Concerns Raised Regarding Risk Of Infection

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert related to gastrostomy devices manufactured by Medicina.

The notice relates to the measuring device (product code BM01), the direct dilation kit (product code DD12fr, DD14fr and DD16fr) and the balloon gastrostomy kit (product codes EK12fr, EK14fr, EK16fr, EK18fr, EK20fr, EK22fr and EK24fr)

According to the MHRA, there is a risk of infection with the balloon gastrostomy kit as it may contain out-of-date devices and the sterility cannot be assured.

It added that the safety and performance of the devices had not been evaluated, so the CE marking in respect of  the products was viewed as invalid.

Medicina had issued three notices in June regarding issues but the company has not had confirmation that they have been acted upon. All healthcare workers who use the devices and suppliers have been urged not to use them, as well as to quarantine and return them to the manufacturer. 

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Expert Opinion

It is a concern to see yet another medical device alert issued by the MHRA and it is vital that the priority at present is to ensure that steps are taken to remove any products bearing these codes from use or supply as quickly as possible. <br/> <br/>"Patients place great faith in the fact that their safety will always come first during treatment and that includes when it comes to the products used in their care. <br/> <br/>"Sadly, we have seen numerous cases when people have suffered serious injury or long-term health problems as a result of the use of defective products in treatment and it is vital that steps are taken to prevent such issues from emerging again in the future. <br/> <br/>"Issues of this nature raise serious questions regarding the regulatory framework which governs such products and we hope that efforts can be made to ensure only safe devices make it to the treatment table." Kevin Timms - Solicitor