LTR 162: Using HHE for Risk-Based Decisions

Summary

“When done well, HHE evolves from a procedural requirement into a strategic tool that reflects how your organization makes risk-based decisions.”

In this episode of the Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Kerry Flecknoe, Senior Manager, Global Quality – HHE at Getinge, about the role of Health Hazard Evaluations in postmarket risk management.

Kerry explains that although organizations may use terms such as HHE, HHA, or HRA, the terminology is less important than having a structured and documented process for evaluating health risk. In the QMSR era, organizations must be able to demonstrate that risk-based decisions are made consistently and intentionally—not only within formal risk management activities, but across the quality management system.

The conversation explores how ISO 14971 can provide a defensible framework for HHEs, why field actions should themselves be evaluated as risk control measures, and how teams can make responsible decisions when complaint data, probability estimates, or other evidence are incomplete. Kerry also shares practical guidance for smaller manufacturers, cross-functional teams, and distributors of third-party products.

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

Chapters

00:00 – Introduction and Why HHE Matters in the QMSR Era01:24 – What HHE Is, FDA Terminology, and the Need for Documentation05:04 – Building an HHE Process Around ISO 1497106:18 – HHE as Postmarket Risk Management and Field Action as a Risk Control08:41 – Evaluating Probability When Postmarket Data Are Limited14:08 – Cross-Functional Roles and the Mechanics of an HHE16:49 – Feeding Postmarket Evidence Back into the Risk Management File18:42 – Building a Lean HHE Process and Defining Clear Triggers21:11 – Responsibilities of Legal Manufacturers and Distributors23:39 – Career Development and Final Takeaways

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Suggested links:

LTR: Risk-Based Assurance, FDA Expectations Under QMSR.

LTR: The Missing Step in Risk Decisions.