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.
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. Do not use medical gases 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 Authorisation 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 Air and Vacuum 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-2022 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 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. The BCGA also advise against the use of electronic cigarettes, or other electronic devices such as mobile phones, whilst undergoing oxygen therapy as they are a potential source of ignition.
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:
- Guidance Note 2 - Guidance for the storage of gas cylinders in the workplace.
This document defines the principles of safe practice for the storage of gases in cylinders and cylinder bundles.
- Guidance Note 26 - Medical gas cylinders. Selection and maintenance of seals used on high pressure cylinders.
Provides information on best practice for users of medical gas cylinders when they are connecting approved medical equipment to gas cylinders.
- L 7 - The dangers of industrial gas abuse.
BCGA would like the general public and, particularly, the media, to be better aware of the dangers of fooling around with gases.
- TIS 6 - Cylinder identification. Colour coding and labelling requirements.
A guide to the colour coding system used to identify gas cylinders and an explanation of some of the content of a gas cylinder label.
- TIS 14 - Safety precautions and risk management when dealing with domiciliary oxygen incidents.
This document provides guidance to the Medical Oxygen Homecare Service Provider supplying oxygen to either Healthcare Service facilities or to patients at home and to the Emergency Services (predominantly the Fire Service but also to the Ambulance Service) to assist in the preparation of their own procedures related to dealing with domiciliary oxygen incidents.
- TIS 20 - Medical gas cylinders: BCGA policy statement on colour coding.
This document sets out the BCGA policy for the colours used to paint a medical gas cylinder, for both the body and the shoulder, to assist in the identification of the gas within, and discuses the conversion program in place to implement the changes required.
- 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:
European Medicines Agency - EMA website - "GMP/GDP Compliance"