstrated the essential products for biologic, radiation and trauma scenarios that can serve as guidelines, ac-cording to Hamilton.

“ROi’s integrated supply chain enables a real-time, greater understanding of supplies and services used and needed at particular locations and by specific caregivers,” Levy noted. “Within minutes of learning of the Joplin tornado, ROi’s centralized distribu-tion center, with its extensive hub and spoke transportation and delivery network, was able to begin identifying, picking, packing and shipping emergency supplies to Mercy caregivers on the ground in Joplin. ROi and Mercy’s preparation in advance for emergen-cy supplies is heavily influenced by federal, state and local guidelines, best practices in our industry, and our own experiences and learnings from emergency situations, such as the Joplin and Oklahoma tornados. While some of Mercy’s emergency supplies are stored in our largest hospitals, additional supplies are stored in ROi’s central distri-bution centers, from which those supplies can quickly be dispersed, using our owned delivery fleet, in accordance with any loca-tion’s needs at the time of an emergency.”

11. Be prepared to compensate for supply disruptions, such as shortages or off-shore sourcing issues.Imagine how a labor strike at an overseas manufacturing plant during the height of

a crisis might affect your supply lines. That happened during the Ebola crisis, which reinforces the need for preparations.

“Supply chain management during an emergency response demands creativ-ity and flexibility,” Levy said. “During ROi’s response to the Joplin tornado, we were tasked with identifying and obtain-ing products and services that we had never needed before and had never had under contract At one point, Mercy’s Human Resources team asked ROi to acquire multiple electronic street signs that were ultimately used to communicate with Mercy co-workers who had lost all other means of communication. Similarly, much of the mobile equipment that was deployed to support the Joplin tent hos-pital was sourced for the very first time. Mercy caregivers who had used specific products in normal times were required to adapt to other products during the Joplin emergency that were able to be sourced in larger quantities or more quickly.”

12. Just like the hotels, take stock of those incidentals.When the power goes out, batteries can be trusty friends. Bottled water and filters, too.

13. Follow the waste stream.Just like that famous movie line from “Jerry Maguire” where the professional athlete told his agent, “Follow the money!” it’s important to apply that logic to the hazard-ous and infectious medical waste generated during the treatment of pandemic-infected patients. It may require calls to local and state governmental authorities and trans-portation companies to dispose of the material safely, quickly, efficiently and discreetly.

“Preplanning for increased medical waste includes provisions for storing waste in excess of capacity and vendor agreements for rapid disposal,” Hamilton added.

Bottom line: You have to be flexible and nimble from Day 1.You can’t prepare for everything, but you have to be prepared for something, experts insist. You have to be cautious and vigilant — not allowing or enabling the status quo to generate complacency.

“Every month that goes by where we don’t have a disaster we will slip back into our old ways,” one executive warned. “We have to keep people trained. We need to keep people engaged for long periods of time for that one event that may hap-pen.” HPn


hpnonline.com • HEALTHCARE PURCHASING NEWS • March 2016 43

but also imperative that technicians have an understanding of how and why the instru-ments are used. This knowledge allows the sterile processing department to more accu-rately forecast the needs of the surgical team.

Building an inventory safety netAs we received preference cards from the operating room, we quickly pulled our sterile inventory, built case carts and de-livered them to the surgical suite. As the calls for more and more cases poured in, and not knowing how many more patients the facility would be receiving, we started to feel anxious as we watched our inven-tory dwindle. All of the needed trays and substitutions in the inventory had been sterilized and given to the surgical teams or were staged for the following cases. It was at this point that we communicated with the Incident Command Center that we needed more sterile equipment. They put a call out to the Red Cross which coordinated with regional hospitals to borrow sterile trays. Within an hour the sterile equipment began to arrive.

After receiving over 100 sterile trays, ranging from orthopedic drills and saws to

HAVING MY SAY

Responding to a disaster in sterile processingby Jo M. Wood

On the afternoon of April 15, 2013, after two explosions killed three people and injured hundreds more near

the Boston Marathon fi nish line, our facility, Boston Medical Center, received the fi rst wave of casualties.

