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