As if you didn’t have enough to worry about.
You already suffer from respiratory issues. You have a chronic obstructive pulmonary disease such as obstructive sleep apnea or another of the three types of sleep apnea (to find out more about the medical facts of these health conditions click HERE). So, you sought professional medical advice from a health care provider like a sleep medicine specialist to prescribe a CPAP or BiPAP machine designed to increase air pressure in your respiratory tract as you sleep. That higher air pressure was supposed to protect you from the adverse health effects of the disease. That’s why you consulted your health care provider in the first place.
CPAP & BiPAP Machines Recalled for Potentially Causing Dangerous Health Conditions
Now, it turns out that the Philips Respironics company, one of the largest manufacturers of CPAP machines and BiPAP machines, has recalled many of those devices and certain Philips Respironics ventilators because they may, in fact, be harming patients.
The sound-dampening material used in some positive airway pressure BiPAP and CPAP machines breaks down (more about this later) into tiny black particles that can be inhaled or ingested and cause serious problems.
We’ll talk in a minute in more specific terms about exactly how a CPAP or BiPAP device intended by your health care provider to deliver ventilator support instead significantly threatens your well-being. For now, suffice it to say that both Philips Respironics and health care providers have received reports of adverse health effects and acknowledge that, as it states in the Recall Notification: “These issues can be life-threatening, cause permanent impairment and/or require medical intervention to preclude permanent impairment.”
(For a list of the BiPAP and CPAP machines recalled, click HERE.)
A Refresher on the Mechanics of the Recalled Devices
As a reminder, the medical devices that a healthcare provider might prescribe to treat sleep apnea or another chronic obstructive airway disease are those that deliver positive air pressure to the patient while they are sleeping. Most deliver CPAP therapy (continuous positive airway pressure), but some function a bit differently, delivering BiPAP therapy (bilevel positive airway pressure).
Both types, however, utilize continuous pressure, on the inhale (inspiratory positive airway pressure) and on the exhale (expiratory positive airway pressure). No matter the non-invasive ventilation techniques involved, they all push air into your lungs.
Mask Focuses Harmful Substances
To deliver pressurized air to a patient suffering from a chronic obstructive pulmonary disorder, the devices use some type of facial mask – sometimes a full face mask (particularly popular when bilevel positive airway pressure is involved as with most BiPAP machines) and sometimes a nasal mask or nasal plugs.
The type of face mask used, however, doesn’t matter in the context of potential health risks associated with the devices recalled by Philips Respironics. The point is that potentially harmful substances are transferred directly and efficiently from the machine into your airway.
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It's the Noise
Whether we’re talking about a CPAP machine or any of the various types of BiPAP machines, the early models had one thing in common: they were loud. No matter the air pressure settings used, noninvasive ventilation is a process that makes noise.
A characteristic symptom of obstructive sleep apnea is loud snoring, which can cause some discord if one doesn’t sleep alone. One goal of delivering pressurized air to the patient is to promote domestic tranquility by reducing snoring. So manufacturers of CPAP and BiPAP machines sought ways to make their devices quieter so that your bed partner isn’t as annoyed by the racket the machine makes as by the snoring.
Philips Respironics Sound-Dampening Foam
The primary culprit is the foam that Philips Respironics used in some of their CPAP and BiPAP machines to dampen the sound. That foam is made of polyester-based polyurethane, sometimes called PE-PUR.
PE-PUR in a CPAP machine or a BiPAP machine causes problems in one of two ways:
First, by “off-gassing.” That is, the foam emits chemicals such as volatile organic compounds (VOCs) into the atmosphere surrounding the machine and into the tube connecting the machine to the face mask. Thus, instead of receiving, say, oxygen therapy, the patient inhales harmful chemicals with every breath.
