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HYGIA Health Services Successfully Completes Recent FDA Audit with Zero Citations for Essential Clinical Commodity Patient Room Reprocessing
Birmingham, AL – HYGIA Health Services, the premier service provider of patient room Essential Clinical Commodities (ECCs), is pleased to announce it has successfully completed a periodic three day FDA audit of its ECC Management medical device reprocessing facility located in Birmingham, AL in accordance with theGuide to Inspections of Quality Systems for Medical Device Manufacturers.
The successful completion of this audit, for which none of the 483 citations were issued, demonstrates HYGIA’s continued commitment in offering its clients quality products and services.
“This successful FDA inspection represents another major milestone for HYGIA. We place Quality above all else, and I am so proud that the dedication and performance of the HYGIA team resulted in this successful outcome.” — Richard Wallace, Director Quality Management & Regulatory Affairs of HYGIA
FDA Approved Quality Process for Substantial Savings and Green² Impact
The cornerstone of HYGIA’s success is the quality of their processes. With FDA approved protocols, HYGIA provides Green² savings: both $green$ monetary savings and green environmental benefit. The comprehensive savings and Green² program has prevented an average of 300 thousand feet of products and packages from entering landfills per customer and can produce over $5290 in hard cost savings per bed over 5 years.
“HYGIA is pleased that our diligent Regulatory Compliance efforts have once again yielded a report of ‘No Deficiencies’ from the FDA. HYGIA’s Q³ standards stress quality relationships with our partners, quality processes for all devices and quality experiences for patients. We are pleased to have the quality of our processes validated through this FDA Inspection.” – Scott Comas, President and CEO of HYGIA