Training for Development of
Innovative Control Technologies Project
Needlesticks
and sharps injuries are the most common form of occupational transmission of
bloodborne pathogens. Although more than 250 healthcare workers die annually
from occupationally acquired hepatitis B, it was only with the advent of AIDS,
and more recently the adoption of the Occupational Safety and Health
Administration's Bloodborne Pathogens Standard, that there has been a major
focus on the prevention of needlestick and sharps injuries.
Started
in 1990, the Training for Development of Innovative Control Technologies
(TDICT) Project is a collaborative effort of line healthcare workers, product
designers, and industrial hygienists dedicated to preventing exposure to blood
through better design and evaluation of medical devices and equipment. TDICT is
based at the Trauma Foundation, San Francisco General Hospital campus. Sites of
investigation have included the Emergency Department, Intensive Care Unit, and
general medical wards at San Francisco General, as well as the San Francisco
Fire Department and Emergency Response. Current work is focused on the
operating rooms at the University of California San Francisco, the dental
operatories at the University of the Pacific, and various bay area home
healthcare agencies.
The
TDICT Project is directed by Dr. June Fisher, Occupational Health Physician,
Associate Clinical Professor of Medicine at the University of California at San
Francisco, Senior Scientist at the Trauma Foundation, and Lecturer in the
Department of Mechanical Engineering at Stanford University.
Funding
for this project is provided through cooperative agreeements with the HIV
office of the Centers for Disease Control.
TDICT's Methodology
By
directly observing the use of products in the healthcare environment and
involving the end-users of medical and dental technology in systematic
evaluations, TDICT has developed a system for promoting safer medical devices.
Fundamental to TDICT's work is the notion that end-users of medical devices
should be involved in all stages of product development and selection. Our
process includes:
- Reviewing
literature on sharps injuries
- Indentifying
all safety devices commercially available
- Reviewing
sharps injury data
- Clinical
observations by product designers and industrial hygienists
- Training
healthcare workers in principles of product design and evaluation
- Focus group
studies with selected healthcare workers
- In depth
product evaluation by healthcare workers of marketed safety devices and
prototypes still in development
- Structural
and failure analysis of safety products by product designers and
industrial hygienists
In
addition, TDICT works with Stanford University's School of Engineering and the
University of California at Berkeley's School of Public Health to introduce
students to healthcare worker health and safety. We also offer internships for
both product design and industrial hygiene students interested in the medical
device industry.
Evaluation Tools
The TDICT project brings together healthcare
workers, designers, and manufacturers to formulate standards by which the
safety of medical devices can be judged. Although several devices have been
invented as a result of this collaboration, the major focus of the project has
been on the development of Safety Feature Evaluation Forms for the selection of
over 20 different types of medical devices. The sheets were the first written
criteria created for specific devices, and have helped both manufacturers and
healthcare workers to be more critical in developing and selecting medical
devices. The first five of these sheets were published in the American Hospital
Association's "Implementing Safer Needle Devices" (American Hospital
Association Item No. 196310, December 1992).
Currently,
healthcare workers are collaborating with the project to develop scenarios for
simulated testing which will approximate the "real life" use of
various products for the medical industry.
In
addition, the TDICT Project teaches a course entitled "Design Evaluation"
to introduce healthcare workers to the fields of Product Design and Industrial
Hygiene. Participants of this class have gone on to become active leaders in
raising needlestick and safety awareness in their respective workplaces.
Current Work
Device Evaluation and
Selection:
TDICT
is currently collaborating with the American Nurses Association on a series of
workshops providing healthcare workers with the skills to be product evaluators
for their institutions. A draft of TDICT's Evaluation, Selection, and
Institutionalization of Safer Medical Devices can be downloaded here. This file
can be viewed using Microsoft PowerPoint.
Dentistry:
Work
in the dental area has shown that one of the greatest obstacles in designing
engineering controls to prevent exposure to blood and body fluids is the lack
of device and procedure specific information gathered at the time of injury.
Therefore, efforts in this area have focused on the development and pilot
testing of an exposure incident reporting template. Download a copy of exposure
incident reporting template. This file can be viewed and printed using Adobe
Acrobat version 3.0 or higher.
Task Analysis:
Task
Analysis is a systematic method for evaluating and analysing work procedures as
they are performed in the comprehensive work environment context. Task Analysis
for safer devices is a clinically-based assessment that should be done by
frontline healthcare workers.
A USER-BASED
PERFORMANCE STANDARD:
for the design,
evaluation, and selection of medical devices
This
Performance Standard was developed by the TDICT Project, in conjunction with
line healthcare workers and the HIV Office of the Centers for Disease Control.
It steps back from device specific criteria to look at overall procedures and
the fundamental standards which must be met by all products, in all phases of
use. Download a pdf version of this document.
Performance
Standard vs. Selection Criteria
|
Generalized/ Generic
|
Device Specific Applications
|
|
Based on Procedure
|
Based on Device
|
|
Encompasses Product Life
Cycle
|
Point of Use Only
|
MAJOR CATEGORIES
I. PATIENT SAFETY & QUALITY OF
CARE
- Is the
proposed solution of equal or greater effectiveness?
- Will the
device improve patient well-being? (Quality Assurance)
- Does the
device increase time needed for given procedure?
- Is the device
FDA approved? Is it Class I, II, or III?
