ICE

	Medical Device "Plug-and-Play" Interoperability Program The MD PnP program is leading the adoption of open standards and technology to interconnect medical devices for improving patient safety and healthcare efficiency

Figure 1: ICE Functional Elements described in the proposed draft standard and circulated by IEC in September 2007 as "IEC 62A/580/NP".
An unpublished draft - for committee use only - may be downloaded here.

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.

Background of ICE
Multi-disciplinary meetings convened by the MD PnP program (described on this web site), identified key capabilities of a high-acuity patient-centric integrated clinical environment. These capabilities, such as the integration of data and devices to enable real-time decision support, safety interlocks, and closed-loop control, can be achieved through the functions described in an emerging standard for the "Basic Safety and Essential Performance of the Patient Centric Integrated Clinical Environment" (ICE).

Status of Standardization Process
The ICE standardization activity was initiated in 2006 by ASTM International (under committee ASTM F29). An F29-authorized drafting committee prepared a "New Work Item Proposal" for the ICE standard (based on an MD PnP Program document), which was submitted by the USA to IEC and ISO for consideration as a draft standard. Through an international voting process in December 2007, the ballot was one vote shy of acceptance by ISO, and did not have the requisite experts appointed in IEC, so the work will continue in ASTM.