FDA unveils draft guidance for medical device interoperability

Tools

The U.S. Food and Drug Administration on Tuesday unveiled draft guidance it hopes the medical device industry will follow for including interoperability in the design and development of such tools.

Safety is paramount, the FDA says, and the guidance calls on device manufacturers to:

  • Design systems with interoperability as an objective
  • Conduct appropriate performance testing and risk management activities
  • Specify the functional, performance and interface characteristics publicly (such as via labeling)

"Increased use of interoperable medical devices has the potential to foster rapid innovation at lower cost," the guidance reads. "However, appropriate safety considerations, including system level safety considerations that are not taken into account in the device design can result in unforeseen safety and effectiveness issues for the device or for the system."

In addition to the ability to transmit and receive information, the guidance says that interoperability of medical devices also includes "exerting command and control over" other devices and the use of shared data; it calls for standardized architectures and communication protocols.

With security and risk management in mind, the FDA says device manufacturers should consider, among other things, if the device can handle "corrupted" data, or data from "outside the appropriate parameters."

It also calls on device developers to test their tools to determine that electronic data interface interactions occur as intended. "The medical device manufacturer should test the electronic data interface based upon the purpose of the interface and should make sure that it complies with the intended specifications," the guidance says.

Joseph Smith, chief medical and science officer for the West Health Institute, calls the guidance a great first step on the part of the FDA in working with device manufacturers. In particular, he calls the FDA's expansion of the definition of interoperability to include actual use of shared data vital.

"Only through automatic use of information are we going to take full advantage of the many separate gifted gadgets to create an integrated and automated, connected and coordinated whole," Smith tells FierceHealthIT.

What's more, he calls the use of open, consensus standards for communication and data interfaces critical.

"One-off proprietary solutions will become isolated relics in the interoperable healthcare system of the future," Smith says.

Meanwhile, Bradley Merrill Thompson, an attorney with Epstein Becker & Green, P.C., tells FierceHealthIT that the recommendations play a "limited role," but also calls the guidance "important advice" for device manufacturers. He points out that the FDA does not have legal authority to define operations for the whole healthcare ecosystem.

"All FDA has the legal authority to do is convey through guidance, what the agency expects in the way of appropriate labeling, design, validation and so forth for products that the manufacturer intends to be interoperable with some other devices, either specified or not," Thompson says. "FDA can and does play an important role in defining the minimum required labeling, design, validation and so forth to support a product intended to be interoperable. They just can't force a product to be interoperable, nor can they tell the manufacturer with which other products they, the agency, want the product to be interoperable."

To learn more:
- here's the draft guidance (.pdf)

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