Chapter 11 Safety Engineering: Devices and Processes

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Chapter 11Safety Engineering Devices and
Processes

• Paul King

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Introductory map
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Goals

• To discuss safety reABET
• To discuss safety in medicine
• To discuss designsafe

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ABET Requirement

• engineering practice major design experience
  health, safety, ethics,

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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

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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

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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

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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

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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

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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.)

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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

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Other results

• http//www.clmi-training.com/
• http//www.clmi-training.com/safety_links__freebie
  s.htm
• http//www.nsc.org/lrs/statinfo/odds.htm
• Lawsuits (later chapter)
• FDA, etc later
• http//www.designsafe.com (Click on testimonials
  )

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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

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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

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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

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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

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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.

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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

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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

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designsafe example

• Coke machine death
• 12 /year

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Is this safe design?
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Other methods

• FMEA
• Cause and Effect arrow diagrams
• Ergonomics (another chapter)
• Hazard Analysis
• Inherently safer design (Bhopal)
• standards

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Summary map