1. ©ECRI 2007 1 Causes of Device Accidents (taxonomy used in MDSR) Device Factors External Factors Tampering and Sabotage Support System Failures User Factors

2. ©ECRI 2007 2 Causes: Device Factors Device Failure Design or Labeling Error Manufacturing error Packaging Error Software Deficiency Random Component Failure

3. ©ECRI 2007 3 Causes: Device Factors (cont.) Failure of an Accessory Invalid Device Foundation Device Interactions Improper maintenance, testing, repair, or lack or failure of pre-use incoming inspection Device Interactions Improper Modification

4. ©ECRI 2007 4 Causes: External Factors Power Supply Failure –Including compressed medical gases Medical Gas / Vacuum Systems Electromagnetic or Radio Frequency Interference (EMI or RFI) Environmental Conditions –Temperature, Humidity, Light

5. ©ECRI 2007 5 Causes: Tampering/Sabotage (Rare) Family Member Patient Healthcare worker –Doctor –Nurse –Aide Enemy

6. ©ECRI 2007 6 Causes: Support System Failure Poor Device Evaluation During Tendering Process Lack or Failure of Incoming and Pre-Use Inspections Using Inappropriate Devices Improper Storage Failure to Train and Credential Poor Incident/Recall Reporting System Lack of Competent Accident Investigation Failure to Impound Incident Devices Error in Hospital Policy

7. ©ECRI 2007 7 Mechanisms of Injury Taxonomy (used in MDSR) Overdose Underdose Wrong Drug Infiltration Extravasation Barotrauma Suffocation Hemolysis Coagulopathy Exsanguination Hemorrhage Ischemia Hypothermia Hyperthermia

8. ©ECRI 2007 8 Mechanisms of Injury Failure to Deliver Therapy Monitoring Failure Mis-diagnosis Electrical Shock/ Electrocution Burn (thermal, chemical, elec.) Pressure Necrosis Mechanical (cut, crush, puncture) Embolism (gas or particulate)

9. ©ECRI 2007 9 Mechanisms of Injury Infection Particulates Anaphylaxis Fire

10. ©ECRI 2007 10 Oops!

11. ©ECRI 2007 11 Device Accidents

12. ©ECRI 2007 12 Causes: User Error User Error vs. Device Malfunction –Examine instructions and labeling. –Was device used according to instructions? –Was device properly assembled? –Was the user familiar with the instructions? –Does device design invite user error? –If findings are undecided, consider idiosyncratic patient reaction to device or therapy.

13. ©ECRI 2007 13 User Error: References Institute of Medicine, Committee on Quality of Health Care in America. Kohn LT, Corrigan JM, Donaldson MS, eds. To Err is Human: Building a Safer Health System. Washington, D.C.: National Academy Press, 1999. Available from National Academy Press, tel:800-624-6242 or 202-334- 3313. Leape LL. Error in medicine. JAMA 1994, Dec 21: 272(23); 1851-1857.

14. ©ECRI 2007 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. ©ECRI 2007 15 Causes: User Error (cont.) Improper maintenance, testing, repair, or lack or failure of pre-use incoming inspection: –Rare cases –Infant Incubators: back-up thermostats mis-set –Pneumatic tourniquet: poor grounding and EMI)

16. ©ECRI 2007 16 User Error vs. Device Malfunction Examine instructions and labeling. Was device used according to instructions? Was device properly assembled? Was the user familiar with the instructions? Does device design invite user error? If findings are undecided, consider idiosyncratic patient reaction to device or therapy.

17. ©ECRI 2007 17 User Error: Patient as User Homecare Technologies –Orthopedic Implants, IV & Feeding Pumps, Ventilators, Glucose Meters, Oxygen Concentrators, Dialysis Mis-Use Device design and labeling for lay user even more important

18. ©ECRI 2007 18 Accident Investigation Overview Government and Ministry of Health Role Difficulties Device Interfaces Preservation of Evidence Third Party Investigations

19. ©ECRI 2007 19 Government’s Role Public Safety Regulatory oversight of vendors and importers Data Collection Data Analysis Investigation? Recall Authority

20. ©ECRI 2007 20 Difficulties Diversity of Technologies Numerous Causes of Injuries Lines of Communication Variable Biological System (i.e., Patient) Limited information available to manufacturer

21. ©ECRI 2007 21 Difficulties: Diverse Technologies >5000 Device Types Unique Testing and Investigative Approaches for Each Technology The Investigative Process is what is important

22. ©ECRI 2007 22 Patient’s Attorney Difficulties: Lines of Communication Suppliers /Mfrs. Risk Manger Clinicians Administration Purch. Dept. Biomedical Eng. Third Party Investigator Regulators AttorneysInsurer

