Are Medicinal Gas Cylinders Medical Devices?
B) False - Medicinal gas cylinders are NOT classified as medical devices; they are classified as medicinal products (drugs).
Regulatory Classification
Medical oxygen and other medicinal gases are classified as drugs, not medical devices. 1 Specifically, the BTS guideline explicitly states that "Like oxygen, Entonox is classified as a medical gas" and that "Medical oxygen is a drug." 1
Legal Status in the UK
The legal framework clarifies this distinction:
Medical oxygen is a medicinal product on the General Sales List in the UK, meaning it does not technically require a prescription because it is not a "prescription-only medicine." 1
This status was conferred for practical reasons to facilitate domiciliary use where distribution no longer involves pharmacies. 1
However, clinical governance requires that oxygen use by healthcare professionals must be documented similarly to other medicinal products like paracetamol or aspirin. 1
The Cylinder vs. The Gas
An important distinction exists between:
The gas itself (oxygen, nitrous oxide, etc.): This is the medicinal product/drug 1
The cylinder: This is the storage and delivery system for the medicinal gas 1
The cylinders are subject to Pressure Systems Safety Regulations 2000 in the UK, which are intended to prevent risk of injury from pressurized systems, not drug regulations. 1
Clinical Implications
Healthcare organizations must ensure policies for the safety of patients, staff, and contractors in the provision, storage, use, and maintenance of compressed gas systems as required by the Health and Safety at Work Act 1974. 1
The cylinders themselves are regulated as pressurized equipment for safety purposes, but the medicinal gases they contain are pharmaceutical products requiring appropriate clinical documentation and governance. 1