FDA finalizes guidelines on interoperable devices

The FDA recently issued final guidelines outlining its nonbinding recommendations for safe and secure interactions among medical devices and other information systems, calling for devices to be designed with interoperability as an objective.

The guideline is intended to highlight what medical device manufacturers should consider to provide a “reasonable assurance of safety and effectiveness” for their interoperable medical devices, and provides manufacturers with design considerations and recommendations regarding information to include in premarket submissions and device labeling.

“It’s not likely that medical device interoperability is a part of the everyday vocabulary of American consumers — and frankly, we hope it stays that way,” Bakul Patel, MS, MBA, associate director for digital health in the FDA’s Center for Devices and Radiological Health (CDRH), wrote in a Sept. 5 post on FDA Voice, the administration’s official blog. “At CDRH, we want patients and consumers to have confidence that medical devices work as intended without concern over how these devices operate together. But, in working with manufacturers to bring innovative medical devices to patients who need them, interoperability is an indispensable concept.”

In the guideline, the FDA specifically recommends that all medical device manufacturers adhere to the following:

Design devices with interoperability as an objective;

Conduct appropriate verification, validation and risk management activities;

Clearly specify the relevant functional, performance, and interface characteristics to the user.

“Our guidance incorporates comments received from the medical device industry, designers and the public,” Patel wrote. “When premarket submission to the FDA is required, this guidance provides clarity and recommendations for what information on interoperability should be included in a manufacturer’s premarket submissions.”

The guidelines also encourage transparency, Patel wrote, and the FDA recommends that designers and manufacturers provide information on a product’s functional performance and interface characteristics so that those using it with other devices and systems can do so safely.

“Failure to develop and provide this information to the user may lead to an inappropriate use of the device interface in a way that can lead to device malfunction, including the failure to operate, and may lead to patient injury and even death,” Patel wrote.

The FDA also noted that published consensus standards in the design of medical devices remain relevant to the development and design of interoperable medical devices and encourages their use, though manufacturers may choose to use their own design preferences for their interface in lieu of a published consensus standard.

“In either case, problems or misuse of interoperable medical devices can be minimized by making the functional, performance, and interface requirements openly available to all users,” Patel wrote. “Our guidance is a good step towards safer devices, and we will continue to work with all stakeholders to adapt along with the technology.” – by Regina Schaffer

Reference:

FDA Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices. Available at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM482649.pdf.