Once we received the fi rst code message, our sterile processing team came together rapidly and prepared for what would be a long night. It is a common saying that timing is everything and on the day of the Marathon, that could not have been more true. The di-saster code call came through just before shift change. We quickly realized that the impact of the bombings was vast and that hundreds of people were injured. Thankfully, the day shift stayed on as the evening shift arrived, nearly doubling the size of our team. Had the code been called fi fteen minutes later, our department would have been overwhelmed without the extra hands on deck.

Assessing our needsWorking in a busy level-one trauma center means that our sterile processing team is ac-customed to frequently providing service to the operating room for one or two cases at a time. However, our team had never been exposed to a mass casualty situation, real or simulated. Once the severity of what had happened in Copley Square came into focus, we realized that we needed any information that was available — not because what had happened was terrifying and everyone had questions — but to help anticipate what our surgical team would be encountering as pa-tients were rushed into the operating rooms.

Fortunately, for us, our manager was out on leave at the time and able to call in from home to tell us in real-time what kinds of injuries were being reported on the news, namely severe vascular and orthopedic lower extremity injuries. This information was criti-cal as it allowed us to triage our reprocessing needs quickly after having an orthopedic heavy caseload earlier in the day. It is not enough for sterile processing technicians to know what instruments reside in which tray

vascular trays from 10 facilities, we started turning away offers. I created a color-coded inventory system on the fl y to track which items belonged to each facility so that it would be easier to identify and return them later; and we still use this inventory system today to track the loaner instrumentation at our facil-ity. As it turned out, our fears of running out of instrumentation from our own inventory were unfounded and we were able to return all of the trays within the next few days.

Along with the trays, we also sent thank you cards to the departments that had come to our aide during our greatest time of need, although no words could ever truly express our gratitude. Having the additional inven-tory at our disposal gave our team a sense of security that we would be able to handle any situation presented to us. I believe it was that feeling of security that enabled our team to never lose focus on our goal of making sure every patient brought to our facility had the best possible outcome.

In the days and weeks following the Marathon bombing, we all began to refl ect on what did and didn’t work for our depart-ment and how we might have done better. Our team participated in group counseling sessions facilitated by the organization. That time to refl ect and be honest was vital, as it allowed for everyone to emotionally decom-press after experiencing a disaster that had such a huge impact on the city that we live and work in.

The tragic event also reminded our facil-ity of something else that’s very import: Knowledgeable sterile processing techni-cians are valuable members of the surgical team. HPN

Jo M. Wood, CRCST, Compliance and Education Supervisor at Boston Medical Center, is an ac-tive member of the IAHCSMM Massachusetts Chapter for Central Service Professionals where she holds the position of Government Affairs Liaison. Wood is also the 2015 recipient of the Healthcare Purchasing News Jeannie A. Akridge Scholarship.

Donated sterile

loaner trays, color-coded for easier

tracking and return

1603-HMS-Wood.indd 43 2/11/2016 4:45:38 PM


Worth repeating PEoPLE & oPinions

in 2014, Tom Frieden, the Centers for Disease Control and Prevention (CDC) Director, said, “The most advanced

medical care won’t work if clinicians don’t prevent infections through basic things such as regular hand hygiene.”1

Hand hygiene continues to attract at-tention — and for good reason. In 2015, value-based purchasing (VBP) included metrics for clostridium dif-ficile (C. Diff) and MRSA, two multi-drug-resistant organisms (MDROs) frequently transmitted by human contact. Hand hygiene has proven to reduce the incidence of infections in hospitals, including such MDRO infections.2,3

Despite tremendous efforts, com-pliance with hand hygiene protocols remains at only 40 percent.4 In criti-cal environments like the operating room, compliance falls below 20 per-cent and even as low as 2 percent to 8 percent.5,6 Hospitals have attempted to improve compliance — first with manual solutions, and now with automated ones.

