Richard Radford, managing director at BPR Medical considers the implications of the new Medical Device Regulation for the home oxygen industry and questions whether – given the growing body of evidence – smoking while using home oxygen should be considered foreseeable misuse and reported under medical device vigilance requirements.
Fires involving home oxygen have been the subject of numerous research reports over the past two decades. Risks include sources of ignition ranging from candles to gas hobs, but the main danger – and the cause of over 70% of incidents – is patients continuing to smoke while receiving oxygen therapy.1
However, despite the growing evidence around the risks and the volume of media reports of patient deaths and serious injuries, most countries do not routinely gather data on home oxygen fires.
The new Medical Device Regulation (MDR) raises some important questions for all those involved in the home oxygen supply chain though, including whether home oxygen installers should report all incidents.
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