Tim Gee

June 1, 2008

6 Min Read
AAMI Highlights Device Makers’ Shortcomings, Opportunities


Gee: Challenges, opportunities abound

The hospital market's demand for work flow automation at the point of care has prompted many medical device manufacturers to incorporate information technologies (IT) into their products. Clinicians' requirements for improved diagnostic work flows, alarm notification, surveillance, data analysis, reporting, and documentation have driven medtech manufacturers to create medical device systems rather than standalone products.

Yet the integration of these medical device systems into hospitals' IT infrastructures—where they often coexist with other medical device systems—is a growing challenge for the healthcare industry as a whole. And wherever challenges for healthcare providers exist, opportunities abound for device manufacturers that seek to alleviate such burdens in subsequent product offerings.

Specific examples of how 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 earlier this month in San Jose. The AAMI conference targets hospital biomedical technicians and clinical engineers, as well as manufacturers who repair medical devices and are involved in standards development.

Many AAMI attendees are struggling with the increasing role IT is playing in FDA-regulated medical device systems and how those systems are integrated into hospital IT infrastructures. The running theme in many presentations was the confluence of clinical engineering and IT departments. In the best examples, biomedical technicians and IT departments are working together as teams, leveraging each other's strengths and growing to understand the other group's objectives and methodologies. Many of the challenges they are jointly seeking to address are limitations inherent in the IT-enabled medical devices within their facilities.

As IT has become an almost pervasive adjunct to several categories of medical devices—such as imaging systems, vital-signs monitors, and infusion pumps—the role and status of biomedical technicians in hospitals has become threatened. The influence of hospital chief information officers (CIOs) on decisions regarding the purchase and integration of IT-enabled medical devices has grown with the adoption of electronic medical records (EMRs), point-of-care medication administration systems, and similar systems. In fact, it has become increasingly common for CIOs to limit medical device purchase choices to those listed as compatible with a healthcare IT software manufacturers' applications. Thus, the hospital CIO as a decision maker has become an increasingly important link in device manufacturers' communication chains.

In a presentation at this year's AAMI conference, representatives from the University of California Davis Health System's clinical information systems and clinical engineering departments—David Green and Ted Cohen, respectively—described their experience working together to integrate patient monitoring data as vital-signs documentation into the healthcare system's EMR.

Most EMR developers now require that any system feeding patient data into the EMR must have a patient demographics interface—commonly called an admission, discharge, and transfer application, or ADT interface—that is compatible with the EMR. In fact, healthcare IT systems are rapidly phasing out support for medical device data that are only identified by patient location or a unique device identification, rather than the patient's identification number. During their discussion of these trends, Cohen and Green described how clinical engineering and IT worked together to overcome lack of patient-identified data coming from the medical device.

In light of integration struggles such as the one at UC Davis, medtech manufacturers are under increasing pressure to build better IT integration capabilities into their medical devices. At the same time, many provider organizations are pushing systems integration responsibilities, such as those shouldered by UC Davis, 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 advisor 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—one of which can be attributed to the medical devices themselves.

First, the wireless infrastructure used at Massachusetts General cannot simultaneously support more than a few thousand devices at a time. Thus, the hospital's purchase of more than 2000 smart infusion pumps greatly exceeded the wireless network's capacity, making it impossible for Massachusetts General to use its pumps wirelessly. The network limitation is compounded by IT limitations in the smart pumps themselves. The Massachusetts General IT department established wireless data security requirements for all devices connecting to their wireless network. The requirements specified are all industry standards, but these standards were not implemented by the smart-pump manufacturer. Thus, Massachusetts General is being forced to make a major investment in its wireless infrastructure and, at the same time, replace its smart pumps with ones that meet IT's security and authentication requirements.

The smart-pump discussion panel highlighted another challenge that must be addressed by medical device manufacturers: the need to capture the right user requirements. A major feature of smart pumps is their ability to log the entry of pump settings. Such entries are stored in a database and used for continuous quality improvement (CQI). The data captured can include the drug administered, any specific errors in configuring the pump for that drug, the patient, the clinician, and the clinician's unit and shift. This process is generally called establishing patient context, which sometimes includes the caregiver's identity as well. All pump manufacturers use the same basic technology—bar codes—to implement this feature. The problem is that virtually all buyers find the way that manufactures have implemented this feature to be unusable.

Market penetration of smart pumps in U.S. hospitals currently stands at more than 50%. But according to Erin Sparnon, a senior project engineer at ECRI Institute who helps hospitals select and implement smart-pump systems, there are only four hospitals nationwide who currently capture patient context when configuring a pump. Four hospitals out of hundreds have been able to realize the full value of smart-pump CQI databases, a miserable product design success rate by any standard. With a clear market need and customer benefit for establishing patient context, manufacturers must reexamine requirements and look beyond existing designs for an effective solution. There are many ways to establish patient context, and not one smart-pump manufacturer has chosen to look beyond the industry consensus solution to this problem in the years since these devices hit the market. The opportunity for competitive advantage abounds for the manufacturer that can elicit the right requirements and produce a superior design that actually meets them.

Tim Gee is the principal of Medical Connectivity Consulting (Beaverton, OR). For more information, visit www.medicalconnectivity.com.

© 2008 Canon Communications LLC

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