Posted on Sunday, January 15th, 2023 at 6:00 am
On June 30, 2021, the U.S. Food and Drug Administration (FDA) informed the public of a recall of certain CPAP machines manufactured by Philips Respironics. The notice explained the risk of the polyester-based polyurethane (PE-PUR) sound abatement foam used in the machines breaking down and entering the air pathway in the device. Users can swallow or inhale black debris from the foam and other harmful substances, leading to serious health problems.
Although Philips Respironics initially believed it could replace or repair the units within one year, the company is now saying recall efforts will continue this year. Many patients are wondering whether to use a device that can potentially harm them or live without the necessary therapy to treat their sleep apnea.
Common Complications of Recalled CPAP Machines
Continuous positive airway pressure (CPAP) machines force air through a mask to keep a person’s airway open while they sleep. It allows patients to breathe better, alleviating sleep apnea symptoms.
However, the degrading foam in the device can travel into the user’s airway, causing medical issues such as:
- Airway inflammation
- Damage to the liver, kidneys, and other organs
- Allergic reactions
- Skin reactions
- Chest pressure
- Sinus infection
- Respiratory problems
- Some cancers
FDA Presses Philips to Expand Communication Efforts
The FDA ordered Philips Respironics to expand its communication effort in March 2022, the first order like this issued by the agency in decades. The FDA directed that communications should include clearer information about the health risks of using the company’s products.
Philips released a statement about ongoing testing on the recalled CPAP machines. Testing its leading brand device showed low levels of chemical byproducts and particles.
In initial communications about the dangers of the foam, the company said it was a worst-case scenario. The deterioration seems to worsen when patients use unauthorized cleaning methods.
The FDA notified Philips last year of a potential second order to force the manufacturer to improve and accelerate the repair-and-replace program. Although Philips replaced the PE-PUR sound abatement foam with silicone foam, a safety test revealed the new material could move and block the airpath, decreasing airflow to the patient.
The FDA issued a safety communication regarding the reworked Trilogy 100 and Trilogy 200 ventilators last month. Regulators urged Philips to conduct additional testing to confirm the health risks associated with the recalled material and new foam.
Efforts to Repair or Replace CPAP Machines
According to Philips Respironics, tests and assessments of the first-generation DreamStation devices are complete. The test and research program includes five independent, certified testing laboratories. Philips has reviewed and assessed test results with qualified third-party experts and an external medical panel.
The new tests included 61 new DreamStation devices, 96 used devices, and 24 devices with lab-aged foam. The results show exposure to particulate matter emissions from degraded foam isn’t likely to cause appreciable harm to patients’ health.
The manufacturer provided the analyses and data to the FDA and other authorities. However, the FDA is still reviewing the data and analyses to determine whether it will reach different conclusions than Philips and its experts about the research.
Get a Better Night’s Sleep with Silent Night Therapy
At Silent Night Therapy, our experienced New York sleep specialists provide effective services to manage the symptoms of sleep apnea. You should not hesitate to contact our office and learn about oral appliance therapy, a CPAP alternative to treat sleep apnea and other sleep-related disorders.
We’re ready to help you in your journey toward quality sleep and better overall health. Call us today at 631-983-2463 if you’re experiencing adverse symptoms or want to discuss treatments for your diagnosed sleep apnea.