Medical Device Daily Washington Editor

WASHINGTON — Anyone who has been farther into a hospital than the front desk can attest to the bewildering array of medical devices and monitoring equipment – not to mention the appurtenant wires, hoses and other leads – used to track a patient's vital signs, but one of the sessions held on the first day of the World Health Care Congress highlighted the frustration doctors feel for the current situation.

Doctors may feel the cavalry cannot possibly come riding over the hill soon enough, but help, however tardy, is en route, as a session addressing the integration of devices into a hospital's information technology system made clear.

Julian Goldman, MD, director of the medical device interoperability program for the hospital group Partners Healthcare (Boston), led off the discussion by posing the question: "Why include device connectivity in the scope of HIT?"

The first of several answers, he said, is that "complete and accurate [patient] records ... require complete and accurate data, measured from patients with devices." This ideally would include real-time tracking of vital signs, but at a minimum should provide static data along with a time stamp. Goldman noted that e-mails have time stamps, but in contrast, "medical devices are like VCRs with flashing time clocks" because so many lack a time stamp mechanism of any sort. This can leave a doctor rushing into the patient's room with a nasty dilemma. "You don't know if the blood pressure dropped before or after you gave the medication," he observed.

There is also a need for error-resistant systems that will cut down on surgical and medical errors. Goldman described a situation in which a patient died while on the operating room table because the ventilator had to be temporarily turned off while an X-ray was taken. Unfortunately, the film plate became jammed and in the distraction, the anesthesiologist, who was attempting to help dislodge the cartridge, left the respirator off for too long, and the patient ultimately died. Goldman said this could have been averted had the ventilator been synchronized with the x-ray machine.

Anyone who enjoys the universality and convenience of a universal serial bus (USB) port and connector would cringe at the variety of ports and connectors found in the typical hospital suite, but the physical connections used by devices and medical equipment are a secondary issue. "None of them use any kind of standardized data interfaces" either, Goldman remarked.

On the other hand, as any amateur computer geek who ever attempted to reinstall an operating system into a machine with proprietary hardware can attest, software and drivers "are an even bigger problem," Goldman said, adding that the problem isn't exactly news. He said someone spelled out the need for a better system in the early 1990s, but while "you see publication after publication about how we can do better," there is still no "open, standards-based interoperability." There is, however, "a drive toward more complex, heterogeneous networks" in hospitals, and a mix-and-match approach to the marriage of device and IT technologies may render "systems with unanticipated behavior."

Goldman cautioned that wireless data links are not the answer. "Wireless networks are an even bigger problem," he said, "because you can't segregate these [individual] networks with a wire."

The solution, which starts with a plug-and-play approach to linking medical device and equipment to existing data networks, is out there, but Goldman said it will have to be user-driven. "You have to have clinical requirements pull" the technology because a techno-push approach "almost inevitably stumbles." However, he said, that hospitals see an "unclear business case" and that manufacturers "are puzzled why hospitals don't ask" for universal connectivity.

Needless to say, FDA will inevitably enter the picture, but that's another issue. For now, the newest dramatis personae in this unfolding story is the Medical Device "Plug and Play" Interoperability Program, or MD PnP program. Goldman said that this is a consortium of interested parties is working collaboratively toward an interoperability standard, and they have made headway already, as the site at http://mdpnp.org shows. "A document released in October ... conveys our express interest in purchasing interoperable equipment," Goldman said in reference to the Medical Device Free Interoperability Requirements for the Enterprise initiative, or MD FIRE.

Goldman said that Massachusetts General Hospital and the Center for Integration of Medicine & Innovative Technology (both Boston), with support from the Department of Defense, have held a series of meetings to formulate standards for an integrated clinical environment. His documents indicate that more than 85 companies and institutions and more than 700 expert clinicians and engineers have met on four occasions to work on standards and clinical requirements. These have been "developed with ASTM International," Goldman said, adding that the hope is for a standard that "specifies the characteristics necessary for integration of medical devices and other equipment via electrical interfaces from different manufacturers."

The Office of the National Coordinator for Healthcare Information Technology and the American Health Information Community are aware of the work, Goldman said, noting that the two "released in December 2008 the common device connectivity use case." It talks about "quite tight integration" between devices and healthcare information technology. Goldman said the vision is that "we can improve safety and efficiency by changing expectations" of devices and equipment used in hospitals.

So how does all this hit the hospital's bottom line? If one assumes that some sort of integration is inevitable – and the federal government's push toward HIT suggests it is – even interoperability requirements look like a source of savings. Goldman said that data generated by Kaiser Permanente (Oakland, California) indicate that "there is about a 30% savings if you integrate devices [into the in-house electronic medical record system] with a standards-based interface as opposed to without."