MD FIRE: Hospitals Issue Call for Action on Medical Device Interoperability


January / February 2009

Hospitals Issue Call for Action
on Medical Device Interoperability

We highlighted the importance of medical device interoperability for patient safety in an article in PSQH in January/February 2007. Interoperability enables the integration of individual medical devices into a networked system for the care of a high-acuity patient, and will support an infrastructure for innovation in patient safety, treatment efficacy, and workflow efficiency. Such a system can reduce medical errors and healthcare costs to the benefit of patients throughout the continuum of care. In the past year, the primary potential users of such integrated systems — clinicians and healthcare delivery organizations (HDOs) — have begun to strengthen their demand for this vital capability.

Six clinical societies have now endorsed medical device interoperability as enabling improvements to patient safety and healthcare efficiency. These include the Anesthesia Patient Safety Foundation, American Society of Anesthesiologists (ASA), Society of American Gastrointestinal Endoscopic Surgeons, World Federation of Societies of Anaesthesiologists, Society for Technology in Anesthesia, and Massachusetts Medical Society. Similar endorsement language is under consideration by additional groups.

Three leading HDOs — Massachusetts General Hospital/Partners HealthCare System, Johns Hopkins Hospital, and Kaiser Permanente — collaboratively developed draft interoperability requirements that they have agreed to incorporate in their procurement contracts with medical device vendors. The collaborative team — including clinicians, procurement/materials managers, clinical and information systems engineers, and legal counsel from each of the institutions — was convened and led by the Medical Device Plug-and-Play (MD PnP) Interoperability Program and worked together over a 6-month period to develop a white paper and sample sharable contracting language. The resulting document — MD FIRE (Medical Device Free Interoperability Requirements for the Enterprise) — was announced and released at the annual meeting of the ASA in October 2008, and is available for download on the MD PnP web site ( The document’s release was followed by a press release from the ASA and a cover article in the December 2008 issue of Anesthesiology News.

The original collaborating institutions have issued a call to action for interoperability of medical devices and systems — they are encouraging other hospitals and HDOs to adopt MD FIRE or similar language for contracts and RFPs, in order to drive procurement changes that make it clear to medical device vendors what we need. This work is closely aligned with the U.S. FDA’s position on interoperability. The document urges device manufacturers to adopt open electronic data interfaces once they are available, and to participate in the development of such interfaces. Additional large national HDOs are currently considering the MD FIRE language.

A set of interoperability standards called ICE — the Integrated Clinical Environment — is currently under development in ASTM International, one of the world’s largest standards development organizations. The multi-part ICE standard defines the necessary characteristics of a patient-centric clinical environment that can safely support integrated networked medical devices, such as “flight data recorder” capture of network and user data (e.g. keystrokes), and authentication of devices coming onto and going off the network. Part I of ICE is out for ballot, and work is beginning on the drafting of subsequent parts (Device Models and Network Control).

MD FIRE reflects the recognition by HDOs of the need for medical device interoperability in the modern healthcare environment and their deep-felt desire to adopt interoperability standards when available. By releasing the MD FIRE document and encouraging ongoing discussion and improvement of interoperability requirements, HDOs seek to hasten the day when patients and providers can benefit from the same level of interoperability that we all enjoy as consumers of modern computers and consumer electronics that have these capabilities now.

Excerpts from MD FIRE


Susan Whitehead is the program manager of the Medical Device Plug-and-Play (MD PnP) Interoperability program at CIMIT (Center for Integration of Medicine and Innovative Technology), a consortium based at Partners HealthCare in Boston. She coordinates collaborations, communications, and projects for the multi-disciplinary, multi-institutional MD PnP program, which includes a growing network of more than 600 individuals and 85 institutions. Whitehead may be contacted at

Julian Goldman is director of the program on interoperability at CIMIT (Center for Integration of Medicine and Innovative Technology), a practicing anesthesiologist in the Massachusetts General Hospital (MGH) “OR of the Future,” and a physician advisor to Partners HealthCare Biomedical Engineering at MGH. He is the director of the Medical Device “Plug-and-Play” (MD PnP) Interoperability Program, which he founded in 2004 to lead the adoption of open standards and technology for networking medical devices to support high-acuity clinical solutions for improving patient safety and healthcare efficiency. Goldman may be contacted at


Whitehead, S. F., & Goldman, J. M. (2008). Getting connected for patient safety: How medical device “plug-and-play” interoperability can make a difference. Patient Safety & Quality Healthcare, 5(1), 20‚26.

Model contract gives momentum to interoperability movement. (2008). Anesthesiology News, 34, (12), 58-59.

“FDA Perspective,” 2007 Joint Workshop on High Confidence Medical Devices, Software, and Systems and Medical Device Plug-and-Play Interoperability (HCMDSS-MD PnP 2007), xii-xiii, (