Quality Assurance

Quality Assurance
Synergyhealth

Each of our reusable surgical products are washed, inspected, and sterilized before being packaged and delivered to meet your indidivual facility's needs. All of our reprocessing facilities are FDA regulated and all products processed at our facilities comply with device listing of Title 21, Code of Federal Regulations, Part 807, through documents submitted by Synergy Health.
Our reusable textile products have unique RFID microchips to track and trace every item within our system and the number of useful lives remaining for that product.  Each component is individually inspected and if it cannot be properly repaired, the product is permanenty removed from service.
All of our reusable products conform to the following standards:

  • AAMI PB70 "Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities"
  • ANSI/AAMI ST65 "Processing of reusable surgical textiles for use in health care facilities"
  • The reprocessing of these surgical products comply with the FDA Quality Systems requirements of 21 CFR Part 820

For further information please visit our FAQs page, email gogreen@synergyhealthplc.com or call (813) 891 - 9550.

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Contact

 

You are contacting:

Synergy Health Americas Home Office

Synergy Health Americas
12425 Race Track Road
Tampa FL 33626
(USA)

Telephone:+1 (813) 891-9550

 

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