23. ©ECRI 2007 23 ECRI Case Histories Accident Investigator –Fatal Misconnection –Hazards of New Technology –Junk Science and Expert Testimony

24. ©ECRI 2007 24 Cardiopulmonary Bypass Accidents: Involved Devices Reusable –Bypass Pump Consoles –Gas Blenders –O2 Saturation Mon. –Anesth. Vaporizers –Gas Regulators –Gas Flowmeters –Bubble Detectors Disposable –Tubing Circuits –Oxygenators –Arterial Blood Filters –Cardiotomy Reservoirs

25. ©ECRI 2007 25 Cardiopulmonary Bypass Accidents: Mechanisms of Injury Gas Embolism Coagulopathy Exsanguination Anoxia Hypersensitivity Haemolysis Others

26. ©ECRI 2007 26 Gas Embolism Accidents C-P Bypass Units Haemodialysis Units Blood Recovery Systems (Cell Savers) Gas-Cooled Laser Fibers Insufflators –Laparoscopic –Hysteroscopic –Ophthalmic –Arthroscopic Central Venous Cath. Ruptured Balloons: –Intra-Aortic Pumping –PTCA Balloons Nitrogen Gas Powered Surgical Instruments Infusion Devices Radiographic Dye Injectors

27. ©ECRI 2007 27 Electrosurgical (ESU) Accidents Return electrode (“grounding pad”) –Poor Site Preparation –Non-uniform Conductivity –Repositioning (pad or patient) Alternate Current Pathways (injury away from operative site or pad) Malfunction of ESU Active Pencil Failure to use holster Failure to use activation tone Organ Perforations

28. ©ECRI 2007 28 Physiologic Monitoring Accidents: Risk/Accident Considerations Alarm Design Accessory Transducers –Blood pressure –Intra-cranial Pressure –Intrauterine pressure Accessory Cables and Leads Software –Arrhythmia Detection –Patient Data Systems –Memory/Trending Telemetry Systems Equipment Interfaces –Bedside Monitors –Central Stations –Telemetry Transmitters –Patient Data Systems Human Factors

29. ©ECRI 2007 29 Ventilator Accidents: Risk/Accident Considerations Alarm Design Accessories –Breathing Circuits –Bacterial Filters –Humidifiers –External Monitors Software –Version –Patient Data Systems Equipment Interfaces –Central Stations –Patient Data Systems Human Factors

30. ©ECRI 2007 30 Device Interfaces Device - User Device - Patient Device - Accessories (Including disposable devices) Device - Environment –Hospital –Ambulance –Home

31. ©ECRI 2007 31 Device Interfaces Environment Hospital / Home Patient Device User Accessories/Disposables Breathing Circuits Heated Humidifier Exhalation Filter Electric Power Medical Gas Heat, Humidity, Light Ventilator

32. ©ECRI 2007 32 Medical Device Problem Recognition: Based on Patient-Centered Concept Users: Many devices used for diagnosis, treatment, monitoring, and care Accessories/Disposables  Breathing Circuit  Heated Humidifier  Exhalation Filter  Tracheal Tube  Water Trap Medical Devices and Equipment Patient User Facility/Home Environment  Medical Gas  Electric Power  Heat, Humidity, Light  Support Systems  Medications  Reagents  Solutions  Dyes

33. ©ECRI 2007 33 Preservation of Evidence Disposables - Save all!! Photographs Control Settings Error Codes in Device Memory!!! Cleaning/Processing Sequestering Devices

34. ©ECRI 2007 34 Preservation of Evidence For Non-Serious Event: –Hospitals do own investigation –Return device to vendor (see form letter in AI book chapter) Specify no destructive testing –Document correspondence & shipping documents

35. ©ECRI 2007 35 Preservation of Evidence For Serious Event: –Hospitals typically never give up the device Vendor Regulatory Authority? –Investigate in-house (or with 3rd party)

36. ©ECRI 2007 36 Third Party Investigation: When is it indicated? Serious Events Augment, parallel or substitute your investigation If high probability of litigation Insufficient workforce, expertise, or test equipment Expert qualifications needed Elimination of bias Political considerations

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38. ©ECRI 2007 38

39. ©ECRI 2007 39 Accident Investigation Guidelines: Getting Started Immediate Action Plan (hospital or vendor) Investigation Team –Members (each with own responsibilities): Clinical Department Head Clinical Staff Members Risk Manger Biomedical Engineering Legal Counsel Safety Committee –Not on Team: Anyone responsible for patient or device.

