Interoperability: FDA’s Final Guidance on Smart, Safe, Medical Device Interactions

By: Bakul Patel, M.S., M.B.A.

Imagine an intensive care unit for newborns. An interface on a device called a pulse oximeter is sending data on changes in the newborns’ blood oxygen level to a hospital computer system that simultaneously gathers data from EKGs that are monitoring the electrical activity of their hearts.

Bakul PatelBy synchronizing time and information with the pulse oximeter, an EKG is able to identify important signals from the oximeter, information that will ultimately lead to smarter care. “Interoperability” is when devices talk to each other in a safe and effective way enabling smarter care.

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.

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.

Today, FDA issued final guidance that outlines our recommendations for smart, safe, and secure interactions among medical devices and other information systems. 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.

Our guidance incorporates comments received from the medical device industry, designers, and the public. 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.

FDA’s first concern, of course, is safety. 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. Our 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.

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.

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.

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.

Our guidance is a good step towards safer devices, and we will continue to work with all stakeholders to adapt along with the technology.

Bakul Patel, M.S., M.B.A., is Associate Director for Digital Health in FDA’s Center for Devices and Radiological Health

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