Dear Patients of Weightloss & Sleep disorder Center of Maryland LLC
On June 14, 2021 Philips voluntarily recalled all first-generation DreamStation CPAP devices (off-white in color) and System One CPAP devices which were put into service beginning in 2012 until early 2021. The second generation DreamStation 2 CPAP machines (black in color) is not part of this recall. Many of our patients have asked what they should in light of this recall.
This Recall is regarding sound abate foam which is in side the machine to reduce noise during operation.
Foam degradation exposure. Major Complaints. Symptomatic in (0.03%) of patients 2020.
Pieces of Foam Break Down and are inhaled and/or swallowed
Symptoms may include irritated eyes, cough, headaches, wheezing. There may be inflammatory or toxigenic or carcinogenic effects.
Worsened by use of ozone cleaning machines and or high heat or humidity and machine older than 5 years old.
Foam Gassing. “off-gassing”
We understand that “off-gassing” from the foam can release Volatile Organic Compounds (VOC) which may carry similar risks as Foam degradation. Off-gassing appears at this time to principally occur early in the machine life, but can possibly occur through out the life of the machine.
Off-gassing is worsened by use of ozone cleaning machines and or high heat or humidity and machine older than 5 years old.
Inline bacterial/Viral Filters
Using an inline bacterial/viral filter should capture Foam piece, from the machine, based on the filter size but would not capture VOC gases. There is no current guidance on how often the filters need to be changed. Some manufacturers of filters are recommending every day.
What should you do?
Register Immediately for a Replacement.
If you received your recalled Philips CPAP, BiPAP or ASV/AVAPs device from our Practice, even though we have already provided your contact information and device serial number (found on the bottom of your unit) to Philips for a replacement. Philips is requiring that you register your device on the website below.
—> Change: Phillips Respironics will need each person who needs their machine to be remediated to go online and register their device for the recall on the website below.
https://www.usa.philips.com/healthcare/e/sleep/communications/src-update
You may have received your CPAP machine from a separate DME company. Regardless of who you received your equipment from, to ensure your name and device are properly recorded to receive a replacement, please register yourself with Philips as soon as possible. You may do so in the following ways:
Should I Stop Using My CPAP if it is Part of the Recall.
Philips’ official position is to not use your first-generation DreamStation CPAP device or System One CPAP device until the machine is replaced. However, many practitioners take a more reserved and risk-balancing approach with an emphasis on the individual’s specific health condition. For example, the America Thoracic Society published the following guideline:
For patients on Bi-level PAP and CPAP devices who have severe breathing difficulties, or were very sleepy during the daytime before treatment, have significant pulmonary, cardiovascular or neurologic comorbidity, or who work in safety-critical positions (e.g., professional drivers, pilots, heavy equipment operators), we would recommend that they not stop their prescribed therapy until first discussing with their physician.
We recommend that you read the entire ATS Statement at
The decision to continue treatment will ultimately be left up to the patient. If you decide to stop therapy, please do not drive drowsy and monitor your blood pressure and other health metrics.
Timeline
Reports from Phillips state that remediation efforts are accelerating however many believe that this recall may take one year to complete (September 2022). The process of selecting which person will receive a machine appears to be random. Alternative CPAP machines are very difficult to find. Keep in mind most insurances will allow a new machine every 5 years. If you have an interest in getting a new machine kindly email us at admin @thewsmd.com
