MHRA takes action over Steril Milano sterilisation problem

The MHRA (Medicines and Healthcare products Regulatory Agency) has recently been forced to respond to reportedly fraudulent activity at Steril Milano, a medical company that provides sterilisation services to many medical device manufacturers. Although it is an Italian-based company, it serves manufacturers who provide products in the UK, which is why the UK regulator saw fit to take action.

In 2021, Steril Milano was acquired by Ionisos and it then became the subject of suspicion over alleged fraudulent activity. When this was identified, the company’s certification was withdrawn, which means that products which were already sterilised by this point could, potentially, not have been processed correctly.

According to the MHRA, the safety risks are believed to be low, but the regulator is nevertheless obliged to review the issue and mitigate any potential problems as much as possible.

The problem at Steril Milano

In order to provide its services within the appropriate regulations, Steril Milano was required to fully record its sterilisation processes. It is understood that Steril Milano did not do so for a given period, and its certification was revoked.

Despite this, the devices distributed during this time may well be sterile and safe, so hopefully patients are unlikely to fall victim to dangerous devices. However, the MHRA nevertheless took issue with the fact that the documented process was reportedly not followed.

Action taken by the MHRA

There were dozens of manufacturers who had been provided with sterilisation services by Steril Milano, all of which had to be taken into account in the MHRA’s action. In April this year, the MHRA contacted the relevant manufacturers, asking them to complete risk assessments, as well as provide a plan of action regarding the products sterilised by Steril Milano which they provide to the UK.

Some 28 manufacturers had reportedly notified the MHRA about the actions they were set to take to correct any potential issues. Field safety notices have also been issued by manufacturers to notify affected healthcare sector customers of the products and devices that are understood to have been potentially affected.

The MHRA has also engaged in collaborative work to take action against the distribution of devices sterilised by Steril Milano. Working with organisations like patient groups and sterilisation facilities, the MHRA has sought to eliminate safety concerns whilst also looking to reduce any disruption that was set to be caused by the product recalls.

Further advice from the MHRA

Patients are being told to go to their healthcare professionals with any concerns they have, although the risk of unsterilised devices is believed to be small. The MHRA is also advising that any other manufacturers who have yet to take action should contact all those to whom they have distributed products processed by Steril Milano.

Hopefully, it will remain unlikely that patients will be adversely affected by the Steril Milano problems, but it is still important that regulators like the MHRA take precautionary action in such cases. We have represented a number of patients whose health has been compromised by unsafe medical devices, which is why we believe that preventative action is vital to ensuring patient safety.

Anyone who ever suffers due to medical issues can always contact the team here for free, no-obligation advice.