MEDICAL DEVICE REGULATION
l An event has actually happened l The Manufacturer’s equipment is likely to be a contributory cause
l The incident led to a death or a serious deterioration in the state of health.
As the harmonised ISO standard states that a firebreak shall be fitted to an oxygen concentrator and risk control measures make up part of the essential requirements for safety, surely failing to fit them means that these requirements have not been met? The Manufacturer must therefore decide whether all the safety measures have been taken. If so, any failure may constitute ‘abnormal use’. If all measures have not been taken, it cannot be described as such, and abnormal use cannot be cited as a reason for failing to report the incident to the competent authorities under medical device vigilance requirements. Consequently, given that home oxygen fires are foreseeable – considering the weight of evidence around oxygen fires and that patients continue to smoke – if all safety measures were not taken, surely it is difficult to argue that incidents should not be reported?
Implications for the home oxygen industry and patients
As well as harmonising and clarifying medical device regulations, one of the main objectives of the MDR is to heighten safety measures and risk management following some high-profile failures. By strengthening the regulations around foreseeable misuse and incident reporting, especially around Distributors’ responsibilities, it may have significant implications for those involved in the home oxygen supply chain, as well as the competent authorities responsible for national incident reporting and vigilance. Until now, data on the number of home oxygen fires in Europe has been hard to come by, preventing a proper understanding of the issue and limiting patients’ access to important safety medical safety technology. The MDR may just change that. With less than a year until its transition period comes to an end, home oxygen device manufacturers and installers should perhaps take note. CSJ
References
1 Cooper, Brendan G. (2015). “Home Oxygen and Domestic Fires”. Breathe. 11: 5–12. PMC 4487390.
2 ‘Home Oxygen Fire Prevalence in England (2013- 17), BPR Medical, Nov 2018
www.firebreaks.info/wp-content/uploads/2018/12/ BPR-WhitePaper2018.pdf
3 Wolff, B. K.; et al. (July 11, 2016). “Flash Burns While on Home Oxygen Therapy: Tracking Trends and Identifying Areas for Improvement”. American Journal of Medical Quality. 32 (4): 445–452. doi:10.1177/1062860616658343. PMID 27401082.
4 Ahrens, Marty. “Home Fires Started by Smoking” (PDF).
NFPA.org. NFPA Research
NOVEMBER 2019
WWW.CLINICALSERVICESJOURNAL.COM I 45
*We have used ‘Distributor’ and ‘Manufacturer’ with capitals to distinguish between the regulatory roles, defined by the MDR, and generic descriptions.
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