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A Perspective On Medical Device Risk Management

A Perspective On Medical Device Risk Management. Heart Rhythm Society Washington, D.C. September 16, 2005. Two Common Approaches to Analyzing Risk. Bottom-up (inductive, e.g., Failure Mode and Effects Analysis) versus top-down (deductive, e.g. Fault Tree Analysis)

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A Perspective On Medical Device Risk Management

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  1. A PerspectiveOnMedical Device Risk Management Heart Rhythm Society Washington, D.C. September 16, 2005

  2. Two Common Approaches to Analyzing Risk • Bottom-up (inductive, e.g., Failure Mode and Effects Analysis) versus top-down (deductive, e.g. Fault Tree Analysis) • Bottom-up – induce a failure and determine the harm it can cause • Top-down – select an undesired top-level event and identify the faults that can cause it

  3. Fault-Tree Analysis • Requires the selection of an undesired top-level event, e.g, life-saving shock not delivered for an ICD • The analysis should identify all faults that can cause the event • Risk control measures should be included in the analysis

  4. Risk Control Measures • Protective measures, e.g. default operating modes • Information for safety, e.g., warnings in labeling • Many measures require intervention • The correct response for the circumstances, e.g. a patient-specific response • Timeliness

  5. Hazardous Situations • Circumstances in which people are exposed to a potential source of harm • Examples of ICD Hazardous Situations • Life-saving shock not delivered • Pacing therapy not delivered • Usually require a “system” of risk control measures

  6. Hazardous Situation and Causes Hazardous Situation OR Cause #2 Cause #3 Cause #4 Cause #1

  7. Hazardous Situations, Causes, and Control Measures Hazardous Situation OR AND AND OR Control Measure #1 Fails Cause #1 Cntr.Msr. #2,#3.#4 Fails Cause #2 Cause #3 Cause #4

  8. Simplified Example: Part of the Risk Control System for a Hazardous Situation Air Embolism > 0.4mm Enters Blood Stream Dialysis System Incorrect Intervention OR No Intervention OR OR Confusing Instructions Alarm Failure Sensor Failure Inadequate Training

  9. Simplified Example: Part of the Risk Control System for a Hazardous Situation Life-Saving Shock Not Delivered ICD Untimely Intervention OR No Intervention OR Limited Access To Emergency Care AND No Scheduled Appt. Poor Patient History AND Premature Battery Failure No Daily Battery Check By Patient Rural Home No AED

  10. Conclusions

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