More than two years after Philips recalled millions of CPAP, BiPAP and ventilator machines in 2021, hundreds of thousands of patients have yet to receive replacements. Rising demand and chip shortages further contributed to the CPAP shortage. Experts say the shortage could last into late 2023.
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Who Is the CPAP Shortage Affecting?
The CPAP shortage affects millions who rely on CPAP therapy, which is the first line of treatment for sleep apnea. According to the American Medical Association, about 30 million people in the U.S. have sleep apnea, but only six million are diagnosed.
“Patients not having access to their CPAP machine for prolonged periods of time can have increased blood pressure and risk of stroke. The increased strain on the heart over a prolonged period of time could potentially lead to additional cardiac issues,” said Dr. Neisha Hacker-Finey, a registered respiratory therapist and pharmacist.
CPAP Machines Protect Against These Sleep Apnea Complications
In addition to adult sleep apnea patients, the CPAP shortage affects premature babies who are at increased risk for sleep apnea. Children with medical conditions who need breathing assistance are also impacted.
The 2021 Philips CPAP recall — a key contributor to the CPAP shortage — involved about 5.5 million CPAP, BiPAP, APAP and ventilator machines. CPAP machines made up approximately 80% of the devices recalled, and about two thirds of those recalled CPAP machines were in the U.S.
Philips CPAP Recall Worsened Shortage
Many experts believe that the June 2021 Philips CPAP recall made the already ballooning CPAP shortage worse because when Philips recalled its devices, it left a huge void in the market. The company was the largest producer of CPAP machines and made about 40% of CPAP machines sold globally.
That left competitor ResMed and other CPAP makers scrambling to fulfill an already excessive demand — but it wasn’t enough to eliminate the shortage. CPAP makers still faced a shortage of semiconductor chips and pandemic-related supply issues.
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In May 2023, Philips reported it had produced 98% of the new devices and repair kits needed to replace registered recalled devices.
In April 2023, the U.S. Food and Drug Administration said Philips reported shipping 2.46 million replacement devices, but the number of patients who received the machines was far less.
Philips said in May 2023 that about 2,830,000 of those new devices and repair kits are in the U.S. Of those devices, Philips said about 2,360,000 have made it into the hands of American patients and durable medical providers.
Refurbished Philips CPAP Machines May Still Have Problems
Some patients who have received CPAP replacements still have complaints, including Ruth Dillingham. Dillingham had been using her original DreamStation II for less than a year when she started having CPAP side effects such as throat pain that made her throat so raw she could hardly swallow.
Sometimes when using her original machine she noticed a burning smell “that burned her nostrils.” Then, she noticed a “black substance” in her machine that she couldn’t get out by scrubbing with soap.
“After I mailed my machine to [Philips], I only had my oxygen line to wear at night, and I told my lung specialist that I didn’t have another machine to use. It took Philips a year to send me a refurbished CPAP.”
After waiting for a year to get her replacement machine and surviving only by using oxygen, Dillingham got bronchitis and COVID-19. The burning smell is still present in the replacement machine, and she now has to use CPAP and oxygen.
In April 2023, Philips issued a recall for 1,088 previously refurbished DreamStation machines because they may not work correctly or not work at all. Previously, in December 2022, Philips recalled 13,811 refurbished Trilogy 100 and Trilogy 200 ventilators because silicone foam could detach and block the airpath.
What Factors Caused the CPAP Machine Shortage?
While many experts cite the Philips CPAP recall as a major contributor to the CPAP machine shortage, several other factors made it difficult for CPAP makers to produce enough machines to keep up with demand. This has led to fewer choices and higher prices.
CPAP manufacturers faced pandemic-related supply issues and higher shipping costs, which made it more difficult to facilitate manufacturing. Manufacturers also faced a shortage of semiconductor chips used in the machines.
Factors that contributed to the CPAP shortage include:
COVID-19 demand for ventilators in hospitals
Supply chain issues during the pandemic
Original Philips CPAP recall
Semiconductor chip shortage
Medical device makers had to share a meager chip supply with companies that made cars, computers and even video game consoles — all these products faced shortages as well. Philips’ competitor, ResMed, stepped in to try to ease the shortage.
In January 2023, ResMed posted record profits as it increased production to fill the void left by Philips. Initially, the company had to contend with chip shortages, but those have since eased. The CPAP maker opened new plants to increase manufacturing capacity.
What Can I Do if I Need a CPAP Machine Now?
If you need a CPAP machine now and your recalled Philips CPAP machine hasn’t arrived, Philips may still need information or consent before shipping your device. Philips advises you to visit its patient portal or call 877-907-7508.
People who need to buy a new CPAP machine should discuss options with their medical provider. Other CPAP machine manufacturers, such as ResMed, may have machines available. Be sure to check that the machine hasn’t been recalled.
fact
In June 2023, the FDA had received more than 105,000 medical device complaints linked to the breakdown of PE-PUR foam in recalled machines since April 2021. This includes 385 deaths.
Those with less severe sleep apnea may benefit from CPAP alternatives. These include surgery, implantable devices and simple lifestyle changes.
“For some people, simply losing weight, which would decrease the additional adipose tissue around the neck area, could be a solution or a bite guard that could help to displace the jaw line to allow for a more open airway,” Dr. Hacker-Finey advised.
Philips Recall Led to CPAP Lawsuits
Recalled CPAP device
Some patients have filed a Philips CPAP injury or class-action lawsuit to try to get their money refunded for machines they consider faulty. John — who is using an alias to protect his privacy — never received his CPAP replacement. He filed a lawsuit against Philips after he was diagnosed with two cancerous tumors in his lung called synovial sarcomas.
“For the past 21 months, my life and the lives of my family members have been turned upside down,” John said. He added that his faith has helped him through this trying time, but he still suffers from “perpetual mental anguish from dealing with a life-threatening cancer.”
John shared that he has no history of cancer in his family, nor has he ever smoked. He believes the toxic PE-PUR foam in the recalled devices led him to develop cancer.
“[Our clients] are being forced to choose (in consultation with their physician) between forgoing necessary sleep therapy or using a recalled device that emits toxic and carcinogenic compounds.”
Brendan McDonough of the award-winning legal firm Weitz and Luxenberg said he represents several clients like John. After nearly two years, many of his clients are still waiting for CPAP replacements that “may be critical to their normal well-being and health.”
In May 2023, Philips released safety testing results for PE-PUR foam in recalled devices. Toxic gases and emissions from degraded foam were “unlikely to result in an appreciable harm to health in patients,” according to the company.
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Medical device makers had to share a meager chip supply with companies that made cars, computers and even video game consoles — all these products faced shortages as well. Philips’ competitor, ResMed, stepped in to try to ease the shortage.
“[Our clients] are being forced to choose (in consultation with their physician) between forgoing necessary sleep therapy or using a recalled device that emits toxic and carcinogenic compounds.”