The FDA issued a warning letter it sent to single use device reprocessor SureTek Medical earlier this month over issues with the company’s cleaning and validation processes.
The letter was in response to an inspection performed between October and November last year, which SureTek Medical responded to 3 times to address the federal watchdog’s concerns raised during the visit.
The FDA referenced issues related to SureTek’s cleaning process monitoring and assessment in relation to reprocessed single-use devices. The agency said it reviewed the response on the matter from SureTek, who said it would be validating its cleaning process in March, and requested a copy of the test results for review.
The federal watchdog also requested a copy of the validation of its cleaning process, which the agency had touched on in a previous letter, according to the new letter.
Validation and sterilization procedures got knocked by the FDA, which said that previous response letters failed “to adequately address the validity of the statistical techniques used for selecting the number of samples for testing during the cleaning validation studies performed by your firm.
The agency said it acknowledged the changes already implemented by SureTek in response to the earlier letter, which it said had adequately addressed its previous observations.
For the rest of the violations mentioned, the FDA gave the firm 15 days to respond.
