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The Need to Apply Medical Device Informatics in Developing Standards for Safe Interoperable Medical Systems

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

doi: 10.1213/ANE.0000000000001386
Technology, Computing, and Simulation: Special Article

Medical device and health information technology systems are increasingly interdependent with users demanding increased interoperability. Related safety standards must be developed taking into account these systems’ perspective. In this article, we describe the current development of medical device standards and the need for these standards to address medical device informatics. Medical device information should be gathered from a broad range of clinical scenarios to lay the foundation for safe medical device interoperability. Five clinical examples show how medical device informatics principles, if applied in the development of medical device standards, could help facilitate the development of safe interoperable medical device systems. These examples illustrate the clinical implications of the failure to capture important signals and device attributes. We provide recommendations relating to the coordination between historically separate standards development groups, some of which focus on safety and effectiveness and others focus on health informatics. We identify the need for a shared understanding among stakeholders and describe organizational structures to promote cooperation such that device-to-device interactions and related safety information are considered during standards development.

Published ahead of print August 31, 2016.

From the *Office of Science and Engineering Laboratories, FDA/CDRH, Silver Spring, Maryland; MDPnP Program, Massachusetts General Hospital, Boston, Massachusetts; ISO, Geneva, Switzerland, and AAMI, Arlington, Virginia; §Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts; and Partners HealthCare System, Boston, Massachusetts.

Published ahead of print August 31, 2016.

Accepted for publication March 24, 2016.

Funding: Supported by DOD awards W81XWH-09-1-0705 and W81XWH-12-C-0154, NIH Award U01EB012470-03.

The authors declare no conflicts of interest.

This report was previously presented, in part, at the IAMPOV 2015 (Tokyo, Japan).

Reprints will not be available from the authors.

Address correspondence to Sandy Weininger, PhD, US FDA, 10903 New Hampshire Ave, Silver Spring, MD 20993. Address e-mail to

© 2017 International Anesthesia Research Society