Alliance Medical in Full Compliance With FDA's Quality System Regulation - QSR -; No Deficiencies Found During FDA Follow-up Inspection of Phoenix Reprocessing Operation.

Health & Medical Writers

PHOENIX--(BW HealthWire)--Aug. 7, 2000

Alliance Medical Corp. (Alliance), the country's leading medical device reprocessor, Monday announced that the FDA found no deficiencies during a follow-up inspection of its new 42,000 square foot, state-of-the-art Phoenix headquarters.

The FDA inspector determined that Alliance had successfully corrected all observations made during an inspection last December at the company's former location.

Based on the results of this re-inspection and a follow-up inspection last April at Alliance's Apopka, Fla. sorting facility that also found no deficiencies, all Alliance operations are in full compliance with applicable sections of the FDA's Quality System Regulation (QSR).

The QSR addresses the design, manufacture, packaging, labeling, storage, installation and servicing of all medical devices intended for human use.

"The findings demonstrate that we're ready to meet the requirements of the FDA's new Guidance Document for the reprocessing of single-use medical devices," said Don Selvey, Alliance's director of regulatory affairs and quality assurance. "The results also validate our commitment to quality that is unmatched within the reprocessing industry."

Alliance is the only reprocessor that maintains an in-house Engineering Group staffed by specially trained, experienced medical device engineers who design product validation tests, processing protocols and specialized equipment. Their expertise helps ensure that the devices reprocessed by Alliance are at least as safe and effective as the original manufacturer intended.

Alliance's Quality Assurance and Regulatory Affairs Group, the largest in the industry, has integrated ongoing regulatory oversight throughout all reprocessing procedures.

About Alliance Medical Corp.

Formed by the merger of Sterile Reprocessing Services (SRS), ORRIS and Applied Medical Technologies, Alliance Medical Corp. (www.alliance-medical.com) is the industry's oldest, and most experienced reprocessor of disposable 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, as well as large health systems, community healthcare providers and regional and national hospital group purchasing organizations.