Health Hazard Evaluation

A Health Hazard Evaluation (HHE) is a structured risk assessment used to determine the severity, probability, and impact of a device malfunction or defect on patient health. It forms part of recall management, guiding whether corrective actions, removals, or notifications are needed under global medical device regulations.

An HHE supports post-market surveillance (PMS) by analyzing complaint and incident data to identify health risks. It helps determine whether Field Safety Corrective Actions (FSCA), device recalls, or corrections are required. This structured evaluation ensures continuous monitoring and Regulatory compliance throughout the device’s lifecycle after commercialization.

Key inputs include Unique Device Identification (UDI) data, complaint reports, manufacturing and service records, clinical findings, failure-mode analysis, and trend data. These parameters allow objective evaluation of the issue’s frequency, severity, and potential harm, forming the foundation for a scientifically sound risk assessment and Regulatory reporting.

An HHE categorizes device issues into Class I, II, or III recalls based on severity and probability of harm. It supports decisions for corrective or preventive actions, ensuring compliance with frameworks such as 21 CFR Part 806, ISO 14971, and EU MDR 2017/745 for consistent global risk management.

HHEs are governed by international standards and regulations including ISO 14971 for risk management, ISO 13485 for quality systems, EU MDR 2017/745, and FDA guidance on corrections, removals, and recalls. These frameworks ensure structured evaluation, documentation, and reporting of device-related health risks worldwide.

An HHE evaluates actual device incidents—reactive in nature—while a Health Risk Assessment (HRA) anticipates potential hazards before market release. Together they form a comprehensive approach to medical device risk management, ensuring both preventive and corrective measures across the product lifecycle are scientifically justified.

Trend analysis identifies recurring complaints or failures by evaluating aggregated post-market data. Recognizing such patterns improves accuracy in estimating probability of harm and assists in setting thresholds for early action. This proactive assessment strengthens overall risk control and helps prevent widespread device performance issues.

Severity measures the level of harm a device failure may cause—ranging from minor injury to death—while probability estimates how often it may occur. Combining these metrics within a risk matrix determines overall risk ranking, guiding whether recalls, corrections, or preventive actions are necessary.

HHE findings are incorporated into the Quality Management System (QMS) under ISO 13485:2016 and FDA 21 CFR 820 requirements. Integration ensures risk records, CAPA actions, and design controls are updated, promoting continuous improvement and maintaining compliance across the device’s post-market lifecycle.

A Health Hazard Evaluation should begin as soon as a malfunction or adverse event is detected. Typically, evaluations are completed within five to ten business days to meet Regulatory reporting timelines, support timely recalls or corrections, and reduce potential risks to patient safety.