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The Medical Device "Plug-and-Play" (MD PnP) Interoperability Program is promoting innovation in patient safety and clinical care by leading the adoption of secure patient-centric integration of medical devices and IT systems in clinical environments.

 

ICE Standard: Integrated Clinical Environment

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ICE Standard (ASTM F2761)
MD FIRE RFI & RFP


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CONTACT INFORMATION

MD PnP Program
65 Landsdowne St., Suite 200
Cambridge, MA 02139
info@mdpnp.org

Julian M. Goldman, MD
Program Director
jgoldman@mdpnp.org

Drayton Freeman
Program Assistant
dwfreeman@mgh.harvard.edu

Scope and Purpose of ICE

Interdisciplinary meetings convened by the MD PnP program (described on this web site) identified key capabilities of a patient-centric integrated clinical environment. These capabilities, such as comprehensive data acquisition for the EMR and the integration of devices to enable real-time decision support, safety interlocks, and closed-loop control, can be achieved through the functions described in a new series of standards for the "Patient-Centric Integrated Clinical Environment" (ICE).


Figure 1: ICE Functional Model, redrawn from ICE Part I (ASTM F2761-2009).

The ICE Part I late-stage committee draft may be downloaded here.

Copies of the published standard may be purchased from ASTM International.

The online proceedings of the Global Harmonization Task Force 11 (GHTF 11, Washington, DC, October 2007) describe the recommendations of GHTF 10 (Lubeck, Germany, June 2006) to support the ICE standard.

Click here to download a figure of ICE-compliant architecture, redrawn with detail added, from ASTM F2761.

Background and Status of ICE Standardization Process

The ICE standardization activity was initiated in 2006 by ASTM International, committee F29, based on foundational work performed by the MD PnP program and collaborators.
The project is now under the auspices of Subcommittee F29.21, "Devices in the Integrated Clinical Environment," chaired by Dr. Julian Goldman. ICE Part I "Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) — Part 1: General requirements and conceptual model" has been published as F2761-2009 and can be purchased from ASTM International.
(Please contact Steve Mawn at smawn@astm.org if you wish to join the committee.)