New data suggest serious home oxygen fire incidents are not being identified by EU Medical Device Vigilance System – inconsistent reporting processes may be putting patients at risk across the continent.
LONDON (26 May 2022) – Patient safety across Europe may be compromised due to decisions over fire safety and home oxygen devices being based upon inaccurate reporting and incomplete data, argues a new report by BPR Medical.
Available statistics from the European Industrial Gases Association (EIGA) suggest home oxygen fires caused 15 fatalities between 2013 and 2017 across 16 countries in the EU. Yet media analysis by BPR Medical in another five year period revealed 23 deaths in France and Italy alone.
Home oxygen therapy is a lifeline for hundreds of thousands across the continent, yet it can also be a serious hazard when brought into contact with an ignition source – usually a lit cigarette. The fire can spread through the patient’s tubing to the source of the oxygen – leading to deadly flash fires and even explosions.
BPR Medical’s media analysis between 2017-2021, revealed that there were 41 instances of death and serious injury in France and Italy caused by such fires. This included serious injury to firefighters and nearby residents.
Based on the available EIGA figures, deaths from home oxygen users are 0.75 per 100,000 across the EU. However, BPR’s report suggests this is more likely to be closer to the 3.3 deaths per 100,000 patients found in Japan and the 6.6 deaths per 100,000 seen in the US.
The reporting of serious incidents involving home oxygen devices is already required under the Medical Device Vigilance System in the European Union. However, these figures suggest there is a problem with how this system is working.
Speaking on the report, Richard Radford of BPR Medical said, “These findings are hugely concerning given the half a million home oxygen therapy users there are across Europe. Important decisions about fire safety and home oxygen use are being based on incomplete data. We’re now calling on the home oxygen sector in France, Italy and other European countries to take urgent action to recognise, report and reduce the problem of home oxygen-related fires resulting in death and serious injury.”
In light of these findings, BPR Medical points to the existing regulatory framework designed to maximise the safety of home-oxygen users. European Union and ISO regulations imply that safety devices be fitted to various components of home oxygen systems to prevent the propagation of a serious fire incident. In addition, the Medical Devices Regulation 2017/745 (MDR) requires that all medical devices ‘reduce risk as far as possible’ in line with the ‘state of the art’ technology.
Thermal fuse firebreaks are regarded in many countries as such technology. They have been mandatory in England, Scotland and Wales since 2006, and in Germany since 2012. Other countries, including France and Italy, tend to install them for high-risk patients only. Uptake in Spain and Portugal has been very strong, but adoption is slow in much of the rest of Europe.
Richard Radford added: “These findings confirm a multidisciplinary approach is needed to maximise patient safety for home oxygen therapy users across Europe. Patient education, risk assessments and the mandatory fitting of firebreaks have been hugely successful in countries like England where there is now on average about 0.34 deaths a year.
“Stakeholder communication, a review of current reporting and the more robust implementation of existing safety regulations is key. Every death and serious injury from home oxygen therapy is a tragedy and it’s up to us as an industry to act. By working together, we can save many more lives.”
The report can be downloaded here.