FDA final guidance on medical device interoperability highlights connectivity, risk management
The U.S. Food and Drug Administration this week released its final guidance for "smart, safe, and secure" interoperability, both among different medical devices and with IT systems.
Developed using feedback from industry, device designers and the public, the guidance is meant to give manufacturers specific considerations to keep in mind with developing their technologies, and recommendations for information to include in pre-market submissions.
"Today’s healthcare providers and their patients are relying more than ever on rapid, secure interactions among different medical devices," said Bakul Patel, associate director for digital health at FDA' Center for Devices and Radiological Health, in a blog post. "From electrocardiograms to infusion pumps, medical devices must reliably communicate and operate in concert."
He offered the example of a neonatal intensive care unit, where a pulse oximeter is "sending data on changes in the newborns' blood oxygen level to a hospital computer system that simultaneously gathers data from EKGs that are monitoring the electrical activity of their hearts." Proper synchronization of that data is critical to patient safety and quality of care.
The voluntary new guidance focuses on three areas that manufacturers should keep focused on to provide a "reasonable assurance of safety and effectiveness" for their interoperable devices, according to FDA.
First, they should design systems with interoperability top-of-mind as a core objective.
"In designing a medical device’s electronic interface, manufacturers should consider the level of interoperability needed to achieve the purpose of the interface, as well as the information necessary to describe the interface," according to the document. "The labeling should be in sufficient detail to allow anticipated users to connect and use the medical device and interface as it is intended."
Second, they should conduct "verification, validation and risk management activities" as appropriate.
"Manufacturers’ risk management strategies should address the risks associated with the anticipated users of the device, reasonably foreseeable misuse of the device, and reasonably foreseeable combinations of events that could result in a hazardous situation," according to the guidelines. "However, FDA recognizes that a manufacturer cannot be responsible for all possible uses outside of the purpose of the interface."
Third, they should be sure to specify, with clear labeling, the devices' relevant functional, performance and interface characteristics in a user- available manner such as labeling.
"One way to reduce risk and facilitate safe and effective medical device interoperability is to include in labeling the functional and performance requirements of the electronic interfaces that may be used to connect medical devices with other electronic equipment," according to FDA. "The manufacturer should determine the appropriate way to provide the information based upon the anticipated users and the risk analysis."
In his blog post, Patel said the agency's top concern is patient 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. Our guidance recommends appropriate functional, performance, and interface requirements for devices with such interactions."
One way to help safeguard that is through clear labeling and transparency. Without communicating devices' capabilities, clinical users could use them inappropriately, especially in conjunction with IT systems, in ways that could cause device malfunction – leading to potentially serious adverse events.
"Problems or misuse of interoperable medical devices can be minimized by making the functional, performance, and interface requirements openly available to all users," said Patel. "Our guidance is a good step towards safer devices, and we will continue to work with all stakeholders to adapt along with the technology."