Despite recall on CPAP machines, patients should not stop using them without consulting a physician first - The Globe and Mail

A continuous positive airway pressure machine is considered the best way to treat sleep apnea.

Emiliano Rodriguez Mega/The Canadian Press

The question: I suffer from sleep apnea and use a CPAP machine every night to breathe properly. I recently received an e-mail notification saying my CPAP maker – Philips Respironics – is recalling my machine because of a potential problem with the device. The e-mail also said to stop using the machine immediately. But there is no indication when my CPAP will be replaced. What am I supposed to do in the meantime?

The answer: Despite what the e-mail said, you should not stop using your machine without first talking to your family doctor or sleep specialist about the pros and cons of temporarily ceasing CPAP therapy.

“I don’t want my patients to end up in car crashes because they now have daytime drowsiness,” said Mark Boulos, a sleep neurologist at Sunnybrook Health Sciences Centre in Toronto.

As you are likely aware, sleep apnea is caused by the soft tissues in the back of the throat collapsing shut during sleep and blocking the flow of air. Those with the condition wake up repeatedly throughout the night – in some cases, hundreds of times – to literally gasp for air.

They have no memory of rousing but suffer the consequences of poor-quality sleep, including drowsiness and impaired concentration.

A CPAP machine is considered the best way to treat this debilitating disorder. CPAP stands for continuous positive airway pressure. The device is connected to a facial or nose mask, which provides a stream of pressurized air that props open the throat so breathing isn’t interrupted.

Philips Respironics is one of the leading makers of CPAP and related machines, as well as respirators used by millions of people around the world.

When the company announced a voluntary recall in June, the action took many doctors by surprise. “This definitely came out of left field,” said Clodagh Ryan, a sleep physician at Toronto General Hospital.

Suddenly, doctors had to provide expert advice to patients, even though they had limited information about the problems associated with the devices or how the recall would unfold.

According to statements released by Philips, polyester-based polyurethane foam (PE-PUR) used to reduce motor noise may degrade into particles and end up in the airways of the machine. That means patients might inhale or ingest the debris.

What’s more, the foam may emit gases. Lab tests commissioned by the company have identified the presence of various volatile organic compounds, although their potential impact on human health is not yet fully understood. In a “worst-case scenario,” they could have “toxic and carcinogenic effects,” the company disclosed.

“Testing results to date on new devices with pristine foam suggest that emissions of some detected chemicals taper off during the initial days of use of a new device,” company spokesperson Steve Klink said in an e-mail.

However, he added, the use of unauthorized ozone-based cleaning products marketed by other companies, as well as high heat and humid environments, may exacerbate or accelerate degradation of the black foam. “Possible gas emissions of the degraded foam have not been fully characterized yet,” Mr. Klink said.

Miriam Diamond, a professor of environmental chemistry at the University of Toronto, says it’s difficult to assess the chances of developing cancer through exposure to the volatile gas emissions. She noted that the company has not provided information about the potential amount of off-gassing. “You can’t make any judgment of risk without knowing exposure levels.”

The company says it has received “several complaints” from customers who noticed black debris and particles in their machines, tubing and masks. Some users have reported headaches, upper-airway irritation, coughs, chest pressure and sinus infections.

But the rate of complaints has been relatively low – just 0.03 per cent (or 3 out of every 10,000 patients) in 2020.

Government regulators – including Health Canada – have been notified of the recall. According to Health Canada’s classifications, the problem with the machines represents a Type II hazard, which means “the probability of serious adverse health consequences is remote.”

So, should you keep using your machine? Dr. Ryan says the answer will vary from patient to patient, depending on the severity of their sleep apnea and if they have other medical conditions.

Sleep apnea puts a dangerous strain on the body and increases the risk of heart attacks and strokes. “If a patient has underlying cardiovascular disease it could perhaps be even more important to continue with CPAP,” she said.

The therapy improves quality of life – no more sleepy head – and reduces the risk of accidents. Studies have found that people with untreated sleep apnea are at elevated risk of being in a car crash because they can doze off while driving, warns Dr. Boulos.

Unfortunately, there aren’t many alternative treatments for people who want to immediately dispense with their Philips CPAP machines. One option is a dental appliance that repositions the jaw during sleep. But it may not work very well in moderate to severe cases of sleep apnea.

Of course, patients can buy a new machine made by a competing company that doesn’t rely on PE-PUR foam as a sound dampener. But they aren’t cheap – often costing more than $1,000 – and supply is limited.

Philips has pledged to replace or refurbish all the affected machines, estimated to number between three million and four million units. Yet it’s uncertain when the massive worldwide recall will be completed.

“The company has indicated it may take months. But is it going to be three, six, or nine months – or longer? We just don’t know. There is absolutely no timeline,” Dr. Ryan said.

So far, she has discussed the recall with more than 100 of her patients. “The vast majority of them are willing to continue on their devices because they recognize the benefits of treatment,” she said.

Paul Taylor is a former patient navigation adviser at Sunnybrook Health Sciences Centre and former health editor of The Globe and Mail.

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Despite recall on CPAP machines, patients should not stop using them without consulting a physician first - The Globe and Mail
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