The seven steps of FMEA for medical devices
by Winfried Dietz
Risk analysis and assessment are essential for medical devices. They concern statutory and regulatory requirements that have to be thoroughly fulfilled. After all, in the highly sensitive field of medical devices, every single risk must be eliminated as far as possible.
Digression: Risks pertain to events that can potentially happen when a product is used in the future. It is beyond challenging to identify and assess risks with certainty. Therefore, proper use of models and approaches to risk assessment is crucial and requires everyone involved to have great experience and expertise.
To conduct a successful risk analysis in the field of medical devices, the best possible approaches have to first be developed and applied based on all relevant normative, regulatory, and statutory requirements. This will allow any residual risks within development projects to be identified and minimized. For example, a structured approach can be taken in the three categories:
- System analysis
- Failure analysis and risk minimization
- Risk communication
This article aims to explain this structured approach using examples.
The first thing to do is to plan and prepare the risk analysis (step 1). This involves defining the system boundaries, the relevant states of the medical device, the team members in charge, and the schedules.
The structure analysis (step 2) outlines the system boundaries, sub-systems and components in terms of functions.
The function analysis (step 3) organizes and groups the functions from the performance specifications across system structure levels, hence once again verifying the development specifications.
The failure analysis (step 4) identifies and correlates causes, failures and consequences in a logical manner based on the function analysis.
The risk analysis (step 5) documents and evaluates measures for minimizing and controlling risks and introduces unacceptable risks into the system optimization process (step 6). The results of a risk analysis therefore help ensure that a medical device is safe to use.
Documentation (step 7) of the risk analysis forms the basis for communicating the results to shareholders.