Oxygen firebreak

A fire in an oxygen tube approaching an oxygen firebreak

An oxygen firebreak, also known as a fire stop valve or fire safety valve, is a thermal fuse designed to extinguish a fire in the delivery tube being used by a patient on oxygen therapy and stop the flow of oxygen if the tube is accidentally ignited. Oxygen firebreaks are fitted into the oxygen delivery tubing close to the patient, typically around the patient's sternum where the two nasal cannula tubes join and connect to the delivery tubing.

Home oxygen fires

Oxygen is not flammable, but when it is present in increased concentrations it will enable fires to start much more easily. Once a fire has started, if supplemental oxygen is present it will burn more fiercely, based on the principle of the fire triangle. Materials that do not burn in ambient air may burn when there is a greater concentration of oxygen present than there is in air.

Most home oxygen fires are caused by patients smoking whilst using medical oxygen.[1] Despite the inherent dangers, researchers estimate that between 10 and 50 per cent of home oxygen patients continue to smoke.[2] Other sources of naked flames, such as gas flames and birthday candles, can also pose a risk.[3]

Once a fire has started in the patient's nasal cannula it will track back towards the oxygen source and if not stopped may lead to a ‘whole house’ fire. Whole house fires are directly correlated with single or even multiple deaths. According to the US National Fire Protection Association (NFPA), 25% of oxygen fires get beyond the immediate surrounding area to become ‘whole house’ fires.[4]

While an oxygen firebreak / thermal fuse cannot stop the initial ignition, it can limit the potential for whole house fires, more serious injury and death. Firebreaks / thermal fuses can also buy more time for a patient and other individuals in the building to escape, and limit the material cost of fire damage.

Oxygen fire statistics

A study, The prevalence and impact of home oxygen fires in the USA Archived 2019-09-25 at the Wayback Machine, published in September 2019, analysed media reports of home oxygen fire incidents between December 2017 and August 2019. The report found 311 incidents, resulting in 164 deaths, equivalent to one patient death every four days. It also found that a third of reported incidents referenced exploding cylinders, posing a significant risk to third parties, including emergency services. The estimates that there are between 100 and 150 deaths every year from home oxygen fires in the US, describing it as a ‘material health issue’.

In 2008 the NFPA published a report Archived 2017-10-06 at the Wayback Machine suggesting that there are 46 deaths each year in the US from 182 fires. The report also stated that US hospital emergency rooms deal with an average 1,190 cases of burns each year as a result of home oxygen fires. However, the NFPA describes these statistics as "likely underestimates".[5]

Further analysis by Marty Ahrens on behalf of the NFPA in 2017 recorded a likely average annual death rate for home fires involving oxygen administration equipment of 70 people (or 3% or all home fire deaths), based upon figures between 2011 and 2015. The report Archived 2018-12-17 at the Wayback Machine also suggested that these fires or burns are becoming more common.[6] In 2019 the NFPA also reported that "medicinal oxygen was involved in 13% of the home smoking material fire deaths".[7]

The United States Fire Administration (USFA) said in a 2015 report that "While no one factor is solely responsible for the increased fire risk to older adults receiving home health care, smoking in the presence of oxygen is recognized as one important problem."[8]

A study of home oxygen therapy patients in the Veterans Health Administration between 2009 and 2015 examined 123 cases of reported adverse events related to flash burns. It found that 100 cases (81%) resulted in injury, and 23 (19%) resulted in death. Although 89% of veterans claimed to have quit smoking, 92% of burns occurred as a result of smoking.[9]

Not all European countries monitor data on the number of fires that occur as a result of home oxygen. Despite a European Union Medical Device Directive requiring incidents to be reported to national vigilance authorities, there is often inadequate coordination to publish the information centrally.[10] According to the German Federal Institute for Drugs and Medical Devices (Bundesinstitut fur Arzneimittel und Medizinprodukte, BfArM Archived 2017-10-18 at the Wayback Machine) it is likely that such incidents are grossly under-reported.[11]

