Recall of certain Philips CPAP machines impacts patients in Central Virginia

Published: Oct. 12, 2021 at 2:41 PM EDT|Updated: Oct. 14, 2021 at 2:00 PM EDT
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RICHMOND, Va. (WWBT) - As a recall of Philips Respironics Continuous Positive Airway Pressure, CPAP, machines were issued in June 2021, patients in Central Virginia continue to feel the impact.

“I stopped breathing 20-30 times in an hour,” said Phyllis Wilson, of Caroline County.

Wilson was diagnosed with severe sleep apnea in September 2021, months after the Philips recall. She had no idea it would impact her ability to start the use of a CPAP machine.

“I went to the medical supply place and they said they were a month behind, they said I could easily get a machine that day if I could come up with 600 to 900 dollars,” Wilson says. “I was freaking out because after I was told I stop breathing, I was like, do I have 3-6 weeks [to wait] for this?”

Wilson was told that a recall impacting 3-4 million units of Philips Respironics CPAP machines in the U.S. and globally, was impacting the supply chain.

“Philips Respironics is voluntarily recalling the below devices due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and NonContinuous Ventilators: 1) PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and 2) the PE-PUR foam may off-gas certain chemicals,” the company wrote in the recall notice.

Philips Respironics says there have been no reports of death, but there have been reports of: “the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. The potential risks of particulate exposure include: Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and toxic carcinogenic effects.”

As Wilson continued to call around, searching for a medical device company that would help her get another brand of CPAP with insurance, she was able to get help through ABC Healthcare in Richmond.

“I called numerous medical supply places and this is the only one that helped me with my insurance,” she said.

Phyllis Wilson was concerned she would have to wait up to 2 months to get on a list to start...
Phyllis Wilson was concerned she would have to wait up to 2 months to get on a list to start using a CPAP machine after being diagnosed with Sleep Apnea.(NBC 12)

ABC Healthcare Regional Account Manager, Stephanie Harris, says the supply chain has been greatly impacted by the recall. ABC Healthcare is working to get replacement devices, as well as different brand devices to patients, but Harris says there can be roadblocks with insurance companies.

“There’s also a lot of barriers with payers being able to actually pay for new devices if a patient had a machine that was purchased with insurance within a five-year period. So we are at the mercy of waiting for the replacement devices to come from Philips Respironics,” said Harris.

Wilson was grateful to have gotten a machine, but her worries related to the recall still linger.

“I am more worried about those on the machine who can’t get a hold of it--this is my first time on it,” Wilson said.

Wilson says she worries for people like Charley Bruce, whom she has never met. Bruce, a technical media producer for NBC 12 has been using a Philips machine since 2005, he describes it as “life-supporting.”

“If I don’t have it, I will not sleep,” said Bruce. “I am looking at something that I need vitally, that could end up hurting me.”

Bruce first registered his machine when the recall was issued, he continues to wait to find out when it could possibly be replaced. He has had his current machine for four years, falling within the window where insurance companies don’t usually cover replacement devices.

“To date, I have not heard from [Philips] directly, I have followed up on their website and such and they said that this month they were saying they are starting to replace and refurbish machines but it could take a year,” Bruce explained.

Bruce says right now, he and his doctor have discussed that it could do more harm than good to stop using the device, so he is still using it, hoping it will be less than a year before it is replaced.

The FDA released the following recommendations for those impacted by the recall:

  • Talk to your health care provider to decide on a suitable treatment for your condition, which may include: Stopping the use of your device.
  • Using another similar device that is not part of the recall.
  • Continuing to use your affected device, if your health care provider determines that the benefits outweigh the risks identified in the recall notification.
  • Using alternative treatments for sleep apnea, such as positional therapy or oral appliances, which fit like a sports mouthguard or an orthodontic retainer.
  • Initiating long-term therapies for sleep apnea, such as losing weight, avoiding alcohol, stopping smoking, or, for moderate to severe sleep apnea, considering surgical options.

In a statement to NBC 12, Philips Respironics says September 1st, it started the repair and replacement of CPAP’s in the US.

The company says it increased the production of repair kits and replacement devices to 55,000 per week. It aims to increase that capacity to 80,000 units per week in the fourth quarter of 2021.

“To address affected devices, Philips has mobilized the necessary resources across the company to correct the foam component quality issue that we have identified. Our priority is to replace the foam in all the affected devices either by repair or replacement with like devices with the new foam. The repair and replacement program will be at no cost to consumers in the U.S.,” Philips explained in a statement. “Regarding estimated timing, we are working to address this issue as expeditiously as possible. Given the number of devices currently in use (estimated at 3 to 4 million units globally based on production and shipment data – about half are in the U.S.), we expect to complete the repair and replacement programs in each country within approximately 12 months from obtaining the relevant regulatory clearances.”

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