FDA Issues Draft Guidance for Medical Device Interoperability

The FDA issued new draft guidance aimed at improving interoperability among connected medical devices, Clinical Innovation & Technology reports.

Details of Draft Guidance

The draft guidance provides connected medical device manufacturers with:

• Design considerations for developing interoperable medical devices; and
• Information to include in pre-market submissions and device labeling (Walsh, Clinical Innovation & Technology, 1/26).

FDA noted that "errors stemming from inadequate interoperability can occur, such as the transmission of weight in kilograms when the receiving medical device assumes the measurement is in pounds, and that can lead to patient harm and even death" (Conn, Modern Healthcare, 1/26).

FDA called on device manufacturers to:

• Conduct appropriate performance testing and risk management activities;
• Design systems with interoperability as an objective;
• "Exer[t] command and control" over other devices;
• Publicly share the functional, performance and interface characteristics; and
• Standardize architecture and communication protocols.

The agency also said manufacturers should consider whether their devices can handle data:

• That have been "corrupted"; or
• From "outside ... appropriate parameters." 

FDA in its draft guidance said, "Increased use of interoperable medical devices has the potential to foster rapid innovation at lower cost," adding, "However, appropriate safety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."

Reaction

Joseph Smith, chief medical and science officer at the West Health Institute, praised the draft guidance's expansion of the definition of interoperability to include actual use of shared data. He said, "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."

Meanwhile, Bradley Merrill Thompson, an attorney with Epstein Becker & Green, said, "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." He added, "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" (Bowman, FierceHealthIT, 1/26).

Cybersecurity Advocacy Group Calls for Universal Principles

In related news, a cybersecurity advocacy group has published an open letter to the health care industry to adopt five principles for creating, using and maintaining medical devices, Computerworld reports.

The group, called I Am the Cavalry, urged medical device manufacturers and other health care stakeholders to:

• Capture and analyze evidence of potential failures;
• Collaborate with security researchers;
• Implement security by design;
• Provide easy-to-install security updates; and
• Safeguard critical elements for operation in adverse conditions.

To achieve the goals proposed, the group, among other things, recommended:

• Avoiding known flaws;
• Avoiding unsecure remote access;
• Implementing proven processes for receiving vulnerability reports; and
• Making the medical device update process more secure (Constantin, Computerworld, 1/19).