Doc. 195/15 Safe Design and Operation of On Site Generation of Oxygen 93% for Medical Use

"Oxygen for medicinal use is a prime requirement for all healthcare facilities for both the treatment of patients with respiratory disease and for providing additional oxygen to patients being treated within the facility.

For those hospitals and clinics, oxygen is normally distributed throughout the facility using a medical gas pipeline system. The design requirements for the supply source used to supply medical oxygen to the pipeline system are detailed in the standard EN ISO 7396-1 for medical systems.

Two different products are included in the standard:

  • Medicinal oxygen supplied from liquid oxygen vessels and/or gaseous oxygen cylinders; and
  • Oxygen 93 manufactured on-site within the healthcare facility, using an oxygen concentrator unit.

Within the European Union medicinal oxygen, supplied either in cylinders or as a cryogenic liquid, is required to be manufactured by an approved supplier with a manufacturer’s licence and the supplier is required to hold a marketing authorisation.

The specification of the product is detailed in the Pharmacopoeia monograph for medical oxygen, which specifies a minimum purity of 99.5% oxygen. The quality and safety of the medical oxygen are ensured through a quality management system under the responsibility of a qualified person. Oxygen 93 can be manufactured on-site within the healthcare facility, under the responsibility of the healthcare facility pharmacist, using an oxygen 93 supply system. Oxygen 93 is not being ‘put on the market’, so it currently falls outside the regulation for the manufacture and supply of the medicinal product directive.

The purpose of this publication is to provide a guideline, where the use of an oxygen 93 concentrator system is permitted, for the supply of oxygen for medicinal use to a healthcare facility pipeline system and to identify the best practices that should be used to ensure patient safety.

There are recommendations concerning the design of the system, the continuity of supply, the quality management systems used to manage the production of the oxygen and the quality control requirements to ensure that the product quality remains within the specification range.

This publication applies to the planning, technical design, location, installation, operation, maintenance and quality management of oxygen 93 concentrator systems used for supplying medical gas distributions systems in healthcare facilities. It provides recommendations regarding the roles and responsibilities required to manage such a mode of supply.

It is intended for use by EIGA Members, healthcare facility managers and responsible pharmacists, manufacturers of oxygen concentrators; and national regulatory authorities involved in the regulation and inspection of the manufacturing and administration of medical gases."