Medical Device Reprocessing - mdrao.ca · MDR: Out of the past—into the future • Original plan...

Annual Conference September 8-10, 2013

Medical Device Reprocessing Out of the past—Into the future

Presented by : Barbara Bolding RN, BSN, MBA 09 September, 2013


MDR: Out of the past—into the future

• Original plan • Start with the current revolution in MDR

• Focus on the future of MDR

• Brief overview of the past

• What I found

• An amazing revolution in medical device reprocessing

• 1850-1900

• Origins of MDR as we know it • Science • Technology • Surgery


MDR: Out of the past

• Ancient times—before 500 CE (AD)

• Disinfection • Pitch, tars, aromatics (embalming)

• Moses—1450 BCE • Camp cleanliness—1st sanitary code • Fire for purification

• Greeks

• Hippocrates—460-377 BCE • Boiled water and medicated dressings for wound treatment

• Egyptians—300 BCE • Surgical instruments • Embalming and preserving

• Romans • Galen—130-200 CE • Boiled instruments when treating wounded Roman gladiators

Rome 2 CE

Aswan 300 BCE

Rome 2 CE



• Dark and Middle Ages—500s to 1300s CE

• Previous knowledge lost

• Academic surgeons, but few noteworthy contributions in the West

• Barber surgeons

• Amputations, dental extractions, setting fractures, blood letting

http://www.google.ca/imgres?imgurl=http://www.medievaldesign.com/variousitems/surgicalset.jpg&imgrefurl=http://www.bucks-retinue.org.uk/index2.php?option=com_smf&Itemid=314&topic=483.0&usg=__f3XNaRnLMAmB2igQWwULj0LEQbQ=&h=1928&w=1417&sz=377&hl=en&start=101&zoom=1&tbnid=CgMGac_HkURT6M:&tbnh=150&tbnw=110&ei=ngl_UIORM4P88gSI8ICQCg&prev=/search?q=barber+surgeons+tools+in+medieval+times&start=100&um=1&hl=en&sa=N&gbv=2&tbm=isch&um=1&itbs=1



• Middle ages—1300 and 1400s

• Patient care was monastery based e.g.

• Hotel Dieu de Beaune 1443

• Hotel Dieu de Paris 1500

Ill patients on left Well patients on right

http://www.google.ca/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&docid=BfaAemsdsUBe0M&tbnid=m7GA1HxG_4OZoM:&ved=0CAUQjRw&url=http://www.art.com/products/p13055557-sa-i2294859/adam-woolfitt-tableau-shows-work-of-the-nursing-sisters-hotel-dieu-beaune-burgundy-france.htm&ei=j6TUUbX0FLCPigKr5oCICA&bvm=bv.48705608,d.cGE&psig=AFQjCNGzWt9Sg2sdlxpnXXNU7LDgPW0W7g&ust=1372976348302277



• Renaissance—1400s-1600s

• Plague 1350-1400 • PPE

• Denis Papin—1680

• “Digester” • Steam under pressure i.e. pressure cooker

• Antony van Leeuwenhoek—1683

• Microscope and microorganisms

http://archives.microbeworld.org/images/meetmicros/tools/tool_1_leuw-scope.jpg Perkins, JJ. Principles and methods of Sterilization 1956

Block, Seymour. Disinfection Sterilization and Preservation. Lippincott Williams & Wilkins. Philadelphia PA. 2001. p5.



