Patients, Physicians, Sleep Labs, and Hospitals Left Holding the Bag
June 2021: amidst ongoing scrutiny and regulatory issues, Philips Respironics was forced to “come clean” recalling millions of CPAP machines, stranding patients, physicians, sleep centers and hospitals without equipment for critical sleep apnea care. Multiple investigations uncovered Philips’s deliberate failure to report thousands of patient complaints ranging from “dirty looking/contaminated water”, black particulate matter/debris in their machines, and issues with respiratory illnesses, kidney failure and development of cancer(s) after utilizing CPAP therapy with their machines.
What we didn’t know then, we sadly know now. In response to complaints of noisy machines dating back to 2010, Philips began inserting polyester-based polyurethane foam in CPAP machines to muffle sound. Good-bye Darth Vader. This wonder material did indeed make machines “whisper quiet”. It also degraded, giving off chemical gases depositing bits of black debris that was swallowed or inhaled by unsuspecting patients. So, the benign looking CPAP machine on millions of nightstands, thought to be a lifeline for so many was now, a silent killer. The FDA assigned a Class I designation to the immediate recall. Class I literally means the CPAP machines have the potential to cause serious adverse health consequences or death.
The critical nature of the defect and thousands of documented patient complaints were kept under wraps for years by Philips, then slowly leaked to the public and regulatory agencies. Regulators (FDA), Medicare and even the Veterans Administration were not fully informed as to how serious the recall issue was. In an attempt to avoid notoriety and preserve their market share, Philips poorly planned and executed the recall, and DME providers, doctors and hospitals were given no guidance from Philips. Physicians and hospitals were led to believe that this was an isolated “one off” event, and patients could continue using machines safely. Mega Insurers such as Medicare mistakenly sent letters to all participants instead of targeting specific patients supplied with the recalled machines. Without a specific emphasis on who received the immediate “stop using your machine” notices, thousands of letters went into the bin unread, and people remained unwarned. Chaos and confusion ensued and continues today. Physicians, patients, hospitals and DME providers continue to drown while trying to navigate impossible waters to obtain replacement or repaired/refurbished machines for patients.
Remediation or replacement of machines by Philips has been slow, or non-existent with patients waiting upwards of 18 months-2 years without equipment. Individuals made ill and families of others who actually died from the particulate matter and toxicity issues are lining up in droves to join multiple class action lawsuits against Philips. It’ll take YEARS for all of the claims to be processed, and in the end the loss of health and life can never be recompensed regardless. In response, and to “mitigate escalating damages”, Philips elected to cease selling any of the products on their posted announcement list January 25, 2024. Bottom line, they put corporate profits way ahead of due diligence and responsible patient care provision. In essence, the King abdicated the throne and the people to go and live in riches somewhere else. Bailing on all new airway related equipment sales compounds exponentially the number of patients left stranded without access to therapy. Which, no surprise to anyone, seriously increases risk for health complications and adds to the stressor’s physicians, hospitals and facilities must deal with.
NICU, pediatric and adult patients in hospitals are all losers here too! No wonder sleep clinicians and adjunctive employees are leaving DME jobs in droves. It isn’t easy to listen to irate patients and physicians all day long when they are the messenger, not the cause of acute shortages and long waits for replacement or repaired machines. DME providers are the middleman here post recall and expecting them to effectively move the deck chairs on the Titanic is extraordinarily unfair.
Once Philips announced the recall, patients and physicians believed that stockpiles of replacement machines were immediately available. Wrong! Citing excuses of Covid related supply chain shortages for parts and components has severely delayed if not suspended the remediation process in huge swaths across the country. Furthermore, patient postings on CPAP blogs and the Facebook cite Philips for actually supplying other models of “refurbished” machines also included on the list of recalled products. Not exactly confidence inspiring.
This certainly doesn’t help the millions of patients still waiting on replacement/repair of their machines, or the physicians who care for them. In 2021 recall issues were bad. In 2024 they are not a lot better. Patient and physician dissatisfaction, mistrust of the medical system, and serious declines in CPAP adherence/usage due to fear, and lack of access to care are at all-time highs.
If patients are lucky enough to have the socioeconomic means to either simply change brands or buy a new machine outright, the recall has little impact on their lives and ability to maintain therapy as usual. Hooray for them. Whew. But, what about everyone else? What about the folks who can’t afford to pay out of pocket for a new machine? What if an individual is only able to use a donated or previously discarded machine, or has an insurance clause prohibiting purchase of any new equipment if theirs is less than 5 years old? Insurance companies are not advocating for the patients, but rather directing them back to Philips. And finally, what about the babies and kids? Yes, they’re affected by this too, and we may not know how their health will be impacted for many years to come. No one wants to think of the possible downstream cases of kidney failure or cancer(s) in the most precious commodity there is, our children. And kids on CPAP, are as fragile as they come.
So, what do we know?
- Philips is one of the top three CPAP providers worldwide in an industry who according to Markets Report World controls 73% of the market share. In hard numbers, that’s millions of CPAP machines and respiratory medicine machines equaling thousands of millions of dollars – per year.
- As part of the 2021 recall Philips vowed to replace or repair all recalled machines. Right? Wrong. People are still waiting. Fast forward to January 25, 2024: the company announces immediate discontinuation of sales CPAP machines, in the interest of streamlining their portfolio and protecting their market shares. Compounding this ethical atrocity, Philips also bailed on sales of numerous other lifesaving products such as sleep lab testing equipment, respiratory care products including oxygen concentrators, hospital/home ventilator units and even nebulizers. Nebulizers? Yes, nebulizers are used in high numbers by whom? You’ve got it, babies and kids, thanks Philips.
- Patients without the financial means to replace machines on their own have insurance clauses prohibiting replacement with alternate machines are simply “going without” therapy in the thousands. What does this mean in the long run? Increases in heart attacks, stroke, workplace and road accidents, poor school performance, and ultimately earlier death tolls across the board.
If we look at this pragmatically, it’s every man, woman, and child for themself. High levels of patient/physician mistrust of industry caused by massive dishonesty has essentially and dangerously turned thousands of folks OFF of CPAP in general. Patients report even when they receive refurbished machines, they’re afraid to use them.
You’d think alternate therapies would swoop in and make a killing here too, right? Not so much. Yes, alternate therapies may help many of those left without their CPAP. But there is a big IF attached to that. All of those abandoned CPAP patients need to medically qualify for and financially afford care such as oral appliance therapy, orthodontics, surgical correction or Inspire for example. The more invasive the treatment, the higher the cost. Bottom line, the vast majority of CPAP users left in the lurch by Philips’s abandoning ship simply cannot afford, nor automatically assume any other therapy is correct for their individual condition. Those difficult treatment conversations and decisions belong between patients and their physicians who are now squashed between a rock and a very hard place. Folks, it’s not their fault.
If you or a loved one is still waiting on replacement or refurbished machines, make yourselves known. Empower yourselves by making sure Philips knows you do not approve, and they have endangered yours or a loved one’s life. Most of all, do anything you can to try and get therapy of some kind on board quickly. Any treatment is better than no treatment. You deserve it, your family deserves it, and frankly so does everyone else suffering from this travesty of the modern age. Use the Internet and resource Blogs to locate equipment if money is an issue. There are plenty of responsible, caring, and ethical agencies to serve all patients regardless of ability to pay. Take charge of your life! Leaving it in the hands of the corporate world as we have just seen hasn’t worked out all that well.
