The manufacturer Philips Respironics has issued a field safety notice for ventilation devices used for sleep apnoea and respiratory care.
A type of foam used in the affected devices may break down into particles or release chemicals. People may inhale the foam particles or chemicals when they use an affected device.
We are working with the Health Products Regulatory Authority (HPRA) and our hospital and community services to assess the issue and the potential impact on patients in Ireland. We will continue to review this advice as Philips Respironics provides more information.
Keep using your device
Keep using your device until you can get it replaced or repaired, or your doctor prescribes another treatment.
Do not stop or change your treatment without talking to your doctor if you have:
- severe breathing difficulties
- excessive daytime sleepiness
- ventilator failure using non-invasive or invasive ventilation
- other serious conditions, such as pulmonary, cardiovascular or neurological conditions
- a risk of accident at your workplace or when you drive
If you are worried about using your device, talk to your doctor. They will discuss with you the risks of using your device and the risks of stopping treatment.
The devices affected include:
- continuous positive airway pressure (CPAP) devices
- bilevel positive airway pressure (BiLevel PAP) devices
- mechanical ventilators
Check if your device is affected on the Philips website
These devices are used in public and private hospitals, residential care settings and people’s homes.
What to do if you use an affected device
If you think you have an affected device:
- Check the serial number and register your device on the Philips website.
- Contact the company that supplied your device.
The company that supplied your device can give you advice on getting it repaired or replaced.
You can also call the Philips support number 1800 851 241 to register your device.
The company that supplied your device may call you about the field safety notice.
Companies that supply these devices in Ireland include:
Tel: 1800 740 202 (option 3)
Tel: 090 649 0190
Tel: 1800 220 202
Health risks from affected devices
Polyester-based polyurethane (PE-PUR) is a foam used to reduce sound and vibration. In the affected devices, there is a risk that the foam may break down into particles or release chemicals.
There is a higher risk of the foam breaking down:
- if the device is cleaned with a machine that uses activated oxygen (ozone)
- in environments with high heat or high humidity
People may inhale the foam particles or chemicals when they use an affected device. This can cause irritation in your airway, a cough, headache and sinus infection.
Talk to your GP if you have any of these symptoms.
We do not know if there are other short-term or long-term effects on health. But some of the chemicals have the potential to cause cancer.
There have been no reports of serious illness as a result of these issues.
Read more about the health risks on the Philips website
Report any health issues you have with these devices on the HPRA website
Advice on cleaning your device
Philips have advised that the foam degradation may be exacerbated by the use of unapproved cleaning methods, such as ozone. Customers and patients are advised to adhere to the Instructions for Use provided with their device for approved cleaning methods.
While proper cleaning may help to identify the presence of particles within the device, it is important to note that patients remain at risk of exposure to degraded sound abatement foam particles and VOCs.
What we are doing
We are working with the HPRA and our hospital and community services to assess the issue and the potential impact on patients in Ireland.
We have started identifying where these devices may be in use. We have contacted other care providers about the field safety notice including Nursing Homes Ireland, contracted care providers and private hospitals.
We will continue to work with the HPRA to give more information and guidance.
Read the safety notice from the HPRA