Secondly, but likely more prevalent and problematic, the foam, itself, degrades, breaking down into tiny particles that can find their way into the air hose and be inhaled (and sometimes swallowed) by the user. Some of these particles are large enough to be seen as minute black dots collecting in the tube and other parts of the equipment. Others are microscopic and more easily inhaled or ingested.
To Make Matters Worse
Any machine used to treat sleep apnea or other breathing disorders can cause nasal dryness. To ameliorate this condition, many CPAP and BiPAP machines, including those recalled by Philips Respironics, incorporate humidifiers into their design to warm and moisturize the air delivered to the wearer.
Sounds great, right? The problem is that PE-PUR foam degrades more quickly and more thoroughly in hot, humid environments. The process is called “hydrolysis,” the name for the phenomenon that occurs when water reacts with a chemical compound to form two or more different products. The fact that PE-PUR foam is particularly susceptible to hydrolysis is well-known and has been documented in numerous peer-reviewed studies.
Philips Respironics Also Blames Cleaning Methods
Also, as you might imagine, CPAP and BiPAP machines can get kind of grungy after continued use, particularly the face mask or nasal plugs and hose. Sometimes users will utilize methods like ozone or ultra-violet light to clean their equipment. According to Philips Respironics, foam degradation may be caused or exacerbated by these and other “unapproved” cleaning methods.
The Identified Health Risks of Exposure
The health risks associated with both foam degradation and chemical off-gassing can be quite serious, even life-threatening, and can require medical intervention.
According to the Food and Drug Administration, the potential risks of these two types of possible exposure are:
Inhaling polyurethane foam particulate matter:
- Irritation to the skin, eyes, nose, and airway (respiratory tract)
- Inflammatory response
- Toxic or carcinogenic effects, including to organs such as kidney or liver
Inhaling chemical compounds and VOCs released from polyurethane foam:
- Irritation of the nose, eyes, or respiratory tract
- Hypersensitivity reaction, such as an allergic or other immune system response
- Nausea or vomiting
- Toxic or carcinogenic effects
Adverse event reports received by the Food and Drug Administration and linked to a CPAP or BiPAP machine since April 2021 include cancer, pneumonia, asthma, unspecified general respiratory problems, infections, headache, cough, difficulty breathing (dyspnea), dizziness, and chest pain.
“Inflammatory response” in this context does not mean simple inflammation of tissues like you might experience with seasonal allergies. Rather, it refers to Systemic Inflammatory Response Syndrome, which can result in sepsis, multiple organ dysfunction syndrome, and even death.
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Another Potential Problem
When the PE-PUR foam degrades, tiny black particles sometimes can be observed in the hose, mask, and other parts of a CPAP or BiPAP machine. Those tiny black particles are what the user inhales. While the Phillips company maintains that most of the degraded particles are too large to penetrate deeply into lung tissue and collect in the lungs’ air sacs (the alveoli), this possibility remains a concern.
Whenever foreign matter invades lung tissue, problems can result. When microscopic particulate matter invades lung tissue in the setting of a positive airway pressure BiPAP or CPAP device, designed to ensure that the airway stays open – whether with higher pressure or lower pressure – one can easily see how the potential for deeply imbedded particles increases.
While this potential has not yet been discussed in medically reviewed journals to date, and while Philips Respironics maintains that the particles involved in CPAP and BiPAP machined foam degradation are too large to become lodged deeply into lung tissue, the situation bears watching.
What You Should Do as a Patient
First, obtain healthcare advice from sources qualified to provide medical advice, preferably your healthcare provider or medical team, whether that includes a respiratory therapist and a physician board-certified in sleep medicine or your family practitioner.
Your healthcare team, in whatever way it is comprised, not only has ready knowledge but also has access to academic research institutions studying this situation as well as reputable sources of medically reviewed journals.
If your device is on the list of recalled machines, consult with your doctor about continued use and what steps you should take in your care. Your health is the important thing, and you should always consult your healthcare provider when making medical decisions, from which pain reliever to take to which BiPAP machine is appropriate.