Philips' Recall of Sleep Apnea Machines and Ventilators Leaves Users Breathless
A few months ago, my husband happened to be checking his newsfeed, and he came upon a story about the massive Philips’ recall of ventilators and pressure support sleep devices. Most patients who use them require CPAP or Bi-Pap pressure to ensure adequate oxygenation at night.
We were shocked. I use the Trilogy 100, a Philips ventilator. I wasn't sure what bothered me more, the recall itself or the fact that I had to stumble upon the news myself. I have been a Bi-pap user for almost 20 years because of my low lung volume due to my kypho-scoliosis.
The recall was issued because of the noise-abatement foam degrading inside some Philips machines manufactured between 2009 and 2021. When it breaks down, pieces can come off that are then pushed into the user's lungs. Additionally, even if the foam doesn't break off, it can off-gas carcinogenic fumes. Philips referred to the issue in their April earnings call, and then in June, the FDA issued a formal recall notice. It is a Class 1 recall, meaning that the use of the device could cause serious injury or death.
The recall affects an estimated three to four million machines globally, over half of which were sold in the United States. Every device represents a patient who needs it to get a healthy night’s sleep and have a high quality of life. Many patients who are prescribed these machines as a medical treatment have multiple health issues they are trying to manage. Conditions such as high blood pressure, chronic headaches, pulmonary insufficiency, just to name a few. They need CPAP to help them live healthier, not become sicker because they are breathing in toxic materials. It boggles my mind how Philips did not use the highest quality parts in their life support medical devices. Wouldn't the safety and integrity of air quality and airflow be your highest priority as a ventilator manufacturer?
It is unclear when Philips actually knew about this problem. I doubt it was as recent as they are stating. My suspicion stems from the fact that some patients have been complaining for years. Some users have inhaled debris and others have experienced headaches. I should note that not all Philips ventilators and sleep machines are on the recall list. Their newer devices were not impacted, making me think they must have been aware enough about the foam degradation issue not to keep using it. Philips claims, however, that their decision to use different materials is simply because of "advances in materials and technology."
Another potential red flag is that when you register your machine for the recall, they specifically ask if you have ever used an Ozone cleaner on your machine. Ozone cleaners are special devices that are highly promoted in the sleep device industry for users to clean and sanitize the inside of their machine. I don't, nor would ever, use something like that. I think they and similar "cleaning" devices are just a gimmick. These Ozone cleaning systems have been linked to incidents of increased foam deterioration. Users who have access to all the equipment have done their own testing to prove it. I think if a random joe-shmo can figure this out, how does a multi-billion dollar medical manufacturer not figure it out too?
Moving forward
Regardless of when Philips was truly made aware of the problem, the whole situation is terrible. A significant trust has been broken. A part of me doesn't even want a Philips machine anymore. I'm considering asking my doctor if I can switch to a different vent manufacturer. On the other hand, now that Philips is under FDA scrutiny, maybe it would be better to stay with them. How am I supposed to know if companies are being safe and ethical when marking life-dependent devices? I think it is ludicrous that I even have to wonder such a thing! There needs to be a third-party who is tasked with independently investigating what exactly happened. Philips needs to be held accountable for its actions. We deserve to know what they knew, when they knew it, and their internal discussions on how to resolve the problem. Such an investigation will help rebuild trust among patients and make sure nothing like this can happen in the future.
As for the status of my machine in the recall process, the home health company I rent my vent from informed me that it was my responsibility to register my vent with Philips, saying that is what Philips wants. I found this a little frustrating. I'm very restricted in being able to adjust my Bi-Pap settings, etc. But when it comes to managing its replacement, well, that's on me. They insist that they are just following orders from Philips, and maybe they are. I suppose I am just a little salty. Anyone who has had experience dealing with a DME company or home health provider can probably relate. Patient-centered or self-directed care when you have a disability can be a tricky thing. Oftentimes companies always think they know better. But we know that isn't always the case. Advocating for ourselves is always a lot of work. But it requires even more effort when dealing with a company or institution that we know or feel is not acting in our best interest.
When exactly I am going to get a new vent remains a mystery. As this Verge article points out, I shouldn't be holding my breath (pun intended) for anytime soon. Philips response has been slow or non-existent. Many patients have had no follow-up from Philips at all. My home health company said they won’t even answer their calls at this point.
Aside from the usual disclaimer of “consult with your doctor,” Philips default answer is to just stop using the machine. They seem to be missing the "life-support" part of their vent descriptions. The whole purpose of sleep machines is to keep a person's airway open during sleep. Many people who use one of their sleep devices for mild, or more traditional sleep apnea should not go a night without their machines, either. For people with severe sleep apnea, sudden death while sleeping can be a real possibility. It is common knowledge that good quality sleep is essential for healthy living. For people such as myself, sleeping without supportive ventilation at night is not an option. It is also not an option for full-time vent users. The fact that Philips would even suggest such a thing is ridiculous and not realistic.
Thankfully, I don't feel like I am having any adverse side effects from the vent I am currently using. As a precaution I am using an additional bacterial filter to capture debris that might be expelled from the machine, so it doesn't enter my lungs. It won't do anything for any off-gassed toxins, but I'm not experiencing coughing or headaches, so that is good. Also, my respiratory therapist said when they do routine testing and cleaning of the devices they inspect the foam and other internal components. So that gives me some peace of mind.
This brings me to a few final thoughts. Disability activist Alice Wong has started the #SuckYouPhilips on Twitter. She, too, a Philips vent user, has been very public in her disgust and anger over this situation. She feels, and I agree, that Philips' behavior is just another example of the disregard and disposability that larger society exhibits toward disabled people. Our lives are literally less valued. This attitude comes from a wildly inaccurate bias that a disabled life is not a worthy life. This bias creates a belief and a perception that we don't experience, appreciate, or value our own existence the same as a non-disabled person values their own.
Frans van Houten, CEO of Royal Philips, said in a statement: “Patient safety is at the heart of everything we do at Philips.” Forgive my side-eye, but is it really? Are they really sorry? Or are they just sorry they got caught? Because I think that if they genuinely valued disabled people, understanding the fragility of our health and dependence on their equipment, they would have spared no expense to make them safe.
Additionally, they would be managing this recall better as well. Philips would be putting more resources into getting machines replaced faster. They would also be more communicative and transparent in the process. But mostly what patients have heard is nothing.
So while we wait for answers we know will never come, we must keep reminding ourselves and our community that despite how disabled people continue to be ignored and dismissed by the world, we are valued, worthy, and strong. We will never stop fighting for our rights, quality healthcare, and our lives.