chapter 11 safety engineering: devices and processes paul king
TRANSCRIPT
Chapter 11Chapter 11Safety Engineering: Devices and Safety Engineering: Devices and ProcessesProcesses
Paul King
Introductory mapIntroductory map
GoalsGoals
To discuss safety re:ABETTo discuss safety in medicineTo discuss designsafe…
ABET RequirementABET Requirement
… engineering practice … major design experience … health, safety, ethics, …
Safety in BMESafety in BME
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 ...Safety in BME ...
Preventable hospital adverse outcomes cost $25 Billion – medical tx, deaths, lost wages, …
Bogner, MS Human Error in Medicine, 1994
FOR MORE INFO...
Safety in BME ...Safety in BME ...
“The use of medical devices differs from the use of equipment in other industries in the range of characteristics of users”
– Bogner, MS, BIT 33 No 2 April/March 1999, 105-108
FOR MORE INFO...
Safety in BME ...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 ...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 training…the cost is paid everyday. With inappropriate design … no assurances
Weiner, E, Congressional Testimony… Report 109, U.S.House 1988:65-71
FOR MORE INFO...
Freedom of Information ActFreedom of Information Act
FOI – US government actAny 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)One Result (via FDA)
http://www.fda.gov/cdrh/maude.html Search for hill-rom & death in the
past 5 yearsSearch for death in the past 10 years
Other results:Other results:
http://www.clmi-training.com/ ht
tp://www.nsc.org/lrs/statinfo/odds.htm
Lawsuits (later chapter)FDA, CPSC, etc – laterhttp://www.designsafe.com
designsafedesignsafe
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
designsafedesignsafe
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
designsafedesignsafe
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
designsafedesignsafe
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
designsafedesignsafe
Name: Laser surgeryDescription: Excision of tumorsAnalyst Name(s): CasperGuide sentence: When doing [task], the
[user] could be injured by the [hazard] due to the [failure mode].
designsafe - design modedesignsafe - 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 modedesignsafe - 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:Techniques:
Eliminate by design!!!!!!!!!!Guard againstWarn of hazardTrain userPersonal Protective Equipment
Coke machine example
designsafedesignsafe example example
Coke machine … death
~ 12 /year
Is this safe design?Is this safe design?
Other methodsOther methods
FMEACause and Effect – arrow diagramsErgonomics (another chapter)Hazard AnalysisInherently safer design (Bhopal)… standards
Summary mapSummary map