High Percentage of Medical Devise rejections

High Percentage of Medical Device Rejection (kri)
Type of indicator Risk
Risk Category IMP
Golden KRI NO
Therapeutic Area Medical Devices
IF Risk-Event if the implanted Medical Device is rejected by the body
DUE TO Risk Causes various reasons
THEN Risk Impact MAY RESULT the Medical Device may not get the approval by the health authorities
Risk Indicator High Percentage of Medical Device Rejection
Metric Percent of medical devise rejections
Unit %
What level should be measured Study, Country, Site
Purpose Promptly identify and address cases of device rejection, assess the impact on Subject safety and treatment outcomes, and implement measures to minimize the occurrence of device rejection, ensuring optimal Subject care and well-being.
Description Monitors the occurrence of medical devices being rejected by a human body, highlighting potential risks and guiding mitigation strategies.
Formula Devide a number of rejected medical devices by a Number of installed medical devices, multiply by 100%.
Suggested Thresholds - High >2 %
Suggested Thresholds - Medium >1 %
Associated Metric 1 Number of installed Medical Devices
Associated Metric 2 Number of rejected Medical Devices
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