Philips CPAP Recall: Understanding the Facts and Alternatives

Man with sleep apnea sleeping with CPAP mask

In 2021, Philips voluntarily recalled certain CPAP, BiPAP, and ventilator machines, leaving consumers with questions.

If your CPAP device made the recall list, read on to learn more about this recall and available alternatives to treat your obstructive sleep apnea (OSA).

 

Philips CPAP Recall Facts, Questions, and Answers

The Philips CPAP recall is a Class I recall, the most severe kind, so it is essential to take it seriously. Here is what you need to know:

 

Why did Philips Recall These CPAPs?

In the recalled products, Philips used a sound-diminishing foam that was polyester-based polyurethane-based and known as PE-PUR. In these affected devices, the foam might break down, allowing particles to enter the air pathway of the device. The PE-PUR foam might also give off harmful chemicals in the form of a gas. 

The person using the CPAP will potentially breathe in or swallow chemicals or debris from the PE-PUR foam, which has the potential to cause serious health consequences and could be life-threatening.

Adverse Reactions and Consumer Complaints

Philips has received complaints of particles and debris found in the air pathway of affected devices. The air pathway includes the tubing, humidifier, and mask. Reports of cough, chest pressure, headaches, sinus infections, and upper airway irritation were reported.

Other possible adverse effects from debris exposure include inflammatory response, asthma, carcinogenic effects, and adverse effects to the liver, kidneys, and other organs.

Other possible adverse reactions from chemical exposure include dizziness, headache, skin and respiratory tract irritation, nausea, vomiting, and carcinogenic effects.

Which Devices Did Philips Recall?

The Philips CPAP recall, issued on June 30, 2021, includes CPAP devices manufactured between 2009 and April 26, 2021. Get a complete list of all recalled CPAP, BiPAP, and ventilator machines on the FDA’s website.

Philips CPAP Recall: Update

On September 1, 2021, Philips announced their plans for repairing and replacing affected devices. “Philips anticipates reworking to commence in the course of September 2021,” according to Philips Respironics. “…the company has already started replacing certain affected first-generation DreamStation CPAP devices in the U.S. with DreamStation 2 CPAP devices…and intends to complete the repair and replacement programs within approximately 12 months.”

What to Do if Philips Recalled Your CPAP Machine

The FDA advises you to keep using your device until your physician decides the benefits do not outweigh the risks. In the meantime, take these steps. Please refer to the following website from Philips to review specific instructions related to the recall: 

https://www.usa.philips.com/healthcare/e/sleep/communications/src-update

If the risks of your affected machine outweigh the benefits, your physician may recommend that you switch to a different CPAP machine or an alternative treatment to your OSA.

If you switch to a different CPAP machine, you may be able to keep the same user interface that you are used to. If you like the way your current CPAP device feels, this may be the easiest transition. All CPAP devices run on their own algorithms and have different components so there may still be a period of acclimation when switching CPAP machines.  

Alternative Treatments for Obstructive Sleep Apnea

If you have been struggling with your CPAP device, your physician may decide you should try an alternative treatment for your OSA. It is important to note, some alternative therapies only treat mild to moderate OSA and are not meant for severe cases.

Here are some alternatives to your recalled device:

 

Nasal Expiratory Positive Airway Pressure (nEPAP)

A nasal expiratory positive airway pressure device sits in your nostrils, providing positive pressure when you exhale. This pressure prevents the collapse of your upper airway.

Nasal EPAP devices do not eliminate OSA, but they can help to improve outcomes.

 

Mandibular Advancement Devices (MADs)

MADs are mouthpieces to wear during sleep that hold the bottom jaw forward, lifting the tongue, keeping your upper airway held open. With your jaw and tongue out of the way, air moves freely as you sleep, reducing snoring and obstructive apneic periods.

Tongue Stabilizing Devices (TSDs)

TSDs work similarly to MADs, but instead of moving the jaw forward, TSDs lift and stabilize the tongue, holding it out of your airway.

MADs and TSDs are not meant to treat severe OSA.

The Somnera System (Positive Airway Pressure System)

Somnera’s low-flow technology eliminates the cumbersome humidifier and allows the system to feature a hose so light that patients don’t feel attached to anything during sleep. This is the first sleep apnea treatment that provides positive airway pressure without the continuous high airflow of CPAP. The reduced airflow has additional benefits: less drying so no humidifier is needed, and the hose is the smallest, lightest available. 

