The QMN Weekly Bulletin

FDA Issues Warning Letter to SureTek Medical Over Contamination Assessment Issues

May 13, 2016

An FDA warning letter takes SureTek Medical to task for its procedures related to assessing contamination for reprocessed single-use devices.

The March 3 letter stems from an FDA inspection at the orthopedic and laparoscopic instrument maker’s facility in Greenville, S.C., from Oct. 26 to Nov. 10, 2015.

SureTek’s validated cleaning process is not routinely monitored to assess contamination levels for reprocessed single-use devices, the FDA says. The letter states that the most recent assessments for contamination were performed in 2012, even though the firm’s procedures call for bioburden monitoring on a quarterly basis.

The company responded to the inspector’s Form 483 with letters in December 2015 and February, indicating that bioburden samples for the first quarter of 2016 were scheduled for testing in March. As a result, the FDA requested a copy of the testing results.

SureTek also failed to adequately identify the worst-case product used during the validation of its sterilization process, according to the warning letter. The warning letter requests a copy of the sterilization validation process for verification.

In addition, the agency complained that the number of samples used in the cleaning validation studies were not statistically adequate, the warning letter says. It goes on to say that proposed changes in the company’s letters fail to resolve that issue.

SureTek could not be reached for comment by press time.

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