• 1750-1850 Industrial Revolution

• Rise of large city-based hospitals to care for indigent poor

• Guys in London 1724

• Pennsylvania General in Philadelphia 1751

• Vienna General 1784

• Montreal General 1821

ard.bmj.com accessed 14 Oct 12

Vienna General Guys

collage.cityoflodon.gov.uk accessed 14 Oct 12


Medical Device Reprocessing: The 1st Revolution


MDR: The 1st revolution

• Mid to late 1800s

• End of the Industrial Revolution

• Modern concepts of sterilization linked to developments in

• Science—microbiology and chemistry

• Technology—pressure vessels, surgery

• Workplace—hospitals

• Extent and speed of change = Revolution

• Within 50 years


MDR: The 1st revolution SCIENCE

• 1840s—General anaesthetics for pain control • Nitrous Oxide 1842 • Ether 1842 (1846 demo of painless surgery at Mass. General) • Chloroform 1847

• 1862—Louis Pasteur • Germs cause disease • Heat kills germs

• 1867—Joseph Lister • Carbolic acid disinfects

• On fomites, incisions, hands of OR team • 1st antiseptic surgery • Reduced Berlin General Hospital infection rates from 90% to 15%

• 1881—Robert Koch

• 4 postulates relate microorganisms to disease • Pasteur’s contemporary and competitor

• Moist heat kills microorganisms better than dry heat

images.wellcome.ac.uk accessed 14 Oct 12



TECHNOLOGY • 1838—Codman instrument company

• 1876—Charles Chamberland

• Protégé of Pasteur

• Modernized Papin’s “Digester” for sterilization

• Pressure steam sterilizer (temp to 120 C)

• Rack in the chamber holds items above the water

Papin 1680**

Chamberland*

* Perkins, JJ. Principles and Methods of Sterilization… 1956



WORKPLACE

SURGERY AND HOSPITALS

• 1820s—Operating Rooms appear in hospitals

• 1822 St. Thomas OR—London

• 1824 Massachusetts General OR—Boston

• Both with open amphitheatres

• Closed, once Semmelweis (1847) and Lister (1867) were accepted

The Ether Dome 1846 (Mass General)

St. Thomas



WORKPLACE

SURGERY AND HOSPITALS contd

• 1847—Ignaz Semmelweis • Handwashing reduces child-bed fever

• Compared wards of Physicians to Midwives • Used chlorinated lime

• Before Pasteur (1862)

• 1853-56—Crimean war—Florence Nightingale • Hospital sanitation

http://ldysinger.stjohnsem.edu/@themes/medicine/Semmelweis-mother.jpg



WORKPLACE

SURGERY AND HOSPITALS contd

• 1881—Koch—applied disinfecting properties of hot air, hot water and steam to OR

• 1885—Ernst von Bergmann—steam sterilization of surgical instruments & dressings

• 1889—William Halstead (and Goodyear)

• Surgical gloves

• Halstead (mosquito) forcep

von Bergman

von Bergman



SCIENCE

• Advances in surgery by late 1800s • Control pain • Reduce infection

• Types of surgeries expand

• New instrument designs required • Surgical instruments redesigned to withstand sterilization

• i.e. simple, steel, disassemble-able

Halstead mosquito

Nicolas Senn ~ 1885



TECHNOLOGY

• 1883—Radial, locking-arm door on sterilizer • Steam tight • Easy lock

• 1890—1st hospital steam sterilizer

• Rochester City Hosp • Sprague-Schulyer (later AMSCO) • Thermometer but no temp control • For dressings

• 1892—Hospital steam sterilizer at Roosevelt Hospital NYC

• Sprague-Schulyer • With pressure gauges and thermometer • For water, dressings and instruments

* Perkins, JJ. Principles and Methods of Sterilization… 1956

*

*

*

Chamberland 1876



Year Event

1820s ORs appear in hospitals

1838 Codman instrument company

1840s General anesthetics

1847 Handwashing—Ignaz Semmelweis

1853 Hospital sanitation in Crimea War—Florence Nightingale

1862 Germ theory—Louis Pasteur

1867 Carbolic acid as surgical disinfectant—Joseph Lister

1876 Modernized the “Digester”—Charles Chamberland

1881 Hot air, hot water, steam as disinfectants—Robert Koch

1883 Radial-arm sterilizer door

1885 Steam sterilized surgical dressings—Ernst von Bergman

1889 Surgical gloves—William Halstead (and Goodyear)

1890 1st hospital steam sterilizer—Sprague-Schuyler (later AMSCO)

Late 1890s Surgical instrument redesign

GA & Instruments

Infection Prevention

Sterilization


Medical Device Reprocessing in the 20th Century


MDR in the 20th century

TECHNOLOGY 1900s to 1930s

• 1885—early 1900s • Germany-many notable contributions re: steam

sterilization, chemical disinfection. • e.g. importance of saturated steam and air removal,

• Early 1900s

• Aesculap—rigid stainless steel and chrome plated sterilization drums with valves and vents.

