The CPAP Recall and Sleep Apnea Treatment

As of November 2021, The U.S. Food and Drug Administration (FDA) is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices due to potential health risks. If you use one of these machines, there are steps you can take to ensure your safety from sleep apnea. Keep reading to learn more about CPAP machines, sleep apnea, the CPAP recall, and other effective treatments for sleep apnea that do not involve CPAP machines.

What is a CPAP Machine?

According to the University of Michigan, Continuous positive airway pressure therapy (CPAP) uses a machine to help a person who has obstructive sleep apnea (OSA) breathe more easily during sleep. A CPAP machine increases air pressure in your throat so that your airway doesn’t collapse when you breathe in. When you use CPAP, your bed partner may sleep better too.

You use CPAP at home every night while you sleep. The CPAP machine will have one of the following:

• A mask that covers your nose and mouth.
• A mask that covers your nose only—called nasal continuous positive airway pressure, or NCPAP (this type of mask is most common).
• Prongs that fit into your nose.

Is a CPAP Right For Me?

There are many pros and cons to using a CPAP machine. Some of the pros include:

• Ability to have a more restful night sleep
• Reduces daytime fatigue and sleepiness
• Improves mood
• Improves the ability to lose weight
• Lower risk of having a heart attack, stroke, or other cardiovascular issues
• Reduces blood pressure

Some of the downsides to using a CPAP machine include:

• An uncomfortable mask that covers the face
• Difficult to find a comfortable sleeping position
• Feeling claustrophobic
• Skin irritations from where the mask touches the skin
• Loud sounds that are difficult to adjust to
• Difficulty traveling
• Bed partner may not be able to adjust

What is Sleep Apnea?

According to the American Sleep Apnea Association, Sleep Apnea is an involuntary cessation of breathing that occurs while the patient is asleep. The Greek word “apnea” literally means “without breath.” There are three types of sleep apnea: obstructive, central, and mixed. Of the three, obstructive sleep apnea, often called OSA for short, is the most common.

Despite the difference in the root cause of each type, in all three, people with untreated sleep apnea stop breathing repeatedly during their sleep, sometimes hundreds of times during the night, and often for a minute or longer. In most cases, the sleeper is unaware of these breath stoppages because they don’t trigger a full awakening.

Types of Sleep Apnea

As mentioned, there are three types of sleep apnea. Sleep apnea is diagnosed after a sleep study has been performed. Untreated sleep apnea can lead to a wide array of health issues, and could potentially be fatal.

An individual may suffer from one type or a combination of two or more. Types of sleep apnea include:

• Obstructive Sleep Apnea. This form of sleep apnea is the most common. Obstructive sleep apnea (OSA) occurs when the airway has been blocked, such as from tissue relaxing in the back of the throat. It is also the most treatable, typically through a CPAP machine or an oral appliance, such as the treatment offered by Gorman Health and Wellness.
• Central Sleep Apnea. When central sleep apnea (CSA) is present, the brain does not send the proper signals to the muscles responsible for breathing.
• Mixed Sleep Apnea. Mixed, or complex, sleep apnea involves a combination of both central and obstructive sleep apneas.

What is the CPAP Recall?

The potential health risks involved with the CPAP recall include the polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway, according to the FDA. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device. These issues can result in serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent damage.

If you use one of these affected devices, talk to your health care provider to decide on a suitable treatment for your condition and follow the recommendations listed below. Philips Respironics is recalling the following affected devices manufactured between 2009 and April 26, 2021.

The affected devices include:

• DreamStation ASV
• DreamStation ST, AVAPS
• SystemOne ASV4
• C-Series ASV
• C-Series S/T and AVAPS
• OmniLab Advanced+
• SystemOne (Q-Series)
• DreamStation
• DreamStation Go
• Dorma 400
• Dorma 500
• REMstar SE Auto
• Trilogy 100
• Trilogy 200
• Garbin Plus, Aeris, LifeVent
• A-Series BiPAP Hybrid A30 (not marketed in US)
• A-Series BiPAP V30 Auto
• Continuous Ventilator, Non-life Supporting
• A-Series BiPAP A40
• A-Series BiPAP A30

What is the Risk of the CPAP Recall?

Also according to the FDA, to date, Philips Respironics has received several complaints about the presence of black debris/particles within the device’s air pathway. Philips Respironics also has received reports of headache, upper airway irritation, cough, chest pressure, and sinus infection, which may be related to this issue, though the cause of the symptoms cannot be definitively linked.

