Estimating risk of harm for your medical device is a requirement of ISO 14971:2019. However several practical challenges make it difficult to accurately estimate the risk of harm. This is partly because a common practice in the medical device industry confuses failure analysis with hazard analysis. As a result, risk of harm is generally confused with risk of failures. 

A couple of recent FDA warning letters have highlighted the need for better accuracy in risk estimation. In this warning letter, for example, the FDA argues that the probability of occurrence has been underestimated because the formula used to calculate occurrence utilizes the number of devices shipped and not the number of devices in use by patients. 

 Regulatory authorities, including the FDA, are becoming increasingly sensitive to the accuracy of risk estimation methods. In this live discussion series, we reviewed the ISO 14971:2019 requirement for risk estimation and shared a few best practices for a logical approach you can use in your risk management process. 

Highlights from Episode 2: Understanding Risk Estimation

Check out the video below which opens our discussion with a brief slide presentation on this topic. ISO 14971:2019 defines the term risk as a combination of the probability of occurrence of harm, and the severity of that harm. But what does that mean? How do you combine these two factors? 

Industry practice is to use a numerical scale to assign a level to the probability of occurrence and a level to the severity of harm. Generally, a scale of 1-5 is used. 

A simple way to combine the two is to multiply the numerical value assigned to each of these two levels. In this way, the risk level can range from a numerical value of 1 to 25. It is best to not assign a qualifier such as low, medium or high to the risk level. In this way, risk is estimated as a numerical value on a scale ranging from 1-25.

In future discussions, we will go deeper into this  topic and share best practices on estimating the probability of occurrence and severity of harm. 

Following the opening presentation, we discussed the following comments/questions from the attendees:

• Why it is important to accurately estimate risks.
• Why harm risk estimation in FMEAs is challenging.
• Why aligning the risk estimation method with post-market process is important.
• Additional discussion on FMEA, risk estimation and post-market process.
• How to develop a Severity level scale for risk estimation.
• How to develop a Probability level scale for risk estimation.
• Confusion about regulatory requirement for harm severity in FMEA.
• Why we don't have to use P1, P2 in pFMEA.

Watch the video above to learn more about these questions. You can use the time stamps to jump ahead to a specific topic of interest. 

Join our weekly live discussions!

In these weekly discussions, we focus on specific questions or topics that practitioners of risk management find challenging from a practical, day-to-day point of view. Our focus is not on regulatory compliance, but on sharing common problems and best practices. 

These sessions generally last for about 30 minutes. We open with a short slide presentation to introduce the topic or a specific question of interest. You can participate by sharing your question or comment via live chat at any time. However, there are a few key points to note:

• This is an open forum; therefore, do not share any proprietary or business sensitive information
• Our discussion is meant to share information and knowledge purely for the purpose of education

 How you can participate

These discussions will occur via live streaming on LinkedIn and YouTube. If you already follow us on LinkedIn or YouTube, you will get a notification as soon as we go live. Otherwise, connect with us here on the Achieve LinkedIn Page or subscribe to our YouTube channel. During the live meeting, you can use the chat/comments section to ask a question or share comments and best practices. 

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