Direct observation has been the most common approach but it can introduce bias and error.7 It is also time-consuming and costly.8 By sampling only 1 percent to 3 percent of all hand hygiene opportunities, questions arise on the statistical va-lidity of reported compliance rates.8,9

Compliance can be over-reported as much as 300 percent due to the Hawthorne Effect,10 in which behav-ioral changes occur only because the subject is aware of being observed.

With so much at stake in patient safety and VBP measures, many hospitals are turning to automated electronic monitoring for 24/7 sur-veillance. There are now more than 20 companies promoting electronic solutions which can make choosing the right system a real challenge.

Here are five key considerations to keep in mind when selecting a hand hygiene moni-toring system that is right for your facility:

Did you wash your hands? Ask less and do more: selecting the right hand-hygiene monitoring systemby Hosniyeh Bagheri, RN BSN CIC, Janis Ober, RN MSN CIC, Jason Burnham, BSME MBA SSBB, and Sudhanshu Gakhar, MSEng BSPhys*

1. individual monitoring, community monitoring ... or both: Two categories of monitoring solutions are Individual and Community Monitoring. Soap and sanitizer companies may offer Community Monitor-ing, which counts sanitizer dispenses with formulas to approximate compliance. Will

these formulas require daily staff headcount or census to stay accu-rate? Are these formulas custom-ized for each environment (e.g., ICU, medical floor) and how will staff managers address individuals if team data is poor? Value analysis might also consider the implications of being locked into a specific manu-facturer’s dispenser and sanitizer for multiple years.

Individual compliance systems monitor personnel using a staff badge or tag, and may identify in-dividuals or provide de-identified individual data. These solutions locate people and equipment in a hospital with sensors (Bluetooth, Wi-

Fi, RFID, infrared, ultrasound). Con-sider if the system requires changing dispensers or sanitizer vendors. Stud-ies suggest individual monitoring systems can increase hand hygiene rates by over 200 percent.11,12,13,14

Your staff may want more flexibil-ity. Some systems are able to blend community and individual monitor-ing in a facility or expand from com-munity to individual monitoring over time.

2. accurate data without impact-ing staff workflow: An effective hand-hygiene monitoring system must sync seamlessly with workflow to ensure staff participation. Systems that add steps or do not accurately credit staff can create frustration.

Early technologies were based on detecting alcohol-based hand rub (ABHR), with some requiring an extra step of placing hands near an alcohol sensor for confirmation. A comprehensive system should distinguish between using hand rub and hand-washing without adding steps. When hand-washing

“We all have to be very honest from a CS/SpD perspective. i believe the majority of facilities can state that they follow iFU on a daily basis. how-ever, do we all really follow the iFU in a way that is intended and surveyed? to follow the iFU from start to finish takes time, and most CS departments do not have the luxury of time in order to follow every single step of an iFU perfectly.”

IAHCSMM President-Elect Steven J. Adams BA, RN, CRCST, CHL, Manager of Sterile

Processing/Anesthesia for Greater Baltimore Medical Center

“For those of us who are passionate about data standards, the transition may never feel like it’s happening fast enough. But that’s because there are a lot of moving parts in imple-mentation. providers need to modify their internal processes in order to be able to consume the data. Suppliers need to put UDis on their products. and then the two parties need to transact with each other using UDis.”

David Reed, Vice President, Healthcare Business Solutions and Operations, and

Corporate Compliance Officer, Cook Medical Inc.

“although specialized instrumenta-tion for some procedures may come with increased costs, purchasing decision-makers should consider that over time the cost curve will be driven down if the technology en-ables surgeons to save time, reduce complications and allow patients to return home quicker.”

Paul Davison, Vice President, Research and Development, Invuity

“You need to appoint a public in-formation officer who will write the communications plan for internal as well as media use. all communication is approved by the incident com-mander prior to distribution. Most hospitals or hospital systems have professionals with expertise in crisis communications who are familiar with internal messaging issues.”

