My latest column is out on Health-IT World's e-zine. Titled "IT & Biomedical Engineering: Cats & Dogs," it provides a look at the sometimes tumultuous relationship between these two key groups. I actually did some interviews for this column, and a couple interesting points didn't make it into the piece.

I think it's a given that the integration of medical devices into the hospital IT environment will continue - and this is really the crux of the issue. According to Rick Hampton, corporate manager of wireless communications at MGH, “If you asked IT if a network with medical devices was regulated by the FDA, they’d say no. If you asked the FDA that question, they’d reply that it is, but through regulatory discretion granted by Congress, the FDA has not regulated it as such.”

Recent controversial papers on CPOE implementations shows that clinical information systems have an increasing impact on patient safety. This effect on patient safety has not gone unnoticed. The FDA and regulatory bodies in Europe and Japan have begun investigating the creation of industry standards or regulations targeting the implementation and use of certain clinical information systems. While we are still a few years away from this, the regulatory burden will probably fall on hospitals (biomeds and IT departments) before it hits vendors. (More on pending regulations of mixed medical device/IT systems here, here and here.)

This confluence of medical devices and information systems is strongest at the point of care. When these projects are biomed driven, a certain enterprise IT perspective is lost. When IT drives the project, an appreciation for things like clinical workflow, maintainability, device design and reliability are frequently absent. Point of care automation projects too focused on data flow and systems integration can create a net loss in caregiver productivity and potentially impact patient safety.

Besides localized workflows that are changed by point of care systems, the biggest problem area is the hospital network. Surveillance and alarm notification (both “medical devices” per the FDA) are red flag applications for networks. Networks must be managed properly to ensure continuous operation and quality of service.

The needs assessment and vendor selection process for these chimera-like medical device/IT systems is different from both a traditional stand alone medical device and an information system. A new process is needed that accurately captures all the clinical needs (caregiver productivity, evolving care delivery methods, patient safety and comfort, etc,) and all the IT requirements (enterprise solution, systems integration). The needs assessment/vendor selection process should also create a clearly defined set of requirements for the ongoing operation, maintenance an support of the selected system within the hospital. Service level agreements must be negotiated across users, biomed and IT. A situation like this cries out for one thing, a connectologist - someone with a foot firmly planted in both the clinical realm and IT. If you don't have your own connectologist, I'd be glad to help you out.

Since the delivery of health care can't be separated from patient's physiological data or financial data, it seems to me that IT and biomeds are really two sides of the same
coin. Putting biomeds "under" IT - a supposed industry trend - won't accomplish anything. Their current position, typically under facilities management or purchasing, best reflects biomed's past mission as the in-house medical device repair shop. I would argue that biomed's mission is evolving to that of a patient safety and clinical efficacy watchdog.

If you want to read the recommendations in the column, can catch it here.