What you need to know
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, an oxygen firebreak is a requirement.
On March 12, 2018, the VA issued a Patient Safety Alert requiring that thermal fuses (firebreaks) are fitted to all veterans’ home oxygen installations.
The Patient Safety Alert states that two thermal fuses must be fitted per patient installation – in the case of portable devices, the requirement only applies to those with a continuous flow.
In addition, the Patient Safety Alert states that all unidirectional thermal fuses must be replaced with bidirectional versions at the next scheduled visit or sooner unless the unidirectional device is designed so it cannot be fitted in the wrong orientation.
Frequently Asked Questions on the VA announcement
Q. When does the VA’s Patient Safety Alert come into effect?
Steps to implement the Patient Safety Alert start seven days after publication, however, VISNs (Veterans Integrated Service Network) must ensure that their home oxygen installation contracts are amended within 180 days of the Alert (in other words by October 2018).
Q. Does the Patient Safety Alert affect all patients?
Yes, unless there are clinical reasons why a patient cannot use a firebreak. The Patient Safety Alert does not distinguish between patients that are deemed ‘high risk’ and those who are not. Besides, the risk of fire does not just come from smoking, it can come from many other sources, such as household appliances, birthday candles or stoves, so all patients are potentially at risk.
Q. Do fires involving home oxygen now have to be reported?
Following the Patient Safety Alert DMEs will be responsible to report all fires involving home oxygen to the local VA medical center and must provide specific information about the fire. For more information speak to your local VA medical center or VISN office.
Q. I’m a supplier – how do I find out more?
For more information about regional contracts, contact your local VISN. Details can be found here.