What are the four different types of medical device risk analysis?

Everyone in the medical device industry is familiar with ISO 14971 as the standard for risk management, but did you know that are four different kinds of risk analysis?

I’m not talking about four different tools for risk management, but four different quality system processes that need risk analysis. The one most people are familiar with is risk analysis associated with the design of a medical device. Do you know what the other three are?

The first is design risk management, and this is typically documented by medical device manufacturers on a design FMEA (dFMEA). The second type is process risk management where you document your risk estimation in a process FMEA (pFMEA). The third type is software hazard analysis, and the fourth type is a Use-Related Risk Analysis (URRA).

Each of these types of risk management documentation requires different information and there are reasons why you should not combine these into one risk management document or template.

Thank you to our other guest that posted the question about IFUs. "Can you use only the IFU to prevent use-related risks?" The answer is no. Not everyone reads the IFU, and you cannot guarantee that everyone will understand the instructions and remember any warnings or precautions. This is the reason why we have color-coding, design features that eliminate the possibility of a use error, we provide training to users, and we are required to monitor use-related risks for medical devices. Formative usability testing is intended to identify use-errors we did not anticipate, to help us develop instructions for use (IFU), and to help us develop training for users. Summative testing is intended to validate that the design, training, and IFU are effective at preventing use errors. All three of these aspects work together--not the IFU alone. In fact, there is an entire alarms standard that identifies protective measures that shall be used for electromedical devices to prevent use errors (i.e. - IEC 60601-1-8).

Thank you to Rick Stockton for his participation in today's live video. Here's a link to another interview we did with Rick on the topic of risk: https://youtu.be/ct6OyCKRAQk

Links to webinars on risk (both will be updated in March 2022):
https://medicaldeviceacademy.com/risk-management-training-webinar/
https://medicaldeviceacademy.com/24971-risk-management-guidance/

Related standards:
Design Risk Analysis (dFMEA) - ISO 14971:2019 and IEC 60812:2006
Process Risk Analysis pFMEA) - ISO 24971:2020 and IEC 60812:2006
Fault-Tree Analysis (FTA) - ISO/TR 24971:2020 and IEC 61025:2006
Software Hazard Analysis - ISO/TR 80002-1:2009
Use-Related Risk Analysis - IEC 62366-1:2015