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MEDICAL DEVICE REGULATION
The MDR and incident reporting?
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.
Under-reporting of home oxygen fires
At present, the UK is the only country in Europe to routinely collect data on home oxygen fires. Since a major review in 2006 of the way home oxygen is provided, installers are required to report all incidents to the Department of Health. Elsewhere, there is no formal reporting requirement, which means that data gathering is reliant on the reporting procedures referred to as ‘vigilance’. However, under-reporting via vigilance
has been recognised by authorities including the German Federal Institute for Drugs and Medical Devices (BfArM), the French Agence National de Sécurité du Médicament et des Produits de Santé (ANSM), and the US Food and Drug Administration (FDA). The reasons for the lack of reporting are not entirely clear. Anecdotal reports suggest that some service providers do not see home oxygen fires as a failure of the medical device, even it has not been set up according to the Instructions to Use (IFU), with all fire protection measures installed. Instead they point to the actions of patients.
Mitigating the risk of home oxygen fires
Some efforts have been made to mitigate the issue of home oxygen fires, with the NHS in England and Wales leading the way in tackling the problem. Following the introduction of the Home Oxygen Service over a decade ago, patient education has been enhanced and risk assessments are now routine. Thermal fuses, also known as firebreaks – small devices that automatically activate to stop the oxygen flow in the event of a fire in the tubing – are also mandatory. BfArM in Germany and the Veterans Health Administration (VA) in the US also now insist on the use of these
At present, the UK is the only country in Europe to routinely collect data on home oxygen fires. Since a major review in 2006 of the way home oxygen is provided, installers are required to report all incidents to the Department of Health.
NOVEMBER 2019
Richard Radford, managing director at BPR Medical
devices in home oxygen installations. Recent evidence from a Freedom of Information request in the UK proves that, when combined, these measures work. Only one fatality relating to a home oxygen fire was reported in England in the five years from 2013 to 2017.2
This equates
to 0.34 fatalities for every 100,000 patients compared with 6.6 per 100,000 in the US.
Do home oxygen fires constitute foreseeable misuse?
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. Section Annex 1, Chapter 1, para. 3c states that: “In carrying out risk management, manufacturers shall:… c) estimate and evaluate the risks associated with, and occurring during, the intended use and during reasonably foreseeable misuse.” In the case of home oxygen equipment, there is not only overwhelming evidence that fires present a risk of death and injury to patients, but also that education alone does not work. Research on behalf of the VA examined the causes of 139 fires between 2009 and 2015 involving veterans using home oxygen. The study found that, although 89% of patients claimed to have quit, smoking was the cause of 113 (92%) of the incidents.3
As the VA
put it: ‘Although almost 90% of veterans claimed to have quit smoking, more than
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