FDA learns of problems with medical devices in different ways. Most often, a firm will notify its customers and FDA that it is issuing a recall. At other times, FDA’s analysis of medical device reports will indicate a greater than expected failure rate. In either of these cases, FDA must review the risks to determine the actions needed to resolve them.

Health Hazard Evaluations (HHEs) and Health Risk Assessments (HRAs) are the processes that FDA follows to determine the risks of certain device problems and the actions firms should take to resolve them. HHEs and HRAs are designed to reflect the language in the recall regulations and are used specifically for recalls and related safety work. HHEs and HRAs follow the same process and use the same documentation, but they serve slightly different purposes:

• HHE is a tool for classifying a voluntary recall by a firm. The evaluation g uides FDA in determining the risk to the public from the defective product and appropriate actions for the firm and the FDA to take to protect public health.
• HRA is a tool for predicting possible harm that can come from a defective or malfunctioning device. The assessment helps the FDA and the firm determine if any actions are necessary such as recalling the devices or notifying the public about the risk.

Collecting and Reviewing Device Information

An FDA physician may conduct an HHE or HRA alone, or FDA may convene a committee of physicians, engineers and other scientists to reach consensus on the level of risk posed by a specific device problem.

In an HHE or HRA evaluation, the physician or committee collects and reviews a wealth of information about the device to gain a better understanding of the problem. They start with basic information, such as the manufacturer, the number of devices in use, the intended use of the product, and the number of devices subject to recall, if one occurs.

They also consider the specific problem with the device, including information known about the cause, to determine how likely the device is to fail and how serious this might be to users. The risk may be related to problems with the design or manufacture of the device, or it may be due to errors made by users.

The physician or committee then reviews a summary of the investigation and analyzes adverse events, complaints, and problems that may be related to the device defect. They also consider the likelihood of disease, injuries, and death as a result of exposure to the defective device, as well as factors that may reduce the risk of harm. This involves forecasting the frequency and severity of health consequences among two groups of people â?? those at greatest risk (infants, the elderly, pregnant women, the critically ill, and people with compromised immune systems) and everyone using the device.

All the information taken together allows the physician or committee to characterize the total health risk of the device and support the agency decisions and recommendations that follow.

Additional Information

• Health Hazard Evaluation Form

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