High Percentage of Med Device Malfunction

High Percentage of Med Device Malfunction (kri)
Type of indicator Performance
Risk Category study complexity
Golden KRI NO
Therapeutic Area Medical Devices
IF Risk-Event the Medical Device is not being inserted correctly
DUE TO Risk Causes a lack of training
THEN Risk Impact MAY RESULT inadequate Medical Device function
Risk Indicator High Percentage of Med Device Malfunction
Metric Percentage of medical device failure
Unit %
What level should be measured Study, Country, Site
Purpose Ensure Subject safety, data integrity, and effective healthcare delivery by minimizing medical device malfunctions.
Description KRI monitors the occurrence of malfunctions or failures in medical devices used in clinical settings or research studies, ensuring Subject safety and data integrity.
Formula Calculate all devices what have malfunctions reported, devide by a total number of deviced what are in use, multiply by 100%.
Suggested Thresholds - High >2 %
Suggested Thresholds - Medium >1 %
Associated Metric 1 Number of devices in use
Associated Metric 2 Number of devices in use with malfunctions reported
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