title: The Need to Apply Medical Device Informatics in Developing Standards for Safe Interoperable Medical Systems.
abstract: 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.
authors: 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.
authors: Sandy
authors: S
authors: Weininger
authors: Michael B
authors: MB
authors: Jaffe
authors: Julian M
authors: JM
authors: Goldman
mesh_terms: D015415:Biomarkers / Q000097:blood; D003299:Cooperative Behavior; D003625:Data Collection / Q000379:methods / Q000592:standards*; D004562:Electrocardiography; D057286:Electronic Health Records; D004867:Equipment Design; D004869:Equipment Safety / Q000592:standards*; D004864:Equipment and Supplies / Q000009:adverse effects / Q000592:standards*; D006339:Heart Rate; D006801:Humans; D033183:Interdisciplinary Communication; D008490:Medical Informatics / Q000379:methods / Q000592:standards*; D008498:Medical Record Linkage; D010092:Oximetry / Q000592:standards; D010100:Oxygen / Q000097:blood; D061214:Patient Safety / Q000592:standards*; D017410:Practice Guidelines as Topic; D011237:Predictive Value of Tests; D018570:Risk Assessment; D012307:Risk Factors; D018511:Systems Integration; D013673:Technology Assessment, Biomedical / Q000379:methods / Q000592:standards*
chemical_list: D015415:Biomarkers; D010100:Oxygen