In England and Wales, central reporting of adverse incidents is a requirement of the NHS Service Specification for Home Oxygen. After firebreaks became mandatory in 2006, the average number of deaths by fire was 0.36 per thousand patients per year. In the US, where firebreaks were not required, almost twice as many patients (0.62 patients per thousand) died.[12] A Freedom of Information request in 2018 revealed that only fatality relating to home oxygen fires was recorded in the five-year period between 2013 and 2017.[13]

Firebreak effectiveness

In 2018, a freedom of information request to all clinical commissioning groups in England (where firebreaks are mandatory) revealed that during the five years between 2013 and 2017 inclusive, 63 serious incidents involving oxygen fires were recorded and just one fatality. 73% of CCGs, representing 71% of patients in England, responded to the request. When the results are extrapolated to cover the whole patient population of 81,000, the figures are 89 incidents and 1.4 deaths.[14] The fatality rate is significantly lower than any other previous study in the UK or internationally, and significantly lower than rates in the US or Japan where, compared with the equivalent patient population, they were 27 and 14 respectively.[15] The white paper report suggests that the mandatory introduction of firebreaks, in conjunction with a "multidisciplinary approach to patient education", as well as risk assessments, is responsible for the low level of fatalities.[16]

Home oxygen fire incidents

Some of the incidents involving deaths and injuries to patients, their relatives, fellow residents, as well as firefighters include:

Richmond, Indiana, US. November 19, 2018

Two people were killed and six injured in an apartment complex fire, 48 year old Andrew Thornburg and 56 year old Richard Wilkinson. A number of senior citizens live in the apartments many of whom use walkers and wheelchairs making the task of evacuating the residents harder for fire crews. The fire is believed to have been caused by 'smoking materials', with many of the residents understood to be home oxygen users." [17]

Tilford, South Dakota, US. September 7, 2018

43 year-old firefighter David Fischer was killed when a propane tank exploded during a fire. Home oxygen patient Raymond Joseph Bachmeier (82) was also killed in the incident. Authorities said that the fire was caused by "a cigarette being smoked in bed while on oxygen." [18]

Fayetteville, Arkansas, US. July 14, 2018

An explosion at a house left a 69 year old man dead. The man's daughter reported that he had been smoking near his oxygen concentrator.[19]

Marion County, Indianapolis, US. May 19, 2018

A man died in a fire which is believed to have started after he was smoking near an oxygen cylinder.[20]

San Remo, Italy. March 23, 2017

A woman died in a fire which started while she was smoking and simultaneously using her oxygen cylinder. Her husband also died trying to escape the blaze.[21]

Pont-Sainte-Maxence, Oise, France. March 11, 2017

A 60-year-old wheelchair-bound patient, described as a 'big smoker', died when his liquid oxygen dewar exploded following a nighttime fire in his apartment. His wife also suffered injuries.[22]

Pau, France. February 19, 2017

A patient died and an apartment was destroyed after medical oxygen cylinders exploded, leading to a fire. Fifteen other residents had to be relocated after the incident.[23]

Winchester, Kentucky, US. March 11, 2016

Patient Jackie Hisle Jr. was sentenced to ten years’ imprisonment on three counts of manslaughter after an incident in which his son, Donald Hisle, and two other residents were killed and six others were injured. Mr Hisle Jr. was smoking while using an oxygen concentrator, despite warnings.[24]

Knox County, Tennessee, US. February, 2012

A jury awarded $2.5 million in damages against Apria Healthcare after the death of 72-year-old Jimmy Kelley from Knox County. The award was reduced to $1.275 million after the jury found Kelley to be partly responsible. Mr Kelley, a smoker, also used a space heater in a camper van where oxygen cylinders were stored.[25]

Regulation

United States

Before placing a new concentrator on the market, all oxygen concentrator manufacturers need to make a 510(k) premarket submission Archived 2017-10-10 at the Wayback Machine to the US Food and Drug Administration (FDA).

