Frequently Asked Questions
Oxygen firebreak standards are complicated. Here are the answers to some of the most frequently asked questions.
- What is the scale of the problem of home oxygen fires?
A report in 2017 by the National Fire Protection Association (NFPA) 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 NFPA also reports that US hospital emergency rooms deal with an average 1,190 cases of burns each year as a result of home oxygen fires and that these fires or burns are becoming more common. It also notes that these figures are “likely underestimates”. However, the issue isn’t about the level of risk anymore, firebreaks are now a standard requirement.
- What evidence is there to show that firebreaks save lives?
A Freedom of Information request conducted among Clinical Commissioning Groups in England revealed that only one fatality was recorded in the five year period between 2012 and 2017. This compares to 27 deaths in the US among the equivalent patient population and 14 deaths in Japan over the same period. This suggests that, alongside a programme of awareness, education, and other support, firebreaks save lives.
- Don’t firebreaks just encourage patients to smoke?
There is no evidence to suggest that the use of firebreaks increases smoking. What the evidence does say is that they save lives. A firebreak won’t prevent the damage from the initial ignition, therefore the advice to patients doesn’t change whether they have a firebreak installed or not.
- Shouldn’t the patients behave responsibly and not smoke?
Of course, but smoking is an addiction and behaviour change can be challenging. The issue is not a moral one; it is a case of being compliant. Firebreaks are now a standard requirement.
- How much does a firebreak cost?
A firebreak costs a few US dollars. For a device that lasts four years and can save a life, it is a small price to pay.
- What does the ISO standard say about extinguishing tubing fires?
ISO 80601-2-69:2014 includes specific requirements that mitigate the risk of fire associated with oxygen therapy. In summary: The applied part (nasal cannula and tubing or mask and tubing) shall be provided with a means to extinguish a tubing fire and isolate the oxygen flow. This should be fitted close to the patient. A means to prevent propagation of fire into the oxygen concentrator outlet shall be provided. The means can also stop the flow of oxygen but it doesn’t have to. If a bubble humidifier is fitted to the concentrator, the means must protect the bubble humidifier too. More Information
- Doesn’t the CE marking apply to the equipment, not the installation?
That is true as long as the equipment is used in accordance with the instructions and as intended by the equipment manufacturer. The oxygen concentrator manufacturer will stipulate in their Instructions for Use that you ‘fit a firebreak’, not doing so means that the Essential Requirements for performance and safety of the Medical Device Directive are not met and the CE mark is no longer valid. You must follow the manufacturer’s instructions when installing the oxygen concentrator and fit a firebreak. The regulations make clear that a distributor modifying a product to the extent that compliance with the Essential Requirements becomes affected, becomes the manufacturer. More Information
- What are the requirements of CE Marking?
Oxygen concentrators supplied to the European market with a CE mark since January 2015 should:
- Have a means to prevent propagation of fire into the oxygen concentrator outlet, and
- Include in the Instructions for Use an instruction that installation accessories (nasal cannula and tubing or mask and tubing) shall be provided with a means to extinguish a tubing fire and isolate the oxygen flow. This should be fitted close to the patient.
- Are firebreaks mandatory in the US?
The Veteran’s Health Administration (VA) now requires that all veterans’ home oxygen installations (both stationary and portable) must be fitted with thermal fuses (firebreaks). More information Elsewhere, while as yet there is no law that specifically says firebreaks have to be fitted in the US, to legally market an oxygen concentrator it must have gone through the 510(k) process to demonstrate that the device is substantially equivalent to one legally in commercial distribution in the United States. If the ISO standard (ISO 80601-2-69:2014) was used to demonstrate the safety of the device, a firebreak is a requirement.
- Do firebreaks have to be registered with the Food and Drug Administration?
Yes. All firebreaks must be registered with the FDA as a Class 1 510(k) exempt device.
- Are firebreaks mandatory in Europe?
