1. ©ECRI 2007 1 VII. Human Factors Considerations in Medical Device Accident Investigation TRAINING SEMINAR ON MEDICAL DEVICE ACCIDENT INVESTIGATION for Kingdom of Saudi Arabia Saudi Food & Drug Authority Riyadh 11-14 February, 2007 Presenter: Mark E. Bruley Vice President, Accident and Forensic Investigation ECRI 5200 Butler Pike, Plymouth Meeting, PA, 19642 USA Tel: +1 610-825-6000, ext. 5223 E-mail: mbruley@ecri.org Web Sites: www.ecri.org www.mdsr.ecri.org

2. ©2007 ECRI 2 Human Factors Considerations in Surgical Accidents with Medical Devices uECRI uDevice Accidents: Causes uUser Error and Human Factors in Surgery uDevelopments in Human Factors uExamples and Case Histories

3. ©2007 ECRI 3 ECRI and Human Factors (HF) 30 years of HF application to: –Comparative medical device evaluations –Investigation of thousands of problem reports –Accident Investigations –Sponsored 1989 international symposium on Human Factors in Medical Devices

4. ©2007 ECRI 4 Human Factors Means different things to different people –Visual Displays –Anthropometrics –Time-motion studies –Safe design that is not prone to causing misuse Ergonomics ( User-Tool_Relationship) Definition of Human Factors: Aggregate of design characteristics that determine the work relationship of product and user.

5. ©2007 ECRI 5 Human Factors: Definitions Error: –Actions or omissions leading to results that were neither foreseen or intended –Most errors are benign –Combinations of errors lead to accidents Slip: Correct action done incorrectly Mistake: Wrong action done correctly or incorrectly

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7. ©2007 ECRI 7 Human Factors Considerations in Surgical Accidents with Medical Devices uECRI uDevice Accidents: Causes uUser Error and Human Factors in Surgery uDevelopments in Human Factors uExamples and Case Histories

8. ©2007 ECRI 8 Causes of Device Accidents (* Human Factors related) uDevice Factors uExternal Factors uTampering and Sabotage uSupport System Failures uUser Factors (Error and Human Factors) If findings are undecided, consider idiosyncratic patient reaction to device or therapy.

9. Copyright ECRI 2000 9 Accident Causes: Device Factors Device Failure Design or Labeling* Manufacturing Packaging* Software Random Component Failure Failure of an Accessory

10. ©2007 ECRI 10 Accident Causes: Device Factors (cont.) Invalid Device Foundation Device Interactions Improper maintenance, testing, repair, or lack or failure of pre-use incoming inspection Device Interactions * Improper Modification *

11. ©2007 ECRI 11 Accident Causes: Support System Failure Poor device evaluation during tendering process Lack or failure of incoming and pre- use inspections Using inappropriate devices Cleaning, sterilization, storage *

12. ©2007 ECRI 12 Human Factors Considerations in Surgical Accidents with Medical Devices uECRI uDevice Accidents: Causes uUser Error and Human Factors in Surgery uDevelopments in Human Factors uExamples and Case Histories

13. 13 Device Accidents

14. ©2007 ECRI 14 Causes: User Error 50 - 70% of Device Accidents Pre-use inspections Labeling * Mis-assembly * Mis-connection * Improper (“bad”) connection * Incorrect clinical use Incorrect control settings * Incorrect programming * Spills Abuse * Inappropriate reliance on automated features* Failure to monitor Maintenance or incoming inspection

15. ©2007 ECRI 15 Human Factors and the O.R. Domain (Gaba 1994. In Bogner, ed. Human Error in Medicine, Hillsdale, NJ, Lawrence Erlbaum Assoc.) Complex and dynamic setting (ICU and Emergency Dept. also) Multiple clinical specialists (surg, anes, neuro, nurse, perfusion) Significant Risk Uncertainty/ Fatigue Limited space/time EMI Hundreds of devices/instruments

16. ©2007 ECRI 16 Human Factors: The O.R.’s Structure vs. Aviation Model Useful in many respects, but limited in scope Medical Devices vs. Aviation –5,000:1 –Medical Devices - 5,000 device types, plus subsystems and components –Aviation - 1 aircraft, plus subsystems and component

17. ©2007 ECRI 17 Human Factors: O.R. vs. Aviation Model Both decentralized –1000s of operations/flights per day –1000s of hospitals vs. few air carriers Aviation is highly regulated: O.R.s are not Aircraft work setting (cockpits) are integrated systems when procured O.R. equipment and systems are procured piecemeal

18. ©2007 ECRI 18 Device - User Device - Patient Device - Accessories (Including disposable devices) Device - Environment –Hospital, Ambulance, Home Human Factors: Device Interfaces

