1. Chapter 11 Safety Engineering: Devices and Processes Paul King

2. Introductory map

3. Goals To discuss safety re:ABET 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... 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: 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, … Bogner, MS Human Error in Medicine, 1994 FOR MORE INFO...

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” –Bogner, MS, BIT 33 No 2 April/March 1999, 105- 108 FOR MORE INFO...

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 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...

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. htmttp://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 Usersurgeon Task invasive surgery Hazardshock Failure Mode fault Severity Serious Probability Possible Risk LevelHigh RemedyEliminate by design Status/Commentsto 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