A few months ago, news broke that CPAP manufacturer Philips Respironics had issued a massive recall that covered practically all of its CPAP and BiPAP machines. As one of the biggest manufacturers of CPAP equipment in the world, this recall affected an estimated three to four million products.
News surrounding the recall has continued to make headlines, and is obviously a major source of concern for individuals with sleep apnea. Here is a closer look at some important information that you should be aware of.
A Refresher on the Recall
Philips Respironics issued a voluntary recall in June after it was discovered that the sound abatement foam used in the company’s DreamStation CPAP and BiPAP devices (including the portable DreamStation GO), as well as their Trilogy mechanical ventilators, was prone to suffering significant degradation. As the foam broke down, it actually entered the tubing and mask, leaving behind black particles that users would discover in the morning.
Obviously, constant exposure to foam debris over the course of the night is far from ideal. Philips Respironics reported that exposure to the foam particles could cause headaches, asthma, and irritation of the skin, eyes, and respiratory tracts. Though the company had not received reports of serious health outcomes at the time, it noted that adverse kidney and liver effects, nausea, dizziness, and possible carcinogenic outcomes were possible.
The company advised individuals to stop using affected CPAP and BiPAP devices immediately, explaining that it would replace devices for its customers with new or refurbished models that no longer used the defective material. Individuals who absolutely needed to continue using a life-sustaining ventilation device were advised to use an inline bacterial filter.
More Recent Updates
When the recall was first announced, Philips Respironics reported that the foam degradation was primarily due to environmental factors like heat and humidity. The company also claimed that using CPAP sanitizing devices (which use ozone to kill bacteria) accelerated the foam degradation.
However, lawsuits have since been filed alleging that a flawed design is what is to blame for the foam degradation — not sanitizers. It shouldn’t be surprising that several class action lawsuits have also been filed in connection with the recall, claiming negligence, product liability, consumer law violations, and more.
In July, the FDA updated its warning about the Philips Respironics products, designating this as a Class I recall — or the most serious type of recall, in which the recalled item is believed to potentially result in life-threatening injuries or impairment.
In addition, the scope of the repairs is proving problematic for Philips Respironics. In a recent statement, the company said, “We are working to address this issue as expeditiously as possible. Given the number of devices currently in use (estimated at 3 to 4 million units globally based on production and shipment data – about half are in the U.S.), we expect to complete the repair and replacement programs in each country within approximately 12 months from obtaining the relevant regulatory clearances.”
The company has produced around 55,000 replacement units per week. While it says it plans to increase that to 80,000 per week in the near future, it will clearly be some time before all affected units have been replaced. In fact, it is currently estimated that the recall will last until September 2022.
What Can You Do?
First and foremost, if you own a Philips Respironics device affected by the recall, you should call the company directly at 877-907-7508. Regardless of where you bought your device from (including Help Medical Supplies), you must call this number to begin the registration process for getting a replacement device. You will need to provide your device serial number as part of this. Philips Respironics will help you with getting your device replaced.
After that, however, you have two main options regarding CPAP therapy: wait for your replacement to arrive (which could take months), or buy a replacement from a different brand. It is recommended that you consult with your physician to determine what will be best for your sleep quality and overall health.
Insurance often will not cover purchasing a replacement CPAP unit if your Philips Respironics device is less than five years old — an important concern to be aware of.
If you used a Philips Respironics device for an extended period of time, it would also be wise to monitor your own health for any of the symptoms or illnesses mentioned in the recall. Consult with your doctor if you have any concerns.
Get Your Replacement CPAP From Help Medical Supplies
At Help Medical Supplies, we understand how frustrating and disturbing this recall can be for Philips Respironics users. You don’t want the medical device you depend on for quality sleep to harm your health. At the same time, many people simply can’t afford to go without using a CPAP machine — particularly as extreme fatigue can put you at greater risk of falling asleep and causing an accident while driving or at work.
We no longer sell Philips Respironics devices subjected to the recall, but we offer several quality devices from brands such as ResMed, 3B Medical, and Fisher & Paykel. Even more importantly, our website helps make what may be an unexpected purchase more affordable with discounted prices, available no-interest financing on purchases over $500, and free shipping on all orders over $89.
While navigating the recall can be undoubtedly stressful, we’re here to help you get the quality sleep you need.