In the midst of the pandemic, what seemed like a mundane chore for Diana – checking her mailbox – quickly turned out to be the beginning of panic and confusion. She had received a notice from Philips Respironics stating that her life-saving medical device, Continuous Positive Airway Pressure (CPAP), had been recalled over potential health risks.
“I was confused. I did not know what the problem was until I heard it on the news and social media. [ I wondered] am I going to be sick?” recalls Diana, who suffers from sleep apnea and treats it using a Philips CPAP device. She was uncertain if its benefits would outweigh the cost. Worse, she had no one who could guide her on this issue.
Imagine this: the very treatment that is supposed to sustain you at work, prevent you from falling asleep behind the wheel, protect your job, becomes the source of fear of losing your job, anxiety about going to sleep, risk crashing into another vehicle and worse, may cause cancer!
A PERFECT STORM OF 2021
In 2021, when the entire world was mired in the COVID-19 pandemic, the Food and Drug Administration (FDA) recalled several Philips Respironics PAP devices over safety concerns. It was one of the largest medical device recalls in history!
Diana had one of the estimated 15 million recalled PAP devices worldwide.
A PAP device pumps pressurized air through a mask into the airway during sleep and is used to treat sleep apnea. The recall was initiated due to potential health risks associated with the degradation of the polyester-based polyurethane foam used in the devices to reduce sound and vibration. The concern was that the degradation could harm users through inhalation of toxic particles and gas emissions, which could irritate the nose, eyes, skin, and respiratory tract, cause inflammation, dizziness, nausea or have cancer-causing effects.
Many, like Diana, heard about it on the news. “If this is so serious, why don’t I have a phone call from my hospital or a real person to tell me about the recall, to give me support, or information about the problem?”
At that time, I was mad, feeling anxious and frustrated thinking that sleeping with this device can cause me physical, mental and financial problems.
For someone like Diana, stopping CPAP therapy was not an option. So, she called Philips in the USA in the hopes of exchanging reliable communication with a “real person”; not social media, not the T.V. news, not her internal dialogue. “I felt better to get the news from a real person.”
Philips promised her a replacement device, “because I was registered somewhere, at some point somebody knew about me and about my machine.” She added, “It took a year and a half to receive my new machine. The new device costs at least 2000 dollars with masks, tubes and other things. So, it’s quite expensive. At that time, Philips had refused to reimburse if we purchased another device.”
So, until then, Diana decided to keep using the same device, “because I have a severe apnea on my back. I absolutely needed my machine. If I don’t use CPAP, I can fall asleep when I drive. I snore while I sleep – I hear myself. I feel my tongue collapsing back, and I need to get up.”
She hoped that the benefits were higher than the risks. “I just hoped that my health would stay good. Occasionally, I had wheezing problems. I wondered if it was due to CPAP. I would look into my device’s container every morning to see if I had particles in the water.”
ON AND OFF RELATIONSHIP WITH CPAP
Her journey of using CPAP was bumpy. Her husband noticed Diana’s snoring and difficulty breathing during sleep, which prompted her to take a home sleep test recommended by her doctor.
She immediately got diagnosed with severe positional obstructive sleep apnea, i.e. severe sleep apnea episodes when she sleeps on her back, but not on her sides. Her doctor did not prescribe her CPAP therapy; instead, she was advised to sleep only on the sides where she had no apnea.
It was all fine until 2011, when she had hip surgery. She was forced to sleep on her back. “So, I bought a Philips CPAP machine. I used it only for six months, just until I healed my hip.” Three years later, her other hip was operated on, and she returned to the same approach.
But in 2019, when Diana was 62, she noticed some changes in herself. She was feeling tired during the day and falling asleep behind the wheel. “I was scared. When your car steers to the side of the highway, and you wake up to the ‘ggrrrrrr’ sound. I would say to myself, ‘Oh my God! That is scary.’” That is when her respirologist diagnosed that she had developed moderate sleep apnea on both sides, along with severe apnea on the back.
Since then, she has used CPAP every night.
THE PAP STORY HAS NOT FINISHED YET!
In 2021, when a perfect storm hit the sleep apnea patients, Diana recalled, “the biggest problem was the lack of information. I felt like I was left alone.”
She has a laundry list of unanswered questions for Philips.
