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PHC 6314, Unit 6:

Product Design & Evaluation, Part 1 of 2

Donna Haiduven, PhD, RN, CICDJH2017

https://upload.wikimedia.org/wikipedia/commons/3/34/Sharps_Container.jpg Let’s look at you favorite kitchen utensil…..

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https://upload.wikimedia.org/wikipedia/commons/e/ef/Kitchen_utensils-01.jpg

Design Exercise

• What do you like about the device?

• What don’t you like about the device?

Fill in up to 5

likes &

dislikes of

kitchen

product onsheet NOW

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Assignment #6: Part I

Overview of Product Evaluation

• Who regulates?

• Why do it?

• How to do it?

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Image courtesy of Dr. June Fisher

In Health Care…

Both patient safety & healthcare worker safety are critical considerations when evaluating products

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http://floridamedicalprep.com/images/phlebotomy_03.jpghttps://upload.wikimedia.org/wikipedia/commons/thumb/0/0d/ICU_IV_1.jpg/512px-ICU_IV_1.jpg

Interrelationship Between Patient &

Healthcare Worker Health & Safety

PATIENT

SAFETY

&

HEALTH

HEALTH

CARE

WORKER

SAFETY

&

HEALTH

Overlap

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Who Regulates Products?

• Environmental Protection Agency (EPA)- disinfectants

• Food & Drug Administration (FDA) (Not regulated for healthcare worker [HCW] safety)– medical devices

– hand hygiene agents

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https://upload.wikimedia.org/wikipedia/commons/8/81/Food_and_Drug_Administration_(United_States)_(logo).jpg

https://upload.wikimedia.org/wikipedia/commons/7/72/

Environmental_Protection_Agency_logo.png

Why Evaluate Products?

• To determine potential safety problems

• To ascertain if infection risk to patient or employee

• For cost-effectiveness

• As part of regulations (e.g., Needlestick Safety & Prevention Act)

• Because you might use them

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What Types of Products?

• Urinary catheters

• Needle devices

• Soaps, waterless hand hygiene agents,

lotions

• Cleaners, sterilizers, disinfectants

• Gloves, gowns, masks

• Numerous other examples

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http://nurseendeavor.files.wordpress.com/2010/11/dynd11756v23.jpg

http://tangentindinc.com/wp-content/gallery/needles/istock_000011194935medium.jpghttps://upload.wikimedia.org/wikipedia/commons/2/2e/ATOMO_De

ntal_premium_quality_Nitrile_Gloves_blue_for_dental_clinics.jpg

How do products get purchased?

Individual institutions Group purchasing organizations

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http://www.greyhouse.com/healthcare_group.htm

How is this Influenced?

Usual Process• What is available on

group purchasing list?

• Sales representatives demonstrating device to purchasing or managers

User-based Process• Product evaluation

committees (should involve front-line users)

• User evaluation

• User feedback

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What is Infection Control’s Role?

• Protect patients, employees, visitors

• Have input into product selection & evaluation using these goals

• Serve on committees (Infection Control, Safety, Product Evaluation)

• Work with other departments to assure user involvement

• Provide feedback to manufacturers re: design

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Design in Everyday…

WorkLife

http://www.apartment2024.com/wp-content/uploads/2007/08/crocks-of-kitchen-utensils.jpg

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vitalitymedical.com

https://pixabay.com/static/uploads/photo/2015/03/31/14/17/kitchen-appliances-701129__180.jpg

https://pixabay.com/en/stethoscope-medical-doctor-448621/

https://en.wikipedia.org/wiki/File:Ophthalmoscope_and_otoscope.JPG

Pioneer in Product Design & Evaluation for HCW Safety

June Fisher, MD

San Francisco, CA

Director, TDICT Project, Trauma Foundation, San Francisco

General Hospital & Associate Clinical Professor of Medicine University of CA, SF

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Image courtesy of Dr. June Fisherhttps://pixabay.com/en/golden-gate-bridge-san-francisco-690711/

Device Exercise

Dr. Fisher’s favorite:

(A love/hate relationship)

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https://www.flickr.com/photos/bag-promoitems/8063592054/

https://en.wikipedia.org/wiki/File:Peeler_01_Pengo.jpg

https://c2.staticflickr.com/2/1403/1029924054_9619d08ba3.jpg

General Considerations

• Usability

• Intuitiveness

• Adaptability

• Universality

• Skill

• Learning curve

• Safety/cleanliness

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Questions• Is its use apparent/intuitive?

• Does it work with ease?

• Is there a learning curve?

• Would use be apparent to a stranger in your kitchen?

• Are there any potential hazards?

– Does it need to be kept away from children?

• Are there any built-in safety features? DJH2017

Questions• Is it sanitary?

• Is it better than the previous device you used for the same purpose?

• Are directions necessary? Were these clear?

• Is it multi-functional?

– Is it apparent?

– Is there a compromise in design because of this?

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Let’s Re-evaluate your Utensil...List some likes & dislikes using new criteria

you just learned

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https://www.flickr.com/photos/timo/867754/

Needlesticks in Healthcare Workers (HCWs)

• 600-800,000 needlesticks occur annually in HCW in the U.S.

