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Michael Causey

FDA Compliance

FDA Guidance Advises Device Makers to Think About Home Use

Consider the human factor

Published: Thursday, August 28, 2014 - 12:37

Medical device manufacturers would be well-advised to address any risk with potential home-use products during their design phase, according to an August 2014 guidance from the FDA.

As the agency notes, “Failure to adequately consider potentially hazardous situations during the design of home-use devices may result in inappropriate use, use error, or incompatibilities between the use environment, the user, and the device,” states the guidance. “This could cause the device to malfunction, possibly contributing to death or serious injury.”

It could also make the FDA really angry.

The guidance offers advice designed to address the entire manufacturing process—and beyond. It covers environmental issues, user issues, design issues, labeling challenges, post-market considerations, and the always-fun human factor.

Digging a little deeper into the guidance, the FDA covers many layers of these topics, including:
• Environmental considerations such as location, contaminants, water supply, temperature, dampness and humidity, atmospheric pressure changes, air flow, travel and international use, fluid exposure, and storage
• User considerations such as physical location, sensor or perception requirements, plus cognitive and emotional product demand.
• Design issues, including lock-out mechanisms, maintenance and calibration, mechanical issues, and a special emphasis of electrical issues. As noted earlier, this is probably the section deserving the closest examination by medical device makers.
• Human factors ranging from user training to certifications
• Labeling issues, including describing the basic handling of the device, how to dispose of it in an emergency, normal disposal, and hygienic maintenance
• Post-market considerations such as robust customer service and medical device reporting.

The FDA’s Medical Device Reporting (MDR) regulation requires manufacturers to submit reports to the FDA whenever they become aware of information that reasonably suggests that a device they sell may have caused or contributed to a reportable death or serious injury, or has malfunctioned, and the malfunction would be likely to cause or contribute to a reportable death or serious injury should it recur.

For additional guidance on the MDR regulation and the reporting requirements, refer to FDA’s guidance, “Medical Device Reporting for Manufacturers” (March, 1997). The FDA advises medical device manufacturers to also take a look at its draft guidance, “Medical Device Reporting for Manufacturers” (July 9, 2013).

First published Aug. 13, 2014, on the AssurX blog.


About The Author

Michael Causey’s picture

Michael Causey

James Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past 10+ years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers. Causey is the editor and publisher of eDataIntegrityReport.com and is a contributing writer on the AssurXblog.