In this world of increasingly smart technology, the one place that interconnectivity is critical is in healthcare. Patients and their care givers should be confident that the devices that are “talking” to one another are doing so safely and without error.

To help ensure that this is the case, FDA recently issued its final guidance outlining 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.

Bakul Patel, associate director for digital health in FDA’s Center for Devices and Radiological Health, notes in a recent blog that CDRH wants “patients and consumers to have confidence that medical devices work as intended without concern over how these devices operate together.” For you the manufacturers, he says, “interoperability is an indispensable concept.”

The guidance incorporates comments from industry, designers, and the public. Patel says that the guidance “provides clarity and recommendations” as to the interoperability information manufacturers should include in their premarket submissions.

FDA’s first concern, he says, 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,” Patel says. “Our guidance recommends appropriate functional, performance, and interface requirements for devices with such interactions.”

Patel notes that 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.

A key point, says Patel, is that “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.”

The guidance recognizes a number of consensus standards relevant to the development and design of interoperable medical devices. As an alternative, manufacturers may “choose to use their own design preferences for their interface for their medical devices,” Patel says. In either case, however, Patel stresses that problems or misuse of interoperable medical devices can be minimized by making the functional, performance, and interface requirements openly available to all users.

Patel calls the guidance a good step toward safer devices. Ditto.

Sherrie Trigg

Editor and Director of Medical Content

Note: The guidance doc can be found at here.