She waited for a year and a half to get the replacement machine. But now she wonders, “How come some of the patients got their machine faster than me? How come my friend, who is a bit older than I, received his replacement machine right away? Is it because he was not with the same supplier in Montreal as I was? Maybe it is something to look into.“
“What did Philips do with the machine I sent back to them? Did they destroy it? Did they study it to see if there was a problem? If it was, why did they not tell me anything?“
She continued passionately, “PAP recall story has not finished yet! Some people did not receive their CPAP because they didn’t get the information, especially when you do not live in a city! What about them?“
Philips is still not talking! It is the lack of responsibility that is the issue!
When a nurse doesn’t give the right medication to the patient, her responsibility is to tell the patient, to evaluate the patient, the doctor needs to know, and the papers have to be signed. Philips doesn’t do that! How does it make sense?”
THE NEED FOR CHANGE
1. Improve Patient Education and Access to Information
Diana’s story highlights gaps in access to information about sleep apnea and PAP therapy. While PAP users are often prescribed and provided with equipment, they may not receive sufficient education or ongoing support to confidently manage their therapy.
Diana urged, “They need to give you a document, a video or an app that teaches you how to clean your device? How does your machine work? and gives you information on sleep apnea, the new available devices etc. Because it is easy to forget small details. The doctors don’t have much time to explain all this information. Should I have a follow-up test? Are they necessary? Important? You must think about it yourself.”
She was perplexed, “You know something funny, it’s my machine, I paid for it. But nobody shows me how to change a bit of pressure, let’s say by 0.5, to test it. I need to rely on the therapist.”
2. Need for clear communication pathways
The PAP recall highlighted strong gaps in i) communication between manufacturers, healthcare providers, patients, and regulatory agencies and ii) preparedness to respond to massive recalls which severely affect patient care. When the recalls arise, reliable communication pathways should be in place which allow patients to access timely information on updates, alternatives for CPAP treatment, and get emotional support.
3. Increase Public Awareness of Sleep Health and Sleep Disorders
Diana shared that sleep disorders receive insufficient public attention despite their substantial impact on health, safety, and quality of life. “You know, when we see a warning on the television saying, ‘A child is missing’? We act, we move. But when we have a big health problem like this one that affects millions, why don’t we do the same? Why wasn’t Phillips all over the news despite being a universal problem with huge consequences for patients?“
We both speculated whether this was rooted in the fact that sleep disorders are not considered as important as other health problems.
4. Strengthen Patient-Centred Partnerships in Research and Care
Diana is a patient partner. She shared that the patients and healthcare professionals should work as a team as they bring complementary expertise. She said, “The patient has their expertise about their health problems, and they should be treated as one and patients should have autonomy in deciding to choose the device, the manufacturer, and when to stop, continue, or purchase a new CPAP device.”
Diana worked as a nurse throughout her life. She discussed her fulfilling role as a patient partner and urged that one should become one. “I am a partner with the Centre of Excellence on Partnership with Patients and the Public, Université de Montréal. As a patient partner, you give your point of view as a patient, what you need, and what is the relation you have with the doctor to the students at the faculty of medicine, nursing, psychology, pharmacy and to researchers.“
As a patient partner, you give your point of view as a patient, what you need, and what is the relation you have with the doctor to the students at the faculty of medicine, nursing, psychology, pharmacy and to researchers.
Diana has been actively involved with the sleep apnea researchers from Canada and has contributed to publications related to research on the PAP device recall. “I have been with them for 10 years now, and we are always talking. I give my perspective on policy and designing a research question.”
5. Improve Equity and Timely Access to Sleep Care
“It’s like you really need to beg and cry your eyes out to have something for your health, you know?”, Diana said frustratingly while discussing her sister’s experience of trying to get a sleep test.
She raised concerns about long wait times and disparities in access to sleep assessments, more so for individuals living in remote areas. For example, her sister lives in a village in the woods near Quebec City. “She’s waiting for a sleep test for a year. Nobody calls her. She wants to know if she has sleep apnea because she falls asleep while driving. There’s inequity. Either you need to have a connection with a doctor, or you need to live in a city to get quick access.”
This is an important issue which needs to be acted upon.
6. Improve Early Detection of Sleep Apnea
We discussed the challenges faced by individuals in recognizing sleep apnea symptoms for those who do not have a bed partner, such as snoring, breathing pauses, or abnormal sleep behaviours. Through public education and mandatory sleep disorder screen tools, support should be available for everyone and early, particularly those without a bed partner.
If you or someone you know is affected by the PAP recall, reach out to us to share your sleep story!
