Consent and the use of Foley catheters in epistaxis.
The Medicines and Healthcare Products Regulatory Agency stated in 2003 that doctors should endeavour to avoid using products in treatments not covered by their product licence. Foley catheters are commonly used in the management of epistaxis although their product licence does not cover this. We undertook a questionnaire survey of members of the British Association of Otorhinolaryngologists--Head & Neck Surgeons to study the extent of the use of these catheters and the knowledge that members had of their legal status. Most members appear to use Foley catheters in the management of epistaxis; however, many are not aware that the product is not licensed for this purpose. Because of this lack of knowledge, only half obtain verbal consent for treatment with this device and only a very small number obtain written consent from patients. In the era of increasing litigation, documentation of informed consent could be considered mandatory to protect us from possible legal action, and this needs to be known by all practising otolaryngologists.
Pellard
Sarah
S
Department of Otolaryngology--Head & Neck Surgery, Royal Gwent Hospital, Newport, UK. sarahpellard@hotmail.com
Boyce
Jamie
J
Ingrams
Duncan R
DR
D002404:Catheterization / Q000009:adverse effects / Q000592:standards / Q000706:statistics & numerical data*; D004844:Epistaxis / Q000628:therapy*; D019538:Health Care Surveys; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data; D008004:Licensure; D008499:Medical Records / Q000592:standards; D011361:Professional Competence / Q000706:statistics & numerical data; D011364:Professional Practice / Q000706:statistics & numerical data; D011795:Surveys and Questionnaires; D006113:United Kingdom