MHRA raises alert regarding potential “incomplete sterilisation” – Steril Milano

The Medicines and Healthcare products Regulatory Agency (MHRA), the UK government regulator that monitors the practices of medical product manufacturers and the safety of the goods they produce, has reportedly identified fraudulent activity involving a company based in Italy. Steril Milano is understood to provide services for sterilising medical equipment and devices for a number of manufacturers, including some who supply products to the UK.

However, following its acquisition by a new parent company in 2021, it is believed that Steril Milano did not complete sterilisation processes to the required standard for dozens of manufacturers to whom it provides its services. In response, according to the MHRA, they were forced to take action to ensure that the risk to patients in the UK is minimised.

Whenever concerns are raised about the safety of medical products, it is essential that regulators act to investigate the manufacturers suspected of negligence, as well as alerting relevant hospitals and healthcare centres to give them an opportunity to protect their patients. The MHRA has hopefully acted quickly enough in this case to prevent as many patients as possible from being harmed.

What is Steril Milano believed to have done?

The alarm of reported fraudulent activities was raised in April 2021, at which point Steril Milano’s certification as a sterilisation plant was withdrawn. Many of the devices processed by Steril Milano prior to 14^th April 2021 potentially may not have been properly sterilised according to approved procedure. While the MHRA asserts that these devices did not go completely unsterilised, and so are likely to be sanitary, it is alleged that Steril Milano was not operating the proper documented process of sterilisation.

The safety risk is said to be minimal, but regulators like the MHRA cannot take any risks in situations such as these, where the sterilisation process has not been recorded.

How has the MHRA acted in response?

The MHRA contacted manufacturers who have been provided with sterilisation services by Steril Milano, requesting that they undertake risk assessments and inform the regulators of their intentions regarding products that are being supplied to the UK. Manufacturers have since issued field safety notices for recalling the relevant devices as a safety precaution.

Furthermore, the MHRA has conducted its own risk assessments and has worked with other healthcare organisations in the UK to ensure that all are aware of the affected products and know what action must be taken.

Any further manufacturers who have yet to take action are urged to do so.

Precautionary action by medical regulators

As specialists in group actions and medical negligence, we are of the belief that there is no room for error when it comes to patient safety. We are pleased to see that the MHRA has taken fast measures in the case of Steril Milano, and we hope that similar precautions will be afforded in future cases like this.

Unfortunately, we have had to deal with many cases of faulty or dangerous medical products that have been approved by medical product regulators in spite of the risks they posed to patients. We have represented clients whose health has been adversely affected by devices such as PIP breast implants and vaginal mesh devices, among a number of other medical products.

If you have been harmed by an unsafe medical product, you may have a compensation claim to make, so please do feel free to contact us for free, no-obligation advice should you need us.