Interoperability summit calls for better standards, systems engineering to improve safety

The healthcare industry needs a better understanding of the risks and improved interoperability standards before it can truly grapple with the patient-safety issues posed from healthcare technology, according to a paper compiled from a summit on medical device interoperability conducted by the Association for the Advancement of Medical Instrumentation and the U.S. Food and Drug Administration.

The report, "Medical Device Interoperability: A Safer Path Forward," focuses on seven "clarion themes" distilled from the discussion. The themes largely echo those in the Institute of Medicine's report on health IT safety, according to an announcement.

"There are interdependencies in these systems and their ecosystems, and we're only beginning to understand those interdependencies," Elliott Sloane, president of the Center for Healthcare Information Research and Policy said. "We need different rules of the road than we have had in the past."

The paper points to a number of calls for improved interoperability to protect patient safety, including the ECRI Institute report that lists interoperability failures with medical devices and health IT systems among the top 10 health technology hazards.

Among the themes from the interoperability meeting:

  • Widespread use of better standards and tools are needed to improve the safety, effectiveness, and efficiency of medical technology and to unleash innovation.
  • Systems engineering principles must be employed to improve design and management of medical technology. A collection of safe devices does not equal a safe system, speakers pointed out, nor will a safe device or network in one system be safe in another. Nancy Leveson, professor of aeronautics and astronautics and engineering systems at the Massachusetts Institute of Technology, noted that hospital leaders often lack a background in systems engineering, a problem that needs to be addressed.
  • Improving interoperability as a sociotechnical system means understanding human behavior, as well as how it fits into clinical workflow. Indeed, in a review of nearly 4,000 electronic health record-related events, the Pennsylvania Patient Safety Authority found a range of problems stemmed from the ways healthcare providers interact with the technology.

The paper emphasizes that strong leadership is essential to making interoperability a priority, and encouraged executives to surround themselves with "multilingual" advisors to help create a comprehensive action plan.

A RAND Corp. analysis published this week in Health Affairs cited lack of interoperability among the reasons that healthcare IT, so far, has not lived up to its promise.

And another of the summit's themes--improving regulatory clarity--seems to take a hit in the U.S. Department of Health & Human Services response to the IOM report. As FierceEMR's Marla Durben Hirsch points out, the Office of the National Coordinator for Health IT plans to monitor adverse patient safety events via the FDA's manufacturer medical device database. However, the FDA has stated before that it doesn't consider EHRs, personal health records, and other general IT products to be medical devices. That raises the question of how EHR-related safety issues would be monitored.

To learn more:
- read the report
- here's the announcement


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