Understanding the Risks Associated with BiPAP, CPAP Recalls

What Is Sleep Apnea?

Sleep apnea impacts breathing during sleep. Despite the general premise, there are three different types of sleep apnea: obstructive, central, and complex sleep apnea.

Patients with obstructive sleep apnea attempt to breathe; however, they cannot get air to flow in or out of the nose or mouth. Often — in approximately 94% of patients — this type of sleep apnea results in snoring. The National Institute of Neurological Disorders and Stroke (NINDS) notes that obstructive sleep apnea occurs when the tissue in the back of the throat blocks air passage.

Globally, the National Council on Aging (NCOA) estimates that 936 million adults have mild to severe obstructive sleep apnea.

Meanwhile, central sleep apnea, which is a less common form of sleep apnea, occurs when the body is not attempting to breathe because the brain is not sending the appropriate signals. Complex sleep apnea combines the two subtypes.

These lapses in breathing occur in episodes that usually last 10 seconds or longer, depending on the severity. In between the episodes is when the snoring typically occurs. Other symptoms include periods of silence and gasping for air, restless sleep, falling asleep during the day, headaches, difficulty concentrating, irritability, forgetfulness, mood swings, anxiety, and depression.

Beyond these symptoms, untreated sleep apnea can increase a patient’s risk of stroke, transient ischemic attacks, coronary artery disease, heart failure, irregular heartbeats, heart attack, and high blood pressure. 

Lifestyle changes, such as medication and alcohol, weight loss, or smoking cessation, may help alleviate sleep apnea. Additionally, some individuals may change their sleep environments by using pillows or devices that help them keep their airways open.

However, severe cases of sleep apnea may require the assistance of positive airway pressure machines to assist with airflow.

BiPAP

The Cleveland Clinic notes that bilevel positive airway pressure (BiPAP) machines push air into the airway and allow the air to be released from the lungs by providing different pressures when a patient inhales and exhales through inhalation positive airway pressure and exhalation positive airway pressure.

These machines can be set to a specific time or can be automatic, allowing them to adjust to the user’s natural breathing pattern.

CPAP

CPAP machines use masks to deliver continuous air to patients while they sleep.

The NCOA notes that continuous positive airway pressure (CPAP) can be an effective treatment option for obstructive sleep apnea, with approximately 85% of obstructive sleep apnea patients using a CPAP machine.

This treatment method can reduce the severity of the condition, blood pressure, and daytime sleepiness. In addition, it can help improve quality of life.

Overview of Recalls

BiPAP and CPAP machines can be lifesaving technologies for patients with sleep apnea; however, since 2021, there have been multiple recalls on these machines and the masks associated with them. As a result, many patients have had to wait for new machines, potentially compromising their health.

In the remainder of this article, LifeSciencesIntelligence explores the recalls on these devices and what that means for patients who use these devices.

Foam

In June 2021, Philips Respironics recalled multiple ventilators, BiPAP, and CPAP machines due to risks associated with the polyester-based polyurethane foam in the devices.

The initial recall applied to multiple machines, including the following:

• A-Series BiPAP A30, A40 (ventilator), Hybrid A30 and Auto (ventilator)
• C-Series ASV (ventilator) and S/T and AVAPS
• DreamStation ASV, Go, and ST, AVAPS
• Dorma 40 and 500
• E30
• Garbin Plus, Aeris, LifeVent (ventilator)
• OmniLab Advanced+
• REMstar SE Auto
• SystemOne ASV4
• SystemOne (Q-Series)
• Trilogy 100 (ventilator)
• Trilogy 200 (ventilator)

According to the recall notice, foam is incorporated into the devices to minimize the sound and vibrations that come from the machines. However, the company found that when the foam breaks down, some patients may inhale the foam or chemicals released from the breakdown.

While the foam can break down over time, the risk is exacerbated by excess heat, humidity, and inappropriate cleaning procedures.

As a result, these patients may experience serious injuries from inhalation. The side effects of inhalation or swallowing pieces of the foam include eye, nose, skin, or airway irritation. Additionally, patients may have an inflammatory response, headaches, asthma, or organ toxicity.

Beyond the actual impacts of the foam, inhaling the chemicals released from its breakdown may cause headaches, dizziness, irritation, hypersensitivity, nausea, vomiting, and toxic or cancer-causing side effects.

The FDA notes that, since April 2021, over 105,000 medical device reports were submitted, with nearly 400 deaths associated with foam breakdown or suspected foam breakdown.

“We recognize that patients rely on these devices, and we are closely monitoring the company’s actions to ensure that the issues are resolved in a timely manner given the impact on patients. We are committed to continuing to regularly update the public about the status of this recall, including any new recommendations or actions regarding Philips Respironics’ devices,” stated Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in an FDA update published in November 2021.

Since these recalls, Philips has worked with the FDA to produce 3.3 million new devices that replace the polyester-based polyurethane foam with a silicon-based foam.

Masks

In September 2022, Philips issued another set of recalls that affected patients with BiPAP and CPAP machines. However, these recalls applied to the masks, including the DreamWisp, DreamWear, Amara View, Wisp, and Wisp Youth masks, used by patients who have these machines.

The FDA estimated that over 17 million patients were impacted by this set of recalls. According to the organization, the magnets inside the masks may have impacted metallic medical devices, including brain stents, aneurysm clips, pacemakers, implantable cardioverter defibrillators ventriculoperitoneal shunts, ocular implants, magnetic denture attachments, insulin pumps, certain neurostimulators used in and around the neck, and cochlear implants and metallic objects in patients’ bodies, such as shrapnel or splinters.

The magnets in the masks can shift these devices or objects and alter the efficacy of metallic devices.

At the time of the recall, Philips had received reports of 14 injuries associated with the mask’s magnets, including pacemaker failure, arrhythmia, seizures, and irregular blood pressure.

More recently, on December 20, 2023, ResMed issued a similar recall on all ResMed masks, linking the recalls to issues with magnets in the mask.

As the FDA continues to investigate the recalls, patients and providers should continue to monitor the recalls and consider how to manage them with alternative machines or treatment options.