Medical Device Alert: Neonatal And Paediatric Endotracheal Tube Clamp/Holder Manufactured By EMS Medical

In short

UK’s regulatory authority the MHRA has issued a Medical Device Alert(MDA) pertaining to all lot numbers and product codes of  the above named  product because of a risk of airway loss due to slippage of the clamp/holder or airway obstruction as a result of over-tightening of the clamp/holder.

Background

The MDA can be found here, and in it the MHRA points out that the supplying company EMS has gone into administration so cannot be contacted.

That an ET tube clamp can become a critical component in maintenance and control over airway maintenance, emphasises the point that the most insignificant of parts can have a significant bearing on health, hence the issuance of this MDA, which has been circulated to all staff likely to come into contact with the device in question.

Users are asked to identify all such devices and dispose of them.

Source: UK MHRA