1. ©ECRI 2002 Risk Management-09 Mechanisms of Harm and Human Factors: SFDA Presentation November 2005 Joel J. Nobel, MD Founder & President Emeritus ECRI

2. Page 2 ©ECRI 2002 Risk Management-09 Discussion Topics Consequences of adverse events Perspectives on risk Mechanisms of harm Human factors Priorities

3. Page 3 ©ECRI 2002 Risk Management-09 Consequences of Adverse Events (1) Prolonged hospital stays Injury, disability, and death Liability and lawsuits Loss of time and money

4. Page 4 ©ECRI 2002 Risk Management-09 Consequences of Adverse Events(2) Loss of the ethical and moral high ground Loss of reputation of individuals Loss of reputation of institutions Evolution of a fearful, self-protecting institutional culture that is left behind

5. Page 5 ©ECRI 2002 Risk Management-09 General Observations on Risk (1) Most device related adverse events are preventable because the requisite body of knowledge exists.

6. Page 6 ©ECRI 2002 Risk Management-09 General Observations on Risk (2) Most adverse events occur because this knowledge is unknown by some individuals at a critical time and place or, if known, is not applied consistently.

7. Page 7 ©ECRI 2002 Risk Management-09 General Observations on Risk (3) Knowledge, even when known to an individual, is not applied consistently because of competing priorities, overwork, rushing, fear, fatigue, and psychological distraction.

8. Page 8 ©ECRI 2002 Risk Management-09 General Observations on Risk (6) Some critical knowledge has not yet evolved. What we don’t know yet can lead to adverse events. Therefore, all adverse events require reporting and competent analysis to determine cause and advance knowledge.

9. Page 9 ©ECRI 2002 Risk Management-09 Perspective on Risks Of all healthcare technologies, medications and medical and surgical procedures lead to many more injuries and deaths than do devices.

10. Page 10 ©ECRI 2002 Risk Management-09 What is the most common cause of patient injuries after medication- and procedure- related adverse effects? Falls from beds!

11. Page 11 ©ECRI 2002 Risk Management-09 Perspective on Risk The most common cause of equipment-related harm to patients is user error, not machine failures caused by design errors, manufacturing quality control, maintenance, service problems or ergonomic design of devices.

12. Page 12 ©ECRI 2002 Risk Management-09 The Causes of Medical-Device- Related Incidents (1) Device failure Device interaction User error Maintenance error Packaging error

13. Page 13 ©ECRI 2002 Risk Management-09 The Causes of Medical-Device- Related Incidents (2) Tampering Support system failure Environmental factor Idiosyncratic patient reaction

14. Page 14 ©ECRI 2002 Risk Management-09 Causes of Device Failure Design/labeling error Manufacturing error Software deficiency Random component failure Power-supply failure Failure of accessory

15. Page 15 ©ECRI 2002 Risk Management-09 Mechanisms of Device-Related Injury and Death (1) Overdose Suffocation/barotrauma Infection Embolism (gas/particulate) Skin lesion (puncture/cut/burn)

16. Page 16 ©ECRI 2002 Risk Management-09 Mechanisms of Device-Related Injury and Death (2) Electrocution Fire Performance failure Crushing Exsanguination

17. Page 17 ©ECRI 2002 Risk Management-09 Perspective on Risk Device-related harm to patients is frequently caused by failure to follow standard procedures, suboptimal skills at a critical moment, and failure to understand the basic principles of operation and limitations of the device.

18. Page 18 ©ECRI 2002 Risk Management-09 Human Factors & Device Incidents Human factors design (ergonomics) of medical devices impacts ease and safety of use and contributes to user error Human factors design of the care environment, culture and educational processes causes many more errors and inhibits prevention of risk

19. Page 19 ©ECRI 2002 Risk Management-09 Deficient Human Factors Design of Devices: Historical Examples Defibrillator failures (mode switches) Infusions pumps Patient beds Electrosurgical units

20. Page 20 ©ECRI 2002 Risk Management-09 What Inhibits Recognition & Reporting of Device Adverse Events? (1) Because adverse events only happen occasionally, they lie outside the experience of most personnel. Physicians and nurses frequently compensate for suboptimal conditions and their own errors, adjust on the fly, and regard some problems as “routine.” They are more gratified by their own effort to overcome a problem than to prevent one.

