7 Guiding Themes to Advance Safety of Medical Device Interoperability

The Association for the Advancement of Medical Instrumentation compiled a list of seven "clarion themes" identified at the AAMI-FDA Interoperability Summit Oct. 2-3 in a new report.

The report, "Medical Device Interoperability: A Safer Path Forward," describes the challenges under each theme and next steps to move toward safe interoperability of medical devices. The seven themes include the following:

1. Standardize to achieve success. Use of accepted standards for interoperability will improve the safety, effectiveness and efficiency of medical technology, according to the report.

2. Align incentives, expectations, roles and responsibilities. Leadership and incentives for patient safety will drive healthcare organizations to use interoperable medical technology to improve quality and safety.

3. Drive patient safety with a systems approach to design and implementation. A systems engineering approach can help healthcare more effectively design and manage interoperable medical technology.

4. Focus on human behavior first. The report states, "Understanding interoperability as a sociotechnical system will reduce risk, improve clinical efficacy, and optimize the value of medical technology investments."

5. Improve regulatory clarity. Clarifying regulations around device interoperability will reduce patient safety risks and improve the implementation of interoperable medical technology.

6. Streamline clinical workflow to improve return on investment. Standardizing and coordinating clinical workflow can enable healthcare organizations to scale interoperable medical technology.

7. Remove barriers with shared, continuous learning. Sharing successes and failures and using data from interoperable medical technology more effectively will support safe patient care.

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Study: Few EHR-Related Events Involve Patient Harm in Pennsylvania Hospitals

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