Medical Gases

Gases supplied for medicinal use are medicines.  Along with their associated equipment, they are widely used for treating patients.

Medicinal gases are classified as a medicine in compliance with The Human Medicines Regulations. Within a medical environment they must always be managed and controlled by an appropriately qualified healthcare professional. In a hospital this will be the Pharmacist. Information on managing medicinal gases by Pharmacists is provided by the Specialist Pharmacy Service.

Medicinal gases are administered by healthcare professionals in hospitals, clinics and care homes, by para-medics within the emergency services or are self-administered by the patient at home (having received appropriate training).

All medicinal gases and much of the associated equipment is regulated by UK legislation. UK and European legislation are generally aligned. 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. Some gases used for medical purposes can also be classified as medical device gases where they do not have a specific therapeutic outcome for the patient.

Manufacture, distribution and sales

Medicinal gases, like other medicinal products, are required to have a Marketing Authorisation (product licence) in order to be sold. The Marketing Authorisation defines the quality specification, when a gas can be used and how it should be administered to a patient. For patient treatment, all medicinal gases must be supplied with an appropriate Marketing Authorisation.

Although medicinal gases are similar to non-medical gases, medicinal gases are not to be used for non-medical purposes. Equally, non-medical gases must not be used as a medicinal gas. The UK Regulator for medicinal gases is the Medicines and Healthcare products Regulatory Agency (MHRA), who are an Executive Agency of the Department of Health and Social Care (DHSC). The MHRA 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 medicinal gases must have a Manufacturer’s Authorisation issued by the MHRA. The organisation is required to operate a quality management system which complies with the basic principles and practices of Good Manufacturing Practice (GMP) for medicinal products and specifically for medicinal gases. Any organisation that wishes to supply and / or distribute medical gases 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 (GDP). BCGA GN 32 was developed with the MHRA to ensure compliance with good distribution practice for medicinal gases.

Some equipment, such as medical gas regulators, demand valves and medical gas flow meters, that are associated with the administration of medicinal gases, are classified as medical devices. Medical devices must comply with the Medical Devices Regulations. Any organisation that wishes to manufacture medical devices (including medicinal gases classified as medical device gases) must be registered with the MHRA.

Conformity assessment.  Medical devices must undergo Conformity Assessment for compliance with the legislation where they are placed on the market.  In the UK, conformity assessment is carried out by an Approved Body and compliance is indicated by the use of a certification mark, the UKCA mark. The MHRA provide guidance, including for placing medical devices on the market in Northern Ireland, here.  In Europe, conformity assessment is carried out by a Notified Body and compliance is indicated by a CE mark. The MHRA provide guidance on conformity assessment and the use of the European CE mark for medical devices placed on the market in the UK here.

Storage and supply

Every site where medicinal gases are routinely used must have a suitable storage area with appropriate security provision.  Advice on the management of security at healthcare facilities is available in BCGA TIS 50, Security of facilities where medical gases may be present.

All personnel required to handle, move or use medical gases must be competent to do so, having received appropriate information, instruction, training and, as required, be under supervision. The appropriately qualified health care professional / Pharmacist must provide written policies and Standard Operating Procedures for the management and safe use of all aspects of medicinal gas supply and administration.

As with all medicines, medicinal gases have a defined shelf life which is specified within the relevant Marketing Authorisation. Where the medicinal gas is supplied in a gas cylinder it will have a label that will show the expiry date as well as the batch number of the medicinal product. Do not use medicinal gases once this shelf life has expired; upon expiry the gas cylinder should be returned back to the owner (normally the gas supplier).

Within medical facilities the primary method of supply for a medicinal gas is for it to be supplied into a bulk storage tank(s), from where it is delivered through a medical gas pipeline system (MGPS) into the facility. The MGPS can include vacuum systems, dental systems and dental air vacuum systems (DAVS). These MGPS have to be compliant with various standards, including those required by the DHSC.  Compliance is required, for example, with:

Health Technical Memorandum (HTM) 02 – Medical Gas Pipeline Systems

  1. Part A, Design, Installation, Validation and Verification.
  2. Part B. Operational Management

HTM – 2022 Supplements:

  1. Dental Compressed Air and Vacuum.

Copies are available here.

Some medical facilities may utilise on-site gas generation systems. Where these systems are in use they must meet the requirements for the manufacture of medical gases, including compliance with GMP and the site quality management systems.

Gas cylinder storage

Within medical facilities an alternative method of supply is through the use of transportable medical gas cylinders. Where a MGPS is in use, gas cylinders are a secondary source of supply. Gas cylinders contain dangerous substances. Individual gases have hazardous properties and the gas is contained under pressure. Gas cylinders must always be stored and handled with care. When not in immediate use all gas cylinders must be kept:

  • in a designated store, being appropriately marked with safety signs and warning notices;
  • in a well ventilated store, away from any sources of ignition, excessive temperatures, flammable materials and from any incompatible products;
  • in a secure location where access is controlled;
  • under cover (but still with good ventilation), kept in a clean condition suitable for use in a medical environment.

