FDA acceptance letter* to Nova Medical EtO Sterilization Procedure and Protocols.
“Under this scenario we agree with the previous FDA advice that you are not required to register or list with FDA, and that you are in compliance with the associated FDA regulations”
OEM’s allow for the re-sterilization of Cath lab EP cables. Onsite ETO sterilization is done away with in modern hospitals. As a result, cables that could be re-sterilized need to be purchased or sent to reprocessing companies. Some of these companies can cost facilities up to 50% of the original price.
You save money re-sterilizing your cables through Nova Medical’s ETO re-sterilizing program. We partner with an accredited lab to provide ETO sterilization. We have a four-step protocol in place for this.
Nova Medical conducts an initial visual inspection by a SPD CRCST certified technician. A proper cleaning following the manufacturer’s specifications is performed.
Nova Medical utilizes an EP Cable Tracking System. A unique barcode is tied to each individual cable. This way we track how many times a cable has been reprocessed and allows us to timely return the cable to the facility unprocessed and tagged for replacement.
Each cable is packaged with a label that includes the make and model number, a control number and the sterilization parameters. Our QA program ensures that each cable is packaged following manufacturer’s sterilization parameters.
Nova Medical follows all manufacturers specifications for ETO re-sterilization. Any cable reprocessing is conducted in-house and by a SPD CRCST certified technician. Confirmation of sterility is determined by using biological indicators.
Each batch of cables will be boxed and shipped back.
Nova Medical returns a batch of cables with a turn-around time of 7 to 10 business days.
To exceed our customers expectations and partner with healthcare facilities to help extend the life of their surgical instruments and medical equipment via our low-cost repairs and ancillary services.