ADVISORY/Expert Available to Comment on New FDA Guidance Document on Reprocessing Single-Use Medical Devices.News/Assignment Editors ADVISORY PHOENIX--(BUSINESS WIRE)--Aug. 2, 2000 The Food & Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) Wednesday published a Guidance Document that authorizes the reprocessing Reprocessing may refer to:
The document was published in the Federal Register and is available on the FDA's Web site www.fda.gov/cdrh/comp/guidance/1168.pdf. The guidelines guidelines, n.pl a set of standards, criteria, or specifications to be used or followed in the performance of certain tasks. will likely spark a surge in reprocessing by third-party reprocessors. Some hospitals that have been doing in-house reprocessing may not have the resources to meet the paperwork and quality requirements of the new FDA requirements and hospitals that have never reprocessed any of their devices may now be interested in doing so. The industry may also experience a shake-out as smaller reprocessors determine that they don't have the resources to comply with the Guidance Document requirements. If you would like to interview Don Selvey, an expert on reprocessing who can discuss the requirements, implementation and probable impact of the FDA's new Guidance Document, contact Jan Shulman at Alliance Medical Corp., 480/763-5368. Selvey, Alliance's director of regulatory affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: About Alliance Medical Corp. Formed by the merger of Sterile Reprocessing Services (SRS SRS, SRS-A see slow-reacting substance. ), ORRIS and Applied Medical Technologies, Alliance Medical Corp. (www.alliance-medical.com) is the industry's oldest, largest and most experienced reprocessor of medical devices. The company's programs maintain patient safety while providing cost reduction strategies for healthcare facilities suffering from shrinking reimbursements. Alliance's customers include many of the country's top healthcare facilities as identified by U.S. News & World Report U.S. News & World Report Weekly newsmagazine published in Washington, D.C. U.S. News was founded in 1933 by David Lawrence (1888–1973) to cover important domestic events; he founded World Report in 1945 to treat world news. The two magazines were merged in 1948. , as well as large health systems, community healthcare providers and regional and national hospital group purchasing organizations A group purchasing organization is an entity that leverages the purchasing power of a group of businesses to obtain discounts from vendors based on the collective buying power of the GPO members. Many GPOs are funded by administrative fees that are actually paid by the vendors. . |
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