Cardiopulmonary Corporation: FFA Sciences Final Rule - Active Patient Monitoring or Medical Device Alarm Management Requires More Than an MDDS
3/24/2011 9:29:20 AM
MILFORD, Conn., March 24, 2011 (GLOBE NEWSWIRE) -- Cardiopulmonary Corp. (CPC) supports the Food and Drug Administration (FDA) for issuing regulatory requirements in the healthcare information technology space governing medical device connectivity for documentation to an electronic medical record (EMR). The recent announcement of the Medical Device Data System (MDDS) Final Rule provides necessary clarification regarding the critical difference between the handling of medical device data for documentation and the handling of medical device data for active patient monitoring and alarm propagation. The FDA indicated in its February 14, 2011 press release, which Final Rule is published in the Code of Federal Regulations 21 Part 880, Docket No. FDA-2008-N-0106, that MDDS classified devices are intended only to transfer, store, convert from one format to another according to preset specifications, or to display medical device data. MDDSs are intended to perform all functions without controlling or altering the function or parameters of any connected medical devices. Further, the Final Rule stipulates that MDDSs are not intended to be used in connection with active patient monitoring or alarms. Any medical device data system that facilitates clinical assessments or monitoring, or is intended for use beyond permitted uses under the ruling, such as alarm or alert functionality based on preset clinical parameters (including low priority physiological conditions), is not an MDDS.
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