MDIDS (Medical Device Interface Data Sheets)


Applying Medical Device Informatics to Enable Safe and Secure Interoperable Systems: Medical Device Interface Data Sheets

Goldman, Julian M. MD, Weininger, Sandy PhD; Jaffe, Michael B. PhD
doi: 10.1213/ANE.0000000000004251

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We are developing a reference compendium of medical device interface capabilities and data elements which could enable more complete, effective, and safe device integration.

This compendium, which we call Medical Device Interface Data Sheets (MDIDS) will serve as a reference for standards development organizations (SDOs), manufacturers, researchers, and clinical organizations.

Clinical organizations are contributing interface capabilities that will support more effective device-to-EMR integration, innovative clinical care, and more effective clinical management.

Medical device manufacturers are contributing expertise to ensure completeness of the MDIDS.

Standards development experts are matching MDIDS data elements to existing standards and helping to identify standards gaps that must be addressed.

MDIDS include both “generic” and device-type sheets

Generic: The generic sheet includes device identification data such as Serial Number, FDA-mandated Universal Device ID (UDI), software version numbers, and a description of the data encoding used for device-specific data elements. Other categories of data found in generic MDIDS are Patient Identification and Location information, as well as data about the Operating Conditions of the device and its Configuration.

We have developed preliminary MDIDS for the Pulse Oximeter, Ventilator, Anesthesia Workstation, Defibrillator, and Dialysis Machine. Each of these sheets contains device-type specific information in addition to the generic data.

As we develop the MDIDS library, we will continue to add variables, alarms, and other data to the sheets. These data items will come both from existing devices on the market as we survey their capabilities, and from an analysis of the future device capabilities necessary to support advanced clinical and technical scenarios.

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