It may not have made many headlines, but when the new Medical Device Regulation (MDR) came into force on May 26 this year, it brought important implications for all economic operators in the medical device supply chain in Europe, including home oxygen providers.
While it doesn’t change the status of home oxygen providers from the existing Medical Device Directive (MDD), the MDR does strengthen regulations and brings much needed clarity to their role, responsibilities and liabilities.
Where home oxygen providers bring together discrete medical devices to form an assembled system they must follow the ‘system assembler’ rules under the MDD (Article 12), and now the MDR (Article 22), if they are not to create a new medical device. Doing so changes the status of a home oxygen provider from distributor to manufacturer, with significant additional responsibilities which, let’s face it, most home oxygen providers would be keen to avoid.
The system assembler rules under the MDD and MDR can be loosely summarised as: ensuring that only CE Marked devices are used, that they are mutually compatible, and that they are used as intended and in accordance with the manufacturer’s instructions.
Even if a home oxygen provider uses a single medical device with an accessory, under the MDD and MDR that accessory must be used as intended by the device manufacturer.
The EU harmonised type standard for oxygen concentrators requires that the instructions for use for an oxygen concentrator include a statement to the effect that the accessories (e.g. a nasal cannula) ‘shall’ include a firebreak that stops the flow of gas fitted as close to the patient as possible. Given that all oxygen concentrators placed on the European Union market since January 2015 must meet this harmonised type standard to comply with the Essential Requirements for safety and performance and therefore will have this statement in their instructions, it becomes clear that fitting a firebreak – quite aside from all the proven safety benefits for patients – is now a legal requirement across Europe.
It’s also worth noting that the type standard does not provide for selection of patients based upon perceived risk (which is impossible to judge anyway).
The MDR also pulls together the risk management obligations of all economic operators in the supply chain. The relatively recent regulatory shift away from the ALARP principle (as low as reasonably practicable) to ‘as low as possible’ in line with the ‘state of the art’ is currently spread across the requirements of the MDD and ISO 14971 – Risk management for medical devices.
Firebreaks have been around for over 10 years, are mandated in the UK and Germany, and are a requirement in ISO equipment type standards. It is difficult to argue that they are not ‘state of the art’ or that they do not represent the ‘lowest risk’, when the alternative is to not fit one.
The enshrining of ‘lowest risk’ into EU regulations for all economic operators clearly leads to the conclusion that fitting firebreaks is a legal requirement for all home oxygen installations whether the oxygen source is a concentrator, liquid oxygen dewar, or an oxygen cylinder.
To put it another way, failing to follow the clear principle enshrined in the MDD (which is transposed into national law in every member state), made even clearer in the MDR, of reducing risk to as low as possible means the oxygen service provider is likely operating outside the regulations.
Implementing the lowest risk solution by following manufacturers’ instructions to fit a firebreak also has implications for incident reporting under medical device regulations and may require home oxygen fires to be reported to the competent authorities, where in some circumstances they might not if it can be shown to be abnormal use. To claim abnormal use, all possible risk control measures must have been deployed.
I’ve heard the argument that the oxygen concentrator is compliant and that therefore home oxygen providers need do nothing more. But now the MDR has clarified the situation, it has hopefully dispelled that misconception once and for all.
BPR Medical has worked with home oxygen providers and healthcare professionals for nearly thirty years, helping them improve patient safety and stay
compliant with the latest regulations.
The new MDR sets a very clear direction of travel for medical device regulation and all economic operators in the supply chain should constantly review their status and operational policies to stay compliant in this increasingly regulated market.
For a copy of BPR Medical’s White Paper ‘The status of home oxygen service providers under EU regulation and the legal requirement to fit oxygen firebreaks’, contact [email protected] or call 01623 628 281.