Jeff Hamilton, Regional Emergency Management Coordinator, Mercy

Janis Ober

Hosniyeh Bagheri

Sudhanshu Gakhar

Jason Burnham

1603-PO-Halyard.indd 44 2/11/2016 4:30:48 PM

PEoPLE & oPinionswith soap and water is required, such as for C. Diff patients, give preference to systems that can confi rm soap was used rather than ABHR.

Some systems require a manual download or automated processing which can delay immediate access to important data. Data should be available live to check and adjust behaviors in real time.

Some systems rely on vibration to detect dispensing or an infrared beam to detect hands. If staff bump a dispenser or wave a hand under a beam for credit without using sanitizer this can undermine data integrity. Systems should require a full compression of the dispenser actuator for compliance.

Some next generation technologies can detect staff location relative to a dispenser us-ing infrared, ultrasound, or RFID. Accuracy is still an important question. Infrared tech-nologies can require line of sight for accurate location, 15 raising concerns about tags read-ing through personal protective equipment (PPE) and other equipment. And some RFID showed accuracy issues when staff did not directly face dispensers.16 Consider a variety of workfl ow scenarios. Is data accurate if the tag is covered by PPE or surgical gowns or obstructed behind an employee badge? If multiple staff enter a room, can the system determine who to credit for dispensing?

Compliance protocols vary from monitor-ing hand hygiene on entering or exiting a patient room to the World Health Organi-zation’s (WHO’s) Five Moments for Hand Hygiene.17 Community systems do not typically monitor entry-exit. Some individual monitoring systems monitor basic entry-exit, while others can defi ne patient zones to provide data on hand-cleansings between entry and exit or between patients in the same room. Know your data needs for each patient environment.

Recent technologies leverage Wi-Fi plus Bluetooth for detection through fabric, PPE, or equipment. Further, some software can process data for multiple workfl ow situa-tions, such as an area where multiple patients or staff are present and there is a need to determine who to credit for hand-cleaning.

3. installation, maintenance, and it: Be wary of hidden installation costs. Some technologies require wired power or network cables for sensors in rooms or communication devices in hallways. Wireless technologies reduce costs, change orders, and patient care interruptions.

Be wary of escalating device counts. Ven-dors may use different quantities of devices for sensing and require one to several de-vices per room. If performing poorly, some may later insist upon change orders to add sensors. Require all vendors to perform a walkthrough and bid with device count

maximums which will help to limit change orders and long-term maintenance.

Resist comparing device pricing as a bench-mark between vendors, as one high-tech device may outperform multiple inferior devices and avoid the need for supplemen-tal devices later. For support, consider how many different technologies are involved in the solution. One company may provide hardware devices (badges, sensors) using another company’s Wi-Fi location software (Cisco, Aruba) with another company’s

reporting software. Having one provider of hardware, middleware, and software is ideal if issues arise.

4. expanding to other applications: A sys-tem that can expand to applications beyond hand hygiene can deliver multiple valuable use cases. Seek systems that are expandable to track equipment, staff, patient fl ow, inven-tory, and temperature. Having one source of visibility into operations can benefi t numer-ous stakeholders.

With over 20 hand hygiene monitoring systems available,

how do you choose?

Get started atChooseYourSystem.com

Wear under PPE Wear under PPE

Soap & SanitizerSoap & Sanitizer

Fits DispensersFits Dispensers

Works in the ORWorks in the OR

Expandable UsesExpandable Uses

*Registered Trademark or Trademark of Halyard Health, Inc. or its a�liates. © 2016 HYH. All rights reserved.