When choosing a cylinder for use, good stock management principles should be applied, for example, by selecting those with the shortest life remaining first, ‘first-expired, first-out’ (FEFO).

NOTE:  Gas cylinders are attractive to thieves and are frequently stolen, both for the value of the materials they are made from and for their contents. This is particularly true of medicinal gases. Each store must incorporate appropriate security features and be included within the site security plan.

For more information, refer to BCGA CP 44, The storage of gas cylinders.

The use of medicinal gases

Only medicinal gases, which are connected to suitable medical devices, shall be used to administer medicinal gases to a patient.

Each person who administers a medicinal gas to a patient must be competent to administer the gas, as well as being competent in the use of medicinal gas cylinders and their associated medical gas devices. All personnel who store, handle or use medicinal gases shall be competent to do so, including being appropriately trained in manual handling, local security measures, general gases safety, as well as the safe management of any associated medical devices.

The gas suppliers provide information on the safe and appropriate use of their medicinal products. Equipment manufacturers / suppliers provide information on the safe and appropriate use of their medical devices. This information includes ‘Instructions for use (IFU)’.

The European Industrial Gases Association (EIGA) provide a useful video which explains the safe use of opening, closing and using an integrated cylinder valve on medicinal oxygen gas cylinders: EIGA TM 1, Operation of medical valve integrated cylinder valves.  Additional advice is available in BCGA TIS 36.

Where medicinal gases are in use ensure there is adequate ventilation available, with management controls in-place to protect staff from any potential occupational exposure. 
HTM 03-1 provides advice on ventilation in healthcare premises. The NHS provide specific advice on managing exposure to nitrous oxide in healthcare settings.

WARNING: Do not smoke or use naked flames close to gas containers or any areas where medicinal gases are in use. When oxygen is in use there is the potential for localised oxygen enrichment, leading to an increased risk of fire. Always carry out local risk assessment and implement suitable and sufficient controls, in particular for the management of electrical equipment, advice is available in BCGA Leaflet 16.

Domiciliary use of medical gases

Medicinal oxygen is supplied to patients in their home, care home or other domiciliary facility.

Medicinal oxygen is provided by a Homecare Service Provider along with the associated therapy equipment. The medicinal oxygen may be supplied from cylinders, cryogenic containers or oxygen concentrators. There is a range of associated therapy equipment available for use, including continuous positive airway pressure (CPAP) machines, dependant on the patient’s needs. The Homecare Service Provider will work with the patient and, as appropriate, with those providing care for the patient, to install the oxygen equipment and to provide literature and training for safe management and use. Useful advice is available in BCGA GN 29, Medical gases. The management of medical oxygen in domiciliary use, and BCGA GN 46, Medical gases. Safe management of oxygen in care homes.

Cryogenic gases

Gases at cryogenic temperatures are used by and for the treatment of patients. As examples, liquid nitrogen is used within cryotherapy to treat skin conditions and for some specialist medical procedures. Storage of oxygen as a liquid provides a bulk source which converts to a large quantity of gas, this can be beneficial for patients who are travelling or who require larger quantities for domiciliary use.

Cryogenic liquids are at extreme cold temperatures and require to be kept and used from specialist containers. All those handling and using cryogenic gases need specific training and competence.

For liquid nitrogen, refer to BCGA CP 30, The safe use of liquid nitrogen dewars.

For liquid oxygen, refer to BCGA GN 29, Medical gases. The management of medical oxygen in domiciliary use, and BCGA Leaflet 13, Medical gases. Medical oxygen in a vehicle.

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Licensed manufacturers and distributors

The manufacture and supply of medicinal gases is regulated and only gas suppliers who have the appropriate authorisations can manufacture and then supply medicinal gases in cylinders. Advice on choosing an authorised medical gas supplier is available in Leaflet 22.

Several BCGA member companies are authorised by the Regulatory Authorities to manufacture and supply medical gases in the UK, they may also provide a range of associated equipment and services.

To view the full list, visit our Services Directory.

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Links

See below for further information regarding medical gases.

Committees

Within BCGA, all aspects of medical gases are managed by Technical Sub-Committee (TSC) 7.  Members can access information on TSC7 via the Members Area.

The primary objective of BCGA TSC7 is the safety of patients.  This is achieved by ensuring that all products provided by BCGA member companies are safe to use and fit for their intended purpose. TSC7 promote safety through liaison with the MHRA and other government departments, produce best practice guidance and participate in relevant standards work.

Publications

Publications

CP30 The safe use of liquid nitrogen dewars. Revision 3: 2019

01/09/2019 Codes of Practice CP30

Covers the storage, maintenance, handling, filling and use of dewars. Specifically addresses the use of liquid nitrogen in open dewars and dewars fitted with liquid withdrawal devices operating at less than 0.5 bar.

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CP36 Cryogenic liquid storage at users’ premises. Revision 2: 2013

01/09/2013 Codes of Practice CP36

This document covers the installation of cryogenic liquid storage tanks and associated equipment at customer sites. For liquid oxygen, nitrogen and argon. Tank sizes range from 0 to 125000 litre water capacity.

