Re: Philips Issues DreamStation CPAP Recall
On June 14th, Philips (Respironics) issued a recall notification for specific Philips bi-level positive airway pressure (BPAP), continuous positive airway pressure (CPAP), and mechanical ventilator devices. The recall is in response to potential health risks related to the sound abatement foam component in these devices, which helps the machine run quietly. The majority of the affected devices are in the first-generation DreamStation product family, but Philips reports that the recently launched DreamStation 2 is not affected by the issue.
Although the reported complaint rate has been low at 0.03% in 2020, testing done by Philips indicate that there are possible risks to users related to the type of polyester-based polyurethane (PE-PUR) foam used in these devices. There are two potential risks associated with the breakdown of this foam:
- The foam may degrade into particles, which may enter the device’s ai pathway and be ingested or inhaled by the user. These foam particles may cause irritation and airway inflammation, headache, asthmas, adverse effects on kidney and liver and toxic carcinogenic effects.
- Using an In-Line Bacterial Filter (between the machine and the hose) would help reduce the risk of particles that may be present.
- The foam may degrade into a gas containing certain potentially harmful chemical emissions that may have short- and long-term health effects.
- Using an In-Line Bacterial Filter (between the machine and the hose) would not help reduce the risk of Volatile Organic Compound (VOC) gases that may be emitted from the machine.
NOTE: Philips indicates that this foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone. High heat and high humidity environments also may contribute to foam degradation.
Philips has advised patients using affected BPAP and CPAP devices to discontinue use. Each patient should work with their physician or DME provider to determine the most appropriate options for continued treatment. Patients with a lack of alternative treatment options should work with their physician to determine if the benefit of continuing therapy with your device outweighs the risks identified in the recall.
Philips indicates that it will replace the current sound abatement foam with a new material and has already begun the preparations. Philips plans to address all affected devices as quickly as possible. Philips is creating a registration process that will allow patients to look up their device serial number and begin a claim if the unit is affected. Within the next week or so, patients will be able to look up their device serial number and begin a claim if the unit is affected at the following website.
https://www.usa.philips.com/healthcare/e/sleep/communications/src-update#section_2
Patients and DME Suppliers can also call Philips at 877-907-7508 for additional support.
Sleep Medicine Associates of Texas believes that each patient must make their own decision about the continued or discontinued use of their device. Each patient needs to consider the known risks of untreated sleep apnea versus the potential risks of using affected devices. Devices that have been exposed to high heat, high humidity environments or have been exposed to ozone cleaning devices, such as SoClean, would be at greater risk of degradation of the sound abatement foam. That information needs to be factored into your decision.
If you choose to stop using your device, then you should self-monitor your blood pressure and excessive daytime sleepiness and seek medical care as needed. As always, do not drive or operate heavy machinery when drowsy.
If you choose to continue to use your device until Respironics can repair/replace your current device or until you replace it with a different vendor model like from ResMed, then the use of an In-Line Bacterial Filter can be used to help mitigate the potential hazards of particles that may be present. These in-line filters can be purchased from us at $5 each or at many online retailers.
We will continue to monitor this information and do our best to make updates to our website as we can.
Thank you,
Larry Brewer, BA, RPSGT, RST
Business Manager
214-750-7776 x 203
