Medical Device Alert: Unomedical Reinforced ET Tubes Potential To Delaminate And Restrict Airflow

The UK’s regulatory agency, the MHRA has issued a device alert relating to reinforced endotracheal (ET) tubes manufactured by Convatec company Unomedical The device types are Murphy, Magill, Murphy with stylet and Magill with stylet.

Background

Devices in question are available under three brand names: Unomedical UnoFlex™,  Euromedical™  TrachealFlex™ and  PharmaPlast. Specific sizes and lots are affected which can be found in the manufacturer’s Field Safety Notice.

The problem lies in the potential for inadequate patient ventilation. Seemingly the affected tubes may delaminate, which can lead to constriction of the lumen, resulting in a reduction of airflow to the patient.

As is often the case with MHRA alerts, this one follows a manufacturer-issued Field Safety Notice from 13 March which has not been fully complied with by all users. The advice given was to withdraw the affected devices but has not had confirmation from a significant number of users that they have received and acted upon this information. So, what to do at this point? As is often the case the device alert tells users to stop using the devices in question, quarantine them for return to the manufacturer.

The full alert, including a link to the original Field Safety Notice can be found here.

Source: MHRA