AAMI-FDA Interoperability Summit Pinpoints Top Challenges

October 11, 2012. A lack of both standardization and coordinated financial incentives were identified as among the top challenges to achieving interoperability with medical devices in healthcare at a summit hosted by AAMI (Association for the Advancement of Medical Instrumentation) and the U.S. Food and Drug Administration (FDA).

The Oct. 2-3 AAMI/FDA Interoperability Summit, which was followed by a two-day wireless workshop, drew more than 250 healthcare technology management professionals, manufacturers, clinicians, regulators, information-technology experts, academics and others to a hotel in Herndon, VA, at which they shared best practices, challenges, unknowns, and ideas about moving interoperability forward in a way that keeps patient safety at the forefront.

“The magic in the room was having all of those multidisciplinary and multi-stakeholder perspectives working together to identify what’s needed in order to achieve the common goal of safe and useful integration of medical devices,” said AAMI President Mary Logan.

Various health information technology (IT), device, and clinical experts spoke about the challenges to device integration throughout the summit. One was a lack of financial incentives to encourage hospitals and industry to invest in interoperability.

“There are profit margins that don’t encourage interoperability,” David Muntz, principal deputy national coordinator at the Office of the National Coordinator for Health Information Technology (ONC), said during his presentation. Hospitals need to prove to their executives that investing in interoperability can help increase efficiency and drive down costs, he said.

Other experts pointed to a more nuanced challenge. They say there are financial incentives, but they aren’t aligned properly given the varying priorities among the different players. For example, hospitals do have a financial incentive from the government to achieve “meaningful use” of electronic health records (EHRs). And there is lots of money for EHR vendors to make. Medical device manufacturers and smaller IT companies have difficulty seeing a workable financial model when the EHR vendors won’t standardize, and if hospitals don’t standardize clinical workflows and practices. And hospitals say they can’t afford to keep moving forward on an ad hoc basis, paying millions of dollars to make all of this work.

Device manufacturers and IT vendors cannot create affordable or scalable products when every hospital wants to keep its own unique clinical workflow, sometimes at the unit level, these experts say. Standardization of practices is key to achieving the right scale for device interoperability.

Another issue was the lack of standardization among interoperable products.

Devices transmit data at different rates to a receiving system, said John Zaleski, chief technology officer and vice president of Clinical Applications at Nuvon Inc., which manufactures interoperability systems. “Significant parameters for managing the patient can be different across devices,” he said during his presentation.

At the end of the two-day summit, the attendees reached consensus on a list of potential actions. Among them are creating consistent device implementation standards; empowering healthcare organizations with standardized contracting language; developing a device interoperability design control process, including a decision tree; and helping hospitals make a business case to promote interoperability’s benefits to C-Suite executives.

A publication detailing the summit presentations, discussions, and “clarion themes” will be available for free by the end of the year.

Immediately following the summit was the invitation-only workshop on wireless challenges in hospitals, which was attended by almost 100 experts. It was jointly convened by AAMI, the American College of Clinical Engineering, ECRI Institute, and the American Society for Healthcare Engineering.

“The wireless workshop was a key companion event to the summit, because wireless issues are pervasive and persistent in healthcare organizations,” Logan said. “You can’t achieve the desired state with integration unless you have highly secure and dependable wireless networks.”

Takeaways from the workshop include, for example,  the need to better manage radio spectrum in hospitals, develop stronger “how to” tools that support the importance of the network risk management standard IEC 80001, and help the C-Suite understand the enormous patient safety risks if these issues aren’t addressed as a high priority.

By the end of the year, AAMI will also release a wireless workshop publication, which will synthesize the presentations and priorities moving forward.

See related news, “AAMI and UL to Develop Interoperability Standards.”