If the manufacturer chose to apply ISO 80601-2-69:2014 Archived 2017-10-10 at the Wayback Machine to demonstrate the safety of the new device, the fire safety elements of the standard, including ‘a means to extinguish a tubing fire and isolate the oxygen flow’ are a requirement. Approval to market the product would then be based upon compliance to the standard.

In March, 2018, the US Veterans Health Administration issued a Patient Safety Alert Archived 2018-05-11 at the Wayback Machine mandating the use of thermal fuses in all its patients' home oxygen installations, unless there is a clinical reason for not doing so. The Patient Safety Alert applies to all patients, not just those deemed to be at 'high risk'. It requires two thermal fuses to be fitted per patient installation, and any unidirectional thermal fuses must be replaced with bidirectional versions at the next scheduled visit (unless the unidirectional thermal fuse is designed so it cannot be fitted in the wrong direction).

In January 2020, in coordination with Fire Departments around the state and other agencies, the Wyoming State Fire Marshals Office Archived 2020-02-04 at the Wayback Machine launched the statewide community risk 307 CRR initiative[26]. This aims to “to reach users of home medical oxygen, place safety devices on their units, and provide a home-risk checkup for the residents when possible”.[27] The initiative follows Wyoming fire data which revealed that more than fifty percent of the deaths in residential structure fires throughout the state have been in homes with medical oxygen. The goal of the initiative is to reduce fire deaths and injuries by 2024 by installing inline oxygen firebreaks in 100% of home using medical oxygen across the State.

Europe

In the European Union the fitting of firebreaks is a legal requirement for all home oxygen installations.[28]

All economic operators in the EU, including home oxygen service providers, must comply with the Medical Device Directive (93/42/EEC) Archived 2019-04-02 at the Wayback Machine or the Medical Device Regulation (2017/745) Archived 2017-10-16 at the Wayback Machine.

The instructions for use for an oxygen concentrator placed on the EU single market must include an instruction to the effect that a firebreak shall be fitted close to the patient to stop the flow of oxygen in the event of a fire. By including this statement the oxygen concentrator manufacturer is complying with the harmonised EN ISO type standard for oxygen concentrators EN ISO 8359:2009+A1:2012 Archived 2017-10-10 at the Wayback Machine, which provides the manufacturer with an immediate presumption of conformity Archived 2017-10-16 at the Wayback Machine to the Essential Requirements of the Medical Devices Directive and allows them to properly apply the CE mark. Since January 2015 all instructions for use provided with oxygen concentrators placed on the European market will include this statement.

The applied CE mark is reliant on the home oxygen service provider following this instruction and fitting a firebreak. If the firebreak is not fitted, then the Essential Requirements for performance and safety are not met and the CE mark is no longer valid. It also means that the home oxygen service provider's status, within the framework under which the single market for medical devices operates, changes from ‘distributor’ to ‘manufacturer’. This has significant regulatory implications.

The EU Medical Devices Directive also requires that economic operators adopt solutions that ‘reduce risk as far as possible’ in line with the ‘state of the art’. The fitting of firebreaks is therefore a requirement irrespective of the oxygen source, including oxygen concentrators, liquid oxygen dewars or gas cylinders.[29]

United Kingdom

An additional legal requirement applies in the UK, where the fitting of firebreaks has been mandatory under the service specification of the home oxygen service[30] since 2006.[31]

Germany

In 2011, the German Federal Institute for Drugs and Medical Devices recommended ‘corrective actions to prevent fires in oxygen concentrators’. It issued a notice stating that from July 1, 2012 all devices should be equipped with installations for stopping encroachment of the fire into the device, and interruption of the delivery of oxygen in the accessory as close to the patient as possible, in case of ignition. Manufacturers were also required to offer retrospective refitting for devices placed on the market before July 1, 2012.[32]

World Health Organization guidance

The World Health Organization recommends ‘firebreak connectors to stop the oxygen flow in the event of fire’ in all oxygen concentrators.[33]

Oxygen firebreak standards

Three main standards cover the use of oxygen firebreaks / thermal fuses:

The safety requirements for oxygen concentrators are governed by the amended standard ISO 8359:1996+A1:2012 Archived 2017-10-10 at the Wayback Machine. The US FDA recognized the standard from January 2014. In January 2015, it was superseded by ISO 80601-2-69:2014 Archived 2017-10-10 at the Wayback Machine. Health Canada, which is responsible for national public health, still recognizes the standard.

