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:
- In 2010, the FDA, Continua Health Alliance, and the Center for Integration of Medicine & Innovative Technology (CIMIT) sponsored a public workshop to bring together relevant stakeholders and find common ground for interoperability, safety in an interoperable environment, and regulatory pathways.
- In 2012, the FDA and the Association for the Advancement of Medical Instrumentation (AAMI) identified challenges to device interoperability, including standardization, at a Summit on Medical Device Interoperability. Read more about the summit in the AAMI report, “Medical Device Interoperability: A Safer Path Forward.”
- In 2015, the FDA, the Centers for Disease Control and Prevention (CDC), and the National Library of Medicine (NLM) of the National Institutes of Health held a public workshop, “FDA/CDC/NLM Workshop on Promoting Semantic Interoperability of Laboratory Data,” where stakeholders discussed approaches to promoting the semantic interoperability of laboratory data between in vitro diagnostic devices and database systems, including laboratory information systems and electronic health records.
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 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.
- FDA Voice: Building a Case for Medical Device Interoperability: FDA’s Call to Action
Bakul Patel, CDRH’s Associate Director for Digital Health, discusses the importance of interoperability and cybersecurity for medical devices.
- FDA Voice: Improving Patient Care by Making Sure Devices Work Well Together
Patel discusses FDA’s role in promoting innovation and safety through medical device interoperability.
The National Institute of Standards and Technology (NIST) website on Medical Device Interoperability
This website describes NIST’s efforts to promote standards-based medical device interoperability and communication.
Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap
The Office of the National Coordinator for Health IT’s (ONC) vision for a future health IT ecosystem where electronic health information is appropriately and readily available to empower consumers, support clinical decision-making and advance science.
- AAMI White Paper on Medical Device Interoperability
An overview of medical device interoperability, including a discussion of what is meant by interoperability, relevant standards, and the challenges in achieving safety.
- The Value of Medical Device Interoperability: Improving Patient Care with more than $30 Billion in Annual Health Care Savings
A discussion of the business case for medical device interoperability by West Health Institute.
- Medical Device Plug-and-Play (MD PnP) Interoperability Program
A research program investigating patient safety aspects of medical device interoperability and proposed solutions based on open systems.