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Philips CPAP Overview
- Who: Philips recalled millions of CPAP and other breathing devices, worsening a supply shortage.
- Why: The continuing COVID-19 pandemic and Philips CPAP recall have left supplies stretched thin, say experts.
- Where: The Philips CPAP recall and pandemic affect US consumers, as well as the world.
A Class 1 recall of Philips CPAP machines has worsened a serious shortage of breathing devices that has been heightened by the COVID-19 pandemic, reportedly leaving patients and physicians at a loss.
In June, Philips first announced the recall of its CPAP, BiPAP, and ventilator devices, which the Food and Drug Administration found may cause serious injury or death due to potential risks of chemical exposure posed by noise-reducing foam in the devices made from polyester-based polyurethane.
According to the agency, risks from the chemical exposure include irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects. Between three and four million of the Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices were recalled.
Philips CPAP Recall Escalates Shortage
Due to the recall, there is now an even steeper shortage in ventilators and other respiratory care machines that was brought on by the COVID-19 pandemic, leaving providers concerned as the pandemic continues to surge across the country, Advisory Board reports.
David Schulman, a pulmonary and critical care medicine specialist at Emory Healthcare, told The New York Times that the number of people coming into the hospital with severe respiratory symptoms had increased as a result of COVID-19, and “the demand for these devices has also increased, which is problematic since available supply has decreased as a result of the Philips recall.”
In April 2020, more than half of medical equipment suppliers were already reporting delays for CPAP machines, with the majority saying those delays were more than 60 days, a survey by American Association for Homecare showed.
CEO Thomas Ryan said: “Given the shortages of materials to make these devices, such as resins and computer chip modules, and transportation bottlenecks, I expect that supply will continue to lag behind demand into 2022. It is becoming a crisis.”
The American Hospital Association has restarted a program that delivers ventilators and other supplies to areas that have been hit the hardest by the COVID-19 Delta variant, spokesperson Thomas Jordan said.
The FDA has required Philips to submit a repair-and-replacement program for the faulty components in the devices, but those replacement parts may face delays due to supply shortages and backlogged orders of similar devices being used in ERs and ICUs.
A company spokesperson said it was “already producing repair kits and replacement devices in large quantities.” Philips has recommended that customers with affected devices register their products and consult their doctors about what to do next.
But even doctors don’t have the answers. Schulman, of Emory Healthcare, told The New York Times that both physicians and their patients were”extremely uncertain,” with a lack of clear information.
“How do we advise our patients when we know that the potential risks are serious, but haven’t any idea whether they are extremely rare or just uncommon?”
Sleep medicine specialist at the Mayo Clinic Timothy Morgenthaler said it would be helpful for physicians to know how much time was needed for replacements and how to quantify the health risks for patients.
“The risk of good or bad decisions is passed to the patient and provider,” he said.
Has the Philips CPAP recall affected you in any way? Tell us your experience in the comments section!
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28 thoughts onPhilips CPAP Recall Has Left Supply Shortage, Confusion for Physicians and Patients
I am also affected by this recall. Reading through the comments I may now know why I wake up in the morning with a headache and wake up in the middle of the night gasping for air. Following this one. I am fortunate that I have a back up travel unit tha5 will need to become my main unit. Checking with my physician as well.
I have used the Dream Machine cpap since December 2015. Since I could not obtain an immediate replacement, I had to purchase another brand cpap for $932. I also have the SoClean cpap cleaner. I have suffered severe respiratory conditions. open heart surgery and `severe headaches since 2015. My breathing is so severe now I cant walk more than 20 feet without having to sit down and rest and I have to use a walker. This makes me pretty much home bound.
I was on Philips dream station for two years before the Dr required a second sleep study to see if a Bipap would help me more. He prescribed Bipap March, 2021which date on machine was Dwc 2020 so when I received notice letters from both Phillips and provider for Bipap Via Christi I registered and confirmed my new Bipap was on recall because if date if manufacture which used the foam under investigation. My Dr prescribed the inline filter for a short term solution as he said I needed to continue use of Bipap. I purchased a so clean machine wen I used the CPAP but received warnings not to use it in my Bipap so I haven’t used it. I would appreciate since so clean us still on warranty and there was no notice from Phillips or So clean not to use it on Phillips CPAP to get a total refund half from so clean and half from Phillips
My CPAP was recalled with no guidance from Phillips other than follow your Dr ‘s advice only Phillips gave the Dr’s no guidance either. I was fortunate to find a new machine but it cost me almost$900 out of pocket.
Add me please I am a user of this cpap ty
My cpap machine has been recalled also.
I’ve been headaches for months and now on meds for migraines. I kept telling my sleep doctor but all they would do is adjust it and now I’m wondering if it’s from the machine. I’m trying to get a new machine, but it’ll cost me out of pocket since I’m not due for a new one covered by insurance until next year
My Cpap has been recalled. I started getting a really bad cough and in November of 2020 and now I know why. I stopped using my Cpap in July 2021. To say the least, I need a Cpap replacement as I sleep maybe, 3 hours a night and its tough on other health issues I have..
Husband’s got recalled n he can’t sleep more than 2 hrs at a time
Every Manufacturer is out of stock and Pap devices are all on back order!