High Percentage of Medical Device Malfunction Table
Type of indicator
Performance
Risk category
Technology
Golden KRI
NO
Therapeutic area
Medical devices
IF risk event
The medical device is inserted, applied, or operated incorrectly
DUE TO risk causes
Insufficient training, inadequate maintenance, incorrect setup, or user error
THEN risk impact may result
Device malfunction, subject safety risks, protocol deviations, and potential data integrity issues
Risk indicator
High percentage of medical device malfunction
Metric
Percentage of medical device failures
Unit
%
What level should be measured
Study, country, site
Purpose
Monitor the performance and reliability of medical devices used in a study to ensure subject safety, data quality, and operational effectiveness.
Description
This KRI measures the proportion of medical devices that experience malfunctions or failures during use. A high rate indicates potential quality, training, or process issues that require investigation and corrective action.
Formula
(Number of devices with reported malfunctions ÷ Total number of devices in use) × 100%
Suggested thresholds - high
2%
Suggested thresholds - medium
1%
Associated metric 1
Number of devices in use
Associated metric 2
Number of devices with reported malfunctions
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