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, we have convened working and writing groups for ICE standard Parts II and III (for the ICE network controller and device models), such as the Medical Device Interoperability Safety (MDIS) Working Group and the AAMI / UL2800 joint committee standard for certifiable safety of medical device interfaces, and to manage their work to produce draft standards for submission to ASTM Committee F29. We have also organized requirements that will facilitate adoption by the DoD, the VA, and device manufacturers. We continued collaborating with FDA, NIST, NSF, ONC, DocBox, UMass, Penn, and others for work on smart alarms initiatives, smart dynamic checklists, certifiable safety of medical device interfaces, and the updated Pre-IDE regulatory submission to FDA. We leveraged our work to provide leadership and program artifacts and results to related federal initiatives such as the FCC Consumer Advisory Committee and the White House sponsored SmartAmerica NSF Challenge.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2014
- Accession Number
- ADA624473
Entities
People
- Diana Lu
- Julian M. Goldman
Organizations
- Massachusetts General Hospital