Last month, the Dutch-based multinational conglomerate Philips corporation, one of the world’s largest manufacturers of personal health care appliances, announced a voluntary recall of millions of its highly popular CPAP (Continuous Positive Airway Pressure) machines, which are relied upon by people with a condition known as sleep apnea to get an uninterrupted night’s sleep. The machine provides a continuous flow of slightly pressurized air through a flexible tube connected to a face mask or nose mask that will keep the CPAP user’s internal airways open while they are asleep. The airflow prevents the temporary airway blockages typical of sleep apnea, which interrupt sleep and cause other damaging health effects.
The company said that it had discovered that the PE-PUR foam sound insulation material used inside its machines can degrade over time and give off dangerous tiny particles and chemical emissions which are potentially dangerous to users if they enter the machine’s air pathway tube and are breathed into the lungs. Some of the possible health risks from inhalation of the foam particles included headaches, inflammation, respiratory issues, toxic and carcinogenic effects, and other irritations. Risk from breathing the chemical emissions include headache, irritation, hypersensitivity, nausea/vomiting, and possible toxic and carcinogenic effects.
The company says it has received reports from users who felt sick and found black particles of the insulation material inside their CPAP machine’s air path tube. However, there have not been any consumer reports of exposure to the chemical emissions, and none of those sickened by the particle emissions have died.
UP TO FOUR MILLION CPAP MACHINES AFFECTED
The recall affects an estimated three to four million Philips CPAP-type devices globally. Over half of the devices were sold in the US by the company’s Pennsylvania-based Respironics subsidiary, mostly under its DreamStation brand name. The recall only affects the first-generation Dreamstation machines. The newer model Dreamstation 2 machines are not affected by the recall.
While Philips has promised to fix the problem for all its affected machines already in use, it has not yet announced how the recall will work or how long it will take for all of them to be repaired or replaced. Meanwhile, the company is sending letters to all users of the affected machines asking them to register them online to get their machines repaired or replaced, or to call Philips at 877-907-7508.
Industry observers predict that a shortage of new CPAP machines is likely to develop quickly as word of the recall spreads and affected users seek replacement machines from Philips or other CPAP machine manufacturers.
CHECK WITH YOUR DOCTOR BEFORE DISCONTINUING USE
Because untreated sleep apnea can have serious health consequences, Philips recommends that all users of its CPAP machines check with their doctors before discontinuing their use. According to Philips, only a doctor can determine whether the potential risk to a particular person’s health from breathing in the particles and chemical emissions that can be produced by the deteriorating insulation is greater than the risk from discontinuing use of the machine. Philips advises its CPAP machine owners to “continue to use your affected device, if your health care provider determines that the benefits outweigh the risks identified in the recall notification.”
In addition to the basic Philips CPAP machines, the recall also affects the company’s APAP machines, which automatically adjusts its air pressure to the user’s breathing during the night, and its BiPAP machines, which delivers different air pressure to its users depending upon whether they are inhaling or exhaling.
Philips also warns patients using its life-sustaining mechanical ventilators with the same insulation problem not to stop using the devices before talking to their doctor about alternative treatment options.
In a statement accompanying the public recall notice, Philips CEO Frans van Houten said, “We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing today to ensure patient safety. In consultation with the relevant regulatory agencies and in close collaboration with our customers and partners, we are working hard towards a resolution, which includes the deployment of the updated instructions for use and a comprehensive repair and replacement program for the affected devices.”
MOST SLEEP APNEA CASES GO UNDIAGNOSED
Health experts estimate that about one in 15 adults, or about 18 million people in the United States, suffer from sleep apnea, but about 80% of them are undiagnosed and therefore untreated. The condition is diagnosed through a sleep study, in which the breathing of patients while they sleep is electronically monitored throughout the night.
According to a study by the CDC, the risk for sleep apnea increases with age, and may affect between one third and two thirds of all people over the age of 60. In addition to the frequent interruption of sleep during the night, the symptoms of sleep apnea include gasping for breath during sleep and awakening with a dry mouth or headache. Those who suffer from sleep apnea also commonly experience excessive periods of daytime sleepiness, increased irritability, and difficulty in paying attention while awake.
CPAP COSTS COVERED BY MEDICARE AND MOST INSURANCE
The common treatment for sleep apnea is the use of a CPAP machine, 80% of whose cost is covered for Medicare patients as well as those with most forms of private health insurance. Without insurance coverage, the retail cost of a CPAP breathing machine typically ranges between $500 and $1,000, depending on its size and features.
The continuous air pressure from the CPAP machine pushes against any blockages in the user’s airway to keep it open and maintain the flow of oxygen to the lungs.
All CPAP machines contain the same basic components, including an electric fan motor housed in the main unit and a flexible air tube that connects the motor to a mask held in place by adjustable straps and which comes in three varieties: one that fits over the user’s whole face, just their nose, or just into their nostrils.
Most full-size CPAPs include an optional heated water reservoir which humidifies the air flow generated by the machine for the patient’s comfort. There are also a wide variety of small, portable battery-operated CPAP machines which are popular for use during overnight trips away from home.
Aside from their other health benefits, CPAP machines make it much easier for people suffering from sleep apnea to fall asleep and rest undisturbed throughout the night. It will be very difficult for the many people who have grown to rely on these machines to get along well without them.