40. ©ECRI 2007 40 Responsibilities Clinicians (Doctors, Nurses): Do’s –Respond to the injury –Preserve evidence –Record information –Instruct witnesses to temporarily withhold comments –Report incident to Risk Manager, etc. –Notify Biomedical Engineering –Help determine if device caused or contributed to incident

41. ©ECRI 2007 41 Responsibilities Clinicians (Doctors, Nurses): Do Not’s –Contact vendors/suppliers –Contact Government Agencies –Release equipment –Test equipment independently These “Do Not’s” apply immediately after the incident but may become “Do’s” later.

42. ©ECRI 2007 42 Responsibilities Biomedical Engineers: Do’s –Impound devices –Consult with clinicians to determine device contribution to incident –Help determine if 3rd party investigation is needed

43. ©ECRI 2007 43 Responsibilities Biomedical Engineers: Do’s –Help collect information Serial Numbers Model Numbers Inspection records Software revisions Displayed data Instrument settings Alarm settings Maintain device memory data!!! Other relevant parameters

44. ©ECRI 2007 44 Responsibilities Biomedical Engineers: Do’s –List other involved equipment (disposables too) –Determine sources of power, compressed gases, and vacuum –Collect service information Who serviced last When last services What modifications made, before or after incident –Research other reported problems (information resources)

45. ©ECRI 2007 45 Responsibilities Biomedical Engineers: Do’s –When Asked to: Examine equipment Test to determine if device caused or contributed to incident Prepare report

46. ©ECRI 2007 46 Responsibilities Biomedical Engineers: Do Not’s –Contact vendors/suppliers –Contact Government Agencies –Release equipment –Test equipment independently These “Do Not’s” apply immediately after the incident but may become “Do’s” later.

47. ©ECRI 2007 47 Responsibilities Risk Manager - Hospital: QA/Reg Affairs Manager - Vendor: –Develops investigation strategy –Coordinates investigation –Collects information about the incident –Consult with clinicians to determine device contribution to incident

48. ©ECRI 2007 48 Responsibilities Risk Manager - Hospital: QA/Reg Affairs Manager - Vendor: –Controls communication with outside parties –Helps determine liability –Takes steps to to prevent similar incidents –Liaison with Insurer

49. ©ECRI 2007 49 Responsibilities Risk Manager: QA/Reg Affairs Manager - Vendor: –Takes steps to minimize damage to hospital’s/vendor’s reputation –Helps determine need for 3rd party investigation –Communicates with all departments regarding conclusions of the investigation

50. ©ECRI 2007 50 Responsibilities Risk Manager: QA/Reg Affairs Manager - Vendor: – Helps determine whether device(s) caused or contributed to incident –Communicates with regulatory agencies

51. ©ECRI 2007 51 Guidelines: How to Investigate Time is critical Elements of an Investigation –Preserve and impound evidence –Collect and review information-patient and device related –Interview personnel –Assess the injury –Inspect and test devices

52. ©ECRI 2007 52 Guidelines: How to Investigate - Approaches ECRI References –Technology and Systems Related Information Root Cause Analysis (RCA) –Joint Commission on Accreditation of Healthcare Organizations (JCAHO) –Airline Industry –Why, Why, Why…. Remember: Examine the “Big Picture”

53. ©ECRI 2007 53 Guidelines: How to Investigate - Approaches “Root Cause” Analysis (RCA) –“A process for identifying the basic or causal factors that underlie variation in performance.” Applies to Devices, Systems, Policies, and Procedures Causal Tree Analysis Handout

54. ©ECRI 2007 54 Guidelines: How to Investigate - Approaches “Root Cause” Analysis (RCA) Seeks: –Proximate cause –Systemic Cause –Common Cause Variation –Special Cause Variation –Risk Points

55. ©ECRI 2007 55 Guidelines: How to Investigate - Approaches “Root Cause” Analysis (RCA) Tools: –Flow Charts –Cause and Effect Fish-bone Diagrams –Pareto Charts –Scatter Diagrams –Failure Mode, Effect, and Criticality Analysis –Fault Tree Analysis –Barrier Analysis –Change Analysis

56. ©ECRI 2007 56 Guidelines: How to Investigate - Approaches RCA Root “Canal” Analysis (can be a painful experience) Why, Why, Why… –Why me?

57. ©ECRI 2007 57 Guidelines: How to Investigate - Approaches Causal Tree Analysis (handout) Reasoning from general to specific Working backwards in time Several sub-events need to occur for a negative event (accident) to occur

58. ©ECRI 2007 58

59. ©ECRI 2007 59 QUESTIONS? Medical Device Accident Investigation Seminar