Medical Gases and their associated equipment are widely used for treating patients in hospitals, at home, and by the emergency services.
BCGA member companies are licensed to manufacture and distribute the medical gases used within the UK and provide a range of associated equipment and services. Within BCGA, all aspects of medical gases are managed by Technical Sub-Committee (TSC) 7.
All Medical Gases and some of the associated equipment used are highly regulated by European Directives and UK legislation. The gases are classified as medicinal products for administration to a patient and the associated equipment is classified as a medical device when used to administer the gas.
Although medical gases are very similar to other non-medical gases; like other medicinal products they need to have a Marketing Authorisation (product licence) in order to be sold. The Marketing Authorisation defines when a gas can be used and how it should be administered to a patient. Only these medical gases with an appropriate licence should be prescribed for the treatment of patients
Note: Medical gases are not to be used for non-medical purposes, other than a power source for medical equipment or for testing medical equipment.
As with all medicines, medical gases have a defined shelf life which is specified within the relevant Marketing Authorisation. Each cylinder will have a label that will show the expiry date as well as the batch number of the medicinal product. It is not recommended that Medical Gases are used once this shelf life has expired; upon expiry the cylinder should be replaced.
Some equipment such as medical gas regulators, demand valves and medical gas flow meters, that are associated with the use of medical gases, are classified as medical devices. European Medical Devices Directives 93/42/EC (as amended) covers the placing on the market and the putting into service of medical devices. Medical devices carry a CE marking that is the manufacturer's declaration that the equipment complies with the essential requirements of the relevant Medical Devices Directive.
The Medicines and Healthcare products Regulatory Agency (MHRA) is the Executive Agency of the Department of Health which protects and promotes public health and patient safety by ensuring that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness, and are used safely.
Any organisation that wishes to manufacture medical gases must have a Manufacturers Authorisation issued by the MHRA to manufacture medical gases. They are required to comply with the basic principles and practices of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) as laid down in the European Guidelines.
Any organisation that wishes to provide and distribute medical gases must have a Wholesale Dealer's licence issued by the MHRA and is required to comply with the basic principles and practices of Good Distribution Practice.
Any organisation that wishes to manufacture medical devices must conform to the requirements laid down in the relevant Medical Device Regulations and must be registered with the MHRA or another European competent authority.
All Medical Gas Pipeline Systems (MGPS) and Dental Gas Systems (DAVS), which includes vacuum systems, are to be compliant with the standards required by the Department of Health. Compliance is required, for example, with:
a. Health Technical Memorandum (HTM) 02 - Medical Gas Pipeline Systems
(1) Part A, Design, Installation, Validation and Verification.
(2) Part B, Operational Management.
b. HTM-02 Supplements:
(1) Dental Compressed Air and Vacuum.
(2) Medical Gas Systems for Ambulances.
(3) Pressure Systems Safety Regulations.
All staff who are required to handle or use gases are to be appropriately trained in the safe handling and use of the gases as well as any associated equipment.
The primary objective of BCGA TSC7 is to safeguard patients by ensuring that all products provided by BCGA member companies are safe to use and fit for their intended purpose. This is achieved by promoting safety, producing best practice guidance, liaising with the MHRA and other government departments and participating in relevant standard work.
One particular concern has been the safe use of medical oxygen, especially when used in the domiciliary environment.
WARNING: The careless use of medical oxygen, especially in a confined space, can result in oxygen enrichment of that space, leading to an increased risk of fire. Do not smoke or use naked flames close to oxygen.
Current work topics include:
Quality Risk Management
European Harmonisation of colour codes for cylinders
Transport of cylinders used by patients at home
Those interested in medical gases and their associated equipment should consult the minutes of TSC7 located in the members area.
Amongst others, the following documents are available within the publications section. Many are free to download:
TIS 21 - Medical gas cylinders: BCGA policy statement on valve outlets. This document details the BCGA policy, agreed with the MHRA, on rationalising the number of different valve outlets available for medical gases to minimise the risk of administering the wrong gas to a patient and discuses the conversion program in place to implement the changes required.
EIGA held an oxygen safety workshop in January 2012. The following presentations may be of interest: