Intravascular catheters are reprocessed in a Class 10,000 clean room and utilize a high capacity RO/DI water system and only environmentally safe detergents.
Each ClosureFast catheter sent for reprocessing is subjected to four separate inspections during the reprocessing process before packaging and sterilization.
Sterilization is performed at the reprocessing facility using single-purpose ETO systems that limit waste and ensure sterility.
Our reprocessing services for ClosureFast catheters have been validated to meet all relevant performance and safety standards, including the applicable parts of the following industry standards:
ANSI/AAMI ST 35: Safe handling and biological decontamination of medical devices in health care facilities and in nonclinical settings
AAMI TIR 30: Cleaning validation for reprocessing of single use devices
ISO 10555: Sterile, single-use intravascular catheters
ISO 11135: Sterilization of health care products – Ethylene Oxide
ISO 10993: Biological evaluation of medical devices
IEC 60601: Medical equipment/medical electrical equipment
AAMI 2-2 HF18: Medical electrical equipment – Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
ASTM F-1140: Internal pressurization failure resistance of unrestrained packages
ASTM D-3078: Determination of leaks in flexible packaging by bubble emission