Accession Number : AD1023923

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

Descriptive Note : Technical Report,21 Sep 2014,20 Sep 2015

Corporate Author : Massachusetts General Hospital Boston United States

Personal Author(s) : Goldman,Julian M ; Whitehead,Susan

Full Text :

Report Date : 01 Oct 2015

Pagination or Media Count : 24

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 2014-2015, we have played a leadership role working on interoperability standards with ASTM, AAMI, ISO, and the AAMI/UL2800 Joint Committee developing standards for certifiable safety of medical device interfaces, and have developed core content for an ICE Data Logger draft standard to be submitted to a standards organization. We organized and disseminated clinical and system requirements that will facilitate adoption by device manufacturers, thereby providing products for procurement by the DoD and others. We led the submission to the FDA of a supplement to the pre-IDE for interoperable medical devices (published on our web site), and subsequent responses to FDA requests.

Descriptors :   interoperability , medical equipment , health services , patient care , information exchange , test beds

Subject Categories : Medical Facilities, Equipment and Supplies
      Medicine and Medical Research

Distribution Statement : APPROVED FOR PUBLIC RELEASE