Sleep Treatments | Sleep Review
In the absence of a clear schedule of when to replace the foam on affected CPAPs, bilevel PAPs, and ventilators, sleep laboratory administrators and clinicians employ a patchwork of strategies to assist patients with titration studies and continuation of home therapy.
By Lisa Spear
Last week’s announcement that Philips is recalling millions of its CPAPs, bilevel PAPs and ventilators set shock waves across sleep medicine, adding to the rush of sleep laboratory administrators and sleep medicine professionals looking for alternative sleep apnea therapies for their patients.
Without enough equipment and with the question of how long it will take to replenish supplies, sleep professionals had to quickly find solutions to cope with the current situation.
The recall affects 3 to 4 million devices worldwide, based on the company’s production and shipping data received from AARP. More than half of the machines were purchased in the US, with most of the DreamStation products being first generation. DreamStation 2 products are not affected by the recall.
According to clinicians interviewed by Sleep Review, the recall has become a major barrier to care. Akhil Raghuram, MD, medical director of the Vancouver Sleep Center in Portland, Ore, says approximately 50% of his sleep apnea patients use Philips devices and his team has launched an email campaign to alert them to the problem do. For the new patients, the recall means a delay in supply because there are not enough machines.
How big is the problem of the recall? “It’s huge,” says Raghuram in a telephone interview.
He learned the news after waiting for a pending CPAP order from Philips for the past two months. “I knew something was brewing.” Then, on Monday morning, an online article drew his attention to the recall.
According to Philips, the PE-PUR foam can be dangerous if it gets into the airway of the CPAP machine and could be ingested or inhaled by the patient. The foam can also outgas certain chemicals. Although some clinicians have speculated that adding a particulate filter to the devices (like the type that prevents CPAPs from aerosolizing viruses and bacteria) might help, Philips has not released any information on whether these filters alleviate the problem.
In its recall notice, Philips indicated that certain “non-approved” cleaning methods such as ozone can aggravate foam breakdown. High heat and high humidity environments can also help break down the foam, the company said. Raghuram speculates that the age of the device could also play a role in the release of particulate matter, as many people don’t replace their machines as often as they should.
Even the smallest sleeping possibilities are affected. In Kentucky, a two-bed sleep lab had to postpone its upcoming titrations. Before the recall, the center had leased Philips equipment, but the lab is now working to get new equipment from an alternative supplier, says Candace Martin, RRT, the cardiopulmonary manager at Caldwell Medical Center in Princeton, Ky.
“My first answer was that it wasn’t going to be that big of a deal, but then I realized how difficult it would be to replace the equipment we already have,” she said in a phone interview. Despite the news, Martin thinks the risk is likely to be low and, as a sleep apnea patient, decides to continue therapy with her Philips device at home.
“I’m not going to stop using mine, and I will keep using it until something else replaces it,” she says. “It would be a big deal for me to stop.”
Many laboratories have looked into communicating with patients to warn them of the potential danger. Since the level of risk is still largely unknown, some still offer titrations with Philips devices and advise patients on the potential risks.
At Vanderbilt Medical Center, a risk management team is working to use the patient portal to send a letter to patients who have been seen in the past 5 years, according to Beth Ann Malow, MD, Professor of Neurology and Pediatrics and Director of the Vanderbilt Sleep Division. Malow shared this information last week during a virtual event held by the American Academy of Sleep Medicine (AASM) entitled “The Impact of the Philips PAP Recall on Patient Care and Sleep Center Operations.”
Sara Elizabeth Benjamin, MD, a neurologist and sleep specialist at the Johns Hopkins Center for Sleep, says she is giving her patients the option to proceed with laboratory titrations. All patients who wish to proceed must sign an informed consent form warning them of possible harm.
“If they’re not comfortable with this, we can still do a baseline split or delay the titration part of the study,” Benjamin said during the AASM event.
To develop an informed consent protocol, Hopkins medical directors from two laboratories developed the form and a risk management strategy. There are also plans to send out a letter developed in collaboration with the Legal Department that will be distributed to patients via the center’s online card system. Hopkins sleep laboratories also equip Philips devices with inline particulate filters.
For some patients, the harm of discontinuing CPAP therapy can pose a greater threat than the particulate matter.
“There are definitely risks associated with that [Philips] Respironics turned out to be, but at least from my reading the risks are actually pretty unclear and they could actually be quite small, “said Najib Ayas, MD, faculty member of respiratory medicine at the University of British Columbia in Canada, during the AASM event.
“There are very specific risks for patients who abruptly stop CPAP or biPAP, and mostly because I feel it will take months, if not longer, to get replacement devices from Philips,” says Ayas. “The last thing you want is for someone to be in a car accident. I think we need to be more nuanced and say what’s best for our patients. “
“I also feel like the ground is shifting a lot, so I hope that there may be more information available in the next few weeks regarding longer-term cancer risk.”
During this time, many vendors have turned to another major CPAP manufacturer, ResMed, to order new equipment. ResMed-made machines were not affected by the recall and use a different noise control material, said Jayme Rubenstein, PR director at ResMed, in an email interview.
Some clinicians have anecdotally reported that ResMed has an order backlog. But Rubenstein says the company continues to monitor demand closely. “Our number one priority is the patients and making sure those who need treatment get it when they need it,” he says.
Disruptions can last for months or longer
According to an email interview with Philips spokesman Mario Fante, Philips has developed a plan to work with consumers to replace the current soundproof foam with a new material.
Patients are instructed to fill out a form online so the company can keep in touch with them about next steps. The website also contains a list of affected machines.
“We cannot emphasize enough that Philips is treating this matter with the utmost seriousness and dedicating a lot of time and resources to addressing this issue,” says Fante.
Apart from the interruption of care, however, there will be significant financial costs and it remains unclear whether patients will be provided with alternative therapy devices in the meantime. In its press release on the results for the first quarter of 2021, Philips states: “Given the estimated scope of the intended precautions for the installed base, Philips has made a provision of 250 million euros.”
Thomas Heffron, Senior Director of Marketing and Communications at AASM, said during the AASM event, “The need for advocacy in the coming weeks and months will be enormous. The first issue we are currently dealing with is contacting CMS and the private payers to try to obtain temporary exemptions or exemptions from some of their policies.
Patients with devices that are less than five years old cannot get new devices that are insured under current policies, according to Heffron. So when it is going to take months or up to a year to get a device through the Philips registration process, it becomes a problem.
“You can’t be without treatment that long,” he said. “So we’re really asking the payers for some flexibility.”
Lisa Spear is co-editor of Sleep Review.