In 2021, the U.S. Food and Drug Administration (FDA) announced a recall of specific models of Phillips Respironics CPAP machines for potential safety issues. In turn, Phillips released a voluntary recall notification to ensure patient safety in consultation with regulatory agencies. Since then, the FDA has released this update providing even more information regarding the Philips recall.
This recall has significantly impacted the medical device industry for treating sleep apnea. Due to this recall, you may have a defective CPAP machine, find that the industry faces a shortage of quality devices, or want to explore other alternatives.
This article outlines an overview of why the Phillips CPAP was recalled, what to do if you have one, and explores alternatives to a CPAP to treat sleep apnea.
Why Was the Phillips CPAP Recalled?
In 2021, Philips CPAP machines were recalled due to reported safety issues. Among other risks, foam used in certain Philips devices may break down due to exposure to hot and humid conditions, according to the FDA. When this occurs, black pieces of foam or dangerous chemicals may be inhaled or ingested, presenting health risks that could require medical attention. The FDA received thousands of Medical Device Reports, including over 100 reports of patients dying. Consequently, due to potential risks, the FDA issued a statement urging people to stop using certain models of Philips CPAP machines as soon as possible.
As a result of these reports, Philips initiated a voluntary recall to ensure their customers’ safety and issued an “Urgent Medical Device Recall Notice” in February 2021, alerting consumers about the defective CPAP units. The potential risks posed by defective Phillips CPAP machines are dangerous for patients relying on these medical devices. Additionally, this increased demand has led to higher prices for those purchasing a new machine, and replacement parts have been difficult to find due to inadequate supply. The recall affected millions of patients worldwide and required them to stop using the devices and seek alternatives for treatment.
Which Philips CPAP Units Were Affected by the Recall?
According to the FDA, devices that were recalled include the following:
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- C-Series ASV
- C-Series S/T and AVAPS
- OmniLab Advanced+
- Noncontinuous Ventilator
- SystemOne (Q-Series)
- DreamStation Go
- Dorma 400
- Dorma 500
- REMstar SE Auto
As part of their response effort, Philips has made multiple efforts to inform customers about this recall and what steps they should take if they own one of these potentially faulty devices. Patients are urged to return their units for repair or exchange to receive a replacement product or part. Phillips provides information for consumers about what devices are affected by the recall and what actions they can take.
What Do I Do if I Have a Recalled Philips CPAP?
According to the FDA, consumers with an affected CPAP machine should talk to their healthcare provider to decide on a suitable treatment for their condition, which may include:
- No longer using your CPAP device.
- Using another similar device that is not part of the recall.
- Using alternative treatments for sleep apnea, such as oral appliance therapy, or positional therapy
- Initiating long-term therapies for sleep apnea, such as losing weight, decreasing alcohol use, smoking cessation, or a surgical option for moderate to severe sleep apnea.
What Are Alternatives During the Recall?
The recent recall of certain Philips CPAP machines has left many sleep apnea sufferers searching for alternative treatment options. Fortunately, a range of effective oral device treatments is available to treat sleep apnea beyond a CPAP machine. Consulting with a sleep provider to determine the best approach to treat your specific case is essential. A sleep provider may recommend a device, in combination with other options such as:
- Oral Appliances
- Lifestyle changes, such as avoiding large meals and screen time before bedtime
- Sleeping on your side instead of your back using positional pillows.
- Surgery to remove excess tissue in the throat or nasal area which causes an airway obstruction.
Oral Devices for Sleep Apnea:
Oral devices are a treatment option for sleep apnea and a great option to use as an alternative to CPAP machines. They provide an unobtrusive, comfortable, and effective solution for many patients suffering from mild to moderate Obstructive Sleep Apnea (OSA).
Oral devices work by positioning the lower jaw slightly forward while sleeping, thus increasing the size of the airway and gently preventing the tongue from blocking the airway during sleep. These devices are precision-made and custom fit by a qualified sleep dentist. Most patients find oral appliance therapy to be comfortable and effective.
Common oral devices for sleep apnea include:
- Mandibular advancement devices (MADs). MADs move the lower jaw forward, which helps open the airway.
- Tongue retaining devices (TRDs). TRDs hold the tongue in place to prevent it from blocking the airway.
The American Academy of Sleep Medicine recommends oral appliances as a viable treatment option for mild-to-moderate obstructive sleep apnea when other treatments have been unsuccessful. They can also reduce snoring, mouth dryness, and problems with jaw alignment caused by long-term CPAP use.
Oral devices are often recommended for patients who cannot tolerate CPAP machines or prefer a more comfortable and convenient sleep apnea treatment option. They are also effective for mild to moderate cases of sleep apnea and are often covered by insurance.
Benefits of Oral Sleep Devices
Oral appliances can provide numerous benefits. Many users find that these devices are:
- Comfortable: These devices fit in your mouth like a retainer or mouthguard and are easy for patients to use.
- Customizable: Oral devices are made from an impression of your mouth, ensuring the devices fit perfectly.
- Easy to use: Unlike a traditional CPAP machine, these devices require minimal effort before bedtime and have no wires or cords.
- Portable: Oral devices can fit in your pocket, making them easy to travel with, allowing you to sleep comfortably anywhere!
If you are suffering from sleep apnea and your Philips CPAP device was recalled, call our office. Our experienced team will help you find relief through our oral appliance therapy. You will enjoy the restful sleep you deserve without worrying if your CPAP machine is harmful. Oral devices offer a practical option to alleviate your sleep apnea symptoms. We encourage you to learn more about oral device therapy and call us with any questions you may have regarding the Philips CPAP recall. The Sleep Matters team is here for you!