1603-PO-Halyard.indd 45 2/12/2016 10:28:56 AM


STANDARD PRACTICESThe Supply Chain link to the Triple Aimby Karen Conway, Executive Director, Industry Relations, GHX

SUBMIT YOUR QUESTIONSemail: [email protected]: (941) 927-9345 ext. 202

In 2006, the Institute for Healthcare Im-provement (IHI) launched the Triple Aim, a framework for simultaneously

improving the individual patient experi-ence and the health of populations, while reducing the per capita cost of health care. The visionaries behind the Triple Aim — many of whom are devotees of Dr. W. Edwards Deming and the principles of continuous quality improvement — rec-ognized that to achieve these goals, the

healthcare system would need these five key components: • Focus on individuals and families• Redesign of primary care services and

structures• Population health management• Cost control platform• System integration and execution

Each of these are obvious to most of us; what we often miss is the significance of the word “system.” The brilliance of the

Triple Aim is understanding that health-care is a system, albeit an unhealthy one because it is not producing the desired results. Many of the problems — incon-sistent quality, high costs, inaccessibility, to name a few — stem from the fact that many people in healthcare are focused on their discrete roles, with little regard to the downstream impacts of their actions nor the larger system-level issues that cause problems in the first place. Many blame perverse and unaligned incentives for the problems in healthcare. I believe the misalignment is a function of a lack of systems thinking.

If any function in healthcare should understand systems thinking, it’s supply chain. The consultant who first used the term in 1982 was trying to explain how functional silos in business reduce the end value delivered to customers. That’s exactly what we are trying to do in health-care — to breakdown the silos between clinicians, finance and operations to de-liver better value to patients. Supply chain takes that further, by extending beyond functions in care delivery organizations to other entities, including suppliers and their suppliers. Supply chain is also about collecting and sharing data to facilitate better decision making about what drives higher quality and lower costs. The end goal is reduced waste, improved efficien-cies, and better value at all nodes in the system.

That’s the concept behind the Cost-Qual-ity-Outcomes (CQO) Movement, launched by the Association for Healthcare Resource and Materials Management (AHRMM). In advance of its 2016 annual conference, the AHRMM board of directors took a closer look at the connection between CQO and the Triple Aim, as depicted here. You can check out the full infographic and learn more about the conference, which will focus on the Triple Aim, at www.ahrmm.org/cqo-movement. HPN

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1603-SP.indd 46 2/9/2016 4:14:43 PM

Publisher, Executive EditorKristine S. russell, publisherHealthcare Purchasing News2477 Stickney Point Road, Suite 315BSarasota, FL 34231Phone: (941) 927-9345, ext. 201 Fax: (941) 927-9588Email: [email protected]

sEnD EDiToRiAL inQuiRiEs & MATERiALs ToValerie J. Dimond, Managing editorHealthcare Purchasing News2477 Stickney Point Road, Suite 315BSarasota, FL 34231Phone: (941) 927-9345, ext. 202 Fax: (941) 927-9588Email: [email protected]

sEnD ADVERTising MATERiALs Totiffany CoffmanHealthcare Purchasing News2477 Stickney Point Road, Suite 315BSarasota, FL 34231Phone: (941) 927-9345, ext. 203 Fax: (941) 927-9588Email: [email protected]

EAsT CoAsT sALEsBlake holtonEmail: [email protected] holtonEmail: [email protected] Long Lake DriveOviedo, FL 32765Phone: (407) 971-6286 Fax: (407) 971-8598

MiDWEsT sALEsDonna Boatman-riley5352 Denise Drive Davis Junction, IL 61020Phone: (815) 393-4624 Fax: (815) 393-3633Email: [email protected]

WEsT CoAsT sALEsBlake holtonEmail: [email protected] holtonEmail: [email protected] Long Lake DriveOviedo, FL 32765Phone: (407) 971-6286 Fax: (407) 971-8598

WEB/CLAssiFiED/RECRuiTMEnT ADstracy arendtHealthcare Purchasing News2477 Stickney Point Road, Suite 315BSarasota, FL 34231Phone: (941) 927-9345, ext. 204Fax: (941) 927-9588Email: [email protected]

suBsCRiPTionsplease visit our website or send all subscription requests to:Healthcare Purchasing News2477 Stickney Point Road, Suite 315BSarasota, FL 34231Phone: (941) 927-9345 Fax: (941) 927-9588Email: [email protected] Visit www.hpnonline.com/subscribe

CLiniCaL inteLLigenCe For SUppLY Chain LeaDerShip

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This index is provided as a service. The publisher does not assume liability for errors or omissions.