• The potential risks of particulate exposure include irritation to the skin, eye, and respiratory tract, inflammatory response, headache, asthma, and toxic or carcinogenic effects to organs, such as kidneys and liver.
• The potential risks of exposure to chemicals released into the device’s air pathway from the PE-PUR foam include headache; dizziness; irritation in the eyes, nose, respiratory tract, and skin; hypersensitivity; nausea/vomiting; and toxic and carcinogenic effects.
• The foam degradation may be exacerbated by high heat and high humidity environments, and by use of unapproved cleaning methods, such as ozone.
• To date, there have been no reports of death as a result of these issues.

What is the FDA Doing About the Recall?

The FDA’s recall website states that it has initiated on-site inspections of Philips Respironics’ manufacturing facilities to assess compliance with regulatory requirements.

In addition, on September 10, 2021, the FDA updated the frequently asked questions about this recall on FDA.gov: Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions. 

• The FDA is working to assure Philips Respironics adequately evaluates the issue with the device, the scope of the recall, and the most appropriate mitigation strategies, including corrective actions by the company.
• The FDA is analyzing medical device reports (MDRs) related to the affected devices over the period of 2009-2021 for reports that could be related to this issue.
• The FDA does not have evidence at this time that any other CPAP machines, BiPAP machines, or ventilators, from Philips or other manufacturers, are affected.

The FDA is committed to using every tool at our disposal to increase the availability of these medical products. The FDA is working with Philips Respironics to monitor the repair or replacement of impacted devices as expeditiously as possible and is continuing to gather information to inform our actions. We are collaborating with other manufacturers and government partners to support the availability of CPAP and BiPAP machines.

What to Do If My CPAP is Recalled

If your device is on the above list and matches all the criteria for the FDA Recall, you can take the following steps, according to the FDA’s recall website:

• Talk to your health care provider to decide on a suitable treatment for your condition.
• Follow the manufacturer’s instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. Ozone cleaners may worsen the breakdown of the foam, and there are other potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories.
• Register your device(s) on Philips Respironics’ recall website to stay informed of updates from Philips
• Respironics regarding any new instructions or other corrective fixes, which the FDA is requiring.
• Report any problems with a device through the FDA’s MedWatch Voluntary Reporting Form.

It is essential to ensure your safety if you have one of the affected devices. Speak with your health care provider to weigh out the risks and other treatment methods available for sleep apnea.

Other Treatments for Sleep Apnea

After speaking to your health care provider and following the above steps to ensure your health and safety in the CPAP recall, you may decide on trying alternative ways to treat sleep apnea. One of the ways you can treat sleep apnea is through a new, non-invasive, clinically approved treatment method offered at Gorman Health and Wellness.

After an initial consultation and a possible scan to better understand the obstruction, Dr. Martin Gorman will create a personalized treatment plan with the goal of improving their nighttime breathing. This often involves the use of a custom-fitted dental appliance the patient will wear while sleeping.

Some of the possible remedies include:

• If the patient’s sleep apnea is being caused by the tongue relaxing in the throat, a tongue-retaining device may be the ideal treatment for maintaining an open airway.
• Should an abnormal jaw position cause breathing difficulties, Dr. Gorman may recommend a particular device to correct this alignment, such as a mouthpiece or a device strapped around the head.
• Oral devices used to address sleep apnea are removable and typically resemble athletic mouth guards.

Sleep Apnea Treatment with Gorman Health and Wellness

If you suffer from sleep apnea, you do not have to be chained to a CPAP machine for the rest of your life. Other sleep apnea treatments are available, such as the one offered by Gorman Health and Wellness, to get you on track toward a more restful night’s sleep.

Dr. Gorman is a part of the breathing wellness movement, aiming to increase awareness and improve treatment for sleep-related airway conditions like sleep apnea. He has partnered with organizations focused on collaborating with dentists to apply the sciences of Craniofacial Epigenetics (the study of cranial modifications caused by gene expression as opposed to genetic code alteration) and Pneumopedics^® (the practical application of oral appliance therapy and non-surgical airway remodeling) in the management of sleep apnea.

For every sleep apnea case at our practice, Dr. Gorman will gather patient data and determine the patient’s specific needs based on home sleep test results, dental impressions, CT scans, and images. Our state-of-the-art technology, paired with Dr. Gorman’s experience with sleep disorders, allows him to find the most effective treatment plan for each individual’s particular case, yielding improved daytime and nighttime breathing for the patient. Together, the application of these sciences allows for underlying causes of airway obstruction to be treated in 98% of cases, resulting in a high success rate among sleep apnea patients.

“I have been helping people suffering from Sleep Apnea with a non-invasive, clinically approved treatment method. This method has allowed my patients to sleep with far fewer events per hour, allowing them to get rid of their CPAP and BiPAP machines. Imagine not having to use one of those machines, getting back a much greater quality of life along with the benefits of being able to breathe better.” – Dr. Gorman.

For more information on Dr. Gorman, improving your sleep apnea, and decreasing your chances for dementia, contact us today.