High Percentage of Medical Device interface performance Issues


High Percentage of Medical Device Interface Performance Issues
Type of indicator Performance
Risk Category Data Collection
Golden KRI NO
Therapeutic Area Medical Devices
IF Risk-Event The interface between the medical device and other connected systems fails to operate correctly
DUE TO Risk Causes Insufficient testing, configuration issues, or other technical causes
THEN Risk Impact MAY RESULT Data synchronization failures leading to incomplete, delayed, or inconsistent data transfer
Risk Indicator High Percentage of Medical Device Interface Performance Issues
Metric Percent of Interface Malfunctions
Unit %
What level should be measured Study, Country, Site
Purpose Ensure the reliability and accuracy of data collected through medical devices by identifying and resolving interface performance issues that could compromise data integrity or subject safety.
Description This KRI monitors the frequency of synchronization or communication issues between medical devices and connected systems. It helps detect and mitigate risks related to data loss, duplication, or delay.
Formula (Number of Synchronizations with at Least One Error) / (Total Number of Synchronizations) × 100.
Suggested Thresholds - High 5%
Suggested Thresholds - Medium 3%
Associated Metric 1 Number of Synchronizations
Associated Metric 2 Number of Synchronizations with at Least One Error
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