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CP44 The storage of gas cylinders. Revision 1: 2022

17/06/2022 Codes of Practice CP44

This document defines the principles of safe practice for the storage of gas cylinders and bundles. It promotes the use of an outdoor store, with good natural ventilation, in a secure location, which meets the required separation distances.

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GN26 Medical gases. Selection and maintenance of seals used on high pressure cylinders. Revision 1: 2019

01/05/2019 Guidance Notes GN26

Provides information on best practice for users of medical gas cylinders when they are connecting approved medical equipment to gas cylinders. It provides advice on non-pressure regulated cylinder valves, the selection of a suitable seal and the correct procedure for the preparation of connections prior to fitting them to a cylinder.

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GN29 Medical gases. The management of medical oxygen in domiciliary use – 2020.

18/06/2020 Guidance Notes GN29

This document covers the supply of medical oxygen for domiciliary use, supplied to patients in their home, care home or other domiciliary facility. It includes advice to patients and carers, as well as healthcare professionals, on the initial actions to take should an incident occur with medical oxygen

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GN31 Medical gases. The use of valves incorporating residual pressure devices. Revision 1: 2023

27/04/2023 Guidance Notes GN31

This document provides guidelines for the selection, installation and use of valves which incorporate a residual pressure device in medical gas cylinders, such that common practices are established across the gas industry. It is intended for those who are involved in the specification of cylinder valves and cylinder operations, as well as providing information to those using these valves.

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GN32 Medical gases. Good distribution practice. Revision 2: 2023

08/06/2023 Guidance Notes GN32

Medical products require effective management control during their distribution to ensure quality and integrity are maintained.

This document provides guidance on good distribution practice as required by the medical regulators

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GN37 Medical Gases. Data integrity. Revision 1: 2023

27/07/2023 Guidance Notes GN37

Data integrity is fundamental in a pharmaceutical quality system. This document provides guidance on compliance with the data integrity requirements for batch documentation relating to medicinal gases.

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GN39 Medical Gases. Responsible Person. 2020

09/01/2020 Guidance Notes GN39

Sets out the duties, roles and responsibilities of a Responsible Person within an organisation that distributes medicinal gases.

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GN40 Medical Gases. Quality management systems. Corrective and preventative actions. 2019

01/05/2019 Guidance Notes GN40

Any company manufacturing or distributing medical gases has to operate a quality management system. This document provides information on possible corrective and preventative actions.

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GN42 Medical gases. Incident reporting. 2021

20/04/2021 Guidance Notes GN42

Provides information on the reporting systems available in the UK if there is an incident with, or a problem is identified with, a medicinal gas or its associated medical device.

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GN46 Medical gases. Safe management of oxygen in care homes

25/08/2022 Guidance Notes GN46

Sets out the safe use of medicinal oxygen, as a liquid or a gas, as well as the medical devices which support oxygen delivery within a Care Home.

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L13 Medical gases. Medical oxygen in a vehicle. Revision 3: 2020

22/07/2020 Leaflets L13

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.

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L16 The safe use of electronic cigarettes and other electronic devices used near medical oxygen. Revision 1: 2020

03/03/2020 Leaflets L16

This leaflet highlights key safety information where medical oxygen and associated oxygen equipment is in use and where people may want to use electronic devices or electronic cigarettes.

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L22 Medical gases. Selecting a medical gas cylinder supplier. 2023

18/08/2023 Leaflets L22

Gases for medicinal use must comply with medical Regulations. Their manufacture and supply is regulated and only Gas Suppliers who have the appropriate authorisations can manufacture and then supply medicinal gases in cylinders. This Leaflet sets out the basic steps to be followed to check you are obtaining your medicinal gas cylinders from an authorised supplier.

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TIS6 Gas cylinder identification. Label and colour code requirements. Revision 4: 2023

10/11/2023 Technical Information Sheets TIS6

An explanation of the content of a typical gas cylinder label and a guide to the colour codes used on gas cylinders.

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TIS20 Medical gases. BCGA policy on colour coding. Revision 3: 2023

28/06/2023 Technical Information Sheets TIS20

This document sets out the BCGA policy for the colours used on a medical gas cylinder, for both the body and the shoulder, to differentiate medical gases from other gases and to assist in the identification of the gas within. It then details the conversion program to implement the changes required.

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TIS21 Medical gases. BCGA policy on valve outlets. Revision 3: 2023

29/06/2023 Technical Information Sheets TIS21

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 discusses the conversion program in place to implement the changes required.

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TIS36 Medical gases. The safe handling and use of gas cylinders fitted with valves with integrated pressure regulators. Revision 1: 2023

20/11/2023 Technical Information Sheets TIS36

Some medical gas cylinders integrate pressure regulators within the cylinder valve. TIS 36 provides advice on the safe handling and use of such cylinders.

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TIS37 Medical Gases. Gas cylinder cleanliness standards. Revision 2: 2019

18/06/2019 Technical Information Sheets TIS37

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.

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TIS39 Medical Gases. Quality control and batch certification of bulk medicinal liquid oxygen. Revision 1: 2023

24/11/2023 Technical Information Sheets TIS39

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.

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