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AAMI and FDA jointly issue device interoperability breakdown

In their report “Medical Device Interoperability: A Safer Path Forward,” the Association for the Advancement of Medical Instrumentation (AAMI) and U.S. Food and Drug Administration (FDA) garner information from the 2012 AAMI and FDA Interoperability Summit to address safety issues in connecting medical devices to EHR systems. Fourteen other groups, including the Joint Commission, participated in the summit.

Concerns about product standardization, EHR interoperability, meaningful use incentives, and improved safety regulations led off the discussion.

First and foremost was a goal to standardize device data interoperability via current industry standards (e.g. HL7, DICOM and Institute of Electrical and

Electronics Engineers or IEEE), the oversight of which summit attendees agreed should be delegated to the FDA, Office of the National Coordinator for Health IT (ONC), HL7 and IEEE. For aspects of interoperability currently lacking in standards – such as security  – attendees aimed to standardize both the design and implementation of new interoperable products.

The report included a 2012 AAMI survey that found most health care technology professionals (72%) cite medical devices and systems as their greatest challenge, with EHR integration on its coattails (65%). But instead of focusing on device issues, most have instead devoted more bandwidth on implementing EHRs, taking a wait-and-see or prove-it-first approach to interoperability between systems. Summit leaders aimed to link the two endeavors, as patient/data mismatches in EHRs contribute to interoperability failures, but interoperability efforts can leverage EHRs to detect and prevent reporting errors.

Summit attendees wanted two other things: to align interoperability requirements with Stage 3 meaningful use conditions and require that interoperable systems that provide safety assurances are eligible for reimbursement by the CMS. They charged the ONC, CMS, and the Health Information Management Systems Society (HIMSS) with this task.

Governance of all these tasks was the last puzzle piece of engineering interoperability between medical devices and clinical data systems. As it is, the FDA’s Center for Devices and Radiological Health (CDRH) regulates stand-alone medical devices and vendor-integrated composite systems, and the Joint Commission (and others) accredit health care organizations. Summit participants agreed CMS [FD1], ONC, the Joint Commission and others should work together to oversee regulations and standards adoption..

Interestingly, among all these technical obstacles, summit participants determined that humans and organizational challenges are even more significant to successful interoperability.

“First, people need to talk,” said Pat Baird, systems engineering specialist at Baxter Healthcare. “Then, organizations need to talk. Finally, medical technology will talk.”

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