Advocates call for solutions for patients with sleep apnea following mass device recall – NBC Chicago
It was a rude wake-up call for thousands of Illinois: an essential device for a safe night’s rest could harm them while they sleep.
After NBC 5 Responds first reported a massive recall of CPAP and other sleep aid devices produced by the Philips electronics company, many viewers contacted, wondering why they weren’t told about this unsafe recall by the company or their medical device supplier.
Now millions of people across the country are scrambling to find a solution, as the company said it would take at least 12 months to repair or replace each recalled device.
This extended delay puts sleep apnea patients like Terri Domingo in an uncomfortable position, trying to find the best way forward for their health.
“I feel like this machine is keeping me alive,” Domingo said. “It changes your life.”
Domingo said her CPAP machine had helped her fight sleep apnea, a disorder where breathing repeatedly stops while sleeping, over the past six years.
“I depend on it to fall asleep,” said Domingo.
Philips’ voluntary recall of three to four million continuous positive airway pressure (CPAP), two-level positive airway pressure (BiPAP) and ventilation machines is linked to potential health risks from the noise-canceling foam in each device.
Polyurethane material can break down into particles that could be inhaled or swallowed while resting. These particles and chemicals could cause injury, Philips said on its website.
The Food and Drug Administration has said the recall is labeled “Class 1” or its most serious type of product safety recall.
Philips told NBC 5 Responds its goal is to resolve the issue by “repairing or replacing” the affected devices, but admits it has “no immediate solution at this time.” Users of the devices must register their information on the Philips website.
To register your affected device with Philips, Click here.
The timeline for a solution could be more than a year away, a spokesperson for Philips said this week, as the company needs its recall solution to be approved by regulators.
“We expect to complete repair and replacement programs in each country within approximately 12 months of obtaining the relevant regulatory approvals,” said a spokesperson for Philips.
But that’s not enough, according to the Civil Rights and Disability Justice Clinic of New York Law School Legal Services and more than two dozen disability organizations and advocates.
In a letter sent to Philips on August 26, the groups called on the company to “immediately develop and implement” a plan that “prioritizes users who depend on their equipment for survival,” particularly the needs of customers. members of the disability community affected by this recall. .
These groups are urging Philips to partner with healthcare providers and contract durable medical equipment (EMR) suppliers to reach those who have received these recalled machines.
The letter also requires the company to publicly release all communications with healthcare providers detailing what “Philips knows of the adverse health effects potentially associated with continued or long-term use of their recalled equipment and how to mitigate those effects.” .
Philips has yet to respond to requests from the Civil Rights and Disability Justice Clinic, nor has the company responded to NBC 5 Responds’ request for the contents of the letter.
To read the letter, Click here.
Millions of Americans suffer from sleep apnea, a condition that can interrupt a person’s airways and breathing while they sleep, and now those people have one more reason to be alert. Lisa Parker of NBC 5 Responds has all the critical details.
In the meantime, users are trying to find alternative solutions to using the recalled machines.
Last week, Medicare beneficiaries were told that if their recalled Philips device is more than five years old, Medicare will help pay for a replacement. But if the device is less than five years old, Medicare has said “the supplier” is responsible for the costs.
A spokesperson for the Center for Medicare and Medicaid Services said Philips users “should discuss with their supplier any non-recalled product that may be available to meet their needs while they wait for Philips to repair or replace their device. “.
To make matters worse, medical professionals said there had been a run on devices from other manufacturers, resulting in a limited supply.
“We hear that sometimes the machines may not be available,” said Raman Malhotra, MD, president of the Academy of Sleep Medicine. “We’ve never had this problem before.”
Malhotra advises all users of these devices to consult their physician to see if their continued use of their Philips device is worth the risk, given their circumstances.
But the problems caused by the recall, Malhotra said, are unprecedented.
“We have never experienced anything like this in my medical career with so many machines,” said Malhotra.
Below is a complete list of impacted Philips machines, according to the FDA:
CPAP and BiPAP devices
|Device type||Model name and number (all serial numbers)|
|Continuous ventilator, minimal ventilatory assistance, use of facilities||E30 (Emergency use authorization)|
|Continuous fan, non-life||DreamStation ASV, DreamStation ST – AVAPS, SystemOne ASV4, C-Series ASV, C-Series S / T and AVAPS, OmniLab Advanced +|
|Non-continuous fan||SystemOne (Q Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto|
|Device type||Model name and number (all serial numbers)|
|Continuous fan||Trilogy 100, Trilogie 200, Garbin Plus, Aeris, LifeVent|
|Continuous ventilator, minimal ventilatory assistance, use of facilities||A-Series BiPAP Hybrid A30 (not sold in the United States), A-Series BiPAP V30 Auto|
|Continuous fan, non-life||Series A BiPAP A40, Series A BiPAP A30|