Forced to choose between using a defective device or suffer medical complications, an Arizona man says it's a decision he's had to make after his sleep apnea machine was recalled last year.
"This has been so frustrating on so many levels," said Ray Lee.
Ray's BiPap machine was recalled along with 11 other models, potentially thousands of machines, by manufacturer Philips last June.
The company found that the foam used in the device can break apart, creating particles that can then be inhaled by the user and potentially causing heart and lung problems.
"There's all these really dire medical consequences that are possible for using this machine," said Ray.
It's now been six months and Ray says he's had no choice but to continue using the recalled device. When he contacted Philips, he says they first promised him a replacement device, but it never came. Now he says he is told it could take until September for a fix to be made — more than a year since the problem was first discovered.
"I'm not able eligible for another machine until December 2025 when Medicare would pay for it," said Ray.
We contacted Philips to see if we could get a clear answer for Ray and why it's taking so long.
They sent a statement referring us to past press releases that show the FDA approved "the rework of the affected first-generation DreamStation devices" in September of 2021. They say that covers about 80% of all recalled machines.
Philips full statement:
In relation to the recall, on June 14, 2021, Philips Respironics voluntarily issued a global field safety notice for specific affected devices within its Sleep & Respiratory Care portfolio. The company also issued a global press release on the notice on the same date.
We fully understand and regret the impact that this recall is having on patients. We have launched a comprehensive patient and customer communication program, which includes dedicated mailings, call centers and websites in more than 100 countries.
In the U.S., Philips Respironics does not own or manage the CPAP patient’s contact information – many patients purchase their devices through third parties. Philips Respironics is working with those third parties (Durable Medical Equipment providers - DMEs) to also reach patients directly as quickly as possible. We are working around the clock to continue to reach out to our customers and patients.
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. At this time, Philips is already producing repair kits and replacement devices in large quantities. These devices and kits are being sent to patients as they are available. As our production capacity is fully focused on the repair and replacement actions, we are currently not taking orders for sleep therapy devices for new patients.
Regarding estimated timing, we are working to address this issue as expeditiously as possible. We expect to complete the repair and replacement programs in in the fourth quarter of 2022. On September 1, 2021, Philips announced the start of the repair and replacement in the U.S. for the first-generation DreamStation product family (that represent the majority of the affected devices). Philips remains in dialogue with the FDA with respect to the remediation of the other affected devices. The remaining affected devices for remediation in the US can be found.
Following ongoing dialogue with the FDA, in November 2021 Philips Respironics updated the guidance in its June 14, 2021 U.S. recall notifications for certain CPAP, BiPAP and Mechanical Ventilator devices to align them with the U.S. FDA’s recommendations in connection with these recalls. This updated guidance is intended to provide broader options for physicians advising patients of affected devices to better account for a wide variety of clinical use cases for patient medical conditions. We will continue to publish updates at the following dedicated web site for the recall.
In December 2021, Philips Respironics provided an update on the test and research program in connection with the recall notification.
Together with certified testing laboratories and other qualified third-party experts, Philips Respironics has been conducting a comprehensive test and research program on the PE-PUR foam to better assess and scope potential patient health risks related to possible emission of particulates from degraded foam and certain volatile organic compounds (VOCs). Specifically, this update covered the test results and assessment to date of the VOC emissions of the first-generation DreamStation devices. The first-generation DreamStation devices represent the majority of the registered affected devices. Additional testing is ongoing. Review of this assessment by an outside medical panel and Philips Respironics has determined that exposure to the level of VOCs identified to date for the first-generation DreamStation devices is not typically anticipated to result in long-term health consequences for patients.
We are absolutely committed to supporting the worldwide community of patients who rely on our Sleep & Respiratory Care solutions for their health and quality of life, and the physicians and customers who are dedicated to meeting patient needs.
They say "the company intends to complete the repair and replacement programs within approximately 12 months."
In addition, they say recent tests show the exposure to the "particulates from degraded foam and certain volatile organic compounds... is not typically anticipated to result in long-term health consequences for patients."
Philips urges patients using the devices to consult their doctors. It's a decision Ray says his doctor doesn't want in his hands.
"The doctor said, 'I'm not saying that you shouldn't use it, you know, it's up to you,'" said Ray.
For now, he says he has no choice but to keep using it, checking in with his doctor a bit more frequently.
In the meantime, we'll keep asking Philips when his repair will be made.