[Photo courtesy of Thinkstock]
Biomedical and Bioengineering Design
Part 1: Why Prevention through Design?
EDUCATION MODULE
Developed by Denny C. Davis, PhD, PE
Howard P. Davis, PhD
Washington State University
Bioengineering
Guide for Instructors
Topic
Introduction to occupational safety issues, accident
data, and “Prevention through Design” (PtD) concept
Slide
numbers
Approx.
minutes
5-14
30
Methods for addressing occupational hazards,
hierarchy of controls, addressing safety in design
15-19
10
Mechanical risks, needlestick case study (with video)
20-21
15
Hazardous materials case study (with video)
23-24
15
Surgical fires case study (with video)
25
10
Quiz and scoring rubric
26
10
Summary
27
2
Bioengineering
Learning Objectives
• Explain the Prevention through Design (PtD) concept.
• List reasons why project owners may choose to
incorporate PtD in their projects.
• Recognize differing types of bioengineering workplace
hazards.
• See Prevention through Design (PtD) as a critical element
of a sound business strategy.
Bioengineering
Overview
• Occupational safety and
the “Prevention through
Design” (PtD) concept
• Approaches and
considerations when
using PtD
• Case studies of different
types of accidents,
related to PtD
• Summary and quiz
[Photo courtesy of Thinkstock]
Bioengineering
Introduction to Prevention through Design
EDUCATION MODULE
Structural
Bioengineering
Steel
Worker Safety and Health
• ACTIVITY: In pairs, prepare a list of things you
would want presented in workplace
safety training.
– Types of hazards to expect
– Causes of hazards (things to avoid)
– Procedures to prevent accidents
–
–
–
Protective clothing
Protective apparatus
Operating procedures
[Photo courtesy of Clip Art]
– Responses when accidents occur
–
–
–
–
First aid
Where to find help
How to minimize injury
Reporting
• Discuss findings: How important is this safety training to:
–
–
–
–
Students and technicians in labs?
Equipment/instrument fabricators
Patients in hospitals or clinics?
Engineers in design and development?
[Photo courtesy of Clip Art]
Bioengineering
Worker Safety and Health
• ACTIVITY: In pairs, prepare a list of things
that can be done (methods) to reduce the
number and severity of workplace accidents.
–
–
–
–
–
Post warnings
Train in safe operations
Wear safety clothing
Add safety appliances to equipment
Redesign to remove hazard
[Photo courtesy of Clip Art]
• Discuss findings
– What does each method accomplish?
– Which method is most effective? Why?
Bioengineering
Worker Safety and Health
• Occupational Safety and Health Administration (OSHA)
[http://osha.gov/]
–
–
–
–
–
Part of the Department of Labor
Ensures safe and healthful workplaces
Sets and enforces standards
Provides training, outreach, education, and assistance
Note: State regulations possibly more stringent
• National Institute for Occupational Safety and
Health (NIOSH) [http://www.cdc.gov/niosh/]
– Part of the Department of Health and Human Services, Centers
for Disease Control and Prevention
– Conducts research and makes recommendations for the
prevention of work-related injury and illness
Bioengineering
OSHA Regulations (Standards - 29 CFR*)
relevant to biomedical workplaces
•
•
•
•
•
•
•
•
•
1910.1904 Recordkeeping requirements
1910.1030 Bloodborne pathogens
1910.1096 Ionizing radiation
1910.1200 Chemical hazard communication standard
1910.36 Means of egress
1910.900 Ergonomics program
1910 Subpart S Electrical safety standard
1910 Subpart D Walking working standard
1910 Subpart L Fire safety standard
* Code of Federal Regulations. See CFR in references.
Bioengineering
Example: OSHA Regulations (Standards - 29 CFR)
29 CFR 1910.1030 Bloodborne pathogens
• 1910.1030(d)(2) Engineering and Work Practice Controls
– 1910.1030(d)(2)(i) Engineering and work practice controls
shall be used to eliminate or minimize employee exposure.
Where occupational exposure remains after institution of
these controls, personal protective equipment shall also be
used.
– 1910.1030(d)(2)(ii) Engineering controls shall be examined
and maintained or replaced on a regular schedule to ensure
their effectiveness.
• 1910.1030(d)(3) Personal Protective Equipment
– 1910.1030(d)(3)(i) Provision. When there is occupational
exposure, the employer shall provide, at no cost to the
employee, appropriate personal protective equipment such
as, but not limited to, gloves, gowns, laboratory coats, . . . .
