Europe


What you need to know

The fitting of oxygen firebreaks is now a legal requirement for home oxygen installations across Europe.

Complying with the Medical Device Directive (93/42/EEC) or the more recently enacted Medical Device Regulation (2017/745) is a legal requirement for all economic operators in Europe, including home oxygen service providers.

The instructions for use for an oxygen concentrator placed on the EU single market will include an instruction to the effect that a firebreak ‘shall’ be fitted close to the patient to stop the flow of oxygen in the event of a fire.

This statement is the oxygen concentrator manufacturer’s way of complying with the harmonised EN ISO type standard for oxygen concentrators, which provides the manufacturer with an immediate presumption of conformity to the Essential Requirements of the Medical Device Directive and allows them to properly apply the CE mark.  All oxygen concentrators placed on the European market since January 2015 will include this statement.

The applied CE mark is reliant on the home oxygen service provider following this instruction and fitting a firebreak.  If the firebreak is not fitted, then the Essential Requirements for performance and safety are not met and the CE mark is no longer valid.  It also means that the status of the home oxygen service provider, within the framework under which the single market for medical devices operates, changes from distributor to manufacturer with significant regulatory implications.

Additionally, the Medical Device Directive requires that economic operators adopt solutions that ‘reduce risk as far as possible’ in line with the
‘state of the art’, so the fitting of firebreaks is a requirement irrespective of the oxygen source, be it concentrator, liquid oxygen Dewar or gas cylinder.

 

Download our White Paper

A White Paper providing a detailed analysis of the status of home oxygen service providers under EU regulation and the legal requirement to fit oxygen firebreaks can be downloaded here.