The FDA this week released final guidance on interoperability in medical devices as more and more healthcare related electronics connect to the Internet of Things.
“As electronic medical devices are increasingly connected to each other and to other technology, the ability of these connected systems to safely and effectively exchange information and use information that has been exchanged becomes increasingly important,” the FDA wrote in an official notice.
The agency outlined recommendations for safer and more secure interactions between devices, recommending that manufacturers design devices with interoperability as a core objective.
The federal watchdog reinforced the necessity of conducting appropriate verification, validation and risk management activities associated with such interoperability, and clear specification of relevant functional, performance and interface characteristics for the user, according to an FDA Voice blog post from FDA Center for Devices and Radiological Health Associate Director for Digital Health Bakul Patel.
“FDA’s 1st concern, of course, is 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 for such interactions. The guidance also encourages transparency, 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,” Patel wrote.
The FDA warned that a failure to develop and provide such information could lead to misuse of devices, which could lead to device malfunctions that could result in patient injury or death.
“Our guidance is a good step towards safer devices, and we will continue to work with all stakeholders to adapt along with the technology,” Patel concluded.