For patients looking to receive a new machine due to the recall, please be aware there is now a global shortage on newly produced PAP devices. Most vendors are unable to provide a new machine due to this shortage, and will be giving machines ONLY to newly diagnosed patients with sleep apnea.
Any newly diagnosed patients waiting for setups will have a longer than usual wait until the approved/scheduled setup. We apologize for this inconvenience and SDCMA strives to get all our patients the proper care.
We thank you for your patience during this crisis.
(updated 8.20.2021)
Philips issued a recall for 3-4 million machines due to potential long-term health consequences due to the deterioration of the foam used to dampen the machine’s sound. Philips is advising patients to stop using their devices at this time.
All Philips Respironics machines created from their System One to DreamStation 1 are affected by the recall due to the breakdown of the sound foam.
If you received the machine through us then we are handling the replacement and switch to the DreamStation 2 on your behalf. Philips Respironics and their partner, Sedgwick, will be contacting our patients either through physician mail or email with a Form for you to complete to receive a replacement DreamStation 2. Please be on the look out for this.
In the meantime, you can register the machine yourself
(https://www.philipssrcupdate.expertinquiry.com/?ulang=en).
It does no harm to be registered twice. As for the continued usage of an affected machine. Per Philips Respironics, they recommend patients to stop usage of the devices if possible. Philips is advising patients who continue to use their machines that they should manually clean the unit and parts according to the Usage and Maintenance Manual provided with their units due to the fact that the health risks related to this recall may be exacerbated by using ozone-based cleaning methods. If you are unable to stop usage, please be aware there is a low chance (0.03%) of the sound foam particulates breaking off which can be inhaled while using the PAP device. If there are particulates, there is also the chance of the chemical emissions while it degrads.
To date, Philips has received a limited number of reports of possible patient impact due to foam degradation, and no reports to date regarding patient impact related to chemical emissions. The company continues to monitor reports of potential safety issues as required by medical device regulations and laws in the markets in which we operate.
If you plan to continue to use the PAP device, other vendors recommend the usage of an "in-line CPAP filter" to be placed on the blower portion of the machine and connected to the tubing. This can be purchased on Amazon, Walmart, and other CPAP related websites. However, insurance does not cover this item. Also, you will not be able to use the humidifier when using the "in-line CPAP filter". There is also the possibility that patients on lower pressures (lower than 10 cmH2O) may feel 'less pressure' coming from the machine due to the filter. A pressure increase may be needed to compensate for the pressure loss.
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If you have any questions regarding the recall or registration, please contact Philips/Sedgwick at 877-907-7508 or https://www.usa.philips.com/healthcare/e/sleep/communications/src-update
If you have any questions for SDCMA (DME Department) or need to schedule consultation with Dr. Hernandez, please contact us at 410-582-9300.
