A Perspective On Medical Device Risk Management

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

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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

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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

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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

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Hazardous Situation and Causes
Hazardous Situation
OR
Cause 2
Cause 3
Cause 4
Cause 1
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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
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Simplified Example Part of the Risk Control
System for a Hazardous Situation
Air Embolism gt 0.4mm Enters Blood Stream
Dialysis System
Incorrect Intervention
OR
No Intervention
OR
OR
Confusing Instructions
Alarm Failure
Sensor Failure
Inadequate Training
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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
Poor Patient History
No Scheduled Appt.
AND
Premature Battery Failure
No Daily Battery Check By Patient
No AED
Rural Home
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Conclusions