TCBI: Time for clinical engineers to take the lead on interoperability
BOSTON—Interoperability is alive and growing in many hospitals today, but you have to know where to look to observe it in each stage of its development toward maturity. Welcome to the world of James P. Keller Jr., vice president of health technology evaluation and safety for ECRI Institute in Plymouth Meeting, Pa., who presented at The Center for Business Innovation’s third annual conference on medical device connectivity at Harvard Medical School Sept. 8 and 9.

“It’s not clearly defined when medical device connectivity will be required as part of meaningful use,” Keller said, “so hospitals [are] kind of holding off in some cases with their interoperability plans until meaningful use is a little more shaken out, particularly as it relates to interoperability.”

Still, according to recent ECRI research, many are diving in. “Almost all the hospitals [ECRI recently interviewed] said, ‘Let’s start small, get a success under our belts and then we’ll start to get a little bit more sophisticated.’” Some hospitals have been both cautious and resourceful, negotiating with equipment manufacturers to donate or loan devices for use with test beds.

As for the present state of connectivity and interoperability on a broad scale, Keller pointed to a survey conducted by HIMSS Analytics and Lantronix late last year. Upon surveying more than 800 hospitals, they learned that approximately one-third of provider institutions had an interface between their devices and their EMR. Of those who had an interface, around 24 percent involved physiologic monitors, 19 percent fetal monitors, 15 percent electrocardiograms and 9 percent ventilators.

“Most of those connections were direct, with a small percentage using some sort of a connection hub,” said Keller. “The big driver was automatic charting to help with a number of factors such as saving nurses time on manual data entry. I saw one report on a hospital that came from an integration vendor claiming savings of one hour per nurse per shift with automatic reporting of data from vital-signs monitors.”

Connectivity will reduce the rate of error associated with manual data entry, said Keller, and there are lots of uses for the story analytics—the information drawn from patient monitoring data and other medical device data that’s transmitted to the EMR.

“A big issue for hospitals is figuring out how they’re going to handle all that data,” he said before naming a reason to figure things out, and quickly: “You’ve got a lot of potential for building efficiency and accuracy, and the financial incentives and penalties associated with the government’s meaningful use criteria will help drive that.”

Keller described how ECRI Institute spent much time in recent months interviewing upwards of 2,000 hospitals about their interoperability experiences. This was part of a project to build ECRI’s “interoperability database,” which the organization will use to offer its subscribers instructive case studies. “We’re planning to put some data related to how well medical devices connect to other medical devices and how well they connect to the HMR,” said Keller.

Of the hospitals that ECRI has interviewed for this particular database, all said they were in the early stages of adoption of interoperability or connectivity. Typical initial efforts have focused on patient monitors and started with “real basic functionality.”

Some of the factors that have emerged as impediments to moving forward more quickly are cost, complexity and the fact that there is lack of standardization. “Legacy equipment is a big issue,” Keller added. “Hospitals tend to hold onto their capital medical equipment for a long time. And a lot of that legacy equipment isn’t set up to easily get involved in interoperability.”

Among the questions hospitals have been asking:
  • Should we be considering a patient-monitoring manufacturer’s gateway with my monitoring system?
  • Does the manufacturer’s monitoring system come with a gateway?
  • Is a third-party integrator’s add-on a better choice?
  • Whose claims should I be believing?

“There’s a lot of information on interoperability features from different sources,” said Keller. “Clearly, the hospitals we heard from were feeling a little bit confused by that. They were wary about getting involved with some of the newer companies because they felt they hadn’t yet been tested.”

Another conspicuous concern is staffing. “Do we have the expertise to support that technology in our hospital? Can we find someone—a clinical engineer or an IT person who is savvy with medical devices—to support this technology? A lot of hospitals don’t have that individual right now, and some are starting to look at that [lack],” said Keller.

“A lot of the hospitals [we interviewed] had inventoried their devices to understand what kind of input/output capabilities they had so they knew what they could and couldn’t do. Some of the things they ran into were unplanned downtime, dealing with troubleshooting, and running into some finger-pointing between multiple vendors—and sometimes between departments within the hospital.”

Keller said ECRI heard much about the need for clinical validation. “That, among other things, was impacting and changing the workflow of the clinicians, which was affecting their psychological or emotional buy-in for interoperability,” he said. “This was slowing things down.”

Nor have clinicians been put at ease to know that ECRI Institute, which tracks medical device problems in order to issue product alerts and recall notices, has documented a conspicuous spike in the number of device problems involving software.

Turning to points of progress, Keller mentioned the promise of cooperative initiatives underway between the Association for the Advancement of Medical Instrumentation (AAMI), HIMSS and the American College of Clinical Engineering (ACCE), of which he is president-elect — such as the CE-IT Community, online here—and said such initiatives are helping provide hospitals with more resources to make interoperability “a more seamless, more widely used technology than we see today.”

Among the initiatives that have worked well for the 2,000-plus hospitals that responded to ECRI’s query on interoperability: the drive for greater collaboration between departments and with vendors. “Relationships are critical,” said Keller. “Clinical engineering and IT have to work really well together, whether they’re part of the same department or in a collaborating role. And that has to be done with nursing as well.”

In order for interoperability to work, he concluded, hospitals need a clear strategic vision that is driven and supported by senior leadership within the institution—a vision that is coordinated with all the healthcare technology plans in the hospital.

“At the last AAMI conference, I told the CE folks: This is their opportunity,” he said. “Clinical engineers have a chance to really seize the day and take the lead in interoperability for the healthcare organization. And the only way for that to work is to study, study, study. Become the expert.”

In an interview following the session, Keller said what, exactly, clinical engineers need to study to position themselves as interoperability experts.

“Clinical engineers need to be familiar with all the standards that relate to interoperability,” replied Keller. “They need to understand the interoperability capabilities of the equipment they have in their institution and take the lead on being their institution’s expert in that area.”

How is that going to sit with IT?

“There’s definitely a role for the IT professional,” Keller said, “but one of the advantages the clinical engineers bring to this issue is that they are intimately familiar with the inside and outside operations of medical devices. This puts them in a really good position to become their institution’s interoperability expert.”