5. accountability and change manage-ment: Individual accountability can drive im-provement in hand hygiene if implemented deliberately to maximize staff adoption. Implementation can transition progres-sively from aggregate team accountability to individual self-correction to more direct individual accountability. Consider whether the supplier is experienced in education and servicing clinical changes over time. Consider also the capability of the vendor to provide adequate IT and device support with one point of contact for hardware and software.

With much at stake for patients, staff, and workflow, it is critical to select the right technology the first time. Implementing the right system will increase hand hygiene compliance, reduce staff and patient infec-tion risks, and potentially deliver savings, effi ciencies, and expanda ble value. Consider these insights to help you choose the right hand hygiene monitoring system for your facility. HPn*Jason Burnham and Sudhanshu Gakhar are employed by Halyard Health Inc.

References can be found at www.hpnonline.com/inside/2016-03/1603-PO.html.

Hosniyeh Bagheri, RN, BSN, CIC is an Infec-tion Preventionist at KPC Healthcare in Southern California with more than 20 years of experience in Nursing, Quality, and Patient Safety and is certifi ed by the Certifi cation Board of Infection Control and Epidemiology.

Janis Ober, RN, MSN, CIC has a graduate degree in and certifi cation in Infection Prevention and 20-plus years experience. She has published and presented on various infection related topics at the state, national and international level.

Jason Burnham, BSME, MBA, SSBB* is a certifi ed Lean Six Sigma Black Belt with 20 years of experience in health and healthcare solution design. Employed by Halyard Health, Jason leads ventures connect-ing technology fi rms with healthcare providers to improve patient outcomes.

Sudhanshu Gakhar MSEng BSPhys* is a Senior Engineer at Halyard Health with 10 years of new product and technology development experience in the consumer products and healthcare industries. His background in electrical engineering and wireless systems design helps improve patient outcomes for healthcare providers.

PEoPLE & oPinions

advertiser page rS# Web

B Braun Interventional Systems ..... BC 17 www.bisusa.org

Boston Scientifi c ........................... 9 8 www.bostonscientifi c.com/gastroservices/hcpn

Case Medical ................................ 25 26 www.casemed.com

ChloraPrep .................................... 15 24 www.bd.com/1ml

Clorox Healthcare ......................... 3 9 www.cloroxhealthcare.com/nasalantisepticswabs

Contec Inc. ................................... 16 1 www.contechealthcare.com

Cook Medical................................ 13 18 barcode.cookmedical.com

Dale Medical Products Inc. ............ 17 2 www.dalemed.com

Dale Medical Products Inc. ............ 19 13 www.dalemed.com

Halyard Health .............................. 45 3 www.chooseyoursystem.com

Hanel Storage Systems .................. 22 16 www.sterilestorage.com

Healthmark Industries ................... 31 5 www.hmark.com

Key Surgical .................................. 37 25 www.keysurgical.com

Midmark ....................................... 33 10 www.midmark.com/HPNmar

Mobile Instrument Service ............ 35 19 www.mobileinstrument.com

Multisorb Technologies ................. IBC 11 www.multisorb.com

Olympus America ......................... 5 12 www.4ksurgicalor.com

Olympus America ......................... 21 21 www.medical.olympusamerica.com/reprocessing

One Source ................................... 23 14 www.onesourcebiomed.com

OR Specifi c ................................... 39 22 www.orspecifi c.com

Pegasus Medical ........................... 8 15 www.pegasusmedical.net

Ruhof Corporation ........................ IFC 6 www.ruhof.com

Ruhof Corporation ........................ 1 7 www.ruhof.com

Vizient .......................................... 7 20 www.vizientinc.com

ADVERTisER inDEX

Continued from page 45

1603-PO-Halyard.indd 47 2/12/2016 3:46:26 PM


Strategy #2: Think like a patient. Like physicians, patients are often wowed by the newest medical devices on the market. They may even request new products by names. But in many cases, they wouldn’t be so impressed if they understood the clinical evidence and outcomes research associated with these shiny new technologies and most importantly, what’s at stake for their health.

