Interoperability Stressed in Recent FDA Medical Device Guidance

By Elizabeth O'Dowd

September 06, 2017 - The FDA released a final guidance for smart and secure interactions among medical devices, emphasizing the importance of incorporating interoperability among devices in the design stage.

“FDA intends to promote the development and availability of safe and effective interoperable medical devices,” the FDA stated in its guidance. “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.”

The FDA recommends that medical device manufacturers do the following:

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.

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“Our guidance incorporates comments received from the medical device industry, designers, and the public,” FDA Associate Director for Digital Health Bakul Patel said in a blog post. “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.”

Patel added that FDA’s top priority for medical devices is safety and that interoperability among devices will significantly improve safety. Something as small as a difference in a unit of measure can disrupt smooth exchanges of data.

FDA encourages that medical device manufacturers provide transparent functional performance and interface characteristics so organizations can successfully use the devices with the systems they already have in place. The transparency allows entities to ensure that the devices will be interoperable with existing systems so IT administrators can make the correct decisions concerning the devices for successful data exchange.

If healthcare organizations are not provided with this information, they risk using the device incorrectly. This could potentially lead to a malfunction resulting in harm to the patient.

The guidance was issued in a response to the desire for healthcare organizations to connect medical devices to other technologies and systems.

“As electronic medical devices are increasingly connected to each other and to other technology, the ability of these connected systems to safely and effectively exchange information and use the information that has been exchanged becomes increasingly important,” FDA wrote. “Advancing the ability of medical devices to exchange and use information safely and effectively with other medical devices, as well as other technology, offers the potential to increase efficiency in patient care.”

Patel stressed that patients and clinicians expect devices that will work together and share data easily.

“We want patients and consumers to have confidence that medical devices work as intended without concern over how these devices operate together,” said Patel. “But, in working with manufacturers to bring innovative medical devices to patients who need them, interoperability is an indispensable concept.

FDA is giving manufacturers 60 days to ensure they adhere to the guidance.

The design of medical devices is crucial to how they perform and interact with the network. Internet of Medical Things (IoMT) devices are especially sensitive to how they are designed.

For example, cellular antennas that are not planned during the design phase of the medical device. There are a lot of high powered electronics in medical devices that can interfere with the signal.

Antennas need to be custom fit to the device for it to be successful. Adding an antenna to a medical device can be complicated, which is why it needs to be done in the design process, not retrofit after the devices has been tested.

FDA’s guidance ensures that device manufacturers understand the importance of interoperability and how it begins with the design process.

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Interoperability Stressed in Recent FDA Medical Device Guidance

The FDA's final guidance on medical device safety stress the importance of interoperability and how it needs to be incorporated in the design of medical devices.

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