Medical Device Plug-and-Play Interoperability Standards and Technology Leadership

Abstract

This award provides core program support to develop key capabilities of the Medical Device "Plug-and-Play" (MD PnP) Interoperability Program to lead medical device interoperability to support clinical solutions for improving patient safety and healthcare efficiency. Under MD PnP program leadership during the past year, our work informed new AAMI/UL joint standards development; preliminary data from our device clock time study informed an ISO resolution on device clock time accuracy; clinical scenarios from our program were included in work by ISO, AAMI, UL, and ONC/FDASIA WG; UL conducted an STPA hazard analysis related to ICE standard functionality; and we presented at HIMSS13 by the invitation of ONC in their interoperability demo area. We continued collaborating with FDA, NIST, NSF, ONC, DocBox, UMass, Penn, and others, including work on smart alarms initiatives, smart dynamic checklists, certifiable safety of medical device interfaces, and the updated Pre-IDE regulatory submission to FDA.

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Document Details

Document Type
Technical Report
Publication Date
Oct 01, 2013
Accession Number
ADA622409

Entities

People

  • Julian M. Goldman
  • Susan F. Whitehead

Organizations

  • Massachusetts General Hospital

Tags

Communities of Interest

  • Biomedical

DTIC Thesaurus Topics

  • Analgesia
  • Computer Programs
  • Department Of Defense
  • Engineering
  • Engineers
  • Health Care
  • Health Services
  • Hospitals
  • Information Systems
  • Materials
  • Medical Personnel
  • Patient Care
  • Patient Care Management
  • Procurement
  • Standards
  • Systems Engineering
  • Test Equipment

Fields of Study

  • Computer science

Readers

  • Aviation Safety Risk Assessment.
  • Defense Technology Research and Development.
  • Medical or Health Care Field.