Yes, firebreaks are mandated in Europe under the Medical Device Directive, which is translated into criminal law in each EU member state. For more details refer to the Europe page.
- Why should I use firebreaks in a hospice?
Firebreaks are a physical risk control and are part of a wider risk management strategy which should include signage and education for patients and visitors. A firebreak is the only product available today which will automatically cut off the oxygen flow if there is a fire in the supply tubing. Firebreaks have the potential to prevent patient death, limit the extent of injuries, and reduce the risk for other patients, staff and property.
- Are firebreaks a legal requirement?
Firebreaks are required by European standards for oxygen concentrators. Within Europe these standards are applied by the manufacturers in order to obtain a CE mark and legally place the products on the market. Any oxygen concentrator which was manufactured since January 2015 should have, within its Instructions for Use, the requirement to fit firebreaks as close to the patient as practicable and a method of stopping fire ingress to the device if there is a fire in the supply tubing. More information
- What is the Medical Device Directive?
The Medical Device Directive is a European Council Directive intended to harmonise the laws relating to medical devices in the European Union. For a manufacturer to legally place a medical device on the European market the Essential Requirements of the Directive have to be met and a CE mark applied. A presumption of conformity with some of the Essential Requirements of the Directive can be given where harmonised standards are applied.
- How do these regulations apply to how I use oxygen with my patients?
In order to meet the requirements for safe use of an oxygen concentrator given in the Instructions for Use, a firebreak needs to be fitted as close as practicable to the patient. Not doing so would be off label use of the concentrator. The fitting of firebreaks is obviously a very sensible precaution for other modalities, even though they may not be specified in the Instructions for Use provided with them.
- What is the easiest way to introduce firebreaks?
We recommend using a very short nasal cannula. If you have any difficulty obtaining these, BPR Medical has developed a range of preassembled oxygen therapy administration kits that make it simple to introduce firebreaks.
- What evidence is there that firebreaks work?
For more than 12 years firebreaks have been mandated by the Department of Health in England and Wales. In 2012 they were mandated by BfArM in Germany (the German equivalent of the Medicines and Healthcare products Regulatory Agency - MHRA) and by the Veterans Affairs Administration (VA) in the USA in 2018. The VA adopted this position following an in-depth analysis of the number of incidents in the US and the potential effect of introducing firebreaks. Data from a Freedom of Information (FOI) request to the Department of Health revealed that only one fatality resulting from a home oxygen fire was recorded in England and Wales between 2013 and 2017. In the US, where firebreaks were not universally mandated, there were 27 deaths among the equivalent patient population over five years. In Japan, the figure was 14.
- Because we don't allow smoking in our facility surely there must be no risk of a fire?
The fire incidents that occur are most often, but not exclusively, started by a patient smoking while using oxygen. There are, however, incidents where a birthday cake with candles may be the cause. Electronic cigarettes may also cause ignition through overheating or sparking. Gas cookers, hair dryers and many other potential sources of heat, flame or sparks also pose a risk.
- What can we do to minimise the fire risk to our patients and staff?
The first thing to do is to ensure patients and their relatives are educated about the dangers of smoking while on oxygen. Ensure your staff are aware and conscious of these risks and are empowered to address a dangerous situation if they encounter it. Ensure there is clear signage in areas where smoking is allowed advising patients not to smoke while using oxygen. Where oxygen is being used, signs should be displayed advising visitors that smoking or naked flames are prohibited. Fit firebreaks in accordance with recommendations.
- How does the firebreak work?
A firebreak is a thermal fuse containing a spring-loaded valve with a retaining ledge that melts and allows the valve to close. When the valve closes, the fire in the tube is extinguished and the flow of oxygen is stopped.
- Where can I find more information about firebreaks?
We regularly post new developments and any revisions to regulation on this website. Add it to your favourites and keep abreast of the latest news relating to this vitally important issue.
- Is it possible to wrongly fit the Firesafe™?
Yes. A firebreak MUST be fitted with the blue arrow pointing in the direction of the flow of oxygen towards the patient.
