center for devices and radiological health william midgette a perspective on medical device risk...
Post on 12-Jan-2016
212 Views
Preview:
TRANSCRIPT
Center for Devices and Radiological Health
William Midgette
A PerspectiveOn
Medical Device Risk Management
Heart Rhythm SocietyWashington, D.C.September 16, 2005
Center for Devices and Radiological Health
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
Center for Devices and Radiological HealthFault-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
Center for Devices and Radiological HealthRisk 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
Center for Devices and Radiological HealthHazardous 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
Center for Devices and Radiological Health
Hazardous Situation and Causes
Cause
#1
Cause
#2
Cause
#3
Cause
#4
OR
Hazardous Situation
Center for Devices and Radiological Health
Hazardous Situations, Causes, and Control Measures
Cause
#1 Cause
#2
Cause
#3
Cause
#4
OR
Hazardous Situation
Control
Measure
#1 FailsCntr.Msr.
#2,#3.#4
Fails
AND AND
OR
Center for Devices and Radiological Health
Simplified Example: Part of the Risk Control System for a Hazardous Situation
OR
Alarm
Failure
Sensor
Failure
No InterventionIncorrect
Intervention
Inadequate TrainingConfusing
Instructions
Air Embolism > 0.4mm Enters
Blood Stream
OR
Dialysis System
OR
Center for Devices and Radiological Health
Simplified Example: Part of the Risk Control System for a Hazardous Situation
OR
Premature
Battery
Failure
No Daily
Battery Check
By Patient
No InterventionUntimely
Intervention
Poor
Patient
History
Life-Saving Shock Not Delivered
OR
No
Scheduled
Appt.
Limited Access To
Emergency CareAND
AND
No
AED
Rural
Home
ICD
Center for Devices and Radiological Health
Conclusions
top related