FDA Encourages Human Factors Testing for Medical Devices and Combination Products

The Association for the Advancement of Medical Instrumentation (AAM) is reporting that the Food and Drug Administration (FDA) has released new recommendations for human factors testing of medical devices-two drafts and one final document-emphasizing the importance it has placed on improving the usability of medical technology.

The final guidance document - Applying Human Factors and Usability Engineering to Medical Devices - is “intended to support manufacturers in improving the design of devices to minimize potential use errors and resulting harm,” according to the FDA. To that end, the guidance provides descriptions of the human factors and usability engineering processes that can be employed by manufacturers during device development.

The agency advises manufacturers to focus specifically on the user interface, which includes elements such as displays, controls, packaging, product labels, and instructions for use. According to the FDA, “Addressing use-related hazards by modifying the device design is usually more effective than revising the labeling or training.” The agency’s reasoning is that these strategies “rely on the user to remember or refer back to the information, labeling might be unavailable during use, and knowledge gained through training can decay over time.”

Manufacturers will not need to submit human factors data to support premarket submissions for all devices, just those that could cause serious harm if a use error occurred. To clarify which device types should include documentation of risk management, human factors testing, and design optimization processes in premarket submissions, the FDA published a draft list that names the highest priority devices for human factors review.

This list includes more than a dozen devices, many of which have been associated with recalls or adverse event reports in the past few years. The list includes:
•Ablation generators associated with ablation systems
•Anesthesia machines
•Artificial pancreas systems
•Automated external defibrillators
•Duodenoscopes with elevator channels (focused on reprocessing)
•Gastroenterology-urology endoscopic ultrasound systems with elevator channels (focused on reprocessing)
•Hemodialysis and peritoneal dialysis systems
•Implanted infusion pumps
•Infusion pumps
•Insulin delivery systems
•Negative-pressure wound therapy intended for use in the home
•Robotic catheter manipulation systems
•Robotic surgery devices
•Ventricular assist devices

Autoinjectors were also included on the list with the caveat that it was when the Center for Devices and Radiological Health (CDRH) was the lead center. This underscores the unique situation manufacturers of combination products face in gaining approval for their products, as investigation and marketing applications are submitted through more than one center at the FDA.

After a report published by the Combination Products Coalition called on the FDA to improve the coordination of combination product reviews, improve communication with manufacturers, and provide better justifications for data requests, the FDA held a series of focus groups to address these concerns. In response to the suggestions they received, the agency released draft guidance specifically focused on human factors studies in combination product design and development to help promote consistency between CDRH, the Center for Biologics Evaluation and Research, and the Center for Drug Evaluation and Research.

Comments are being accepted on this draft, as well as the draft list of priority devices for human factors review. Feedback can be submitted via regulations.gov until May 3.

Manufacturers interested in learning more about how to analyze, specify, develop, and evaluate the usability of a medical device should consult ANSI/AAMI/IEC 62366-1:2015, Medical devices- Part 1: Application of usability engineering to medical devices. More information about human factors can be found in a special Hot Topics section of the AAMI website.
Source: AAMI