FDA has alerted medical device manufacturers to sterility issues and record falsification at two Steril Milano ethylene oxide sterilization facilities dating back to 2016.
Steril Milano closed its facilities in Monza and Reggiolo and began actions to improve quality control at a third Italian site in March. The notified body suspended ISO certification at all three facilities around the same time.
- FDA believes 97 manufacturers of medical devices may be affected. Companies including BD and Medtronic have already recalled products processed by Steril Milano.
Scrutiny of the use of ethylene oxide in the sterilization of medical devices has ramped up since the Environmental Protection Agency classed the disinfectant as a carcinogen in 2016. Since then, Sterigenics has closed facilities in Illinois and Georgia, and lawyers including the Attorney General for New Mexico have filed hundreds of lawsuits.
The Steril Milano situation is a little different. Starting in 2016, the year EPA classed ethylene oxide as a carcinogen, the company is accused by FDA of falsifying graphs and parameters of sterilization certificates for a variety of products regulated by the agency. In a statement last month, the Swiss Agency for Therapeutic Products said the Italian authorities investigating Steril Milano suspect it of "having deliberately falsified process records and validation documentation."
FDA issued an import alert barring tens of medical devices sterilized at Steril Milano's facilities in Monza and Reggiolo from entering the U.S. last month. The agency followed up on Wednesday with a letter asking medical device manufacturers to determine if any of their products now in distribution were processed at the Monza or Reggiolo sites.
Manufacturers with products sterilized at the facilities are to quarantine any affected inventory and contact customers who have already taken receipt of the products. FDA wants manufacturers to assess the risks posed by the devices and contact the agency if they learn information related to patient safety, higher infection rates or non-sterile products in distribution.
As of June 1, 10 manufacturers have voluntarily recalled affected devices, FDA said, although the agency believes 97 companies may be affected. FDA did not name the affected manufacturers but alerts published by other agencies have disclosed the identities of some companies that worked with Steril Milano.
BD is recalling products including infusion sets for Alaris pumps from Canada and other markets after finding Steril Milano had "intentionally falsified their routine process records" and is "suspected to have falsified the validation documentation related to the sterilization of BD products." Similarly, Medtronic issued a 44-page recall notice covering Covidien DAR airway products affected by "potential deviations from validated parameters for ethylene oxide sterilization" at Steril Milano.