Medical Devices

Medical Device Interoperability

What is Medical Device Interoperability?

Medical device interoperability is the ability to safely, securely, and effectively exchange and use information among one or more devices, products, technologies, or systems. This exchanged information can be used in a variety of ways including display, store, interpret, analyze, and automatically act on or control another product.

As electronic medical devices become increasingly connected to each other and to other technologies, the ability of connected systems to safely, securely and effectively exchange and use the information becomes critical.

Interoperable devices with the ability to share information across systems and platforms can:

  • Improve patient care,
  • Reduce errors and adverse events, and
  • Encourage innovation.

Cybersecurity concerns rise along with the increasing medical device interoperability. The FDA is aware of cybersecurity issues related to medical devices, and you can learn about FDA’s activities and recommendations for protecting devices and systems from cybersecurity vulnerabilities at our Cybersecurity page.

How is the FDA involved?

The FDA supports the smart, secure, and safe interaction among different medical devices and information systems. The agency has been collaborating with hospitals, health care providers, manufacturers, standards development organizations, and other interested parties to promote medical device interoperability.

Examples of FDA collaboration on ways to advance medical device interoperability include:

These and other activities led the FDA to release draft guidance, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices. The focus of this draft guidance is to help manufacturers design and develop safe, effective, and interoperable medical devices by outlining important design considerations and providing clarity on the agency’s recommendations for submitting interoperability-related information in premarket submissions and labeling. It also proposes that manufacturers should make all crucial and relevant functional, performance, and interface characteristics openly available, enabling users to safely use medical devices with other devices or systems. The comment period for this guidance has closed and the FDA is working to finalize the guidance.

Standards work

Standards are important to the development of reliable interoperable medical devices. By conforming to standards, we can begin creating medical device systems of interchangeable devices from different manufacturers, leading to new models of health care.

In 2013, the FDA officially recognized an initial set of standards manufacturers could use to improve patient care by making sure devices work well together. The FDA continues to recognize consensus standards, such as ASTM F2761-09 (2013): Medical Devices And Medical Systems - Essential Safety Requirements For Equipment Comprising The Patient-Centric Integrated Clinical Environment, that are relevant to the development and design of interoperable medical devices and encourages their use. In many cases, the standards that support interoperability may not only be used by medical device manufacturers, but also by other stakeholders such as health care delivery organizations. This may include system integrators, system designers, and information technology professionals who work in health care settings. In other industries, products now have the ability to seamlessly interoperate with each other. For example, in the automotive industry, engine control modules or electronic safety systems may be used on a variety of vehicles, or in electronic products, your smart television can communicate with your Wi-Fi router.

To verify which standards the FDA currently recognizes, please refer to the FDA Recognized Consensus Standards Database.
 

Additional Resources

Page Last Updated: 07/21/2016
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