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Capturing Essential Information to Achieve Safe Interoperability

Weininger, Sandy PhD; Jaffe, Michael B. PhD; Rausch, Tracy CCE; Goldman, Julian M. MD

doi: 10.1213/ANE.0000000000001351
Technology, Computing, and Simulation: Special Article

In this article, we describe the role of “clinical scenario” information to assure the safety of interoperable systems, as well as the system’s ability to deliver the requisite clinical functionality to improve clinical care. Described are methods and rationale for capturing the clinical needs, workflow, hazards, and device interactions in the clinical environment. Key user (clinician and clinical engineer) needs and system requirements can be derived from this information, therefore, improving the communication from clinicians to medical device and information technology system developers. This methodology is intended to assist the health care community, including researchers, standards developers, regulators, and manufacturers, by providing clinical definition to support requirements in the systems engineering process, particularly those focusing on development of Integrated Clinical Environments described in standard ASTM F2761. Our focus is on identifying and documenting relevant interactions and medical device capabilities within the system using a documentation tool called medical device interface data sheetsa and mitigating hazardous situations related to workflow, product usability, data integration, and the lack of effective medical device-health information technology system integration to achieve safe interoperability. Portions of the analysis of a clinical scenario for a “patient-controlled analgesia safety interlock” are provided to illustrate the method. Collecting better clinical adverse event information and proposed solutions can help identify opportunities to improve current device capabilities and interoperability and support a learning health system to improve health care delivery. Developing and analyzing clinical scenarios are the first steps in creating solutions to address vexing patient safety problems and enable clinical innovation. A Web-based research tool for implementing a means of acquiring and managing this information, the Clinical Scenario Repository™ (MD PnP Program), is described.

Published ahead of print July 5, 2016.

From the *Office of Science and Engineering Laboratories, Food and Drug Administration/Center for Devices and Radiological Health, Silver Spring, Maryland; MD PnP Program, Massachusetts General Hospital, Boston, Massachusetts; DocBox, Newton, Massachusetts; §Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts; and Partners HealthCare System, Boston, Massachusetts.

Published ahead of print July 5, 2016.

Accepted for publication March 17, 2016.

Funding: Supported, in part, by the National Institutes of Health (grant no. 5U01EB012470-03), National Science Foundation (grant no. IIS-1239242), and Department of Defense (grant nos. W81XWH- 09-1-0705, W81XWH-12-C-0154, W81XWH-11C-077, and W81XWH-13C-0107).

The authors declare no conflicts of interest.

This report was previously presented, in part, at the Innovations and Applications of Monitoring Perfusion, Oxygenation and Ventilation, October 4, 2015 (Tokyo, Japan).

Reprints will not be available from the authors.

Address correspondence to Sandy Weininger, PhD, Office of Science and Engineering Laboratories, Food and Drug Administration/Center for Devices and Radiological Health, 10903 New Hampshire Ave, Silver Spring, MD 20993. Address e-mail to sandy.weininger@fda.hhs.gov.

© 2017 International Anesthesia Research Society
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