Medical Gases and their associated equipment are widely used for treating patients in hospitals, at home, and by the emergency services.
Many BCGA member companies are licensed by the Regulatory Authorities 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 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 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.
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 returned back to the owner (normally the gas supplier).
Some equipment such as medical gas regulators, demand valves and medical gas flow meters, that are associated with the administration 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 Manufacturer's Authorisation issued by the MHRA for the manufacture of medical gases. The organisation is required to comply with the basic principles and practices of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) as laid down in the relevant European Guidelines.
For information on GDP refer to BCGA GN 32
Any organisation that does not hold a Manufacturer's Authorisation or wishes to provide and distribute medical gases that they have not manufactured must have a Wholesale Dealer's Authorisation issued by the MHRA. The organisation is required to comply with the basic principles and practices of Good Distribution Practice as laid down in the relevant European Guidelines.
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.
In a gas cylinder, medical gases are stored under pressure and they should always be handled and used with care, in particular they should not be exposed to fire.
All staff who handle oruse gases shall be appropriately trained in the safe handling of gas cylinders,the safe use of gases as well as the safe use of any associated&equipment.
Gas cylinders are also frequently stolen, both for the value of the materials they are made from and for their contents. This is&particularly true of medical gases.
When not in immediate use gas cylinders should be kept in a secure, well ventilated store, away from any sources of ignition. For more information refer to BCGA CP 44, The&storage of gas cylinders.
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 continues to be 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.
BCGA members interested in medical gases and their associated equipment should consult the webpage for TSC7 located in the member's area. The following documents are available within the publications section and are free to download:
- Code of Practice 44 - The storage of gas cylinders.This document defines the principles of safe practice for the storage of gas cylinders and bundles. It promotes the use of an external store, in a secure location, with good natural ventilation and away from any sources of ignition.
- 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.
- Leaflet 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.
- Leaflet 13 - Medical oxygen in a vehicle. This leaflet highlights the key safety information for patients and drivers where medical oxygen cylinders or medical liquid oxygen equipment is used and / or transported for personal use in a vehicle.
- Leaflet 16 - The safe use of electronic cigarettes and other electronic devices used near medical oxygen. This leaflet highlights the key safety information where medical oxygen cylinders or medical liquid oxygen equipment is in use and where people may want to use electronic devices or electronic cigarettes
- 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 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.
- TIS 36 - Medical gases. The safe handling and use ofgas cylinders fitted with valves with integrated pressure regulators. This document provides advice on the safe handling anduse of such cylinders.
- TIS 37 - Medical Gases. Gas Cylinder cleanliness standards.This document details the requirement to keep medical gas cylinders clean and covers the methods used to either clean the external surface or to return a cylinder in protective packaging. It does not address the internal condition of a gas container or the quality of the gas within.
- TIS 39 - Medical Gases. Quality control and QP batch certification of bulk medical liquid oxygen. This document details both the practical and scientific justification for a concession allowed by the medical regulatory authorities for the retrospective release by a qualified person (QP) of bulk medical liquid oxygen.
EIGA held an oxygen safety workshop in January 2012. The following presentations may be of interest:
The Human Medicines Regulations 2012 (SI 2012:1916)
Medicines & Healthcare Products Regulatory Agency (MHRA)
MHRA - Good Manufacturing Practice (GMP) & Good Distribution Practice (GDP)
MHRA - Good Manufacturing Practice - Data integrity definitions and guidance
MHRA - Medical Devices regulation and safety
MHRA - Good Pharmacovigilance Practice for Medicines (GPvP)
European Commission - EU Legislation - Eudralex
European Commission & Eudralex -GMP Guidelines
European Commission - Good Distribution Practice Guidelines
European Commission - Good Distribution Practice Questions & Answers
European Commission - Medicinal Products for human use
European Commission - Medical Devices
European Commission - Medical Devices - Guidance
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S)
PIC/S - Inspection of Medicinal Gases Facilities
USA - Food and Drug Administration (FDA) - Drugs
USA - FDA - Medical devices
World Health Organisation (WHO) - Medicines and health products
World Health Organisation (WHO) - Training Modules
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
The International Medical Device Regulators Forum (IMDRF)
IMDRF - Quality systems - Corrective action and preventative action (CAPA)
The Health Products Regulatory Authority (HPRA)
HPRA - Guidance documents
The Association for Anaesthetic and Respiratory Device Suppliers - (Barema)
The Association of Anaesthetists of Great Britain and Ireland - (AAGBI)