Page 61 - Safety Risk Management for Medical Devices

40 Safety Risk Management for Medical Devices

8.8.1 Data gathering
If the medical device is based on an existing released product, for which postproduc-
tion data is available, derive probability of occurrence of Hazardous Situations due to
Use Failures from the available data. Use this probability in conjunction with P 2 data
to estimate the risks due to Use Failures.
If the medical product is new, or the part of UI that is under analysis is new, or if
postproduction data of sufficient quality is unavailable, then plan and execute forma-
tive and summative studies to generate the necessary data to support the P 1 estimates.
Compute the risks of Use Failures based on the P 1 data.

8.8.2 Risk reduction and compliance with IEC 62366 process
Absent a value for P 1 , risk of Use-Failures cannot be estimated. The alternative is to
use the process that is prescribed by IEC 62366 [14] to reduce Use Failures to the
degree possible. Additionally, control measures could be implemented to reduce the
severity of the Harm, should the Harm happen.
As Use-Failure risks are not estimated, they cannot be included in the overall
residual risk computations.