LTR 165: Managing Characteristics Related to Safety

Summary

“If we don’t have connections and linkages in our risk management file from top to bottom, it’s hard to manage lifecycle risk.”

In this open discussion of the Let’s Talk Risk! conversation, host Naveen Agarwal explores a requirement in ISO 14971 that is often documented but not fully integrated into medical device risk management: characteristics related to safety.

Too often, organizations work through the questions in ISO/TR 24971 Annex A, document their answers, and file the document away. But identifying characteristics related to safety is only useful if those characteristics can be connected to hazards, hazardous situations, risk controls, design and manufacturing activities, supplier controls, and ultimately post-market data.

The discussion expands as participant Vid joins Naveen to explore usability and software examples, estimating probability of occurrence for repeatedly used devices, and the uncertainty involved in determining appropriate exposure denominators. Naveen also discusses supplier-related risk, why assumptions should be revisited as post-market evidence develops, and why risk management competence comes from combining practical experience with continued learning.

Listen to the full 25-minute podcast or jump to a section of interest listed below.

Chapters

00:00 – Introduction and the Open Discussion Format00:39 – What Are Characteristics Related to Safety?03:16 – Defining Safe Limits and Establishing Traceability06:19 – Connecting Post-Market Data to the Risk Management File07:47 – Usability, Software, and Safety-Critical User Actions11:01 – Post-Market Surveillance and Supplier-Related Risk13:38 – Building Risk Management Skills Early in Your Career16:03 – Estimating Probability of Occurrence for Repeated Device Use18:27 – Managing Uncertainty and Testing Your Assumptions19:21 – Are Medical Device Risks Being Underestimated?21:29 – Let’s Talk Risk as a Knowledge-Sharing Community24:50 – LTR Risk Coach and Closing Resources

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Suggested links:

LTR: ISO 14971 Fundamentals: Characteristics related to safety.

LTR: How Traceable Are Safety-Related Characteristics in Your Risk File?