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 und...

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Bibliographic Details
Published in:Journal of laryngology and otology 2005-10, Vol.119 (10), p.822-824
Main Authors: Pellard, Sarah, Boyce, Jamie, Ingrams, Duncan R
Format: Article
Language:English
Subjects:
(RF) Otorhinolaryngology
Airway management
Biological and medical sciences
Catheterization - adverse effects
Catheterization - standards
Catheterization - utilization
Catheters
Defective products
Epistaxis
Epistaxis - therapy
Foley Balloon Catheterization
Great Britain
Health Care Surveys
Humans
Informed Consent
Informed Consent - legislation & jurisprudence
Informed Consent - statistics & numerical data
Licenses
Licensure
Medical Records - standards
Medical sciences
Non tumoral diseases
Nose
Otolaryngology
Otorhinolaryngology. Stomatology
Patients
Professional Competence - statistics & numerical data
Professional Practice - statistics & numerical data
Questionnaires
Regulatory agencies
Surveys and Questionnaires
United Kingdom
Upper respiratory tract, upper alimentary tract, paranasal sinuses, salivary glands: diseases, semeiology
Urogenital system
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Description
Summary: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.
ISSN:0022-2151
1748-5460
DOI:10.1258/002221505774481318