August 13, 2014
Medical device manufacturers would be well-advised to address any potential risks associated with home-use products at the design stage, according to an August 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. This could cause the device to malfunction, possibly contributing to death or serious injury.”
It could also make the FDA really angry.
FDA Guidance Scope: From Design to Postmarket
The guidance provides advice designed to address the entire manufacturing process—and beyond. It covers environmental issues, user issues, design issues, human factors, labeling challenges, postmarket considerations, and the always-fun human factor.
Key Areas of FDA Home-Use Device Guidance
Digging a little deeper into the guidance, the FDA covers many layers of these topics, including:
- Environmental considerations include location, contaminants, water supply, temperature, dampness and humidity, atmospheric pressure changes, airflow, travel, international use, fluid exposure, and storage.
- User considerations, such as physical location, sensor/perception requirements, as well as cognitive and emotional product demand.
- Design issues, including lock-out mechanisms, maintenance and calibration, mechanical issues, and special emphasis on electrical issues. As noted earlier, this is probably the section deserving the closest examination by medical device makers.
- Human factors encompass a range of aspects, including user training and certifications.
- Labeling issues, including describing the basic handling of the device, how to dispose of it in an emergency, and hygienic maintenance.
- Post-market considerations such as robust customer service and medical device reporting.
Medical Device Reporting (MDR) Requirements
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.
Resources for MDR Compliance and Reporting
For the FDA Form 3500A, instructions for completing specific items on the form, and the coding manual, see MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
For additional guidance on the MDR regulation and the reporting requirements, refer to the FDA’s guidance Medical Device Reporting for Manufacturers (March 1997). FDA advises medical device manufacturers to also take a look at its draft guidance Medical Device Reporting for Manufacturers (July 9, 2013).
