MEDICAL DEVICE REGULATION
90% of flash burns started because of smoking’. The Administration points to estimates on the proportion of patients who continue to smoke while using home oxygen, despite being warned of the inherent dangers, which range from 10% to 50%. Numerous other studies firmly establish the link between patients smoking and home oxygen fires. In 2019 for example, the US National Fire Prevention Association (NFPA) reported that ‘medicinal oxygen was involved in 13% of the home smoking material fire deaths’.4
It has previously reported a likely annual death rate from home fires involving oxygen administration equipment of around
70. That’s in addition to over 1200 injuries, figures it admits are ‘likely underestimates’. The ISO standard that covers oxygen concentrator equipment (ISO 80601-2- 69:2014) is also conclusive. Under the subclause covering ‘Additional requirements for fire prevention’ it states that: “It is reasonably foreseeable that patients who are on supplemental oxygen will continue to smoke.” In the face of this evidence, it is hard to argue that home oxygen fires are not entirely foreseeable, and that risk control measures, such as oxygen firebreaks, which now constitute the ‘state of the art’, should be installed.
The MDR and new reporting requirements
So, if home oxygen fires are foreseeable, measures are available to prevent or mitigate their impact, and the standard requires them, the question arises: ‘should home oxygen fires be considered reportable incidents?’. The MDR may simplify this question. For the first time, the regulations make it clear that Distributors need to provide Manufacturers with more data on incidents (home oxygen installers are defined as ‘Distributors’ under the MDR).* It will require them to maintain a register of complaints and to forward ‘suspected incidents’ immediately to the Manufacturer, importer, or authorised representative. Distributors will no longer be in a position under the new regulations to make a judgement on whether the incident is reportable or not; responsibility for processing the data lies solely with the Manufacturer. In that case, who should the home
In its guidance on usability and risk assessment, the MDR makes it clear that any misuse of a device that can be reasonably anticipated needs to be addressed during the risk management process.
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oxygen service provider (Distributor) report home oxygen fire incidents to? Is it the nasal cannula supplier, the firebreak manufacturer, or the oxygen delivery device (oxygen concentrator, cylinder, or liquid oxygen device) manufacturer? Without doubt the delivery device manufacturer should be informed, and if the MDR requires at least one report to be filed, I would argue that – as a precaution – it would be as well to inform all the others.
Judgement rests with the Manufacturer not the Distributor
Once it receives the incident data, the Manufacturer is responsible for investigating and considering whether the complaint meets the criteria for reporting. It has to decide whether:
NOVEMBER 2019
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