Italian firm falsified sterilization data, FDA warns device firms

Regulatory NewsRegulatory News
| 03 June 2021 | By Kari Oakes 

An Italian firm that processes medical devices has been falsifying data, including information related to sterilization certificates, since 2016, according to the US Food and Drug Administration (FDA).
As many as 97 different medical device manufacturers may be affected, wrote FDA’s director of the Office of Product Evaluation and Quality for the Center for Devices and Radiological Health (CDRH), William Maisel, in a letter to medical device manufacturers. He wrote that the graphs and parameters of sterilization certificates that Steril Milano falsified have affected a variety of medical device types, include biopsy needles, syringes and catheters, sets for intravascular administration and arthroscopes, among other devices.
Steril Milano S.R.L. had two ethylene oxide sterilization facilities in the Italian cities of Reggiolo and Monza. They were both closed in March 2021, wrote Maisel, and 10 firms whose products were affected have issued voluntary recalls of medical devices that passed through the Steril Milano facilities.
The letter follows a 24 May import alert that barred medical devices processed at Steril Milano sites from entering the US.
Maisel set forth a series of recommendations for medical device manufacturers that begins with determining whether any devices in current distribution were processed at the Reggiolo and Monza facilities. Manufacturers should consider the possibility that they may have purchased products from other manufacturers or distributors that were sterilized by Steril Milano.
Manufacturers should quarantine any affected inventory and notify purchasers of any affected devices that have already been distributed. A risk evaluation exercise should follow, with accompanying corrective actions.
“The FDA is working with medical device manufacturers, international partners, and U.S. federal partners to investigate the scope of medical devices that may be impacted and intends to contact potentially impacted firms that are known to have contracted medical device sterilization services with these Steril Milano facilities,” wrote Maisel.
The agency is asking firms to contact the Center for Devices and Radiological Health (CDRH) at if their devices were processed at a Steril Milano facility and the firm learns of “information related to patient safety, higher infection rates, or non-sterile products in distribution.” Firms should also report any patient injury or death, or device malfunction, that may be related to an affected device.  
If medical device distribution will be disrupted or interrupted, raising the possibility of a shortage, firms should also contact FDA to alert the agency about the medical device supply chain issue.

Any recalls should be reported to the appropriate address within the FDA Office of Regulatory Affairs; the letter provides email addresses and links for other points of contact for shortages or patient safety issues.


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