Philips Issues a Recall Notification to Mitigate Potential Health Risks Related to PAP Sleep Devices
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The reason for the recall is that a specialized sound dampening foam used in the device has been shown to possibly degrade into particles which can enter into the device’s air-pathway and thus could be inhaled or ingested by the user. Additionally, the foam may “off-gas” certain chemicals as well. The manufacturer has recommended that all patients discontinue the use of these devices unless the benefit outweighs the very small risk identified to date (3 out of every 10,000 patients). They are working on a solution.
Based upon the information available to us at this time, we recommend the following:
Every patient has a unique benefit and risk profile from using their PAP device. As per Philips’ recommendation, PAP titration studies are only done when your physicians consider the benefits of treatment outweighs the risk of exposure, within the context of your medical conditions.
Possible Health Risks (not limited to):
- Headaches / Nausea
- Irritation and or inflammation of the eyes, respiratory system
- Inflammatory response
- Adverse effects to other organs (kidney, liver)
- Skin irritation
- Eye irritation
- Possible toxic and carcinogenic effects.
Precautions We are Taking:
If you continue with the device:
- Please register your device at Phillips-Respironics recall website
- Please watch for symptoms 1-8 noted above or other concerning symptoms.
- Please check your instruction manual for proper cleaning methods recommended by your DME provider. Do NOT use ozone or other cleaning units.
- Keep your device in a cool environment, preferably where humidity in the room is low.
If you do choose to discontinue your device:
- Please avoid driving and all other tasks requiring sustained vigilance if feeling sleepy
- Try to avoid sleeping on your back if possible or consider a wedge pillow or other positional sleep device.
- Please avoid alcohol, muscle relaxants or other sedatives before bedtime as these can exacerbate sleep apnea
- Contact our office to schedule an appointment with a Sleep Provider to discuss alternatives to PAP.
Precautions You Should Be Taking:
- We are working with Phillips to order replacement of the recalled devices from service as soon as possible.
- We installed an inline bacterial filter in PAP devices used in this lab.
- Please watch for symptoms 1-8 noted above or other concerning symptoms AND NOTIFY the sleep tech or our office staff immediately.
- We do not use ozone based cleaners for PAP devices in the lab and we continue to follow the cleaning procedures per each device’s “Instructions for Use.”
- We are avoiding the high heat and high humidity environments, which Philips indicates can contribute to foam degradation.
- We visually inspect the device before and after each use, looking for black debris/foam particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). If particles are detected, we will immediately remove the device from service.
- FDA safety communication for PAP recall
- Register your device(s) on Philips Respironics’ recall website
- Report any problems with a device through the FDA’s MedWatch Voluntary Reporting Form.
- Philips Respironics’ recall notification web page
- Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories: FDA Safety Communication