All of the 28 CEN (European Committee for Standardization) national standardization bodies (NSBs) have published EN ISO 8359:2009+A1:2012 Archived 2017-10-11 at the Wayback Machine as national standards. In Europe EN ISO 8359:2009+A1:2012 has harmonized standard status, which triggers ‘presumption of conformity Archived 2017-10-16 at the Wayback Machine’.

Included in ISO 80601-2-69:2014 Archived 2017-10-10 at the Wayback Machine are specific requirements that serve to mitigate the risk of fire related to oxygen therapy. The requirements state that the following should be provided:

  1. A means to extinguish a tubing fire and isolate the oxygen flow in the accessories (nasal cannula and tubing or mask and tubing). The standard states that this should be fitted close to the patient.
  2. A means to prevent the fire spreading into the oxygen concentrator outlet. The standard states that the means can also stop the flow of oxygen although it is not required to do so. It also specifies that if a bubble humidifier is fitted to the concentrator, that the means must also protect the bubble humidifier.

References

  1. ↑ Cooper, Brendan G. (2015). "Home Oxygen and Domestic Fires". Breathe. 11: 5–12. doi:10.1183/20734735.000815. PMC 4487390. PMID 26306099.
  2. ↑ 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.
  3. ↑ Cooper, Brendan G. (2015). "Home Oxygen and Domestic Fires". Breathe. 11: 5–12. doi:10.1183/20734735.000815. PMC 4487390. PMID 26306099.
  4. ↑ 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.
  5. ↑ Ahrens, Marty (August 1, 2008). "Fires and Burns Involving Home Medical Oxygen" (PDF). NFPA. Archived (PDF) from the original on 13 March 2017. Retrieved 5 October 2017.
  6. ↑ Ahrens, Marty (September 2017). Home Structure Fires (PDF). NFPA Research Division. p. 20. Archived (PDF) from the original on 17 December 2018. Retrieved 17 December 2018.
  7. ↑ Ahrens, Marty. "Home Fires Started by Smoking" (PDF). NFPA.org. NFPA Research. Archived (PDF) from the original on 4 February 2019. Retrieved 4 February 2019.
  8. ↑ "Fire Risk in 2015" (PDF). Topical Fire Report Series. 18 (6). September 1, 2017. Archived (PDF) from the original on 5 October 2017. Retrieved 5 October 2017.
  9. ↑ 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.
  10. ↑ Cooper, Brendan G. (2015). "Home Oxygen and Domestic Fires". Breathe. 11: 5–12. doi:10.1183/20734735.000815. PMC 4487390. PMID 26306099.
  11. ↑ Cooper, Brendan G. (2015). "Home Oxygen and Domestic Fires". Breathe. 11: 5–12. doi:10.1183/20734735.000815. PMC 4487390. PMID 26306099.
  12. ↑ Cooper, Brendan G. (2015). "Home Oxygen and Domestic Fires". Breathe. 11: 5–12. doi:10.1183/20734735.000815. PMC 4487390. PMID 26306099.
  13. ↑ "Home Oxygen Fire Prevalence in England (2013-17)" (PDF). www.firebreaks.info. BPR Medical. Archived (PDF) from the original on 4 February 2019. Retrieved 22 July 2019.
  14. ↑ "Home Oxygen Fire Prevalence in England (2013-17)" (PDF). Firebreaks.info. BPR Medical. Archived (PDF) from the original on 4 February 2019. Retrieved 4 February 2019.
  15. ↑ Ahrens, Marty. "Home Fire Structures" (PDF). NFPA. NFPA Research Division. p. 20. Archived (PDF) from the original on 4 February 2019. Retrieved 4 February 2019.
