Action underway: 27 April 2012, action complete: 14 May 2012
Oral swabs with a foam head.
Image of Oral swabs with a foam head.
Foam heads of oral swabs may detach from the stick during use. This may present a choking hazard for patients.
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.
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.
This advice supersedes the advice given in MDA/2008/017.
All those involved in the use and supply of these devices including those who advise patients and carers.
This MDA has been sent to:
NHS trusts in England (chief executives)
Care Quality Commission (CQC) (Headquarters) for information
HSC trusts in Northern Ireland (chief executives)
NHS boards in Scotland (equipment coordinators)
OFSTED (Directors of Children’s Services) for information
Local authorities in Scotland (equipment coordinators)
NHS boards and trusts in Wales (chief executives)
Primary care trusts in England (chief executives)
Please bring this notice to the attention of relevant employees in your establishment. Below is a suggested list of recipients.
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
Adult intensive care units
All clinical departments
All nursing staff
Clinical governance leads
ENT medical staff
ENT services, directors of
Health and safety managers
Intensive care medical staff/paediatrics
Intensive care nursing staff (adult)
Intensive care nursing staff (paediatric)
Intensive care units
Intensive care, directors of
Nursing executive directors
Oral and maxillofacial surgeons
Primary care trusts
CAS liaison officers for onward distribution to all relevant staff including:
Community children’s nurses
Community dental services
General dental practice
Palliative care teams
Care at home staff
Community care staff
Day centres (older people, learning disabilities, mental health, physical disabilities, respite care, autistic services)
In-house domiciliary care providers (personal care services in the home)
In-house residential care homes
Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:
Care homes providing nursing care (adults)
Care homes providing personal care (adults)
Domiciliary care providers
Hospitals in the independent sector
Independent treatment centres
Establishments registered with OFSTED
This alert should be read by:
Educational establishments with beds for children
Residential special schools
Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: firstname.lastname@example.org and requesting this facility.
If you have any comments or feedback on this Medical Device Alert please email us at: email@example.com
If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2012/020 or 2012/003/001/401/005.
Mojisola Ajeneye or Sally Mounter
Medicines & Healthcare products Regulatory Agency
151 Buckingham Palace Road
London SW1W 9SZ