Accession Number:

ADA622409

Title:

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

Descriptive Note:

Annual rept. 21 Sep 2012 20 Sep 2013

Corporate Author:

MASSACHUSETTS GENERAL HOSPITAL BOSTON

Report Date:

2013-10-01

Pagination or Media Count:

22.0

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 AAMIUL 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 ONCFDASIA 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.

Subject Categories:

  • Medical Facilities, Equipment and Supplies

Distribution Statement:

APPROVED FOR PUBLIC RELEASE