Medical Device Plug-and-Play Interoperability Standards and Technology Leadership
Abstract
This award enables the MGH Medical Device Plug-and-Play (MD PnP) Interoperability Program to deliver solutions to enable medical device manufacturers, users, and the regulatory community to improve patient safety and healthcare efficiency through interoperable medical technologies. During 2015-2016, we played a leadership role working on interoperability standards with ASTM, AAMI, ISO, and the AAMI/UL JC2800 developing standards for certifiable safety of medical device interfaces. We developed core content for an ICE Data Logger (black box recorder) draft standard that was submitted to AAMI as a New Work Item Proposal. MD PnP efforts have enabled significant changes to the trajectory of standards and technologies to apply interoperability to support patient safety and innovation. Other standards and products are building on the ICE standard, and will inform changes to future revisions to ICE and to the ICE Data Logger standard. We organized and disseminated clinical and system requirements to facilitate adoption by device manufacturers, thereby providing products for procurement by the DoD and others. We led the submission to the FDA of a second pre-IDE supplement for interoperable medical devices (published on our web site), and subsequent responses to FDA requests. We have leveraged our collaborative work with federal agencies, academia, industry, and standards development organizations to provide leadership, subject matter expertise, and technical content to advance interoperability.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2016
- Accession Number
- AD1032627
Entities
People
- Julian M. Goldman
- Susan Whitehead
Organizations
- Massachusetts General Hospital