• Filters and rubber gaskets introduced in 1930s. • Aluminum replaces SS in the 1960s

• No widespread application in North America until early 1930s

• 1933—AMSCO and Castle • Temperature controlled steam sterilizers

• Earlier models were controlled by pressure

Perkins, JJ. Principles and Methods of Sterilization… 1956



WORKPLACE Up to 1930s • Reprocessing occurred in ORs

• Viewed as sterilization experts • Largest users of sterile supplies • Often produced sterile goods for entire hosp

• Rubber goods—gloves, catheters, tubings • Drapes and gowns • Gauze dressings • Glass syringes • Needles • Sutures • Instruments • Drugs • Solutions

• Sterilizers initially located in theatres

• As ORs became busier, sterilizers relocated to OR workrooms,

• Still supervised by OR nurses



WORKPLACE—St. Paul’s (Vancouver) reprocessing area 1910



• 1st CSRs (Central Sterilization Rooms) probably around 1920 • Product of

• Expanded OR workrooms • Military practices in WW1?

• Centralization for:

• Efficiency • Reduce duplication of equipment, supplies and effort

• Sharing limited resources • Steam sterilizers • Sets and trays

• Standardization • Product • Practices

• American College of Surgeons (Oct 1928)

• “Survey and Study of Surgical Dressings and Materials” • Recommended standards for dressings



• Earliest reference to CSR—1937*

• Preface indicates CSR concept had been around for about 20 years

• Scope of CSR services varied, depending on the facility

• Surgical supplies—gowns, gloves ,needles, sutures, drapes • All sterile supplies—OB forceps, rubber goods e.g. catheters, gloves • Sterile treatment trays • Blood collection and storage • IV and irrigating solutions • Infrequently used equipment—O2 tent, atomizers, crib sides, isolation equipment

• CSR nurse might accompany complex or emergency trays, and assist physician

• e.g. Gastric decompression, IV Therapy, spinal puncture

ACCESSED 18 SEPT 2012

http://www.hardscrabblefarm.com/ww2/central_supply.htm

















• St. Paul’s (Vancouver) CSR 1940s



• SPH 1960s



• 1950s to 1990s

• Early 1950s— Ethylene Oxide sterilization used by hospitals

• 1956—Principles and Methods of Sterilization… by J.J. Perkins • Set the current standards and methods for reprocessing medical devices

• 1959—Prevacuum air removal sterilizer

• 1963—Glutarladehyde (Cidex®) approved as a liquid chemical sterilant by EPA

• 1969—Pulsing vacuum air removal sterilizer

• 1987—Blood and body fluid precautions (Harborview Medical Center, Seattle)

• 1989—Steris System 1®—liquid peracetic immersion

• 1991—Sterrad®—Hydrogen Peroxide vapour


Medical Device Reprocessing: The 2nd Revolution


MDR: The 2nd Revolution

• Lots of the changes in MDR

• Equipment, products, instruments and sets

• In the past year

• Past 5 years

• Since you began your career



• Examples of changes in MDR

• Minimally Invasive Surgery

• Instrument design

• Procedure relocation from OR to Diagnostic Imaging, cath labs, outpatients

• Chemical / low temperature sterilization methods

• Elimination of outdates

• Emphasis on competency through training and education

• Audits

• Centralization



• Biggest and fastest change?



• Biggest and fastest change?

