It was a rude awakening for thousands of Illinoisans: A device critical for a safe night’s rest could be harming them while they sleep.
After NBC 5 Responds first reported a massive recall of CPAP and other sleep aid devices produced by the company Philips electronics, many viewers reached out, questioning why they hadn’t been notified of this dangerous recall by the company or their medical device provider.
Now, millions across the country are scrambling to find a solution, while the company has said it will take at least 12 months to repair or replace each recalled device.
That extended timeline puts sleep apnea patients like Terri Domingo in an uncomfortable situation, trying to figure out the best path forward for their health.
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"I feel like this machine keeps me alive," Domingo said. "This is life-altering."
Domingo said her CPAP machine has helped her combat sleep apnea, a disorder where one's breathing repeatedly stops during sleep, for the past six years.
"I depend on it to go to sleep," Domingo said.
Philips’ voluntary recall of three-to-four million continuous positive airway pressure (CPAP), bilevel positive airway pressure (BiPAP) and ventilator machines has to do with potential health risks connected to each device’s sound abatement foam.
The polyurethane material can degrade into particles that could be inhaled or swallowed while one is resting. Those particles and chemicals could cause injuries, Philips said on its website.
The Food and Drug Administration said the recall is labeled a "Class 1" or its most serious type of product safety recall.
Philips told NBC 5 Responds its goal is to fix the problem by "repairing or replacing" the impacted devices but admits it has "no immediate solution at this time." Users of the devices should register their information on Philips’ website.
To register your impacted device with Philips, click here.
The timeline for a solution could be more than a year away, a spokesperson for Philips said this week, because the company needs their recall solution cleared by regulators.
"We expect to complete the repair and replacement programs in each country within approximately 12 months from obtaining the relevant regulatory clearances," a Philips spokesperson said.
But that’s not good enough, according to the Civil Rights and Disability Justice Clinic at the New York Law School Legal Services and more than two dozen disability rights organizations and advocates.
In a letter sent to Philips on Aug. 26, the groups demanded the company "immediately develop and implement" a plan that "prioritizes users who depend on their equipment for survival," especially the needs of members of the disability community impacted by this recall.
These groups are urging Philips to partner with healthcare providers and contracted durable medical equipment (DME) providers to reach those who have received these recalled machines.
The letter also demands that the company publicly release all communications with health providers detailing what "Philips knows about adverse health effects potentially associated with continued or long-term use of their recalled equipment and how to mitigate those effects."
Philips has not yet responded to the Civil Rights and Disability Justice Clinic’s requests, nor did the company respond to NBC 5 Responds’ inquiry regarding the letter’s contents.
To read the letter, click here.
In the meantime, users are trying to find alternative solutions to using the recalled machines.
Medicare recipients last week received notification that if their recalled Philips machine is older than five years, Medicare will help pay for a replacement. But if the device is less than five years old, Medicare said "the supplier" is responsible for the costs.
A spokesperson for the Center for Medicare and Medicaid Services said Philips' users "should talk with their supplier about any products not impacted by the recall that may be available to meet their needs while they wait for Philips to repair or replace their device."
Making matters worse is that healthcare professionals said there had been a run on other makers' devices, leading to a limited supply.
"We are hearing that sometimes the machines may not be available,” said Raman Malhotra, M.D., President of the Academy of Sleep Medicine. “We never had that issue before."
Malhotra advises all users of these devices to consult with their doctors about whether their continued use of their Philips machine is worth the risk, given their circumstances.
But the problems caused by the recall, Malhotra said, are unprecedented.
"We’ve never experienced anything like this in my medical career with this many machines," Malhotra said.
Below is a complete list of the Philips machines that are impacted, according to the FDA:
CPAP and BiPAP Devices
|Device Type||Model Name and Number (All Serial Numbers)|
|Continuous Ventilator, Minimum Ventilatory Support, Facility Use||E30 (Emergency Use Authorization)|
|Continuous Ventilator, Non-life Supporting||DreamStation ASV, DreamStation ST - AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+|
|Noncontinuous Ventilator||SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto|
|Device Type||Model Name and Number (All Serial Numbers)|
|Continuous Ventilator||Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent|
|Continuous Ventilator, Minimum Ventilatory Support, Facility Use||A-Series BiPAP Hybrid A30 (not marketed in the US), A-Series BiPAP V30 Auto|
|Continuous Ventilator, Non-life Supporting||A-Series BiPAP A40, A-Series BiPAP A30|