Mastering risk analysis for excellence in system safety

Introducing a new series on Let's Talk Risk! to help you build a solid knowledge of medical device system safety and commonly used risk analysis techniques.

Risk cannot be determined unless the hazard is fully understood and described.

This opening quote from Clifton Ericsson II in Hazard Analysis Techniques for System Safety¹, perfectly captures the challenges risk practitioners currently face in the medical device industry.

I have practiced risk management for more than 10 years. Like many of my colleagues, I have struggled with some of the key terms and concepts such as hazards, foreseeable sequence of events and hazardous situations. I have diligently studied the ISO 14971² standard and its companion guidance ISO/TR 24971³ many times. I have also read many textbooks authored by recognized industry experts.

However, I have always felt that something has been missing from our collective understanding of medical device risk analysis, as reflected by an over-reliance on FMEA⁴ for risk management.

Medical device industry, in particular, continues to struggle with correctly identifying hazards and hazardous situations that may lead to harm. Although additional guidance is provided in Annex C of ISO 14971:2019 and section 5.4 of ISO/TR 24971:2020, there is still a lot of confusion in the industry about these basic concepts. As a result, we generally find it hard to identify risks correctly and analyze them accurately.

I have been studying Ericson’s work for nearly two years. Although his decades-long experience did not include working with medical devices, his deep understanding of system safety principles and analysis techniques can offer invaluable guidance to all of us. I loved his introductory work Hazard Analysis Primer so much that I am offering a free copy to anyone interested.

I would like to now invite you on a journey to explore these fundamental concepts at a deeper level. We will be reviewing the basic system safety principles and some of the risk analysis techniques presented in Ericson’s book.

Here is what to expect

Our exploration of basic system safety principles and risk analysis techniques in this series will be grounded in the body of knowledge compiled by Ericson. However, we will apply this knowledge to medical devices and share insights in the context of current industry standards and practices.

We will use different formats to share insightful content using case studies, expert interviews and webinars.

Below are some of the topics we will cover:

1. Medical devices and their use environment as a system

2. Basic principles of system safety

3. Hazard theory and its application to medical device risk analysis

4. Risk analysis types and techniques

5. Mapping analysis type and specific techniques to stages in device lifecycle

Content in this series will be curated under the Risk Management Fundamentals section of the Let’s Talk Risk! website.

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Share your ideas for topics in this series

If you have specific questions or ideas for other topics, you can leave a comment below or send me a direct message.

1. Hazard Analysis for System Safety, 2nd Edition, ISBN 978-1-94038-9, Wiley, Published July 2015

2. ISO 14971: Medical devices - Application of risk management to medical devices, 3rd edition, 2019-12.

3. ISO/TR 24971: Medical devices - Guidance on the application of ISO 14971, 2nd edition, 2020-06.

4. FMEA: Failure Modes and Effects Analysis is one of the risk analysis techniques identified in ISO/TR 24971, Annex B. Despite its limitations, FEMA continues to be the dominant, and often the only, risk analysis technique used in the medical device industry. There is a general consensus in the industry that FMEA alone is not sufficient to adequately identify and manage the risk of harm associated with the use of a medical devices.