Philips safety warning – positive airway pressure (PAP) devices used for treatment of sleep apnoea and respiratory failure

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Note: The information provided here may be updated as further details become available.

On 14 June 2021, Philips Respironics released a Field Safety Notification, this is a safety warning about a product. The products that are affected include positive airway pressure (PAP) devices used for treatment of sleep apnoea and respiratory failure. If you have one of these devices, read the information below and speak with your doctor to decide on the best course of action for you. Do not stop or change your treatment unless your doctor advises you to and monitors your health.

Many Philips PAP devices have foam (polyester-based polyurethane) inside them to reduce noise and vibration. This foam may break-down over time. When the foam breaks down, small pieces of it may enter into the airways of the person using the machine. These small pieces of foam can cause irritation. Some of the chemicals that the foam is made of may carry the risk of causing cancer in the long term.

Read more about this on the Philips website.

A variety of devices are affected, this includes the first generation DreamStation devices, but not the DreamStation 2 devices. You can see the full list on the Philips website.

Philips has created a registration process that will allow you to look up your device’s serial number to see if your machine is affected.

Statement of the European Respiratory Society (ERS)

ERS has issued a statement on this which is summarised below:

1 – It is important to balance the risks for each individual patient. This includes:

  • The known and the possible risks of inhaling the foam from the machine and the likelihood of this happening,
  • The risks of what might happen if you suddenly stop using the PAP machine.

2 – The decision to stop or continue using your PAP machine should be made on an individual basis.

3 – There is no evidence of sudden life-threatening events happening with patients who have used the faulty machines. There have a small number of reports, that have described cough, headache and sinus infection in users.

4 – Therefore, you should not stop or change your treatment, even if you receive notification from the manufacturer.

5 – You should contact your physician / sleep team for advice and discussion.

6 – Their medical recommendation should consider how coming off treatment would affect you, for example:

  • Your levels of daytime sleepiness and how this affects you, risks of accidents at work and when driving, and other related-health risks.
  • How severe your disease is, based on how affected you are in daily life, the Apnoea–Hypopnea Index (AHI), hypoxic load and hypercapnia (the amount of carbon dioxide in the blood).

7 – Your doctor will help you decide on the best action for you for. Some examples may include:

  • Continuing to use the PAP machine if your condition is severe and you would be at risk if you stopped using it.
  • Swapping to a different treatment if your symptoms are mild to moderate.
  • Considering pausing treatment if your symptoms are very mild and it is safe for you to do so.

Any changes to your treatment should be made under medical supervision and you should be regularly monitored by your doctor.  

8 – If you continue using your device, you may be advised to use a in-line bacterial filter.

Questions asked to Philips from the ELF Sleep PAG

How many devices in Europe are part of the recall including CPAP /APAP/Bilevel and presso-volumetric, and specifically how many units are in each country of the 27 member states?

This figure is not known at present and will need to come from the regulators.

Can you confirm that the German regulatory body coordinating the regulatory bodies will give some plans for EU by the beginning of next week?

We do not have information yet how the process of the national regulatory boards will be and how it will organized on the EU level. We may get information this week.

When do you expect to replace all the devices covered by the recall, with the new dreamstation 2 model and with the new noise abatement (reduction) object?

At the moment it is not clear how long this process could take. However, it could realistically take 12 months or more.

What material was the turbine noise abatement (reducer) made of?

The current material is Polyester polyurethane. We do not have information about the material in other devices yet.

Will System One and Dreamstation 1 machines older than 5 years be replaced?

All affected machines will be replaced or refitted.

Does Philips plan to support and promote research studies to assess the health impact this carcinogenic (cancer causing) material may have on patients in the medium to long term?

Studies have already started and will be ongoing.