Bioengineering
Fatality Assessment and Control Evaluation
NIOSH FACE Program www.cdc.gov/niosh/face/
Bioengineering
Work-related Death from Injury
Rate of Fatal Injuries by Sector (2010)
Educational and health services
Financial activities
Information
Retail trade
Government
Rate of work-related deaths from
injuries, selected occupations, 2010
Manufacturing
Leisure and hospitality
Professional and business services
Utilities
Other services (exc. Public administration)
Wholesale trade
Construction
Transportation and warehousing
Mining
Agriculture, forestry, fishing and hunting
0
5
10
15
20
25
30
Fatal Injuries per 100 FTE (200,000 hrs)
Source: Bureau of Labor Statistics (BLS) 2010a
Bioengineering
Work-related Death from Injury
1,600
1,400
Deaths per Year
1,200
1,000
Highway incidents
800
Homicides
600
Falls
Struck by object
400
Source: Bureau of Labor Statistics (BLS) 1992-2010
200
0
1990
1995
2000
2005
2010
2015
Year
Bioengineering
Non-fatal Accidents and Illnesses -- Healthcare
Social assistance total
Nursing care facilities
Nursing and residential care
facilities total
Hospitals total
Job Impacted
Reported Cases
Ambulance services
Physicians, outpatient,
ambulance total
Health care and social
assistance total
Source: Bureau of Labor Statistics (2010b)
0.0 2.0 4.0 6.0 8.0 10.0 12.0
Number of Occurrences (per 100 FTE)
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Approaches to Address a Risk
ACTIVITY: In pairs, identify a list of criteria that should be used in
selecting the best approach to reducing risk.
•
•
•
•
•
Likelihood of preventing a failure or cause for injury
Likelihood of reducing or eliminating injury
Cost
Potential for enhancing comfort of workers
Potential for reducing stress of supervisors
Discussion
• The best approach does all of the above.
Bioengineering
Judge Alternatives for Reducing Risk of Injury
------------------------- Criteria --------------------------Possible Method
Prevent
Failure
Reduce
Injury
Reduce
Cost
Worker
Stress
Supv
Stress
Total
Put Safeguards in Place
+1
+1
-1
-1
0
0
Find a Substitute
+1
+1
-1
+1
+1
+3
Personal Protective
Equipment
-1
+1
-1
+1
-1
Redesign to Remove
Hazard
+1
+1
+1
+1
+1
+5
Train Workers to Avoid
Dangers
0
0
-1
-1
0
-2
-1
Ratings: -1 = bad, 0 = neutral, +1 = good
Bioengineering
Hierarchy of Controls per ANSI/AIHA Z10-2005
best
ELIMINATION
best
Design it out
SUBSTITUTION
Use something else
ENGINEERING CONTROLS
Isolation and guarding
ADMINISTRATIVE CONTROLS
Training and work scheduling
PERSONAL PROTECTIVE EQUIPMENT
Control
effectiveness
Required clothing (Last resort)
Business
value
Slide Adapted from ANSI/AIHA Z10-2005
Bioengineering
Occupational safety and health in design process
Stage
Activities
Problem definition
Identify specific needs for safety in the solution. Quantify allowable risks
Concept selection
Identify concepts with potential for safety; evaluate concepts using risk
analysis techniques
Preliminary design
Eliminate hazards, if possible; substitute less hazardous
agents/processes; establish risk minimization targets for remaining
hazards; assess risk; and develop risk control alternatives
Detailed design
Select safety controls; conduct process hazard reviews
Procurement
Develop specifications for procurements; develop “checks and tests” for
safety acceptance testing on procured items
Prototype fabrication
Control fabrication site safety and fabricator safety
Preliminary
deployment
Conduct “checks and tests”; pre-start up safety reviews; develop SOPs;
risk/exposure assessment; and management of residual risks
Start up and use
Education, management of change, modification of SOPs
Graphic: Courtesy of Denny Davis
Bioengineering
Safety Payoff During Design
High
Conceptual design
Detailed design
Ability to
influence
safety
Procurement
Fabrication
Start-up
Low
Project timeline
[Adapted from Szymberski 1997]
Bioengineering
Examining safety case studies
Bioengineering examples of safety risks
• For each case, identify the following:
1. Potential accident
2. Potential impacts
3. Candidate actions to alleviate risks
Bioengineering
Bioengineering safety – mechanical risk
• One of the most ubiquitous mechanical risks to workers in
biomedical environments is a needle stick injury.
• Among health care workers in the United States it is
estimated that 600-800 thousand needle stick injuries
occur each year 1.
