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AAMI Highlights Device Makers' Shortcomings, Opportunities

Article-AAMI Highlights Device Makers' Shortcomings, Opportunities


Examples of how information technology (IT) demands are affecting medical device manufacturers and healthcare providers were prominent at the recent Association for the Advancement of Medical Instrumentation (AAMI) annual conference and expo, held this June in San Jose.

Many AAMI attendees are struggling with the increasing role IT is playing in medical device systems and how those systems are integrated into hospital IT infrastructures. A theme in many presentations was the confluence of clinical engineering and IT departments.

In one such presentation, representatives from the University of California-Davis Health System's clinical information systems and clinical engineering departments described their experience working together to integrate patient monitoring data as vital-signs documentation into the healthcare system's electronic medical record (EMR).

In light of such integration struggles, medtech manufacturers are under pressure to build better IT integration capabilities into their devices. At the same time, many provider organizations are pushing systems integration responsibilities back onto medical device manufacturers. Last year, Kaiser Permanente instituted standard purchase contract language that makes medical device manufacturers responsible for systems integration with the organization's EMR system.

Likewise, an AAMI panel discussion titled "Smarter Infusion Pumps: Improving Quality with Wireless Connectivity" highlighted more IT limitations found in medical devices. Panelist Nat Sims, MD, a physician adviser for Partners Healthcare Biomedical Engineering at Massachusetts General Hospital, explained that the facility's wireless infusion pumps were not being connected to the network because of an inability to overcome two challenges.

First, the hospital's wireless infrastructure cannot simultaneously support more than a few thousand devices. Second, the hospital's wireless data security requirements—all industry standards—were not implemented by the smart-pump manufacturer.

According to Erin Sparnon, a senior project engineer at ECRI Institute (Plymouth Meeting, PA), only four hospitals nationwide have been able to realize the full value of smart-pump continuous quality improvement databases—a miserable product design success rate by any standard. The opportunity for competitive advantage abounds for the manufacturer that can elicit the right requirements and produce a superior design that meets them.—Tim Gee, principal, Medical Connectivity Consulting (Beaverton, OR)

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