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.

LTR: TR Risk Coach - AI-Powered Decision Support Tool.

Key Takeaways

* An HHE is a structured, risk-based assessment used to evaluate a known or potential issue affecting products in the market.

* Organizations do not have to use a particular name or standardized format. What matters is demonstrating a systematic and documented conclusion about health risk.

* ISO 14971 provides a strong framework for defining the problem, identifying hazards and hazardous situations, estimating and evaluating risk, and considering risk control options.

* A field correction, product removal, recall, or decision to leave a product in the market should be treated as a risk-based decision. The action itself may introduce additional risks, including product shortages or reduced access to alternative therapies.

* Complaint history alone may not provide an adequate probability estimate. Teams should also consider service records, bench testing, production data, inspection results, scrap, nonconformances, and the possibility of underreporting.

* When reliable probability data are unavailable, organizations may need conservative estimates, statistical models, cross-functional judgment, or greater emphasis on the potential severity of harm.

* Quality, R&D, Medical, Regulatory, Legal, and senior management should be involved early enough to provide appropriate expertise and oversight. Medical personnel should retain independence when making the clinical assessment.

* HHE severity and probability classifications should remain consistent with the organization’s risk management system and product-specific risk acceptability criteria.

* Postmarket evidence identified through an HHE should feed back into the Risk Management File so that assumptions, failure modes, controls, and benefit-risk conclusions remain aligned with actual device performance.

* Every HHE should end with a clear, documented decision for or against field action. Regulators need to understand how the organization reached its conclusion—not simply what it decided.

Keywords

AI governance, responsible AI, digital health, systems engineering, risk-based decision-making, quality management systems, third-party AI, model drift, regulatory compliance, critical thinking

About Kerry Flecknoe

Kerry Flecknoe is Senior Manager, Global Quality – HHE at Getinge, where she provides strategic leadership and end-to-end process ownership for the company’s enterprise-wide Health Hazard Evaluation program. Her work includes HHE governance, methods, digital tools, audit readiness, metrics, process improvement, and support of correction and removal decisions across Getinge's global network of medical device manufacturing sites.

Kerry is a quality and regulatory compliance leader and Board Certified Medical Affairs Specialist with more than 20 years of medical device experience spanning quality, medical affairs, clinical support, postmarket surveillance, risk management, and product development. Before her current role, she held senior medical affairs positions at Getinge and spent more than a decade supporting cardiac rhythm management products at Boston Scientific. She holds bachelor’s degrees in Biomedical Engineering and Electrical Engineering from Duke University.

Let’s Talk Risk! with Dr. Naveen Agarwal is a bi-weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every other Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.