Steril Milano is a third-party supplier of sterilisation services to manufacturers of medical devices. It is based in Italy. Fraudulent activities by the company became apparent in early 2021 after it was bought by a new parent company, Ionisos. Once the fraudulent activities were uncovered, the certification for the sterilisation plant was withdrawn, meaning it could no longer provide sterilisation services. The scale of the problem is limited to products which had already been sterilised when the certification was withdrawn on 14 April 2021.
For devices processed before this date, a sterilisation process had been carried out and the devices are likely to be sterile, but they may not have been sterilised in line with the documented, validated process. However, for the majority of devices the risk to patients is low. The MHRA is not aware of adverse incidents reported to us which can be linked back to Steril Milano.
The MHRA was advised of 88 medical device manufacturers for whom Steril Milano provided sterilisation services. Additional companies, that are part of the supply chain for the affected manufacturers, have also been identified.
Reference:Medicines and Healthcare products Regulatory Agency (MHRA) Medical devices sterilised by Steril Milano – potential for incomplete sterilisation (DSI/2021/008). Published 29th June 2021. https://www.gov.uk/drug-device-alerts/medical-devices-sterilised-by-steril-milano-potential-for-incomplete-sterilisation-dsi-slash-2021-slash-008