FDA finalizes guidance on medical device interoperability
- The Food and Drug Administration issued final guidance on medical device interoperability, paving the way for hospitals and other consumers to discern how specific devices share data.
- The 21-page document, released Tuesday, discusses specific considerations for developing and designing interoperable devices, as well as the content of premarket submissions and labeling for such devices.
- Manufacturers submitting applications up to 60 days after the guidance’s publication will not be expected to comply with the recommendations. However, the agency will review any such information if submitted, the guidance says.
Specifically, the FDA wants device makers to treat interoperability as an key objective of medical device design. Companies should perform appropriate verification, validation and risk-management activities and specify any functional, performance and interface characteristics that are relevant to the end user.
“FDA’s first concern, of course, is safety,” Bakul Patel, associate director for digital health in FDA’s Center for Devices and Radiological Health, wrote in the FDA Voice blog. “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.”
The guidance encourages the use of published consensus standards that support interoperability of device interfaces, but says manufacturers may use their own design preferences instead. Either way, the potential for problems can be reduced by openly sharing the functional, performance and interface requirements with all users.
The need for better medical device interoperability was underscored in a recent opinion piece in the Harvard Business Review. While hospitals are eager to adopt cutting-edge equipment, gaps in interoperability undermine the benefits technologies can bring, both in terms of data exchange and clinical care, researchers at Johns Hopkins wrote.
They urged hospitals to exert their purchasing power on vendors to embrace interoperability and suggested vendors offer interoperable components that support a particular aspect of patient care.
Interoperability is also an issue in scaling up digital health tools. “We could have the best tire ever, but if it’s not going to fit on the car, it doesn’t really help anybody,” Frederick A. Browne, an infectious disease specialist and vice president of medical affairs at Griffin Hospital in Derby, Conn., told Healthcare Dive in June. The same goes for healthcare — ultimately, it needs to sync with everything else.