Important Safety Alerts

The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom has issued a Medical Device Alert concerning oral swabs with a foam head. The alert applies to this kind of devices produced by all manufacturers.

The MHRA is aware of a recent incident in Wales where the foam head detached from the stick of an oral swab while a carer was providing mouth care to an elderly patient. The foam head could not be retrieved. The patient subsequently died. The MHRA recommended those involved in the use and supply of these devices including those who advise patients and carers on the following:

• Follow the manufacturer's instructions for use (where available).
• Check that the foam head is firmly attached to the stick before use.
• Do not leave the swabs soaking in liquid prior to use as this may affect the strength of the foam head attachment.
• If required moisten the swab immediately before use.
• If the patient is likely to bite down on the swab consider using an alternative such as a small headed toothbrush with soft bristles.
• Ensure that all users, including unsupervised patients and carers, are aware of this advice and the manufacturer's instructions for use.
• Discard oral swabs after use.

For details, please refer to the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/MedicalDeviceAlerts/index.htm