Insights on risk management topics and tips and techniques for implementation.

Weekly Live Series, Episode 3: Understanding Severity Levels

achievelivesessions postmarket surveillance risk estimation severity warning letter May 16, 2022

In this episode, we focus on some of the practical challenges in implementing a severity scale to analyze the risk of harm associated with medical devices. Industry practice is to use a 1-5 scale where each level is defined using qualitative terms such as "negligible", "minor", "major", "critical" and "life-threatening", or "death". But what do these terms mean? How do we interpret the severity level on a 1-5 scale? Should we consider this scale to be a linear or exponential?

 A couple of recent FDA warning letters have highlighted the need for better consistency and accuracy in assigning severity levels to potential harms associated with a medical device. In this warning letter, for example, the FDA has cited an observation of inconsistency in the assignment of severity ratings for the same type of hazard related to the failure effect of "compromise of product sterility" in a process FMEA. 

Highlights from Episode 3: Understanding Severity Level

Check out the video below which opens our discussion with a brief slide presentation on this topic. ISO 14971:2019 defines the term severity as a "measure of the possible consequences of a hazard". But what does it mean? Is severity really "measurable"? If so, what does a particular level of severity on a 1-5 scale mean? 

In the introductory slides, we highlight two key practical challenges in assigning severity levels to harms:

  1. Qualitative terms used to describe severity levels (for example, negligible, minor, major, critical, catastrophic) may affect risk perception of different team members
  2. Consequences of different severity levels, including death, may be possible from a single event or situation

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

  • Examples of 2 FDA warning letters about consistency and accuracy.
  • Is severity scale linear or exponential? How is it perceived by different team members?
  • Practical challenges in applying qualitative severity levels.
  • Additional discussion on FMEA, risk estimation and post-market process.
  • Example of assigning a severity level and key points to consider.
  • Additional discussion on factors that may lead to inconsistency.
  • Example of contamination in the gas path for respiratory support.
  • Thinking about patient perspective and postmarket surveillance.
  • Learning from and responding to postmarket surveillance.
  • Recap of key points.

Watch the video above to learn more about these key points and common challenges.

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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
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