  16. ↑ "Archive copy" (PDF). Archived (PDF) from the original on 2019-02-04. Retrieved 2019-02-04.{{cite web}}: CS1 maint: archived copy as title (link)
  17. ↑ "2 killed in Richmond apartment fire, smoking materials blamed". Journal News. 20 November 2018. Archived from the original on 22 November 2018. Retrieved 22 November 2018.
  18. ↑ "Report: Fatal Tilford Fire Caused by Smoking While on Oxygen". US News. Associated Press. October 17, 2018. Archived from the original on 2018-10-22. Retrieved 22 October 2018.
  19. ↑ Yager, Peyton (16 July 2018). "Fayetteville Fire Victim Identified". NWAhomepage.com. Archived from the original on 19 July 2018. Retrieved 19 July 2018.
  20. ↑ Evans, Tim; Justin L, Mack (20 May 2018). "Smoking, oxygen tank use suspected in fatal Indianapolis house fire". IndyStar. Archived from the original on 13 June 2018. Retrieved 20 May 2018.
  21. ↑ Di Blasio, Andrea (23 March 2017). "Rogo di Sanremo, colpa della bombola di ossigeno con la sigaretta accesa". Repubblica. Archived from the original on 17 June 2017. Retrieved 6 October 2017.
  22. ↑ Gourru, Simon (11 March 2017). "Oise : un mort dans l'incendie de l'appartement à Pont-Sainte-Maxence". Le Parisien. Archived from the original on 17 June 2017. Retrieved 6 October 2017.
  23. ↑ Marco, Jeanne-Marie (19 February 2017). "Explosion à Pau : des bouteilles d'oxygène retrouvées chez la victime". France Bleu Bearn. Archived from the original on 6 October 2017. Retrieved 6 October 2017.
  24. ↑ Kocher, Greg (15 April 2016). "Two lawsuits allege negligence in fatal March 11 apartment fire". Lexington Herald Leader. Archived from the original on 7 October 2017. Retrieved 6 October 2017.
  25. ↑ Satterfield, Jamie (2 March 2017). "Jury returns $2.5M verdict in Knox fatal camper fire". Knoxville News Sentinel. Archived from the original on 12 March 2017. Retrieved 6 October 2017.
  26. ↑ "Fire Break Campaign". Jackson Hole Fire/EMS. Archived from the original on 4 February 2020. Retrieved 4 February 2020.
  27. ↑ Clay, Kathy (27 December 2019). "The Cowboy State Saddles Up to Community Risk Reduction". Fire Rescue Magazine. Archived from the original on 4 February 2020. Retrieved 4 February 2020.
  28. ↑ Radford, Richard (August 2, 2017). "Medical Device Regulation (MDR) – New framework sparks burning questions". Gasworld. Archived from the original on 17 October 2017. Retrieved 16 October 2017.
  29. ↑ The status of home oxygen service providers under EU regulation and the legal requirement to fit oxygen firebreaks. BPR Medical. July 2017.
  30. ↑ Wedzicha, J. A.; Calverley, P. M. A. (1 January 2006). "All change for home oxygen services in England and Wales". Thorax. 61 (1): 7–9. doi:10.1136/thx.2005.056192. ISSN 0040-6376. PMC 2080718. PMID 16396952.
  31. ↑ Cooper, Brendan G. (2015). "Home Oxygen and Domestic Fires". Breathe. 11: 5–12. doi:10.1183/20734735.000815. PMC 4487390. PMID 26306099.
  32. ↑ "assessment notice (Case no. 2676/10)". Archived from the original on 2017-10-17. Retrieved 2017-10-16.
  33. ↑ Technical specifications for oxygen concentrators (PDF). World Health Organization. 2016-10-25. p. 27. ISBN 978 92 4 150988 6. Archived from the original on 2022-03-14. Retrieved 15 October 2017.
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