The U.S. Food and Drug Administration released on Wednesday final guidance as recommendations for medical device manufacturers on how to include interoperability in the design and development of devices.
The final guidance is a follow-up to the draft guidance that the FDA released back in January.
The guidance is intended to promote the design and development of interoperable electronic medical devices, which are increasingly connected to each other and to other technology. “The ability of these connected systems to safely and effectively exchange and use the information that has been exchange becomes increasingly important,” the FDA wrote in the guidance. “Advancing the ability of medical devices to exchange and use information safety and effectively with other medical devices as well as other technology offers the potential to increase efficiency in patient care.”
“FDA is issuing this guidance to assist industry and FDA staff in identifying specific considerations related to the ability of electronic medical devices to safely and effectively exchange information and use exchanged information. This document highlights considerations that should be included in the development and design of interoperable medical devices and provides recommendations for the content of premarket submissions and labeling for such devices,” the FDA stated in the final guidance.
In a blog post about the FDA guidance, Bakul Patel, associate director for digital health in FDA’s Center for Devices and Radiological Health, wrote, “Today’s health care providers and their patients are relying more than ever on rapid, secure interactions among different medical devices. From electrocardiograms to infusion pumps, medical devices must reliably communicate and operate in concert.”
Further, Patel wrote, “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. 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.”
FDA specifically recommends that all medical device manufacturers:
- Design their devices with interoperability as an objective;
- Conduct appropriate verification, validation and risk management activities; and,
- Clearly specify the relevant functional, performance, and interface characteristics to the user.
FDA’s first concern is safety, Patel notes. Errors and inadequate interoperability, such as differences in units of measure (e.g., pounds vs. kilograms) can occur in devices connected to a data exchange system. The FDA guidance recommends appropriate functional, performance, and interface requirements for devices with such interactions.
The guidance also encourages transparency, recommending 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, Patel wrote.
“In many cases, the consensus standards that support interoperability specify data format, interoperability architecture design, or other aspects associated with interoperability. FDA recognizes the benefits of relying on published consensus standards in the design of medical devices. Accordingly, FDA has recognized numerous consensus standards relevant to the development and design of interoperable medical devices and encourages their use,” Patel wrote in the blog post.
Patel also noted that manufacturers may choose to use their own design preferences for their interface (in lieu of a published consensus standard) for their medical devices. “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.
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