For example, with the introduction of ceramic-on-ceramic bearings in total hip

replacements, vendors made claims of less wear and increased longevity. However, a review of the evidence disputes these claims, fi nding no improvements in revision rates, increased rates of implant fractures, and squeaking in up to 8 percent of patients. Does squeaking sound like an ideal patient outcome? By thinking like a patient, outcomes become tangible and real, not just scientifi c — and isn’t that how you would expect hospitals to be vetting medical devices?

The key takeaway is that simultaneously improving costs, quality and outcomes is challenging but it will get easier by adopting the right strategies and thinking differently. As long as we have a shared focus on patients fi rst, we’re heading in the right direction. HPN

Dee Donatelli, RN, CMRP, CVAHP, has more than 30 years of experi-ence in the healthcare industry, with expertise in the areas of supply chain cost reduction and value analysis. Donatelli currently leads the supply chain consulting practice at Navigant Inc., serves as an advi-sor to Procured Health and is a member of Bellwether League Inc.’s Bellwether Class of 2015. Prior to joining Navigant, Donatelli was the Senior Vice President of Provider Services at Hayes Inc., and Vice President of Performance Services at VHA. Donatelli is immediate past president of the Association of Healthcare Value Analysis Profession-als (AHVAP) and an active member and Fellow of the Association for Healthcare Resource and Materials Management (AHRMM). She is a member of Healthcare Purchasing News’ Editorial Advisory Board. She can be reached at [email protected].

BACK TALK

Creating patient-centered Supply Chain a healthy prescription by Dee Donatelli, RN, CMRP, CVAHP

For healthcare supply chain professionals today, costs, quality and outcomes are at the forefront of almost every conversation — or at least they should be. During recent

interviews with a large corporate supply chain management team there was one word that never came up — patient. Perhaps it is just a “given” that what we do in supply chain is for the patients, but what is clear from these discussions is that value-based care requires Supply Chain to do more than advance processes within their own department. They must create a more patient-centered approach with strong physician engagement in order to make an impact.

While engaging physicians has traditionally been a struggle for Supply Chain, healthcare today is vastly different than it was even a few years ago. Physician priorities have shifted while margins continue to shrink. For the fi rst time, many hospitals realize that preserving the status-quo as the way of doing things is by far riskier than investing in a new approach. The industry is ripe for change, and Supply Chain has a critical role to play.

Creating a patient-centered supply chain starts with reframing what may previously have been a contentious or even non-exis-tent relationship with physicians as a true collaboration. It means re-aligning around patients and value — not products or price.

For this new partnership to develop, the path forward must be paved with meaningful dialogue focused on outcomes and informed by clinical evidence. Two strategies are critical to creat-ing a more patient-centered supply chain.

Strategy #1: Think like a physician. Supply Chain leaders looking to engage physicians must emphasize the ultimate end goal — mak-ing healthcare better for patients. Physicians’ top concern will always be delivering the very best care in the most compassionate manner. Taking a patient-centered approach, rather than leading with a price or standardization conversation, makes physicians more receptive to listening, discussing and ultimately partnering with supply chain in both

the short and long-term. Getting physicians’ attention is just the fi rst step. The next step

to thinking like a physician is evaluating peer-reviewed literature that is accurate, thorough and complete. Supply chain’s role is to provide this much-needed evidence to physicians who are hungry for this knowledge. This is an opportunity for Supply Chain to become a valuable resource for physicians who thrive on interpreting huge volumes of data, studies and complex spreadsheets. Simply put the data in their hands, provide a forum to debate, and a productive dialogue will follow, with patients staying top of mind.

1603-BackTalk-DD.indd 48 2/8/2016 2:58:40 PM


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IFUs: Essential weapons against infections

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Transcript of IFUs: Essential weapons against infections