Philips Recall Updates

We understand that the news of the recall was alarming for patients with affected devices. The highest risk of exposure appears to be in conjunction with ozone cleaning machines such as SoClean devices. 

 

Upon initial assessment of the data provided, we are of the opinion that the risks which prompted the recall are quite small, compared with the well-proven, serious risks for apnic patients of not using CPAP therapy.  We believe the best choice is to continue to use your machine if you are not experiencing one or more of the following symptoms:

-headache

-airway irritation

-airway inflammation

-respiratory issues

 

If you have any of the symptoms listed above or have been using an ozone cleaner, please contact our office to discuss your treatment options going forward.

 

There has never been a more important time to properly clean your CPAP and replace your CPAP supplies on the schedule recommended by your insurance provider. For cleaning, we suggest you use a benign solution, such as a water/vinegar mixture (3 parts water, 1 part vinegar) to clean your equipment.  If you have any further questions, continue reading below, or reach out to us directly at clinicalteam@sleepmetrics.com

FAQs

What has been recalled, why and when? 

On June 14, 2021, Philips Respironics issued a voluntary recall of specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices to address identified potential health risks related to an internal foam component using the polyester-based polyurethane (PE-PUR). The foam component’s function in the device is noise reduction. 

 

What is the risk associated with using my CPAP device?

Philips reports there is a low risk of foam breaking down into small particles that can be ingested or inhaled during use. The consumer complaint rate was 0.03% (3 in 10,000) in 2020. Complaints include reports of throat irritation, headache and cough. Philips has stated it issued the recall out of an abundance of caution.

 

What factors increase the risk?  

The highest risk is associated with the use of ozone cleaning devices such as SoClean. Another risk factor is long-term use of the device in places like southern and southeastern states that have hot, humid climates. A third risk factor is the age of your machine. Newer devices, less than 5 years old, are less likely than older devices to have breakdown of the foam component. 

 

Which Philips CPAP machines are being recalled?
A comprehensive list of affected devices can be found on the Philips website. This voluntary recall affects Sleep Metrics patients with the following machines:

  • Philips DreamStation CPAP

  • Philips DreamStation AutoPAP

  • Philips DreamStation BiPAP

  • Philips DreamStation BiPAP Auto

  • Philips DreamStation BiPAP AutoSV

  • Philips DreamStation BiPAP S/T

  • Philips System One REMstar Pro

  • Philips System One REMstar Auto

  • Philips System One REMstar BiPAP Pro

  • Philips System One REMstar BIPAP Auto

  • Philips System One BiPAP AutoSV

  • Philips DreamStation Go Travel PAP
     

Should I stop using my device?
Please consult with the Sleep Metrics clinical team and consider your personal health history before discontinuing use of your CPAP machine. There is risk associated with the continued use of your CPAP device, as described above. There is also risk associated with untreated sleep apnea including weight gain, diabetes, hypertension, heart disease, stroke and memory problems. We recommend continuing use of your existing device while you await replacement or repair from Philips. If you have been using a SoClean or other ozone cleaning device or your device is over 5 years old, please contact us and we will exchange your device for a new device of the same model. 

 

For patients on Bi-level PAP and CPAP devices who have severe breathing difficulties or who were very sleepy during the daytime before treatment, patients with significant pulmonary, cardiovascular or neurological comorbidity, or patients who work in safety-critical positions (e.g. professional drivers, pilots, heavy equipment operators), our recommendation, in alignment with the American Academy of Sleep Medicine and the American Thoracic Society, is to continue the prescribed therapy until you have consulted with our clinical team. 
 

What can I do to better protect myself if I continue using my device?
Immediately stop use of ozone cleaning devices such as SoClean. The health risk is significantly reduced for patients who do not clean their devices with ozone-related cleaning products. Refer to your device’s Instructions for Use for approved cleaning methods.

 

What are other patients doing?

The vast majority of Sleep Metrics patients are continuing use of their CPAP device while they wait for replacement or repair. 

 

Will my device be replaced?
Yes. Affected devices will be either replaced or repaired to replace the sound abatement foam.

 

Do I need to register my device with Philips to begin a claim?
No. Sleep Metrics has registered all affected devices to guarantee repair or replacement when those options become available. We will ensure that the repaired or replaced device is set up according to your individual needs.

When will I receive a replacement device?
We do not yet know when Philips expects all devices affected by the recall to be replaced or repaired. We will update our patients as more information becomes available.

Will I be charged for device replacement?
No. Recalled devices will be repaired or replaced at no cost to you.

How should I return my recalled device?
We are still awaiting guidance from Philips as to how to facilitate exchanges, but we will do everything possible to ensure the exchange is as minimally disruptive to our patients as possible. 


How would discontinuing therapy affect my insurance coverage?
Usage data is transmitted from your device to Sleep Metrics. Medicare, and some insurance companies, require that we report this usage data to ensure continued coverage. If your insurance company requires usage data and you choose to discontinue therapy, your device may no longer be covered by insurance. Additionally, if you later decide to resume therapy, you will be required to complete another sleep study and assessment before a new prescription can be issued.

At this time, we have not received updated guidance from insurance companies regarding compliance requirements. This section will be updated if these requirements change.    

Can I return my device and stop making payments?
To ensure you receive a replacement or repair as soon as possible, we recommend you hold onto your device and continue making payments as you normally would. If you stop making payments on your device, Philips will cancel the registration of your device and you will lose your spot in the queue for replacement or repair.

I work in a safety-critical position. What happens if I discontinue therapy?
Usage data is transmitted from your device to Sleep Metrics. We are required to report this usage data to your insurance company to ensure compliance. The discontinuation of therapy may lead to the revocation of your license. Discontinuing use may impact your livelihood and your health and safety. It is recommended that patients who work in safety-critical positions continue therapy with their existing device while they await replacement or repair from Philips.

Can I get an alternative device while I wait for my device to be repaired or replaced?
CPAP devices made by other manufacturers will likely be hard to find, due to limited industry supply and the scope of the recall. 

 

We recommend continuing use of your existing device while you wait to schedule your repair or replacement. If you have been using a SoClean or other ozone cleaning device or your device is over 5 years old, please contact us and we will exchange it with the same model.

Will insurance cover an alternative device?
No. From our understanding, If your device was included in the recall and you choose to switch to a different device, the new device will not be covered by insurance.

Do I need to notify my insurance company of the recall?
No. Sleep Metrics has notified your insurance company and is working with insurers to inform them of the recall and determine the best course of action for continuing coverage for our patients.

I am no longer a patient with Sleep Metrics. Will you still handle my device replacement?
If you received your CPAP machine from Sleep Metrics, we have registered your device. No further action on your part is required at this time.   

What should I do if I have questions? 

Please do not hesitate to reach out to us at support@sleepmetrics.com. We will try to respond to all inquiries within 48 hours.