21. Page 21 ©ECRI 2002 Risk Management-09 What Inhibits Recognition of Device Adverse Events? (2) Failure to be open to questioning or corrections because of: – Authoritative environment or personalities – Superior-subordinate psychodynamics – Male-female psychodynamics

22. Page 22 ©ECRI 2002 Risk Management-09 Risk Management Strategies and Approaches 1.Systematically report incidents 2.Prevent adverse events by reducing existing knowledge to consistent practice 3.Educate and train healthcare personnel continuously 4.Determine the causes of adverse events by root- cause analysis 5.Incorporate lessons learned from analysis into routine practice

23. Page 23 ©ECRI 2002 Risk Management-09 Strategies in Risk Management Prevent errors and adverse events. When adverse events occur, determine the root causes through careful analysis. Redesign and implement processes, procedures, and behavior to neutralize such causes. Reevaluate frequently. Train frequently. Facilitate upward and downward communication.

24. Page 24 ©ECRI 2002 Risk Management-09 Why Problem Reporting? Lessons learned from analysis must be: –Openly shared –Incorporated into the general body of medical, nursing, and administrative knowledge –Incorporated into revised practices

25. Page 25 ©ECRI 2002 Risk Management-09 To Minimize Device-Related Risks: Emphasize prevention according to a rational order of priorities. Base priorities on history of frequency and severity of harm. Begin by understanding which devices do the greatest harm.

26. Page 26 ©ECRI 2002 Risk Management-09 Setting Device Priorities If data is available, which types of devices most frequently cause significant harm? If data is available, does the incidence of harm vary with the service supplier? If so, why? If data is not available, establish a program to get data, and base priorities on the experience of other national health systems.

27. Page 27 ©ECRI 2002 Risk Management-09 U.S. Experience (1) Most Frequently Reported Harmful External Devices Anesthesia machines Cardiac interventional catheters Cardiopulmonary bypass systems Defibrillators Dialysis systems

28. Page 28 ©ECRI 2002 Risk Management-09 U.S. Experience (2) Most Frequently Reported Harmful External Devices Disposable surgical trocars Electrosurgical (surgical diathermy) units IV pumps Surgical staplers Ventilators

29. Page 29 ©ECRI 2002 Risk Management-09 Observation (1) Of these top 10 harmful devices, half (5) are used only in the operating theatre. 3 additional ones may be used in the operating theatre. 3 are used in almost all areas of the hospital.

30. Page 30 ©ECRI 2002 Risk Management-09 Observation (2) The most frequently reported problem device is the infusion pump. 3 of the 10 devices are highly dependent on physician technique with very simple devices (i.e., interventional catheters, trocars, and staplers)

31. Page 31 ©ECRI 2002 Risk Management-09 Observation (3) 7 of these 10 devices require mains voltage electrical energy. But in 6 of these 7 devices, almost all reported problems are mechanical. One device, the defibrillator, has frequently reported battery- and power-supply problems (i.e., too little rather than too much electricity).

32. Page 32 ©ECRI 2002 Risk Management-09 Address User Error! Train, test, retrain, and retest. Physicians, nurses, and clinical technologists all require frequent training. Select and buy devices with good human factors (i.e., ergonomic) design.

33. Page 33 ©ECRI 2002 Risk Management-09 Educate Device Users Have them: –Explore www.mdsr.ecri.org –Read case histories of deaths and injuries caused by devices they use in their specialty –Download and publicize safety posters for specific devices

34. Page 34 ©ECRI 2002 Risk Management-09 Detailed Case Histories ECRI maintains a detailed description of many device-related safety issues based on critical case histories on a special Web site. You can search by hospital department specialty, device type, or failure mechanism. Go to www.mdsr.ecri.org

35. Page 35 ©ECRI 2002 Risk Management-09 ECRI Problem Reporting Network ECRI is a member of the Global Harmonization Task Force, Study Group 2—Medical Device Vigilance—Post- Market Surveillance

36. Page 36 ©ECRI 2002 Risk Management-09 Accident Investigation Undertaken for hospitals, public health agencies, health professionals, and insurers Purpose: determine what happened, why, and design prevention techniques On-site and laboratory investigations

37. Page 37 ©ECRI 2002 Risk Management-09 Accident Investigation Rapid response by interdisciplinary team Investigated soon after incident Performed worldwide

38. Page 38 ©ECRI 2002 Risk Management-09 Which is most dangerous if used excessively? EEG? ECG? EGG? EMG?

39. ©ECRI 2002 Risk Management-09 Thank you Page 39