The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a National Patient Safety alert for some Philips CPAP, CPAP-like devices and ventilators.
Philips have issued two field safety notices because of a potential for patient harm due to inhalation of particles and volatile organic compounds in the devices.
The MHRA is advising that reports of incidents related to this issue are rare and that no incidents of harm have been reported in the UK.
The available evidence suggests that the risks to patients of stopping using these devices significantly outweigh safety risks if patients do not have ready access to an alternative.
We are currently carrying out a risk assessment process to help us advise patients about whether to stop using their devices or keep using them until a replacement is available. We will be in touch with patients once this risk assessment is complete but this may take several weeks due to the number of patients using these devices.
We are also working with Philips and the NHS Supply Chain on plans to replace these devices and will inform patients when we know more about how these products will be replaced.
In the meantime, all devices need to be registered with Phillips and UHNM will do this on your behalf once you have completed the form below.
What is the issue with the devices?
There are concerns that sound-reducing foam used in a number of the Philips Respironics devices may degrade into particles which may be ingested or inhaled by the user, and the foam may give off certain chemicals.
Philips has informed us that the risk of this happening is extremely small, and the recall is mainly precautionary.
Should I stop using my device?
At present we are working to better understand the potential safety issues but we would not advise stopping treatment at this stage as the risk of stopping treatment is likely to outweigh potential risks of using the devices.
Is it dangerous if I stop CPAP treatment?
It is not dangerous to stop CPAP treatment. However, it is very likely that your original sleep apnoea symptoms will gradually return one to three days after stopping CPAP treatment. Common symptoms include:
If your original sleep apnoea symptoms were severe and affected your day-to-day life, we recommend that you continue your CPAP treatment.
If you have an underlying health condition, such as diabetes, high blood pressure or cardiac disease, you may find that stopping CPAP treatment causes your condition to become less well-controlled.
Is it dangerous if I stop NIV treatment?
In most situations it is dangerous to stop treatment without your team knowing. In some situations one can deteriorate quickly or in some situations over a longer period and so we recommend that you carry on with your treatment.
Is there anything else I should do?
The risk of foam degradation is increased if the CPAP device is cleaned with unapproved Ozone cleaning products, such as SoClean®. Please stop using any unapproved Ozone cleaning products immediately.
Philips is recommending that customers and patients follow the approved cleaning methods listed in the instructions for use.
Will Philips replace these devices?
We are working with Philips and the NHS Supply Chain on plans to replace these devices. We will let you know as soon as we have more information about how Philips will repair/replace your device.
Can I arrange to speak to my Sleep Consultant/ Physiologist to discuss this?
Our team would be happy to discuss your case with you to give advice relevant to your situation, however to do this we need to gather more information, so please bear with us while we undertake this work. Once we are able to arrange appointments we will be in touch.
What devices are affected by this recall?
CPAP/BiPAP
DreamStation ASV, DreamStation ST AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, Dreamstation Go, DreamStation SystemOne (Q-Series), Dorma 400, Dorma 500, REMstar SE Auto, OmniLab Advanced+
Mechanical ventilators
Trilogy 100, Trilogy 200, Garbin plus, Aeris, LifeVent, A-Series BiPAP Hybrid A30, A-Series BiPAP V30 Auto, A-Series BiPAP A40, A-Series BiPAP A30.
If I have been using one of these devices, am I at risk?
The greatest risk from using the devices is in the initial period of using a new product. Therefore if you have been using your device for some time we would ask you to continue as the risk of stopping treatment is likely to outweigh potential risks of using the device.
