The Food and Drug Administration recently released draft guidance outlining the regulatory agency’s recommendations on design considerations for manufacturers seeking to develop interoperable medical devices. However, critics argue that the guidelines are not enough to ensure device interoperability.

The FDA guidance is meant to provide the industry with a “reasonable assurance of safety and effectiveness of their interoperable medical devices,” according to Bakul Patel, associate director of digital health in the FDA’s Center for Devices and Radiological Health.

“As electronic medical devices become increasingly connected to each other and to other technology, the ability of these connected systems to safely and effectively exchange, and use the information that has been exchanged, becomes increasingly important,” Patel says. “The failure to develop and use appropriate functional, performance and interface information during product development may lead to the exchange of inaccurate, untimely or misleading information between devices. It may also lead to device malfunction, including the failure to operate, and can lead to patient injury and even death.”

To avoid these adverse events, the regulatory agency believes that the use and development of standards that support medical device interoperability is vital to creating interoperable systems that are safe and reliable.

FDA's Bakul Patel
FDA's Bakul Patel

“When the functional, performance and interface specifications, including requirements for use, are made publicly available to the user, it allows the interface to be used and connected safely and effectively,” argues Patel. “In addition, this allows the manufacturer to provide any limits on the use of the device as well as provide warnings that may prevent any potential misuse.”

However, the FDA does not have the legal authority to “define for the whole ecosystem how the ecosystem should operate, or according to what standards product should be made.” contends Bradley Merrill Thompson, an attorney at Washington, DC-based law firm Epstein Becker Green who counsels medical device companies on regulatory issues

According to Thompson, the agency, by its very charter, is a passive regulator. “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,” he asserts. “Manufacturers have complete control over their intended use, and if they want to make their products useful only with specific other products, that’s their right.”

While Thompson thinks the FDA’s guidance is a good first draft and includes important advice for device manufacturers that want to make interoperable devices, he contends that a more comprehensive scheme for interoperability will have to come from the private sector, which has demonstrated the will to make progress through innovative efforts that are not driven solely by government regulation.

Patel acknowledges that there are many industry-led efforts that are addressing the challenges of interoperability, which are encouraging, and the fact that the agency’s draft guidance is not a regulation. Instead, he says it is “intended to provide clarity on the FDA’s expectations for medical device interoperability and to assist medical device manufacturers in incorporating interoperability with safety in mind.”

Still, Matt Patterson, MD, president of mobile health vendor AirStrip, believes that while it’s “hard to argue with the intentions” of the FDA’s guidelines, the lack of interoperability progress lies with the government. Patterson believes that the public sector needs to become more involved in driving interoperable medical devices by implementing a governance structure that defines the “rules of the road” and prohibits information blocking through certification and requiring a basic set of standards.

“The greatest risk to safety has to do with the data blocking which has been pervasive over the last decade and continues to this day, coming from device manufacturers,” he concludes. “To date, there has not nearly been enough enforcement put into interoperability.”

However, Thompson says it’s too easy to blame device manufacturers, many of whom are moving toward interoperable medical devices and the adoption of standards that are helping facilitate “some baby steps in the direction of limited interoperability.”

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