As sleep professionals and patients await repaired or replaced devices, many turn to in-line filters that are readily available over the internet. But are the filters effective against foam particulates and off-gassing?
By Lisa Spear
The gentle hum of his positive airway pressure machine never bothered sleep apnea patient Jeffrey Scott Richards. The device sits by the 43-year-old’s bedside every night in his Texas home, like a trusted friend. He never questioned its safety. After all, he thought, his physician prescribed the machine to keep him healthy.
After about a year of using his DreamStation, the medical device company that sells his device, Philips Respironics, recalled the machine, and millions like it that are used to treat sleep apnea. The company declared that a black piece of foam on the inside of the machines that is used to mitigate noise and vibration from the motor could be breaking down, exposing users to particulates and potentially toxic or carcinogenic chemicals.
Richards’ physician would not advise him on what to do, and Philips gave him no word on how long it will take to repair or replace the device, so Richards decided to continue using the machine, too fearful of going back to the fatigue, heart palpitations, and anxiety that he experienced before his sleep apnea was treated.
“Well, really, you have two options: you could get cancer, or you could die in your sleep, I will probably go with cancer,” Richards says. “I am going to roll the dice and use the CPAP.”
Now, like so many others, Richards turned to the Internet to find an interim solution. Many people in his sleep apnea support group on Facebook, too fatigued during the day or sick with heart conditions to consider stopping CPAP use, turned to in-line filters to mitigate risk while they continue to use their recalled machines.
Richards ordered a CPAP filter off of Amazon, going with the one that had some of the best customer reviews. The CPAP filters that he ordered are often called “in-line” filters because they are usually placed directly inside the tubing that feeds air from inside the positive airway pressure machine to the person’s mouth or nose.
These filters are easy to obtain from online retailers, but there is no evidence they are effective at removing gaseous chemicals. Indeed, the FDA has released a statement stating that in-line filters will not protect consumers from chemicals produced by the polyester-based polyurethane foam inside the recalled Philips machines. It further states, “The FDA does not have evidence of the safety and effectiveness of a filter for mitigating the foam risks, and the FDA’s evaluation is ongoing.”
The in-line filters, Philips says, may trap some foam particles and prevent them from irritating the patients’ airways, but questions remain on just how effective they are for that purpose.
“Product specifications commonly do not always clearly elaborate on performance, such as the particle diameter at which the filter will efficiently remove particles, though they may make more general statements about filtration,” explains Shannon Sullivan, MD, the American Academy of Sleep Medicine’s (AASM) public safety committee vice chair in an email to Sleep Review.
If a company is claiming that filters are N95, meaning they filter at least 95% of very small particles less than .3 microns in size, then they are regulated by the FDA and have to submit data to support their claims. But few, if any, companies that make in-line CPAP filters make such specific claims about what their products are capable of filtering, explains Kristen Hedger Archbold, RN, PhD, co-founder and CEO of Azimuth Sleep Solutions, which produces a N99-rated CPAP mask (not in-line) filter called the PortPatch.
“I think the message is: buyer beware,” says Archbold.
Still, many sleep specialists, unsure of what to do and hoping to prevent some amount of harm to their patients, recommend the in-line filters as a way to cope while they wait for Philips’ next steps. During a recent AASM panel, the moderator mentioned receiving several questions from sleep labs about whether they should consider outfitting their CPAPs used in titration studies with filters.
[RELATED: Sleep Professionals Scramble to Find Solutions for Sleep Apnea Patients Amidst Philips Device Recall]
A sleep specialist at Johns Hopkins Center for Sleep, Sara Elizabeth Benjamin, MD, mentioned that the lab where she works is outfitting its CPAP machines with filters, while making patients aware of the risk by way of a consent form.
But other sleep specialists do not favor their use. These filters will not help filter gases out, so I would not recommend them,” explains Akhil Raghuram, MD, medical director of the Vancouver Sleep Center in Portland, Ore.
In an email to Sleep Review, Philips representative Mario Fante said, “While filters may potentially provide protection from foam degradation, there are design, engineering, and other factors that would need to be addressed to make this use effective.”
The in-line filters, Fante said, should only be used for 1 to 2 days in a clinical setting. Use beyond this period is considered off-label use.
Sullivan cautions that in-line filters can also cause problems with certain devices, including CPAP, APAP, or bilevel devices, which are also the most commonly used devices.
“These devices have design characteristics which may present issues for the use of in-line filters,” says Sullivan, a sleep specialist at Stanford Center for Sleep Sciences and Medicine in California.