• FOCUS ON PATIENT SAFETY



• Clear to all that ensuring Patient Safety is our job

• Patients

• Health care administrators and executives

• Staff—inside and outside MDRD



• What does Patient Safety mean in MDR?

• Reducing a patient’s risk for infection

• How do we do that?

• Strive to meet Best Practices / Standards

• Develop specific MDR Quality Systems to show that standards are being met



• A word about “Quality Systems”

• Lots of names

• Quality assurance—QA

• Quality improvement—Q I

• Quality management system—QMS

• Substitute SAFETY for Quality

• A Quality System encompasses all the things we do to keep patients safe.



• In MDR, how do we keep patients safe?

1. Staff—capable

2. Work space, equipment and supplies

3. Work instructions—comprehensive, documented, based on Standards

4. Process monitoring at critical points e.g. • Cleaning • Sterilization • Minimum effective concentration (MEC) of high level disinfectants (HLD)

5. Regular checks (e.g. supervision, audits) to see that • Procedures are being followed • Monitoring / testing results are within normal limits

6. Feedback and corrective action if things are not as they should be

7. Documentation of each part of the process

• Components of a “Quality System” by any name


MDR: Into the future

• What does all of this mean for MDRTs and MDR in the future?

• Don’t know the future, but we can predict trends:

• Technical knowledge

• Device and equipment complexity

• Computerization

• Safety and Quality assurance

• Centralization

• Responsibility and Professionalism

• View trends in terms of patient safety



1. Technical knowledge • MDR is no longer just about steam sterilization

• Technical knowledge of reprocessing now includes: • Chemicals

• Cleaning • Disinfecting

• Water quality

• Sophisticated monitoring techniques • Sterilization chemical indicators • Cleaning efficacy • Minimum effective concentration of disinfectants

• Trouble shooting • Wet packs • Failed processes (e.g. positive BI)



1. Technical knowledge of reprocessing contd.

• What does this mean for you and for patient safety?

• Standardized, comprehensive training for entry to practice

• Continual updating of knowledge and skills • Stay current

• Certification to confirm both

• CMDRT (CSA)

• Problem solving, critical thinking • Can’t predict every problem • Have to know the science and theory

• Start now

• Attend conferences and take back what you learn • Research studies and results • Standards and best practices



2. Device and equipment complexity

• Reprocessing equipment

• e.g. sterilizers, washer disinfectors

• Single items, sets

• Difficult/impossible to clean

• Materials compatibility

• More reprocessing time required

www.intuitivesurgical.com



2. Device and equipment complexity contd.


• Careful attention to manufacturers’ IFUs • Incorporated into work instructions

• Inservice and training from device and equipment vendors

• Need to ensure you get what you need to be safe

• Personal responsibility

• If you’re not sure, ASK

• Document reprocessing time esp. in Decontam



3. Computerization

• Of equipment • On-board computers for complex equipment

• Newer equipment already there • e.g. washer-disinfectors, sterilizers

• Of information systems

• MDRD one of the last areas to computerize

• Item location (tracking) • Work instructions • Product labels • Monitoring / testing results for QA • Activity reports e.g. set utilization

• Tablets/iPads?

• Apps? • For information, problem solving?

From SPMs website Feb 07



3. Computerization contd


• Continuous learning

• Potential changes

• Department practices

• Work flow

• Job duties

• Work schedules



4. Centralization • Within a site (from numerous patient care areas)

• Within a region (from small volume, small centres)

• Reduces duplication, decreases fixed costs (e.g. sterilizers, washer disinfectors, IMS) • Automation

• Computerization

• Improves quality • Expertise and specialization/focus

• Best practices

• Decreases risk of failure and potential liability

• As hospitals focus on patient care, support services could be provided by a third party



4. Centralization contd.


• Career planning, look ahead

• Possible specialization e.g. • Flexible endoscope reprocessing • OR instruments

• Skills to work with mechanization, automation, computerization



5. Quality (safety) Assurance

• Can’t test the final MDR products (e.g. sterility of an instrument set)

• Focus on control of processes at every stage of MDR

• Trained staff—documented • Manufacturers’ Instructions For Use (MIFUs) followed

• Device • Equipment

• Work instructions—documented • Regular process audits—documented

• Documented verification testing where possible e.g.

