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Chapter 11 Safety Engineering: Devices and Processes

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'The human cost of medical errors is high. Based on the findings of one major study, medical errors kill some 44,000 people ... enteral pump misloaded ... – PowerPoint PPT presentation

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Title: Chapter 11 Safety Engineering: Devices and Processes


1
Chapter 11Safety Engineering Devices and
Processes
  • Paul King

2
Introductory map
3
Goals
  • To discuss safety reABET
  • To discuss safety in medicine
  • To discuss designsafe

4
ABET Requirement
  • engineering practice major design experience
    health, safety, ethics,

5
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

6
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

7
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

8
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

9
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,
    U.S.House 198865-71

10
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.)

11
One Result (via FDA)
  • http//www.fda.gov/cdrh/maude.html
  • Search for hill-rom death in the past 5 years
  • Search for death in the past 10 years

12
Other results
  • http//www.clmi-training.com/
  • http//www.nsc.org/lrs/statinfo/odds.htm
  • Lawsuits (later chapter)
  • FDA, CPSC, etc later
  • http//www.designsafe.com

13
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

14
designsafe
  • what it is...
  • an engineering tool for improving product designs
    and processes
  • a systematic method for conducting a task-based
    safety analysis
  • a technique for eliminating and controlling
    hazards

15
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

16
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

17
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.

18
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

19
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

20
Techniques
  • Eliminate by design!!!!!!!!!!
  • Guard against
  • Warn of hazard
  • Train user
  • Personal Protective Equipment
  • Coke machine example

21
designsafe example
  • Coke machine death
  • 12 /year

22
Is this safe design?
23
Other methods
  • FMEA
  • Cause and Effect arrow diagrams
  • Ergonomics (another chapter)
  • Hazard Analysis
  • Inherently safer design (Bhopal)
  • standards

24
Summary map
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