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A few highlights regarding the Philips Recall

 A few highlights regarding potential health risks and odds of having a defective device:

These highlights are not comprehensive and do not substitute for the importance of you reading the data in the Philips and FDA links.

Question:  What are the odds of your device being damaged by the issues identified in the recall?

Answer:  The odds of your device being affected are unknown.  Philips has reported that the complaint rate in 2020 was low (0.03% or 3 in 10,000 devices). However, the company also has stated, “Philips acknowledges that the low complaint rate may not fully reflect the probability frequency or severity of the occurrence, because users may not detect the particulates and/or report the event to Philips.”  If your PAP device has not been exposed to high heat and humidity for a significant amount of time, or an ozone type cleaner, then the risk of your device being affected is lower.  If you have used an ozone cleaning device such as SoClean or another manufacturer, you should stop using that cleaning device immediately and follow the manufacturer’s recommendations for cleaning your PAP device.

Question:  What is known about “off-gassing” exposure to potentially carcinogenic (cancer causing) volatile organic compounds (VOCs)?

Answer:   According to Philips, the current recall notice reports that off-gassing of VOCs may occur during the initial operation and possibly continue throughout the device’s useful life.   The recall data also states that at the time the recall notification was issued, Philips Respironics relied on an initial, limited data set and toxicological risk assessment. Since then, additional testing and assessments were performed. Review of these assessments to date indicate that exposure to the level of Volatile Organic Compounds (VOCs) for the first-generation DreamStation devices with PE-PUR foam is not typically anticipated to result in long-term health consequences for patients.

It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. Additionally, this new assessment is limited to the evaluation of VOCs for first-generation DreamStation devices and does not evaluate the risks of potential foam particulates or cover other devices affected by the recall. Further health risk assessments are ongoing.

Question:  What are the potential Health risks from the sound abatement foam?

Answer:  The FDA reports –

Polyester-based polyurethane (PE-PUR) foam is used to lessen sound and vibration in these devices and other medical equipment. This particular foam may breakdown and can result in serious injury, which can be life-threatening, cause permanent impairment and require medical intervention to prevent permanent injury to users:

  • Breakdown (degrade) into black pieces that may enter the device’s air tubes and be inhaled or swallowed by the user.
  • Release certain dangerous chemicals, such as volatile organic compounds (VOCs), into the device’s air tubes, and be inhaled by the user.
    • The foam damage may get worse in hot and humid settings, and by use of unapproved cleaning methods, such as ozone cleaners and ultraviolet (UV) light products.

If the foam breaks down, you may or may not see black pieces of the foam in the air tubes or masks.

The potential risks of particulate exposure inhaling or swallowing pieces of foam include:

  • Irritation to the skin, eyes, nose, and respiratory tract (airway)
  • Inflammatory response
  • Headache
  • Asthma
  • Toxic or cancer-causing effects to organs, such as kidneys and liver

The potential risks of inhaling chemicals released into the device’s air tubes from the PE-PUR foam include:

  • Headache
  • Dizziness
  • Irritation in the eyes, nose, respiratory tract (airway), and skin
  • Hypersensitivity reaction, such as an allergic reaction or another immune system reaction
  • Nausea or vomiting

Toxic and cancer-causing effects