• BI results • Cleaning efficacy • In-house product qualification testing for sterilization

• Trays • Sterilizer loads



5. Quality (safety) Assurance contd


• Responsible for following written procedures • Ensure they are available

• Expect regular process audits

• It’s not you, its patient safety

• Monitor processes whenever possible • Measure, test, check displays • Know what you’re doing

• Expected result • What to do with an unexpected result

• Document all activities

• Make the time for it



6. Responsibility

• Expectation by public and by employers that MDRTs will:

• Be “answerable/accountable for actions within their control”

• Specified in job description and /or job duties e.g.

TYPICAL DUTIES AND RESPONSIBILITIES:*

In accordance with the principles of infection control, decontamination, sterilization, and aseptic technique, and established policies, procedures and safety standards: Receives, sorts, disassembles, cleans, decontaminates, sterilizes, assembles, wraps and reassembles all medical devices, trays, carts, supplies and equipment related to the Operating Room (OR) and/or other areas of the hospital; *CSA PUBLIC REVIEW 2012-08-28 Z314-MDR DRAFT 3



6. Responsibility contd


• You need to ensure that you have appropriate knowledge, skills and abilities to ensure safe outcomes • Identify your gaps • Act to fill them

• Requires an active response • Can’t wait for others e.g. employer, to do it for you (passive) • May include:

• Asking for clarification or explanation • Seeking certification • Participating in Inservice • Further education and training • Supervised practice

• Part of professionalism…



7. Developing professionalism

• Five characteristics of a profession:

• Specialized knowledge and training

• Mandatory examination for licensure

• Code of ethics includes individual responsibility, obligation to the public

• Regulated by statute

• Authority delegated to a regulatory body/association



7. Developing professionalism contd.

Characteristics of a profession What does this mean for you?

Specialized knowledge and training • Attend and/or support College programs

• Participate in continuing education

Examination for licensure • Obtain certification e.g. CSA

• Encourage others

Code of ethics includes responsibility • Develop a “responsible” mind-set

Regulated by statute • Monitor activity in the US e.g. New Jersey (2004), IAHCSMM

Authority delegated to an association • Become involved in local, provincial and/or national reprocessing association formation and development

• Use association to lobby for change



• Current revolution and future directions

• Technical knowledge

• Device and equipment complexity

• Computerization

• Centralization

• Safety and Quality assurance

• Responsibility and Professionalism

• Focus on PATIENT SAFETY



• Look where we’ve come from

• Since medical devices were first reused, MDR has been changing

• We’re in the midst of another revolution in MDR

• Science, technology, and workplace

• Perceptions and attitudes

• Happening quickly

• Scope and speed • Can be overwhelming

• Can also be exhilarating

• There’s no going back



• Maybe we can’t go back

• But we can choose how to respond

• Future will be:

• Changing

• Challenging

• Exciting


• It’s a great time to be in medical device reprocessing Thanks Barbara Bolding


mailto:[email protected]



• 1950s to 1990s

• Early 1950s—Ethylene Oxide sterilization used by hospitals

• Previously

• McCormick sterilized spices

• Libraries fumigated books (killed silverfish)

• Device sterilization arose from germ warfare science in WW II

• Fort Detrick—Dr. Charles Phillips

• ETO to sterilize delicate germ warfare lab equipment



• Manual ETO sterilization

• When 12 hours have passed, remove the packages and ventilate them.

• Items used on the human body must be ventilated for 72 hours.

• Discard the bags and empty ampoule in the ordinary rubbish...

Medical Device Reprocessing - mdrao.ca · MDR: Out of the past—into the future • Original plan...

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