- Does the
device expose the patient to harmful elements? (Latex, X-rays, Chemicals,
Extreme Light or Heat, etc.)
- Does proper
use of the device involve unnecessary invasions into the patient's body?
II. USER SAFETY
- Does use of
the device require excessive re-training?
- Can most of
the re-training be done in a lab or simulated setting?
- Do new users
experience a steep learning curve?
- Does the
level of expertise of the user affect the learning curve? (Novice vs.
Expert user?)
- Does the use
of the device change the existing procedure significantly?
- Is the device
intrinsically more simple, as opposed to more complex, than the device it
will replace?
- Does the
device require an action which is counter to prevailing procedures? (Is
the correct use of the device intuitive?)
- Does the
device increase time needed for the given procedure?
- Is the
product self-contained as opposed to an assembly of different parts?
- Does the
product need to be disassembled-assembled prior to disposal?
- Does the
device fit well in the hand of the user as opposed to being cumbersome?
- Who uses the
given product?
- Where and how
will failure occur?
- Can product
be easily misused, used differently, co-opted for alternate use?
- What are the
scenarios for common, uncommon, and inappropriate use?
- If a safety
feature exists on the device, is it passively activated? (Effective
without user interaction/interference)
- Are the
safety cues for the safety feature evident at all times? (Are clicks
audible, visual markings noticeable, tactile sensations noticeable through
gloves?)
III. USER FIT AND SATISFACTION
- Will use of
the device require excessive re-training?
- Can most of
the re-training be done in a "lab" setting?
- Do new users
experience a steep learning curve?
- Does the
level of expertise of the user affect the learning curve? (Novice vs.
Expert user?)
- Does the use
of the device change the existing procedure significantly?
- Is the device
intrinsically more simple as opposed to complex?
- Does the
device require an action which is counter to prevailing procedures? (Is
the correct use of the device intuitive?)
- Does the
device increase time needed for given procedure?
- Is product
self-contained as opposed to an assembly of different parts?
- Does product
need to be disassembled-assembled prior to disposal?
- Does the
device fit well in the hand of the user as opposed to being cumbersome?
- Is the
packaging of the device easy to open?
- Does the
packaging clearly indicate its contents?
- Does the
packaging clearly indicate the correct procedures for use of the device?
- Are recycling
or disposal directions clear on the packaging or product?
- Where and how
will failure occur?
- Can product
be easily misused, used differently, co-opted for alternate use?
- What are the
scenarios for common, uncommon, and inappropriate use?
IV. PATIENT FIT AND SATISFACTION
- Will the
device improve patient well-being? (Quality Assurance)
- Is the proposed
solution of equal or greater effectiveness?
- Does the
device increase time needed for given procedure?
- Does the
device expose the patient to harmful elements? (Latex, X-rays, Chemicals,
Extreme Light or Heat, etc.)
- Does proper
use of the device involve unnecessary invasions into the patient's body?
V. PRODUCT LIFE-CYCLE
- What
environmental factors must be considered in product evaluation?
- What is the
product life-cycle?
- Are recycling
or disposal directions clear on the packaging or product?
- Is product
self-contained as opposed to an assembly of different parts?
- Is the
packaging excessive or cumbersome?
- Does the
device, or its packaging, present any new storage problems?
- Does the
device incorporate materials that are non-recyclable in places where
recyclable materials would be just as effective?
VI. ADMINISTRATIVE FIT AND
SATISFACTION
- Does the cost
of the product correlate closely with other similar devices on the market?
- Is the cost
prohibitive to widespread use of the product?
- Does the cost
of the product appear to be correlated to the expense of production?
- Will
implementation of the device require excessive re-training?
- Can most of
the re-training be done in a "lab" setting?
- Does the
level of expertise of the user affect the learning curve? Novice vs.
Expert user?
- Does the use
of the device change the existing procedure significantly?
- Is the
proposed solution of equal or greater effectiveness?
- Where is the
product used?
- What
environmental factors must be considered in product evaluation?
- What is the
product life-cycle?
- Are recycling
or disposal directions clear on the packaging or product?
- Does the
device, or its packaging, present any new inventory problems?
- Is the device
FDA approved? Is it Class I, II, or III?
- How does the
device affect patient well-being? (Quality Assurance)
- Who uses the
given product?
- Where and how
will failure occur?
- How might
product be misused, used differently, co-opted for alternate use?
- What are the
scenarios for common, uncommon, and inappropriate use?
- Does the
device offer a distinct advantage to the institution using it?
Related Sites
Interested in what you see?
Here are some sites on related topics:
- SHARPS project,
California Department of Health services: www.dhs.ca.gov/ohb/SHARPS/disclaim.htm
- Occupational Safety and
Health Administration: www.osha-slc.gov/SLTC/needlestick/index.html
- "Deadly
Needles" series, SF Chronicle:
www.sfgate.com/news/special/pages/1998/10/needles
- Lynda Arnold's
Healthcare Safety Campaign: www.healthcaresafety.com
- American Nurses
Association (ANA) "Safe Needles Save Lives" Campaign:
www.needlestick.org
- EPINet (International
Health Care Worker Safety Center):
www.med.virginia.edu/medcntr/centers/epinet
- Centers for Disease
Control and Prevention (CDC): www.cdc.gov
- National Institute for
Occupational Safety and Health (NIOSH) Alert - Preventing Needlestick
Injuries in Health Care Settings: www.cdc.gov/niosh