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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

A PerspectiveOnMedical Device Risk Management

Heart Rhythm Society

Washington, D.C.

September 16, 2005

two common approaches to analyzing risk
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
fault tree analysis
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
risk control measures
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
hazardous situations
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
hazardous situation and causes
Hazardous Situation and Causes

Hazardous Situation

OR

Cause

#2

Cause

#3

Cause

#4

Cause

#1

hazardous situations causes and control measures
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

simplified example part of the risk control system for a hazardous situation
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

simplified example part of the risk control system for a hazardous situation9
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