There are increasing reports from the field that insufficiently justified risk acceptance limits have led to problems with product approvals. This indicates that many medical device manufacturers have not sufficiently dealt with the derivation of the risk acceptance limit and have not recognized their central importance.
How you should NOT determine acceptance limits
The specifications for the severity of the damage, as well as for the probability of occurrence, are often taken from chapter 5.5 of ISO/TR 24971:2020. To determine how many damages may occur per year, it is simply asked how much damage the management is willing to accept.
This approach leads to the acceptance limits being more or less arbitrary, not based on sound data, and not corresponding to reality. Thus, this approach to determining acceptance limits is not suitable as a tool in risk management.
How to determine suitable acceptance limits
To define reliable acceptance limits, you must justify why specific harm of a severity category is accepted by society on average from a particular occurrence (under certain conditions). This average social acceptance must be determined from well-founded data. It indicates how much damage we as a society are willing to accept in connection with medical devices.
Why average societal acceptance?
Each person has a different personal risk acceptance limit. The acceptance limit of a family father may be much lower than that of an extreme sports athlete. People in different cultures and social or political systems will have different acceptance limits. It is even demonstrable that the acceptance of harm caused by two products can be different. These effects are offset by determining an average risk acceptance.
The key to justifiable risk acceptance limits is determining the average societal acceptance of harms associated with the specific medical device or group of medical devices.
Author: Bernhard Lindner, MSc
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