In June 2021, Philips Respironics issued a product recall for specific ventilation devices and devices that treat sleep apnea due to a potential health risk. The devices were manufactured between 2009 and April 26, 2021. The recall is due to issues related to the polyurethane foam that may degrade and enter the device’s air pathway. Once in the air pathway, the particles may be inhaled by the device user. Additionally, the foam may off-gas chemicals during use. Unapproved cleaning methods may increase foam degradation. These issues could result in serious health concerns, including difficulty breathing and cancer.
To see the full list of affected devices, consult the Philips Respironics Medical Device Recall notice. If you or a loved one uses a Philips Respironics ventilator, BiPAP or CPAP machine, please contact your health care providers to determine how to proceed.
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It is estimated that there are 25 million Americans with sleep apnea, a sleep disorder that is treated using these medical devices. Many people who suffer from sleep apnea use CPAP breathing machines to ensure that their breathing is consistent and constant each night. Sleep apnea patients have irregular breathing while sleeping, with some patients stopping and starting breathing each night. This could happen hundreds or thousands of times each night. This contributes to other health challenges, including fatigue during the day, high blood pressure, heart problems, Type 2 Diabetes, and complications with surgery and medication.
What Are Sleep Apnea Patients Supposed To Do?
Some patients have reached out to their health care providers and been advised that they should continue using their devices. At the same time, others have been advised to stop using them. If you’re unsure what to do next, contact your healthcare provider, fill out a form on the Philips website and file a report with the MedWatch Voluntary Reporting Program.
Some sleep apnea patients feel that they’re stuck between a rock and a hard place. On the one hand, using a CPAP machine ensures a good night’s sleep and treatment of sleep apnea. On the other hand, the risk of health concerns due to off-gassing and inhaling foam particles is troubling. Sleep apnea patients should not have to choose between treating sleep apnea and not using their treatment device. But the health risks of skipping the machine or utilizing the device are extremely concerning to patients. They are so concerned that some have decided that legal options are necessary.
Some healthcare providers are uneasy with what to tell patients on how to proceed. Dr. David Claman, medical director at Sleep Disorders Center at the University of California, San Francisco, shared this with CBS News, “I’m advising the more severe patients to stay on CPAP. and then I’m to some degree in the milder cases, letting them choose because I also feel uncomfortable with saying I can’t know that this is safe.”
For many sleep apnea sufferers, the potential year it could take to fix or replace a recalled CPAP device is too long. And yet, unless their machine is at least five years old, insurance companies will not pay to get a new one, and many consumers cannot afford to purchase a replacement on their own, leaving many users frustrated.
Philips Devices Affected by the CPAP Recall
Continuous Ventilator, Non-life supporting:
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- C-Series ASV
- C-Series S/T and AVAPS
- OmniLab Advanced+
- SystemOne (Q-Series)
- DreamStation Go
- Dorma 400
- Dorma 500
- REMstar SE Auto
- Trilogy 100
- Trilogy 200
- Garbin Plus, Aeris, LifeVent
Will Insurance Pay For New CPAP Devices Due to Recall?
Insurance companies, including Medicare, may not provide an easy solution to this recall. Sleep apnea patients who have been instructed to stop using their devices due to the recall may not be able to get a new device. Insurance providers and Medicare could deny a new device because it has not been long enough since purchasing their recalled device.
Instead, patients may need to wait for their affected devices to be repaired or replaced. Philips received authorization from the U.S. Food and Drug Administration (FDA) to rework the affected first-generation DreamStation devices, which consists of the replacement of the PE-PUR sound abatement foam with new material. They plan to start making the appropriate fixes to devices starting this month. The company intends to complete the repair and replacement programs within approximately 12 months. But for those with sleep apnea who rely on a device to improve their quality of life, 12 months is a long time to wait.
“We fully recognize that the timeframe for remediation of the affected devices places patients in a difficult situation,” said Frans van Houten, CEO of Royal Philips. “We are mobilized to deliver a solution to them as fast as possible. We have significantly increased our production, service and rework capacity, and further intensified our outreach to our customers and their patients. We urge patients with affected active devices to register these on the dedicated recall notification website.”
Possible CPAP DOJ Investigation & FDA CPAP Updates
In addition to CPAP lawsuits, Philips may be facing an investigation by the U.S. Department of Justice (DOJ). Royal Philips announced they received a subpoena from the Department of Justice (DOJ) regarding the company’s recall of its CPAP and other respiratory devices in April. The DOJ asked Philips for information about what led to the CPAP recall. This request could signify that the DOJ may be preparing to open an investigation.
The FDA’s investigation of the Philips CPAP recall has determined that the company’s efforts failed to meet federal requirements for recall notifications.
On March 10, 2022, the FDA issued a notification order to Philips under section 518(b) of the Federal Food, Drug, and Cosmetic Act. The FDA felt the company’s CPAP recall notification efforts were inadequate. They were given 45 days to notify all device users, durable medical equipment (DME) suppliers, distributors, retailers, and health care providers who prescribe the products about the recall and the health risks posed by the foam used in the recalled products.
On March 14, 2022, the FDA updated its information about Philips’ prioritization strategy for replacement devices. The FDA recommended, and Philips has agreed, to prioritize patients most vulnerable to poor health care outcomes to receive replacement devices as quickly as possible.
On Monday, May 3, the FDA’s Center for Devices and Radiological Health (CDRH) proposed a second order be issued under section 518(b) of the Federal Food, Drug, and Cosmetic Act. They suggested Philips Respironics be required to “submit a plan for the repair, replacement, or refund of the purchase price of recalled devices manufactured after November 2015.” Philips could attend an informal hearing before the FDA decided whether an official order would be given. Philips did not request a hearing but stated it would provide a written response.