Recall Review and How It Impacted Certain CPAP Machines for Patients and Health Care Providers

The recent recall of BiPAP and CPAP machines manufactured by the company Phillips has created several issues for the millions of patients with sleep apnea who rely on the use of these machines every night and for the health care providers who treat patients with sleep apnea.

On June 14, 2021, the manufacturer Philips issued a recall notification for specific affected ventilation and sleep apnea devices due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices. Read more about the recall here.

In the recall notice, the company advised patients using the affected BiPAP and CPAP machines to stop the use of the CPAP devices and to consult with their primary health care provider to determine the best option for continued treatment and to discuss the benefits of continuing therapy and potential risks. Unfortunately for many patients—especially those with severe sleep apnea—that is not a reasonable option, and many sleep specialists agree.

Since the recall was first announced, the FDA has recorded more than 1200 complaints and over 100 injuries related to the issue.¹ The recall affected an estimated 3- to 4 million devices globally, based on the company’s production and shipment data. The devices were distributed from July 2009 to April 2021, and over half of them were sold in the US.¹

Philips has identified the following to be among the potential health risks of using a recalled device:

• airway inflammation;
• skin, eye, and respiratory tract irritation (including upper airway irritation);
• headache;
• asthma;
• toxic carcinogenic effects;
• cough;
• chest pressure; or
• sinus infection.

The company has recommended for users of their recalled BPAP and CPAP machines to discontinue treatment.²

According to many sleep medicine specialists, patients should consider continuing with the use of their device until it is replaced or repaired by the manufacturer.

In response to the recall, the American Academy of Sleep Medicine (AASM) suggests that the medical provider prescribe for their patient a PAP device that is not affected by the recall. However, in the case that this is not a viable option, or another device is unavailable, then it is the AASM viewpoint that clinical factors such as comorbidities, severity of symptoms, risks associated with PAP discontinuation, and safety-sensitive roles should inform the decision to continue or discontinue therapy.²

This decision should be made between the patient and their medical provider. The ultimate judgment regarding any specific care must be made by the treating clinician and the patient, taking into consideration the individual circumstances of the patient, available treatment options, and resources.² The AASM advises that patients contact their medical provider as soon as possible to discuss whether to continue or discontinue treatment.²

In an interview on the website Healthline, Dr Abbas Anwar, otolaryngologist and head and neck surgeon at Providence Saint John’s Health Center in Santa Monica, California, commented that “If you have been affected by this recall, it is important to check in with your doctor before completely discontinuing use of your device — especially if you have not yet obtained an alternative.”³

Additionally, Dr Anwar noted that if unchecked, sleep apnea puts individuals at an even greater risk for many cardiac issues such as hypertension, heart failure, and heart attack, ultimately reducing patient quality of life.³

In speaking with a few sleep specialists and patients affected by the recall, they all stated that the recall has caused many issues and patients expressed anxiety in trying to decide to continue using the CPAP machine or discontinue use. Many patients indicated that they were unable to replace the CPAP machine with a machine not affected by the recall due to the added expense of a new machine or because their insurance company would only pay a partial amount or denied a claim for a replacement. Some patients were still making payments on the recalled machines.

One sleep care specialist stated, “In the first few weeks after finding out about the recall, our office was inundated with phone calls from patients expressing fears and concerns about the recall. Many patients were afraid to continue therapy with the CPAP machine due to the health scares associated with the recall.”

The physician added that she and her colleagues recommended patients, especially those with severe obstructive sleep apnea continue using the machine as the risks associated with not using the machine outweighs the risks associated with the recall. She also noted that, “Many of the health risks associated with the recall generally occurred in the machines of patients using unauthorized cleaning methods.” Lastly, she noted that many patients were unable to buy new machines largely due to the fact that they couldn’t afford them.

One sleep specialist stated, "The CPAP recall has caused anxiety in many patients because they know that they need the CPAP machine, but they are afraid to use them because of potential health concerns. We are recommending that patients continue therapy until a replacement machine can be obtained. We are also providing patients with information about dental appliances that are useful in those with mild to moderate sleep apnea that can be made via many dentists if the patient is eligible."

Another sleep specialist stated, "Our office was not even aware of the recall until one of our patients notified us and we were faced with a lot of phone calls from patients expressing concerns. Some patients have decided to stop using their machines because of fears of adverse health effects due to the recall.  We have suggested that patients especially those with severe sleep apnea continue to use their machines until a replacement or repair can be obtained."

A patient with sleep apnea stated, "I have used a CPAP machine for more than a decade and I cannot afford to sleep without it because without the machine, I experience dizzy spells, blood pressure increases and episodes of tachycardia. The recall was upsetting because I cannot sleep without the machine. I had to pay for a whole new machine because I cannot wait for the company to repair or replace the machine. I was not prepared for the unexpected expense, but fortunately the doctor’s office has allowed me to pay for the new machine in installments and I felt more at ease knowing that I had a machine that was not affected by the recall. While waiting for my replacement machine, I experienced a lot of anxiety when I was using the recalled machine and it affected my health.” 

Another patient stated, “I will continue to use the CPAP machine nightly because my health depends upon it. I have never used any of the unauthorized cleaning devices and check my CPAP tubing daily for black particles as stated in the recall notice. I have also met with my sleep specialist who encouraged me to continue using the CPAP until a replacement is available. I do think the manufacturer should have done a better job in notifying people about the recall.” 

Another patient stated, “I am uncomfortable using the recalled CPAP machine and have decided to discontinue use and consulted with my sleep doctor about alternatives. I will be getting fitted for an oral appliance at my dentist office. While I can tell the difference in my sleep patterns since I discontinued the machine, I feel that is best for me and I don’t worry about health effects of using a recalled machine. I have not received any notification about a time frame for replacement of a machine either.”

Recent Developments

On September 1, 2021, Phillips received authorization from the FDA that the repair and replacement program for all first-generation Dream Station CPAP machines in response to the June 2021 recall which is scheduled to commence in September.⁴ In addition to the rework, the company has already started replacing certain affected first-generation Dream Station CPAP devices in the US with Dream Station 2 CPAP devices. Philips remains in dialogue with the FDA with respect to other aspects of the recall notification and mitigation plan in the US.⁴

In the press release, Frans van Houten, CEO of Royal Phillips stated, “We fully recognize that the timeframe for remediation of the affected devices places patients in a difficult situation. 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.”⁴

This program is expected to be complete within the next 12 months. More information can be found here. 

Conclusion

Sleep apnea is a serious medical condition and if left untreated or undiagnosed can be associated with grave health consequences. The recall has affected millions of patients and has created several issues for both patients and their providers. The challenge that remains for many is to decide to discontinue therapy or continue therapy with the recalled CPAP machine until a replacement is available. Unfortunately, many patients were not prepared for the unexpected medical expense of getting a new machine and many patients can not afford to discontinue therapy because of health risks.  

The best thing that patients can do is to consult their sleep specialists and via shared decision making decide on therapy options. This recall has been an important wakeup call in the urgent need to address the gaps in care for those who have sleep apnea. As one of the most accessible healthcare providers, pharmacists can provide patients with updated information about the CPAP recall and encourage patients to keep the lines of communication open with their sleep specialists to continue to decrease the risk associated with sleep apnea.

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