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Growing Pains: Medical Device Interoperability

June 24, 2011
by John Degaspari
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Regulators and New Standards are Helping to Bring about the Convergence of Medical Devices and Information Management Systems on IT Networks

EXECUTIVE SUMMARY:

Both provider organizations and medical device vendors have made significant, if slow-going, progress over the last several years to network their digitally-enabled medical devices. Recent strides in both the regulatory and standards arenas have provided renewed impetus on the part of both stakeholder groups to bring more interoperability to disparate medical devices, resulting in better security and quality of patient data.

As healthcare providers continue their steady march toward implementing electronic health records as envisioned in the Health Information Technology for Economic and Clinical Health (HITECH) Act, leading hospital systems are confronting head-on the challenge of integrating the disparate medical devices operating within their walls into EHR data flow. And while tying together those medical devices into a truly seamless network is still beyond reach, stakeholders in the effort can point to some victories that are bringing their goal just a bit closer to reality.

A good deal of the push for device interoperability has come from proponents in provider organizations. And, while medical device interoperability has not yet been explicitly mandated under meaningful use, it has been recommended to the Office of the National Coordinator for Health IT (ONC) for inclusion in Stage 3. In the view of more than one expert interviewed for this article, medical device interoperability is not just about moving data around a network; it means making sure that the health data maintains its integrity, and that it is delivered to the right place securely.

Tim Gee
Tim Gee

Julian M. Goldman, M.D.
Julian M. Goldman, M.D.

As noted by Jason Joseph, director of technology and information solutions at Spectrum Health, Grand Rapids, Mich., interoperability presupposes the comprehensibility of data, in a standard format. “I can get the data out of most machines and plug it into somewhere else, but does it mean the same thing across the board?” he asks.

A PATIENT SAFETY ISSUE

One of the early advocates of medical device interoperability has been Julian M. Goldman, M.D., medical director of biomedical engineering for the Partners HealthCare system and an anesthesiologist at Massachusetts General Hospital in Boston. In 2004, he founded the Medical Device Plug and Play (MD PnP) Interoperability Program to encourage the adoption of open standards and technology to integrate medical devices.

I CAN GET THE DATA OUT OF MOST MACHINES AND PLUG IT INTO SOMEWHERE ELSE, BUT DOES IT MEAN THE SAME THING ACROSS THE BOARD?-JASON JOSEPH

Goldman says that interoperability is only a means to an end, which is effective and lower cost system integration. Working with clinicians and clinical engineers, his group identified clinical scenarios in which system integration could improve quality of care. One example: patient injuries and deaths that occur when x-rays are taken of patients on a ventilator. “There are cases where people have died because people turn off the ventilator to take an x-ray and forget to turn it back on,” he says. The clincher, he says, is that more than 10 years ago, a research group in Florida demonstrated that if you can interconnect the ventilator with the x-ray machine, they can be synchronized automatically, eliminating the need to turn the ventilator off in the first place.

The team used that example to elucidate potential interface solutions; for example, that the ventilator has a network connection that lets it be paused for 10 seconds and restart automatically. “If you have the right interoperable components that have the right features, when they are assembled into smarter networks for patient care, they will improve safety,” Goldman says. He calls for an “ecosystem” of interoperable medical products that will enable the development of applications that take advantage of the capabilities of medical devices to improve patient safety and quality of care. To that end, Goldman has participated in the creation of an ASTM standard (F2761), “Integrated Clinical Environments,” which creates a common framework in which devices can safely operate to enable decision support at the point of care.

Goldman has seen positive signs that his message is receiving some recognition. In October 2010, the MD PnP program received a $10 million Quantum grant over five years from the NIH/National Institute of Biomedical Imaging and Bioengineering to develop a “prototype healthcare intranet for improved health outcomes.” The grant is an affiliate of the ONC Strategic Health IT Advanced Research Projects (SHARP) program. In his view, the Quantum grant is a sign of the rising awareness of medical device interoperability issues. One of the current tasks under the Quantum funding is to develop a compendium of medical device interface requirements.

CHANGING THE EMBEDDED MINDSET

Tim Gee, principal at Medical Connectivity Consulting, Beaverton, Ore., observes that medical devices historically have been embedded systems-standalone black boxes that were not connected. That has been changing, Gee says, as some device makers have been migrating to the general-purpose IT world with devices that have built-in connectivity.

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