Chapter 11
Safety Engineering: Devices and
Processes
Paul King
Introductory map
Goals
To discuss
safety re:ABET
To discuss safety in medicine
To discuss designsafe
ABET Requirement
engineering practice major
design experience health, safety,
ethics,
Safety in BME
Safety in BME ...
The human cost of medical errors is high.
Based on the findings of one major study,
medical errors kill some 44,000 people in U.S.
hospitals each year. Another study puts the
number much higher, at 98,000. Even using the
lower estimate, more people die from medical
mistakes each year than from highway
accidents, breast cancer, or AIDS.
Nat'l
Acad Press Catalog: To Err Is Human:
Safety in BME ...
Preventable
hospital adverse outcomes
cost $25 Billion
medical tx, deaths, lost wages,
FOR MORE INFO...
Bogner, MS Human Error in Medicine, 1994
Safety in BME ...
The
use of medical devices differs from
the use of equipment in other industries in
the range of characteristics of users
FOR MORE INFO...
Bogner, MS, BIT 33 No 2 April/March 1999, 105-108
Safety in BME ...
Examples
of adverse events
blood glucose reagent strips - Denver CO
misloaded infusion pumps
walkers with hand brakes & wheels
air in infusion bags air embolus
enteral pump misloaded **
Pressure controlled vent. on child **
Geddes: Medical Device Accidents
Casey: Set Phasers on Stun & The Atomic Chef
Safety in BME ...
Iron
law - if equipment is designed
appropriately for human use in the first
place, the cost may be high, but the cost
is paid only once. If inappropriate designs
must be compensated for in trainingthe
cost is paid everyday. With inappropriate
design no assurances
FOR MORE INFO...
Weiner, E, Congressional Testimony Report 109, [Link]
1988:65-71
Freedom of Information Act
FOI
US government act
Any information not detrimental to
US welfare (intelligence, military
importance) must be accessible to
US citizens if requested
(May require proof of right & need to
know, may slowly get.)
One Result (via FDA)
[Link]
Search
for hill-rom & death in the
past 5 years
Search for death in the past 10 years
Other results:
[Link]
[Link]
htm
Lawsuits (later chapter)
FDA, CPSC, etc later
[Link]
designsafe
dse has developed a fast, easy-to-use tool for
engineers and safety professionals to incorporate
safety through design by:
identifying hazards
prompting engineers to think about hazards
which they otherwise might overlook
conducting a risk assessment for identified
hazards
reducing risks in a structured method
preventing accidents and reducing liability
designsafe
what
it is...
an engineering tool for improving product
designs and processes
a systematic method for conducting a taskbased safety analysis
a technique for eliminating and controlling
hazards
designsafe
what
it does...
gives designers a quick and easy tool to evaluate
safety issues through design
permits quick assessment of engineer's change
orders to safety issues
assists design engineers in completing a safety
analysis for their products/processes
helps companies identify potential hazards and
provides methods for elimination
prioritizes design activities related to risk
designsafe
what
are the benefits...
helps prompt remedy actions for existing hazards
can be employed at all stages of the life cycle of a
design
assists in obtaining the CE mark for assessing
European markets
can be printed for documentation or a technical file
helps assure all hazards are addressed to
completion
designsafe
Name:
Laser surgery
Description: Excision of tumors
Analyst Name(s): Casper
Guide sentence: When doing [task], the
[user] could be injured by the [hazard]
due to the [failure mode].
designsafe - design mode
User
surgeon
Task
invasive surgery
Hazard
shock
Failure Mode fault
Severity Serious
Probability
Possible
Risk Level
High
Remedy Eliminate by design
Status/Comments
to be done
designsafe - risk mode
Risk Level
High
User
maintenance personnel
Task
post operation
Hazard
hazardous waste handling
Failure Mode varies
Severity Serious
Probability
Possible
Remedy Train user other ***
Status/Comments
Techniques:
Eliminate
by design!!!!!!!!!!
Guard against
Warn of hazard
Train user
Personal Protective Equipment
Coke
machine example
designsafe example
Coke
machine
death
~
12 /year
Is this safe design?
Other methods
FMEA
Cause
and Effect arrow diagrams
Ergonomics (another chapter)
Hazard Analysis
Inherently safer design (Bhopal)
standards
Summary map