19. ©2007 ECRI 19 Device Interfaces Environment Hospital / Home Patient Device User Accessories/Disposables Breathing Circuits Heated Humidifier Electric Power Medical Gas Heat, Humidity, Light Ventilator

20. ©2007 ECRI 20 Difficulties in Designing Ideal Medical Devices for O.R. (Gaba, ibid.) Users usually under great stress Smart user’s false confidence in how to do with the device what they want to do. Users unfamiliarity with devices limitations and subtleties of use is common User training time is minimal Few stds/regs on integrated HF performance Existing stds/guidelines cover only sub-systems of HF problem

21. ©2007 ECRI 21 Human Factors: Common Conventions Counter-intuitive designs Oxygen regulator: Clockwise to increase flow (like volume control) Oxygen cylinder tank valve: Counter- clockwise to shut off

22. ©2007 ECRI 22 Human Factors Considerations in Surgical Accidents with Medical Devices uECRI uDevice Accidents uMechanisms of Injury uCauses of Accidents uUser Error and Human Factors in Surgery uDevelopments in Human Factors uExamples and Case Histories

23. ©2007 ECRI 23 Human Factors: Error Reduction Anesthesia Long studied specialty in regard to error Gaba, Cook, Cooper, Woods Anesthesia Patient Safety Foundation (USA) Simulators and training mannequins 24% committed error leading to fatality (MacDonald JA. Anes 1985;63:A497.)

24. ©2007 ECRI 24 Databases on Problem Reports and/or Technology Assessment ECRI’s Health Device Alerts (HDA) ECRI’s Medical Device Safety Reports – www.mdsr.ecri.org US FDA: MDR, PRP, and MAUDE –www.fda.gov/cdrh Australia: Therapeutic Goods Admin. European Union Medical Device Directive (MDD) (future)

25. ©2007 ECRI 25 Human Factors: Error Reduction Design Guidance Human Factors Design Guides/Texts AAMI Human Factors Engineering Guidelines and Preferred Practices for the Design of Medical Devices. ANSI/AAMI HE 48 1993. FDA (USA) “Do It By Design: An Introduction to Human Factors in Medical Devices.” www.fda.gov/cdrh/HumanFactors.html

26. ©2007 ECRI 26 Human Factors: Error Reduction Realizations Device Design: –Total error elimination by design is not possible. Education has only a partial role No “Big Fix”

27. ©2007 ECRI 27 Human Factors: Error Reduction. Training Frequently focused on problematic staff Tends to point blame Seldom has positive long-term effect Targeted Training –Some positive effect –Tool use –Effective staff communication

28. ©2007 ECRI 28 Human Factors: Error Reduction. Users Users’ continuing awareness of hazards is essential Hospital’s Responsibilities –Clinical Evaluations –Equipment Acquisition Tendering Process

29. ©2007 ECRI 29 Human Factors: Error Reduction. Vendors Vendors’ Responsibilities –Technical design –The user’s role –The use environment –Instructions / labeling

30. ©2007 ECRI 30 Human Factors Considerations in Surgical Accidents with Medical Devices uECRI uDevice Accidents: Causes uUser Error and Human Factors in Surgery uDevelopments in Human Factors uExamples and Case Histories

31. ©2007 ECRI 31 Examples and Case Histories High Risk Devices –Surgical Diathermy (electrosurgery) /Lasers Fires (NYU Med Cntr; Cedars-Sinai) –Nitrogen Powered Irrigation Systems Misconnection and gas embolism –Arthroscopic Instruments Breakage (Powered cutters; Small instruments) –Trocars Hand Grip Technique –Cranial Perforators Assembly and Pre-Use Checkout

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36. ©2007 ECRI 36 Examples and Case Histories High Risk Devices –Surgical Diathermy (electrosurgery) /Lasers Fires (NYU Med Cntr; Cedars-Sinai) –Nitrogen Powered Irrigation Systems Misconnection and gas embolism –Arthroscopic Instruments Breakage (Powered cutters; Small instruments) –Trocars Hand Grip Technique –Cranial Perforators Assembly and Pre-Use Checkout

37. ©2007 ECRI 37 Human Factors and Device Accidents in Surgery: The Future Continuing research in HF Need for ongoing user vigilance of device hazards Design for error avoidance and system error tolerance User preference in design and selection versus device performance (especially important in tendering process)

38. ©2007 ECRI 38 Again – Human Factors: Error Reduction Design Guidance Human Factors Design Guides/Texts AAMI Human Factors Engineering Guidelines and Preferred Practices for the Design of Medical Devices. ANSI/AAMI HE 48 1993. FDA (USA) “Do It By Design: An Introduction to Human Factors in Medical Devices.” www.fda.gov/cdrh/HumanFactors.html

39. ©2007 ECRI 39 QUESTIONS? VII. Human Factors Considerations in Accident Investigation