The Italian sterilisation service provider “Steril Milano S.r.l.” has failed to carry out certain sterilisation processes correctly. Potentially affected are numerous medical devices processed by Steril Milano S.r.l. on behalf of its customers. The manufacturers concerned are assessing the risks and taking the necessary measures in cooperation with the relevant market surveillance authorities. In Switzerland too, field safety corrective actions and recalls have already been implemented and published in consultation with Swissmedic.
Field Safety Corrective Actions due to defective sterilisation of medical devices by the company Steril Milano S.r.l.
Information about Europe-wide field safety corrective actions and recalls
Steril Milano S.r.l., based in Monza, offers medical technology companies an ethylene oxide (EO) sterilisation service for medical devices. On 8 March 2021, the company published a press release on its website announcing the temporary closure of its industrial sites in Monza and Reggiolo for further investigations following a review of operating procedures (the relevant certification body has suspended the certification for Steril Milano S.r.l.). According to the Italian investigating authorities, the sterilisation service provider is suspected of having deliberately falsified process records and validation documentation during the ethylene oxide (EO) sterilisation of medical devices for customers.
Based on the latest findings, it may be assumed that devices that have undergone sterilisation procedures since 2016 at Steril Milano S.r.l. were not correctly sterilised. Ongoing measures include risk assessments to ascertain whether the devices sterilised during this period are safe. Swissmedic is working closely with the European partner authorities, and particularly the market surveillance authorities in Italy responsible for monitoring Steril Milano S.r.l..
As part of its remit, Swissmedic has already carried out risk assessments together with medical device manufacturers whose medical devices could be affected by the defective sterilisations. All recalls and safety measures implemented by the companies responsible will be published as usual, and the users will be contacted directly by the companies.
We would advise users, specifically those in hospitals, to note and follow corresponding customer information letters sent out by their suppliers. If you have any questions or potential supply problems, you should contact your suppliers directly.
Sterilisation of medical devices with ethylene oxide (EO)
EO sterilisation processes are used for the low-temperature sterilisation of heat-sensitive medical devices that cannot be steam sterilised. Ethylene oxide is a highly reactive gas that renders bacteria, fungi and viruses harmless. The EO sterilisation process is very effective and offers the advantage of being able to penetrate plastic surfaces.