• Needle stick injuries can lead to contraction of serious
blood borne pathogens.
• Needle stick injuries are under-reported.
1. Trim CJ, Elliott TSJ (2003)
Bioengineering
Bioengineering safety – mechanical risk
• View the video 1of a needle stick case
study
• After viewing the video, brain storm
ways PtD concepts could be applied
to the problem.
• Compare the results of the
brainstorming session to the standards
found here2:How to Prevent
Needlestick and Sharps Injuries
Video courtesy of the Centers for Disease Control
Bioengineering
Bioengineering safety – hazardous materials
• Many bioengineering environments involve laboratory settings.
There are many hazards that can occur in these settings due to
hazardous materials. These can be of biological, chemical, explosive
nature or due to their physical size such as nanomaterials.
• View the video1 highlighting accidents that have occurred in
laboratory settings.
Source: U.S. Chemical Safety and Hazard Investigation Board
Bioengineering
Bioengineering safety – hazardous materials
• How could you design a handling process that would
eliminate the risk of fire due to pyrophoric materials
coming in contact with the air?
• What other safeguards should have been in place?
• Hazardous materials come in a variety of types including
chemical, biological and now nanoparticle materials.
There are standards for handling each type.
Bioengineering
Bioengineering safety – Surgical Fires
• View this video from the FDA - Preventing Surgical Fires
• Surgical fires are a good example of cascading events
where multiple factors coincide to create an accident.
• In Bioengineering, the multidisciplinary environment
requires being alert to interacting events (originating from
different individuals) leading to an unsafe condition
Bioengineering
QUIZ: What Have You Learned?
1. Define “Prevention through Design” in the context of increasing
safety in a workplace environment.
2. List four general ways in which safety can be improved, and order
these according to the “hierarchy of controls” for achieving safety.
3. Give three reasons why safety makes good business sense.
4. Explain how embracing “Prevention through Design” might affect
what engineers do during the problem definition stage of design.
5. Who is NIOSH and how might NIOSH assist in an engineer’s work?
Bioengineering
Summary
• Accidents don’t just happen. Many elements can impact
the risk for an incident.
• The most effective way to prevent unsafe conditions is to
anticipate them and design them out.
• As a bioengineering professional, this is an important
responsibility that is part of your job.
Bioengineering
References Cited in Lesson
• CFR. Code of Federal Regulations. Washington, DC: U.S.
Government Printing Office, Office of the Federal Register.
• BLS [2010a]. Census of Fatal Occupational Injuries Summary,
2010. Fatal occupational injuries by industry and selected
event or exposure. Revised CFOI data from 2010. Washington,
DC: U.S. Department of Labor, Bureau of Labor Statistics,
Safety and Health Statistics Program.
[www.bls.gov/iif/oshwc/cfoi/cftb0250.pdf].
• BLS [2002-2010]. Census of Fatal Occupational Injuries Charts,
1992-2010 (revised data). Four most frequent work-related
fatal injury events, 1992–2010. Washington, DC: U.S.
Department of Labor, Bureau of Labor Statistics, Safety and
Health Statistics Program.
[www.bls.gov/iif/oshwc/cfoi/cfch0009.pdf].
Bioengineering
References Cited in Lesson (continued)
• BLS [2010b]. Industry Injury and Illness Data - 2010. Nonfatal
(OSHA recordable) injuries and illnesses. Industry incidence
rates and counts. Washington, DC: U.S. Department of Labor,
Bureau of Labor Statistics, Safety and Health Statistics
Program. [www.bls.gov/iif/oshwc/osh/os/ostb2813.txt].
• AIHA [2005]. Occupational health and safety management
systems. American Industrial Hygiene Association, Fairfax, VA.
ANSI/AIHA Z10-2005.
• Szymberski R [1997]. Construction project planning. TAPPI J
80(11):69–74.
• Trim CJ, Elliott TSJ [2003]. A review of sharps injuries and
preventative strategies. J Hosp Infect 53:237–242.
Bioengineering
References Cited in Lesson (continued)
• CDC [2012] Stop Sticks : Video - NIOSH [Internet]. Available
from: http://www.cdc.gov/niosh/stopsticks/video.html
• CDC [2012]. NIOSH Publications and Products - Home
Healthcare Workers: How to Prevent Needlestick and Sharps
Injuries (2012-123) [Internet]. Available from:
http://www.cdc.gov/niosh/docs/2012-123/
• Yang L, Mullan B. [2011]. Reducing needle stick injuries in
healthcare occupations: an integrative review of the literature.