Sullivan explains that if someone were to decide to use an in-line filter, it might fit between the device and its tubing. On certain PAP devices, this would interfere with the heated tubing mechanism. Another place the filter might be fitted is between the hose/tubing and the mask, which would be bulky.
Also, heated humidifiers, often used with CPAP, can cause water to collect in the filter chamber, which may clog the filter. The filters may also impact therapy by affecting auto-sensing and/or by adding resistance to airflow, according to Sullivan.
Nevertheless, patients like Richards feel as if they have few options. Some are paying out-of-pocket for new machines. Richards has ordered a ResMed device but doesn’t know when it will arrive. Until then, he says, he has started using an in-line filter and a nagging sore throat that he has had since starting his therapy has dissipated.
“The biggest thing is: I just need to be able to function throughout my day,” says Richards. “Being able to function and being able to do the things that I enjoy to do is important, if that means I have to inhale cancer gas all night long, I will do it until this thing is over.”
Lisa Spear is associate editor of Sleep Review.
Mr. Richards’ thoughts are exactly my own, namely, the risk of dying in ones sleep is greater than a potential risk of cancer, although the risk for me at age 78 is likely greater for sudden death in sleep and less than for Cancer that the risks for a 43 y/o. One of the many travesties (as opposed to tragedies) of this whole scenario is that Philips has chosen not to communicate directly with those who have registered their product for recall nor offered any meaningful timeline for replacement or repair. Nor have vendors for insurers, including Medicare, reached out to their patients. The patient, then, is left on his or her own to make important decisions regarding his or her health.
I have been using the recalled CPap machine for seven months. I do feel more rested and have helped with my headached. Now what do I do, just stop until they get around to replacing my machine. My doctor put an order in to my medical supply company to replace but who is going to pay for this at this time. I do not have money to pay for it and wait months to get the money back. What are my options? I honestly dont have any.
I’m nearly 80, with no pulmonary issues, and have 1630 hours on my Dreamstation Go, used mainly for travel. Have had OSA Dx for 12 years.
My home machine is an Airsense 10. I use CPAP @ 12. Just before the recall, I started using my DS Go at home and slept better with a much better AHI. I have a 30 day trip in Jan 22. I am an MD. I will continue to use my DS Go. My thoughts:
1. Too old to fear the Ca risk. Plus, according to Phillips, the worrisome VOCs blow off in the first 24 hours of use.
2. I had been using the DS Go humidifier and never saw any foam particles. Now I use the Resmed HME setup (HumidX) with their F20 mask, dc’d the humidifier and use an inline filter which has always been clean.
3. My DS Go is registered for recall but no f/u from Phillips. With FDA approval of their foam replacement, I expect to hear soon.
4. My Airsense 10 is a great machine and is super quiet. But I get a better night’s sleep with better AHI’s with the DS Go. The little bit of background noise coming through the tubing is like “white noise”.
5. I am now using a chin strap (Sleep Legends Anti Snoring Chin Strap on Amazon). This eliminated the dry throat I got, especially with the Resmed HME (HumidX). I live in a very dry climate (Las Vegas).
6. The Dreamstation Go is a fantastic travel (and everyday) machine. You can add an integrated battery, and a humidifier. For travel, it’s heavy enough to stay on night stand, small enough to pack easily, doesn’t have a heavy, cumbersome brick, is dual voltage and is quiet enough not to bother your partner. Paired with a chin strap (Amazon), and the Resmed F20 with HumidX, it doesn’t get any better.
I’m a 100% Disabled Veteran and the VA with Philips provided me with a Philips-RESPIRONICS DreamStation machine, I have had issues with it for several years, then as my health deteriorated i was told it might be due to the Philips machine as it has “Issues”.
I notified them of the problems they finally said STOP using it as it is “DEFECTIVE” and to file with Philips (Only) Not the FDA, Not Drug Watch not with the VA etc.??
Here is the case number that Philips gave me 2021072701345006 then they said do NOT report them to the FDA, Philips contacted me this morning and aksed that I not tell other Veterans about the problems and that my machine is on the Recall List and is “Defective”
About the same For me out of the Buffalo VA. If I hadn’t seen something on the internet, I never would have known. The VS told me to just keep using the faulty machine (THEY felt it was worth the cancer risk) and get on the recall list. They would not replace, exchange, or retrofit anything. Not their problem… Damn bureaucrats!
I receive my CPAC five years ago from the VA and not realizing that dog is in affective dysfunctional cpack and I saw this they were recalled all the sea packs that I have which is only one at one travel one I found that the VA recently has required if I want it a a a transplant of my lungs they will do it