The Federal Institute for Dugs and Medical Devices (BfArM) in Germany has issued a notice where it informs manufacturers and users about the inadequate sterilization of medical devices by Steril Milano S.r.l.
Steril Milano S.r.l. based in Monza, Italy, offers a sterilization service for medical products using ethylene oxide (EO) and e-beam. Steril Milano S.r.l. published a press release on its website on March 8th, 2021 (www.sterilmilano.it), according to which it closed its industrial sites in Monza and Reggiolo after a review of the operational processes in order to carry out an investigation and also to take measures to strengthen quality control at its third location to seize in Biassonno.
In the meantime, the certificate from Steril Milano S.r.l has been withdrawn by the responsible accreditation body. According to the current state of knowledge, it can be assumed that the products that Steril Milano S.r.l. allegedly subjected to the sterilization process, were not sterilized in accordance with the validated sterilization protocols to a significant extent.
There are also indications that the underlying validation steps have been manipulated. On the basis of the current state of knowledge, from the point of view of the BfArM, it is not ensured that the devices processed in the affected period products are sterile. Checks of the sterility of corresponding products by at least one affected medical device distributor showed that there was no sterility.
BfArM thus asks all medical device manufacturers and distributors to check whether the products they have placed on the market have been sterilized by Steril Milano and are therefore affected.