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.
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. Medical devices must undergo Conformity Assessment for compliance with the legislation where they are placed on the market. Compliance is indicated by the use of a certification mark. In the UK, the UKCA mark. In Europe, the CE mark. Any organisation that wishes to manufacture medical devices (including medicinal gases classified as medical device gases) must be registered with the MHRA.
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
HTM – 2022 Supplements:
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.
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:
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.
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.
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.
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.
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.
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.
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.Go To Download Page
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.Go To Download Page
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.Go To Download Page
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.Go To Download Page
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 oxygenGo To Download Page
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.Go To Download Page
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
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.Go To Download Page
Sets out the duties, roles and responsibilities of a Responsible Person within an organisation that distributes medicinal gases.Go To Download Page
Any company manufacturing or distributing medical gases has to operate a quality management system. This document provides information on possible corrective and preventative actions.Go To Download Page
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.Go To Download Page
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.Go To Download Page
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.Go To Download Page
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.Go To Download Page
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.Go To Download Page
An explanation of the content of a typical gas cylinder label and a guide to the colour codes used on gas cylinders.Go To Download Page
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.Go To Download Page
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.Go To Download Page
Some medical gas cylinders integrate pressure regulators within the cylinder valve. TIS 36 provides advice on the safe handling and use of such cylinders.Go To Download Page
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.Go To Download Page
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.Go To Download Page