The Food and Drug Administration has issued final guidance outlining the regulatory agency’s recommendations for developing medical devices that safely and effectively exchange and use patient information electronically.
The FDA’s guidance is intended to promote the design and development of interoperable electronic medical devices, which the agency says are increasingly connected to each other and offer the potential to increase efficiency in patient care and to encourage innovation.
“It is important to note that the recommendations in the final guidance focus on the information and content exchanged over electronic connections such as USB (Universal Serial Bus) and wireless, but does not focus on aspects of physical compatibility (i.e. physical connectors),” states the FDA’s announcement. “Additionally, this final guidance will have a 60 day transition period to allow the FDA and industry to perform activities to address recommendations in the guidance.”
Specifically, the document recommends that all medical device manufacturers: design their devices with interoperability as an objective, conduct appropriate verification, validation and risk management activities, as well as clearly specify the relevant functional, performance, and interface characteristics to the user.
According to Bakul Patel, associate director of digital health in FDA’s Center for Devices and Radiological Health, patient safety is the primary concern of the agency when it comes to interoperable medical devices.
“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,” Patel says. “Our guidance recommends appropriate functional, performance, and interface requirements for devices with such interactions.”
In addition, the document encourages transparency by recommending that designers and manufacturers provide information on a product’s functional performance and interface characteristics so that those using it with other devices and systems can do so safely.
“Failure to develop and provide this information to the user may lead to an inappropriate use of the device interface in a way that can lead to device malfunction, including the failure to operate, and may lead to patient injury and even death,” Patel warns.
While medical device manufacturers should consider these items to provide a reasonable assurance of the safety and effectiveness of their interoperable medical devices, ultimately they are nonbinding recommendations and are not legally enforceable when it comes to their design and development.
“FDA has recognized numerous consensus standards relevant to the development and design of interoperable medical devices and encourages their use,” Patel says. “Manufacturers may choose to use their own design preferences for their interface (in lieu of a published consensus standard) for their medical devices. In either case, problems or misuse of interoperable medical devices can be minimized by making the functional, performance and interface requirements openly available to all users.”
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