Adopting systems engineering principles to advance patient safety, improving regulatory clarity, and having shared goals and standards are just three of the priorities named in a new Association for the Advancement of Medical Instrumentation (AAMI) publication on how to best achieve interoperability in healthcare technology.
The report, Medical Device Interoperability: A Safer Path Forward, describes lessons learned at a joint AAMI-FDA summit held this past fall on medical device interoperability and takes a nuanced look into how to assure the safety and effectiveness of connectivity for the wide array of medical and information technologies available today.
Separately, AAMI has also released the publication titled Healthcare Technology in a Wireless World, the result of an invitation-only workshop, held immediately after the summit. That event—which was convened by AAMI, the American College of Clinical Engineering, the American Society for Healthcare Engineering, and ECRI Institute—attracted 75 experts, who discussed wireless challenges in healthcare. They developed five priorities that need to be addressed, including the need to clarify roles and responsibilities, and also drafted a list of the top 10 mistakes in implementing wireless technology in healthcare.
The two-day summit in early October drew roughly 260 attendees who gathered at a hotel in Herndon, VA, outside Washington, D.C., to discuss and debate challenges and solutions related to interoperability. Participants included safety advocates, clinicians, healthcare technology management professionals, as well as representatives from manufacturers; standards-setting organizations; regulatory bodies; and academic and professional groups.
Four additional priorities—or “clarion themes”—are identified in the report: aligning incentives, expectations, roles and responsibilities to improve quality and safety; understanding interoperability as a sociotechnical system with a focus on human behavior to reduce risk; streamlining clinical workflow to improve return on investment; and removing barriers with shared, continuous learning to increase transparency.
The summit came about after AAMI and the FDA—who have joined forces before for healthcare technology summits, including one on medical alarm systems— noted that despite all of the focus on the information side of what technology can do, there has been scant attention paid to the device side of that connectivity, especially in relation to patient safety.
“Prior AAMI-FDA summits were focused on technology-related issues in healthcare that had already been widely publicized from repeated adverse incidents,” explains AAMI president Mary Logan. “This year’s summit focused on bigger and broader issues that haven’t been widely publicized for causing harm—yet. The conclusions drawn by the attendees were consistent with the warnings published in the Institute of Medicine’s 2012 report on health IT safety.”
The report includes summaries of many of the summit presentations, and includes additional insights and quotes from a wide variety of experts. There are multiple tables that list specific challenges, what needs to be done, and how or what needs to be accountable for that action. The report also includes shorts profiles of specific healthcare facilities that have tackled interoperability projects.
One challenge the publication addresses is the development of an exact definition of interoperability. It’s a problem the FDA has wrestled with for more than three years, as John F. Murray, software compliance expert at the agency’s Center for Devices and Radiological Health, notes.
“The term ‘interoperability’ can mean anything from connecting one thing to another through the expenditure of considerable time and effort—most current interoperability is in this category—to spontaneous or plug-and-play interoperability where things just work out of the box,” adds Ken Fuchs of Mindray North America.
Ensuring patient safety is another recurring theme throughout the report. For example, Nancy Leveson, professor of aeronautics and astronautics and engineering systems at the Massachusetts Institute of Technology, emphasizes that safety is a health IT system property. Unfortunately, many in hospital settings don’t have a background in systems engineering, a problem that needs addressing.
Another issue the publication examines is improving regulatory clarity. While the distinctions between what regulatory agency is responsible for emerging technologies is blurring and may cause confusion, it’s not quite in the Wild, Wild West, according to presenter Michael Robkin, president, Anakena Solutions. However, experts say that creating a semblance of order from the array of regulations, standards, and technologies remains a challenge.
“The strongest callout from the summit attendees was that these are sociotechnical issues, with an emphasis on ‘socio,’ in need of strong leadership in the C-Suite,” Logan says. “It’s our hope that each person who receives this publication will pass it on to at least one person in a leadership role who can help influence change.”
This publication was made possible with the financial support provided by the following organizations: ABM Health, Inc., CareFusion, Masimo, B. Braun Medical, Intel Corp., and Philips Healthcare. AAMI also thanks West Health for supporting both the summit and the publication.
To download a free PDF copy of Medical Device Interoperability: A Safer Path Forward, CLICK HERE.
To access the workshop report, Healthcare Technology in a Wireless World, CLICK HERE.