Building a Case for Medical Device Interoperability: FDA’s Call to Action

By: Bakul Patel, M.S., M.B.A.

As Yoda might say: build a case for interoperability, we must. While we may not have yet realized the technological accomplishments of Yoda’s advanced world, today connectivity shows great promise for the future.

From blood pressure to brain scans, today’s health care allows for the rapid transfer and use of information between and among different medical devices. This concept—called interoperability—is less about basic communication and more about the smart and safe interaction among medical devices and information systems.

Seamless interoperability among medical devices can improve patient care, reduce errors and adverse events, and lower costs. In fact, interoperability is one of the key factors for safety that can drive innovation in care delivery.

Think of a scenario in which devices collect a patient’s vitals during surgery. Then think about staff having to manually enter those vitals into a health care record because the format of the data generated by operating room devices isn’t compatible with the format necessary for the health care record, which by the way, only operates in one format. In this situation, the lack of interoperability can lead to errors during the manual entry process, and possible inefficiencies in patient care.

Now think about another scenario in which a patient is connected to a ventilator that can alert a caregiver—or automatically adjust its function—by monitoring an oximeter that measures blood’s oxygen saturation levels. In this situation, the interoperability between the ventilator and oximeter better coordinates their interaction and may reduce nuisance alarms, allowing clinicians to focus on true clinically significant alarms.

FDA has been collaborating with hospitals, health care providers, manufacturers, standards-development organizations, and other interested parties to promote medical device interoperability because it helps patients.

Some key activities in pursuit of this goal include the following:

In addition, we recently released draft guidance, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices, which outlines our ideas on design considerations for manufacturers developing interoperable devices. It contains our recommendations for information manufacturers should include in their pre-market submissions and ultimate product labeling. It also encourages manufacturers to make all necessary and relevant functional, performance, and interface characteristics openly available, enabling users to safely use medical devices with other devices or systems.

This draft guidance is intended to promote and facilitate development of safe and effective interoperable devices, thereby strengthening the much needed “case” for interoperable medical devices. We intend to work with stakeholders toward a future where interoperable devices increase care efficiency and reduce care costs, while keeping patient safety in the forefront.

We’re encouraging all stakeholders to share comments on this draft guidance with us.

We believe now is the time for all stakeholders—including medical device manufacturers, health care organizations, researchers, and information systems firms—to come together and continue to build this case to accelerate the development and availability of safe interoperable medical devices.

In Yoda’s words…may the force of interoperability be with us!

Bakul Patel, M.S., M.B.A., is associate director for digital health in FDA’s Center for Devices and Radiological Health

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