A device sterilized by ethylene oxide (EtO) (Image from the FDA)
An Italian medtech sterilization company falsified records of various FDA-regulated products since 2016, the agency said today.
The company, Steril Milano, falsified graphs and parameters of sterilization certificates for devices processed at its Reggiolo and Monza ethylene oxide (EtO) plants, the FDA said.
Steril Milano on March 9, 2021, announced the temporary closure of the Monza and Reggiolo sites for further investigations following a review of operating procedures. The company said that it has taken steps to strengthen the quality control processes at its Biassonno site. Steril Milano’s certifying body has suspended the certification for its Italian sites, the company added.
The FDA believes that 97 manufacturers of devices that include biopsy needles, catheters, intravascular administration sets, arthroscopes and syringes may be affected. The agency said it is working with medical device manufacturers, international partners and U.S. federal partners to investigate the scope of medical devices that may be affected. The FDA also said it intends to contact potentially affected firms that are known to have contracted medical device sterilization services with these Steril Milano facilities.
The agency issued an import alert on May 24, 2021, to prevent medical devices processed at the Reggiolo and Monza facilities from entering the United States. The FDA is notifying manufacturers, companies, and health care organizations who may have used Steril Milano for medical devices or product sterilization.
As of yesterday, 10 medtech firms have voluntarily recalled their medical devices processed at the Monza and Reggiolo plants, the FDA noted, adding that it is not aware of reports of patient harm.
It is recommending that manufacturers:
- Determine if any of their devices currently in distribution were processed at the Steril Milano Reggiolo or Monza facilities.
- Quarantine any existing inventory that may be affected and notify customers of any distributed medical devices.
- Evaluate the risk and develop corrective actions to address the sterility issues.
The agency is also urging manufacturers to contact the FDA Center for Devices and Radiological Health (CDRH) at [email protected], 800-638-2041, or 301-796-7100 if its medical devices were processed at Steril Milano facilities and they become aware of information related to patient safety, higher infection rates or non-sterile products in distribution.
Manufacturers should report any device-related events involving patient injury, death, or a device malfunction and assess the potential disruption in distribution, including the potential for shortage, and contact the FDA about a medical device supply chain issue, the agency said.
“The FDA is working to provide imports information to device manufacturers and health care delivery organizations to ensure they are aware of the issues and preparing to reduce patient impact if medical devices sterilized at these sterilization facilities become unavailable,” said Dr. William Maisel, director of CDRH’s Office of Product Evaluation and Quality, in a letter to manufacturers. “In addition, the FDA continues to monitor imported products and increase screening activity for impacted firms and products.”
