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Round Peg, Square Hole

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Information technology consultant Tim Gee has a nontechnical description of the current state of connecting medical devices to clinical information systems: “It’s a mess.” Not that direct data capture from medical devices is impossible; some hospitals have been exporting data from devices into clinical information systems for years. But as Gee and other experts point out, the effort can be so confounding that many hospitals don’t even try. Even in highly automated inpatient settings, a common method of data capture from the plethora of monitors, pumps and ventilators is good old pen and paper. Someone, often a nurse, writes down the value and either logs it on paper or re-enters the data online.

Consultants like Gee, whose one-man shop, Medical Connectivity Consulting, is based in Portland, OR, have built their careers helping hospitals—and vendors—bridge the often wide chasm between medical devices and electronic medical record systems. Part of the problem lies in the business conventions that have emerged between hospitals and device suppliers. As clinical IT has broadened its reach, however, many in the industry—on both sides of the fence—are clamoring for device connectivity.

In the short run, hospitals have several options in trying to connect their devices. And looking to more comprehensive solutions, at least one highly visible think tank has formed that is promoting collaboration among key industry players. Until that happens, however, the absence of medical device connectivity continues to be a potential source of medical errors and a proven source of clinical staff aggravation. “In the ICU, tending to and documenting from devices accounts for more than a third of nurses’ time,” fumes Narendra Kini, MD, chief medical officer at Trinity Health, a Michigan-based health system with 45 hospitals in seven states. “If we can automate the data capture, we will make a significant enhancement to nurse productivity. It is a giant issue—one often missed in the discussion.”

Challenges aplenty

Trinity exemplifies the industry’s challenge in capturing data directly from medical devices. The health system maintains more than 2,000 physiologic monitors and 9,750 IV pumps, says Kini, adding that the equipment comes from at least five different manufacturers. In this scenario, the key problem, Gee contends, is the absence of industry standards for how data is formatted and exported from the devices. Even devices from the same manufacturer may vary, he says. “Unless a device has the identical model number, the protocol may change,” he says. “To the medical device vendor, their product is the center of the universe. The idea of connectivity is one that vendors have to be pushed kicking and screaming into by their customers.”

Hospitals have been willing accomplices up to now, Gee acknowledges. “Most hospital IT departments don’t think about data capture from devices,” he says. “They suffer from the same perspective vendors have. The IT department figures nurses will just type in the data.”

Another issue is the relatively long shelf life of medical devices, adds Julian M. Goldman, MD, an anesthesiologist at Boston-based Massachusetts General Hospital and director of MD PnP. Standing for “medical device plug and play,” the group runs a device connectivity lab at the Center for Integration of Medicine and Innovative Technology, an affiliate of Mass General. “Devices may be kept for 10 to 12 years,” Goldman says.

Gee praises Goldman’s interoperability think tank, which was launched in 2004, as “trying to goad vendors into doing the right thing and trying to get hospitals off their butts to make demands.” Indeed, one MD PnP participant, California-based Kaiser Permanente, is already insisting that device vendors commit to building interoperability with EMR systems.

MD PnP’s volunteer projects revolve around determining what type of data needs to be derived from which type of device. Prioritizing data capture is tricky, Goldman observes (see “Where to Begin”). “Many devices are designed because engineers have an idea of clinical technology,” Goldman says. “We are trying to identify clinical needs and turn them into technical requirements.”

Rather than wait for industry standards, Trinity is working with its primary clinical information systems vendor, Cerner, to develop what Kini calls a “universal interface” to all devices. Already one year in the works, the effort would create a software bridge to physiologic monitors and IV pumps first, with other devices to follow, Kini says. Trinity’s clinicians don’t need a complete archive of all device data, he adds—but only “clinically relevant data that represents an abnormality” or unwelcome trend.

Semi-integrated

Other hospitals have already integrated limited data from devices into their electronic records. The Dallas VA hospital has fed data from its physiologic monitors into its ICU information system for the past 12 years, says Steve Rypkema, RN, clinical information systems administrator. Then, about two years ago, the hospital, part of the VA’s North Texas Healthcare System, hooked up cardio-impedance monitors. That effort took three months, Rypkema recalls.

Many EMR vendors have developed expertise in creating device interfaces, Rypkema says. But there are other workarounds, advises Gee. Some companies, such as CapsuleTech, have developed a so-called “third-party” interface that can connect EMR systems to various devices. “The third-party solution can work well once it is configured,” he says. “However, if there is EMR downtime, data may not store in the interface device.”

In addition, hospitals that rely on proprietary medical device company software to connect their devices to EMRs may encounter problems if they change vendors. “When you connect devices to an EMR, you need to make decisions in broad context,” Gee says. “Many hospitals don’t do that. It’s why nurses wind up with an eight-pound tool belt, with a pager for one device, a PDA for another, a phone, and so on.” That’s one reason that Gee endorses the work of MD PnP. “Ultimately, the industry needs standards that facilitate plug and play,” he says.

For Goldman, the key driver is patient safety. “It is too easily assumed that the benefit of interoperability is the movement of data into the EMR,” he cautions. “It is the development of safer systems that is the essential benefit of this work. Technical issues, although not trivial, are the lesser challenge. The political and liability issues are far greater.”

Gary Baldwin is technology editor of HealthLeaders magazine. He can be reached at gbaldwin@healthleadersmedia.com.



Where to Begin?

Given the multitude of medical devices in play, it is hard to know which to connect first to an EMR system. According to Julian Goldman, director of MD PnP, an interoperability think tank that is part of Massachusetts General Hospital, it’s a question of perspective. “If you are a nurse on the ward, you would say the physiological monitor,” he says. “If you are monitoring postoperative complications, it would be CO2 monitors. If you administer medications in a dangerous environment where the patient is being irradiated, you might want to control an infusion pump from 20 feet away.” That’s one reason Goldman champions “plug and play” standards that would enable easy connectivity between devices and electronic medical record systems.