High Percentage of Med Device Malfunction

Type of Indicator Performance
Risk Category Technology
Golden KRI No
Therapeutic Area Medical Devices
IF Risk Event The medical device is not inserted correctly
DUE TO Risk Causes Lack of training
THEN Risk Impact May Result Inadequate medical device functionality
Risk Indicator High percentage of medical device malfunctions
Metric Percentage of medical device failures
Unit %
Measurement Level Study, Country, Site
Purpose Ensure subject safety, data integrity, and effective healthcare delivery by minimizing medical device malfunctions.
Description This KRI monitors the occurrence of malfunctions or failures in medical devices used in clinical settings or research studies, supporting subject safety and data integrity.
Formula (Number of devices with reported malfunctions ÷ total number of devices in use) × 100%
Suggested Threshold – High > 2%
Suggested Threshold – Medium > 1%
Associated Metric 1 Number of devices in use
Associated Metric 2 Number of devices with reported malfunctions
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