Medical Device Integration: A Look Past the EHR
One ripple effect of Meaningful Use is the increasing focus on medical device integration (MDI). However, Julian M. Goldman, MD, medical director of biomedical engineering at Partners HealthCare in Boston, suggests that providers need to strategize beyond Meaningful Use. He discusses the potential and current limitations of MDI with Clinical Innovation + Technology.
With increasing adoption of EHRs, MDI is on the radar for many hospitals. Are there other purposes to integration?
Goldman: The EHR is the current focal point, but it isn’t the sole purpose for integration. In the past, some hospitals have considered integrating data from medical devices for remote data display or alarm distribution. MDI can support device management, workflow and other data display and decision support capabilities that aren’t necessarily based in the EHR.
Hospitals may find a highly EHR-centric approach to MDI to be sufficient, and it may limit some challenges. This strategy also may restrict potential opportunities. A smart approach to MDI begins more broadly than the EHR. It starts with the hospital determining long-range goals while recognizing those goals may not be achievable today.
Can you describe some common MDI challenges?
There is increasing focus on the need for medical devices and IT systems to be interoperable. But the term “interoperable” seems to be open to interpretation. A few years ago, my colleagues and I evaluated a number of systems at the Interoperability Showcase at the annual meeting of the Healthcare Information and Management Systems Society (HIMSS). As we perused these products, we learned many had been successfully integrated to share data as part of the demonstration. But, many didn’t provide interoperability out of the box. It’s difficult to tease out what’s real and available.
A related issue is the rapid changes in the market. Hospitals should determine their needs by conducting an in-depth survey of institutional requirements. For example, at the basic level, a hospital might roll out an EHR and establish the goal of capturing vital signs. Next, the hospital should identify relevant devices. But the device datastream may be fraught with metadata errors—a blood pressure monitor may be used on multiple patients, or a device may not include a time stamp. Many devices do not automatically set clock times, so any time stamp errors may be propagated in the EHR.
It’s important to remember a middleware or integration product may not be able to achieve something that the original device is not designed to do, such as correct time stamps.
At the enterprise level, hospitals need a clear map of device capabilities and constraints. At the global level, the healthcare community needs to find a way to simplify MDI. It’s too burdensome for hospitals to address all of these details.
What resources are available to assist hospitals?
Several institutions have been collaborating to produce publicly available interoperability guidelines. Medical Device “Free Interoperability Requirements for the Enterprise” (MD FIRE) comprises a whitepaper, sample request for proposals and contracting language. Organizations are using relevant sections to procure interoperable devices, convey the importance of interoperability to manufacturers and learn more about manufacturers’ involvement with interoperability efforts.
What other issues should hospitals consider in their MDI strategy?
The budget for devices should include the purchase price, the biomedical and IT staffing resources required for configuration and the middleware or integration technology needed.
The simplest path to interoperability is through the manufacturer. If a product has been built to be interoperable, the manufacturer has addressed regulatory issues. If a hospital needs to write an integration program for a medical device, it may need to handle FDA regulatory issues.
How do you envision MDI playing out in the future?
I was heartened that Meaningful Use Stage 3 comments addressed the collection of relevant data for adverse event reporting in the EHR. This step represents the difference between a very limited dataset, such as blood pressure or weight, and a richer dataset that can help providers understand what went wrong—how a device failed or contributed to an adverse event.
The unique device identifier is an essential step. If a patient is harmed, we need to determine which devices were used. This brings healthcare closer to having a tool like a black box recorder.
The bottom line is the more hospitals and clinical organizations get involved and clarify the potential benefits of MDI, the easier it will be for manufacturers to understand the opportunities and provide these products.