• Safer medical device use, as part of BBP risk-reduction program, can sharps injuries

• CDC estimates 62-88% ofsharps injuries preventedby use of safer devices

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A Brief Chronology of Changing Perspectives on Sharps Injuries

as an Occupational Hazard

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Chronology of Changing Perspectives on

Sharps Injuries as an Occupational Hazard

LATE 1970s

McCormick

and Maki

research on

recapping

FDA approval of Hepatitis B

vaccine (derived from blood

plasma). Limited availability led

to identification of high risk

HCWs

EARLY 1980s

HIV

emerges

Concept of

Universal

Precautions

proposed

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Chronology of Changing Perspectives on

Sharps Injuries as an Occupational Hazard

MID 1980s

Wider

acceptance of

universal

precautions

Beginning attention

to the concept of

engineering controls

Early

manufacturing

interest in

protected devices

JUNE 1988

Safety butterfly

designed by

Steve

Schoenberg

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Steve Schoenberg -Safety Butterfly (1988)

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Images courtesy of Dr. June Fisher

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Chronology of Changing Perspectives on Sharps Injuries

as an Occupational Hazard

JULY 1988

Jagger et. al. –

classic paper on

epidemiology of

sharps injuries

1990

Labor petition to

OSHA for a blood

borne pathogens

standard

First generation of

safety syringes

marketed

1992

OSHA BBP Standard

1) Universal Precautions

2) Hepatitis B vaccine offered

3) Review of engineering

controls (no mandate for

use)

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Chronology of Changing Perspectives on

Sharps Injuries as an Occupational Hazard

MID 1993

FDA alert (re:

Needleless IV

systems)

MID 1990s

2nd generation

of devices

introduced

1997

MMWR

report on

efficacy of

safer devices

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Chronology of Changing Perspectives on Sharps Injuries as

an Occupational Hazard

APRIL 1998

San Francisco

Chronicle series

“Deadly

Needles”

MAY 1998

Migden

introduces

needlestick

legislation

OCTOBER 1998

Bill signed by

governor

1999

CalOSHA BBP

standard

amended

mandating the

use of safer

devices

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Chronology of Changing Perspectives on Sharps Injuries as an Occupational Hazard

2000

Passage of federal

legislation mandating

1) Use of safer devices

2) HCW involvement

in selection

2001

Revision of

federal BBP

standard

Explosion of

new devices

1999

NIOSH Alert

Needlestick

Safety &

Prevention Act

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Needlestick Safety & Prevention Act, P.L. 106-430

2001

Let’s review this document now

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https://upload.wikimedia.org/wikipedia/commons/3/34/Sharps_Container.jpg

Recordkeeping: 1910.1030(h)

Sharps Injury Log

–Only mandatory for those keeping records under 29 CFR 1904

–Confidentiality

–Maintained independently from OSHA 200

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Sharps Injury Log

At a minimum, the log must contain, for each incident:

• Type & brand of device involved

• Department or area of incident

• Description of incident

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Summary of Provisions

definitions, paragraph (b)

• New requirements in the Exposure Control Plan, paragraph (c)

• Non-managerial employees involved in selection of controls, paragraph (c)

• Sharps injury log, paragraph (h)

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HCW Resistance to Introduction of Engineering Controls to Prevent Occupational Blood Exposure

• Increased workload/short staffing/fatigue

• Unsatisfactory experiences with 1st generation devices

• Inadequate training/ long training curves

• Available device may not be appropriate for certain clinical procedures

• Devices not consistently & easily available

• Lack of confidence in competency with device

• FEAR OF COMPROMISING PATIENT CARE

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Strategies for Addressing Patient Needs & Protecting Health Care

Workers from Occupational Exposure to Blood

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Training for the Development

of Innovative Control

Technologies (TDICT) Project

Training for the

Development of

Innovative

Control

Technology

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www.tdict.org

Health Care

Workers

Product

Designers

The TDICT Project is a collaborative effort of

healthcare workers, product designers & industrial

hygienists dedicated to preventing exposure to blood

borne pathogens through the design & evaluation of control technology.

Industrial

Hygienists

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Collaborating Institutions

• San Francisco General Hospital

• Product Design Program, School of Engineering, Stanford University

• Industrial Hygiene Program, University of California, Berkeley

• Dental School, University of the Pacific

• Bay Area Visiting Nurses Homecare Agencies

• American Nurses Association

• Occupational Health Branch, California State Department of Health

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Why Involve Line Healthcare Workers

in All Phases of Control Technology?

• Mandated by OSHA

• Tap their expertise

• Assure that product’s are

user-friendly & truly effective

• Develop systems that

improve compliance

• Improve employee morale

• Improve patient care

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http://www.hse.gov.uk/workers/images/workers2.jpghttps://www.flickr.com/photos/language-translation/3858663363/

A User-Based Systems Approach for the Evaluation, Selection, &

Institutionalization of Safer Medical Devices

June M. Fisher, MD

Director, TDICT Project

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A Step Further…Involve users in the process of

design & evaluation

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design

selection

use

evaluation

“Design Evaluation” Course

• 10 front line HCWs

• 24-hour course spread over 3 weeks

• 250 page text developed by TDICT with intro. to fields of Industrial Hygiene & Product Design

• Lectures, creative problem solving, guided product testing, discussion, & “take to work” assignments

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Design Evaluation Course

Dr. Haiduven’s favorite product

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Image courtesy of Dr. June Fisher

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Design Evaluation Course

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Image courtesy of Dr. June Fisher

“Design Evaluation” Course

Success

“The course is so valuable. Without it I would never have been able to explain to you what’s wrong with this piece of

equipment.”Mary McGee, RN

Labor & Delivery, SFGH

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Design Evaluation Course

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Image courtesy of Dr. June Fisher Design Evaluation Course

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Image courtesy of Dr. June Fisher

Design Evaluation Course

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Image courtesy of Dr. June Fisher

Design Evaluation Course

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Image courtesy of Dr. June Fisher