The Somnera System provides a great option to patients suffering from OSA who don’t want CPAP or who feel claustrophobic and overwhelmed by the continuous rushing airflow required to deliver therapy from traditional CPAP devices. Somnera uses SmartValve™ technology and proprietary software algorithms to deliver positive airway pressure therapy. The valve is placed in the mask right next to the airway and it controls airflow to provide EPAP (expiratory positive airway pressure). With Somnera’s SmartValve, a patient’s expiratory effort generates airflow against the valve that creates the prescribed positive airway pressure at the end of each breath. With CPAP, the positive airway pressure to keep the airway open is generated with rushing continuous airflow forced into the airway at all times. 

When a patient exhales on Somnera, there is no airflow from the Airbox and the SmartValve vents 100% of the exhale out into the room (no intentional leak is needed with Somnera). On inspiration, the patient draws air from the room through the valve supplemented by airflow from the Airbox, compared to CPAP where all airflow comes from the flow generator. 

In summary, with Somnera there is no airflow from the Airbox on exhale and low airflow from the Airbox on inhale, because air is also drawn from the room through the valve. However, if the Airbox detects an obstruction then, just like CPAP the Airbox will deliver the airflow necessary to reach the prescribed pressure and open up the airway. You can think of Somnera as “CPAP on-demand” when disordered breathing is detected. With CPAP, there is constant airflow during inhale, exhale and to vent CO2 from a user’s exhale so it does not go down the hose. The way back-pressure is generated and the airflow profiles between Somnera & CPAP are very different, but the pressure generated at the end of each breath is the same.

Somnera differs from CPAP in a number of ways:

  • There is no humidifier, so condensation and mold in the tubing are not a concern. Say goodbye to humidifier maintenance problems.
  • The system is smaller and designed to disappear on your nightstand.
  • Somnera generates positive airway pressure differently than CPAP. The user’s breathing effort against the SmartValve generates the positive airway pressure at the end of every breath, unlike the continuous airflow delivered with a CPAP machine.
  • Somnera’s technology eliminates the noisy airflow of the programmed leaks on traditional CPAP masks. Lower airflow overall can allow leaks during the night to be much quieter and can reduce the need to pull the mask as tight to avoid leaks.
  • The system’s hose is much smaller and lighter than a typical CPAP hose – moving easily for active sleepers without disconnecting or getting tangled. Users report they do not feel attached to anything.
  • The GoToSleep mode is a new feature that allows you to fall asleep with no airflow, as the ramp gradually increases your pressure while you sleep.
  • The SleepBridge app connects to your Airbox so you can monitor your device usage.
  • Somnera is a complete system with a user interface, hose, and Airbox that cannot be used interchangeably with any other CPAP device or components.

Somnera is one alternative to CPAP for many OSA patients who are newly diagnosed or for current CPAP users that struggle with their CPAP and are looking for a different breathing experience. Somnera’s lightweight and compact design makes it ideal for traveling. 

Different methods of creating positive airway pressure result in very different breathing experiences. Somnera may not be suitable for everyone. If the continuous pressure and airflow from your CPAP is ideal for you, you might want to consider a different traditional CPAP machine, since Somnera offers a different breathing experience. Some patients that are comfortable with, or who have successfully acclimated to CPAP’s continuous airflow, might have trouble adjusting to this device. If this is the case, talk with your doctor to decide which treatment option is best for you.

Final Thoughts

If your CPAP device was recalled by Philips, talk with your doctor to discuss alternative treatments for OSA. It is good to have safe and effective choices to treat OSA since there is no one-size-fits-all option.  Many people are looking for new therapies to effectively treat their disease. If your OSA is mild, you might consider a mouthpiece such as a TSD or MAD. However, if positive airway pressure is what you need and you do not want or cannot tolerate CPAP’s continuous pressure and airflow, Somnera may be the alternative that could work for you. It is important to note that with any new therapy, there is always an acclimation period.  If you are starting as a newly diagnosed patient or a current “unhappy” CPAP user switching to an alternative treatment, expect that it will take one to two weeks to become fully acclimated to your new healthy habit. Pushing through and successfully treating your OSA every night, provides meaningful benefits to your long-term health and well-being.  You can learn more about how the Somnera® System works here.