FDA to offer draft guidance on interoperability of medical devices

The Food and Drug Administration plans to release draft guidance this year for manufacturers seeking to make their medical devices interoperable.

Dr. Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said the guidance is part of the regulator's broader effort to evaluate and better understand efforts that would make medical devices and health information technology systems connect and share data.

The announcement was made Thursday at a medical interoperability conference in Washington co-hosted by the Gary and Mary West Health Institute and the Office of the National Coordinator for Health Information Technology.

Gary and Mary West formed the Center for Medical Interoperability last year to advocate for the cause.

Much of the attention around interoperability has focused on connecting competing health IT systems, such as electronic medical records. However, West Health's efforts have focused on developing standards and bringing together hospital executives to encourage device manufacturers to develop technologies that can interact with each other, as well as with EHRs and other health IT systems.

“Imagine a healthcare system that is simple, streamlined and smart—all made possible by interoperability,” West Health CEO Nicholas Valeriani said during the conference. “Interoperability can help us be more efficient and more effective.”

Improved interoperability between devices and health IT systems is expected to improve care and lower costs. West Health estimates that improved interoperability between medical devices and EHRs would save the healthcare system $30 billion a year. But many systems do not have the capabilities to connect with technology made by a competing manufacturer, which requires hospitals to purchase costly interface platforms from another set of vendors.

A lack of industry standards is another factor that may limit advances in interoperability. Other factors at play include traditional hospital purchasing models, which allow for capital purchases once every 10 or so years, and a lack of interest from some manufacturers, which would have to update or develop technologies with new capabilities.

Last year the FDA identified 25 voluntary standards, which are used by manufacturers as they develop interoperable devices. Shuren said the agency plans to review additional standards this year.

West Health polled the audience during the conference about several issues relating to interoperability. More than half of the participants, about 55%, said that interoperability will improve patient safety. About 46% of participants said that vendors' strategies to maintain market share and increased “switching costs”—the cost of abandoning one system in favor of an interoperable one—as preventing functional interoperability between devices and health IT systems.

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