- If I fit the Firesafe™ the wrong way around will it work?
A firebreak fitted the wrong way in the tubing will still allow oxygen to flow normally but it will not activate in the event of a fire in the tubing.
- Is there a risk that the firebreak may not work in an incident?
BPR Medical has manufactured in excess of 4.7 million Firesafe™ devices. There has never been a report of a device not activating during a fire.
- Why should I use firebreaks in a hospice?
- What configuration of Firesafe™ do I need? - Piped/wall oxygen
- How do I fit a Firesafe™ cannula kit?
If your hospice has wall/piped oxygen delivered through flowmeters fitted to the wall outlet, there are two options:1. If the outlet from the flowmeter is metal, we recommend a single firebreak close to the patient.
2. If the outlet from the flowmeter is plastic, we recommend you fit a Firesafe™ nozzle, which will act in the same way as a firebreak, but is a durable device with an intended life of 8 years.
Firesafe™ flowmeters, which come with a Firesafe™ nozzle as standard, are also available. - Cylinder oxygen, static or portable
Most oxygen cylinders have a metal fitting to which oxygen tubing can be attached. Where this is the case we recommend a single Firesafe™ fitted as close to the patient as reasonably practicable.- Oxygen concentrator
Where oxygen is supplied from an oxygen concentrator, there are three options:1. If a humidifier is fitted, we recommend you fit two Firesafe™ cannula valves; one close to the humidifier outlet and one close to the patient.
2. If a humidifier is not fitted and the outlet from the oxygen concentrator is metal, we recommend a single Firesafe™ cannula valve close to the patient.
3. If the outlet from the concentrator is plastic, we recommend you fit a Firesafe™ Nozzle or Firesafe™ cannula valve close to the outlet and another Firesafe™ cannula valve close to the patient.
Instructions for fitting the kit can be found here.- Wall/piped oxygen - with a Firesafe™ nozzle
Use a 'Single Firesafe™ Kit'. Select the tubing length you need for the patient. Remove the kit from the bag, attach the trumpet connector to the Firesafe™ nozzle on the flowmeter, and fit the cannula to the patient in the usual way. Installation diagram- Wall/piped oxygen - without a Firesafe™ nozzle
Use a 'Two Firesafe™ Kit'. Select the appropriate length tubing for the patient's needs. Connect the trumpet connector to the flowmeter and the attach the cannula to the patient in the usual way. Installation diagram- Portable cylinder
Select a kit with two firebreaks (usually the 2 metre kit to avoid the risk of trips and falls associated with trailing tube). Attach the trumpet connector to the outlet of the cylinder and the cannula to the patient in the usual way. Installation diagram- Static cylinder
Select a kit with two firebreaks (usually the 2 metre kit to avoid the risk of trips and falls associated with trailing tube). Attach the trumpet connector to the outlet of the cylinder and the cannula to the patient in the usual way. Installation diagram- Oxygen concentrator with metal outlet
Select a 'Single Firesafe™ Kit' of the appropriate length for the patient needs. Attach the trumpet end to the outlet of the concentrator and the cannula to the patient in the usual way. Installation diagram- Oxygen concentrator with plastic outlet
Either replace the plastic outlet with a Firesafe™ nozzle or use a Two Firesafe™ Kit. If using the Firesafe™ nozzle (the most economical method of compliance in this instance) select a Single Firesafe™ Kit of an appropriate length and attach the trumpet connector to the Firesafe™ nozzle and the cannula to the patient in the usual way. Installation diagram- Oxygen supply with humidifier
Select a kit with two firebreaks. Attach the trumpet connector to the outlet of the humidifier and the cannula to the patient in the usual way. Installation diagramPlease note that if the patient requires a very high oxygen flow through 22mm ‘elephant’ tubing, a FireSafe™ firebreak cannot be used. Contact your local Fire & Rescue Service for advice about alternative fire protection measures.