ISRN nursing 2011.
• CSB [date unknown]. Video Room Detail, U.S. Chemical Safety
and Hazard Investigation Board [Internet]. [cited 2012 Jul 3]
Available from:
http://www.csb.gov/videoroom/detail.aspx?VID=61.
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Additional References for Lesson #1
• CDC [2012]. Nanotechnology - NIOSH Workplace Safety and Health Topic
[Internet]. [date unknown];[cited 2012 Jul 3] Available from:
http://www.cdc.gov/niosh/topics/nanotech/
• CDC [2012]. NIOSH Publications and Products - General Safe Practices for
Working with Engineered Nanomaterials in Research Laboratories (2012147) [Internet]. [date unknown];[cited 2012 Jul 3] Available from:
http://www.cdc.gov/niosh/docs/2012-147/
• Song Y, Du X, Li X. [2009]. Exposure to nanoparticles is related to pleural
effusion, pulmonary fibrosis and granuloma. Eur. Respir. J. European
Respiratory Journal; 34(3):559–567.
• Rushton E, Jiang J, Leonard S, Eberly S, Castranova V, Biswas P, Elder A,
Han X, Gelein R, Finkelstein J, Oberdorster G. [2010]. Concept of
Assessing Nanoparticle Hazards Considering Nanoparticle Dosemetric
and Chemical/Biological Response Metrics. Journal of Toxicology and
Environmental Health, Part A; 73:5–6.
Bioengineering
Additional References for Lesson #1 (cont’d)
• O’Brien N, Cummins E. [2010]. Ranking initial environmental and human
health risk resulting from environmentally relevant nanomaterials.
Journal of Environmental Science and Health, Part A; 45(8):992–1007.
• Pacurari M, Castranova V, Vallyathan V. [2010]. Single- and Multi-Wall
Carbon Nanotubes Versus Asbestos: Are the Carbon Nanotubes a New
Health Risk to Humans? Journal of Toxicology and Environmental Health,
Part A; 73:5–6.
• Phillips JI, Green FY, Davies JC, Murray J. [2010]. Pulmonary and systemic
toxicity following exposure to nickel nanoparticles. American journal of
industrial medicine; 53(8):763–7.
• Video Room Detail - U.S. Chemical Safety and Hazard Investigation Board
[Internet]. [date unknown]; [cited 2012 Jul 3] Available from:
http://www.csb.gov/videoroom/detail.aspx?VID=61.
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Additional References for Lesson #1 (cont’d)
• CDC. NIOSH Pocket Guide to Chemical Hazards (NPG) [Internet]. [date
unknown];[cited 2012 Jul 3] Available from:
http://www.cdc.gov/niosh/npg/default.html.
• CDC. Workplace Safety and Health Topics - Chemicals - NIOSH [Internet].
[date unknown]; [cited 2012 Jul 3] Available from:
http://www.cdc.gov/niosh/topics/chemical.html.
• CDC. Biosafety in Microbiological and Biomedical Laboratories (BMBL)
5th Edition [Internet]. [date unknown];[cited 2012 Jul 3] Available from:
http://www.cdc.gov/biosafety/publications/bmbl5/index.htm.
• Mecklem RL, Neumann CM. [2003]. Defining and managing biohazardous
waste in U.S. research-oriented universities: a survey of environmental
health and safety professionals. J Environ Health; 66(1):17–22.[cited 2012
Jun 29].
Bioengineering
Additional References for Lesson #1 (cont’d)
• CDC. NIOSH [2009]. Publications and Products - Recommendations for
the Selection and Use of Respirators and Protective Clothing for
Protection Against Biological Agents (2009-132) [Internet]; [cited 2012 Jul
3] Available from: http://www.cdc.gov/niosh/docs/2009-132/.
• CDC. Occupational Exposure to Antineoplastic Agents: Introduction NIOSH Workplace Safety and Health Topic [Internet]. [date unknown];
[cited 2012 Jul 3] Available from:
http://www.cdc.gov/niosh/topics/antineoplastic/.
• Dreesen DW. [1980]. Identifying biohazards in university research. Am J
Public Health 1980 Oct; 70(10):1108–1110.[cited 2012 Jun 29].
• Cocchiarella L, Deitchman SD, Young DC. [2000]. Report of the Council on
Scientific Affairs. Biohazardous waste management: What the physician
needs to know. American Medical Association. Arch Fam Med 2000 Jan;
9(1):26–29.[cited 2012 Jun 29].
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