Erin Sparnon

Medical device integration-- are we there yet?

April 24, 2014
by Sean Ruck, Contributing Editor
Medical device integration is very early in the adoption curve at most health care facilities. While devices like injectors and CTs are experiencing a fairly high level of integration, infusion pumps and other devices are just starting to integrate with EMR systems.

For equipment like infusion pumps, device integration is generally being driven by a call for safety and efficiency rather than cost savings. “It’s very difficult to document ROI for that type of equipment based on efficiency,” says Erin Sparnon, engineering manager for Health Devices Group at ECRI Institute.

“A lot of folks in the medical device industry were really hoping integration would come into Meaningful Use stage 2,” says Sparnon. “Medical device integration can help meet the requirements, but integration itself is not required at this point.”

Significant investment is required to integrate equipment properly, including upfront costs related to implementing the needed systems and servers, building individual interfaces, educating staff on how to utilize the new methods as well as costs related to ongoing maintenance of the systems, e.g., change management.

Still, for facilities striving toward equipment and information system integration, there are three major challenges to overcome.

1. Political challenges — in order for a medical device integration project to get to a state where doctors and nurses can use it, there needs to be coordination between three teams: the hospital, information system vendor and medical device vendor.

While the hospital’s reason for involvement is a given, the coordination between the MD vendor and the IS vendor may require a little bit of explanation. Even though some standards exist from Integrating the Healthcare Enterprise that define messages between the information system vendor and the medical device vendor, these standardized messages are not prescriptive enough to guarantee success. One reason is because information systems are highly customized for each facility. In order for a medical device to send or receive information, it essentially needs to take monitor speak and turn it into EMR speak and vice versa. The MD vendor can tell the hospital exactly what can come out of their system and the IS vendor can tell the hospital what their systems can receive, and it’s the hospital’s responsibility to maintain the necessary translations or mapping.

2. Liability and responsibility — while medical devices are cleared by FDA for a certain use, information systems generally aren’t currently subjected to the same oversight. Hospitals need to know who is liable and what they are liable for if any data fails to arrive promptly, securely and uncorrupted. In practical terms, the answer will usually be the hospital, but it’s important for risk managers to know this up front. As integration becomes more commonplace, more liability questions will arise that hospitals need to consider and be ready to answer.

By the same notion, the hospital needs to know who should be contacted when something breaks. If the information stops flowing, there needs to be agreed upon troubleshooting protocol to determine who gets the call. Under that agreement, there should also be a clear understanding of how far each team pledges to go to fix the problems. For example, the hospital may be responsible for troubleshooting that information is flowing over their network. But if it finds it went out from the medical device and stopped at the door of the information system, they would contact the IS vendor for assistance.

3. Willingness to play — MD vendors and IS vendors may not have equipment integration as their main business focus, so the lengths they’ll be willing to go will vary from company to company. This is especially true if a hospital is trying to create an independent medical device integration implementation when their IS vendor has its own proprietary integration service. That company may be less invested in doing a one-off project with the hospital if the hospital is working outside of the system the vendor sells. Likewise, a vendor that develops a proprietary system after the fact may be less likely to support the hospital’s independent efforts down the line.

Sparnon recommends that a hospital’s legal and technical team should be involved in points one and two while the financial team should also be included for discussions involving willingness to play.