CPAP Cancer Compensation Program

“CLASS I” RECALL OF CPAP MACHINES - WHAT THIS MEANS?

The FDA classified the June 2021 Philips recall of certain ventilators, BIPAP machines, and CPAP machines as a Class I recall, the most serious type of recall. Class I recalls involve a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Source: https://www.fda.gov/medical-devices

THE PROBLEM WITH PE-PUR FOAM FOUND IN CPAP DEVICES

PE-PUR Foam May Be Inhaled or Swallowed, Presenting a Potential Health Risk

Polyester-based polyurethane (PE-PUR) is a sound abatement foam used to reduce sound and vibration in these devices and other medical equipment. The PE-PUR foam in the affected Philips Respironics CPAP, BiPAP, and ventilator devices may:

-Break down (degrade) into particles which may enter the device’s air pathway and be inhaled or swallowed by the user

-Release certain chemicals into the device’s air pathway, which may be inhaled.

These issues can result in serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent damage.

To date, Philips Respironics has received several complaints about the presence of black debris/particles within the device’s air pathway. Philips Respironics also has received reports of headache, upper airway irritation, cough, chest pressure, and sinus infection, which may be related to this issue, though the cause of the symptoms cannot be definitively linked.

The potential risks of particulate exposure include irritation to the skin, eye, and respiratory tract, inflammatory response, headache, asthma, and toxic or carcinogenic effects to organs, such as kidneys and liver.

The potential risks of exposure to chemicals released into the device’s air pathway from the PE-PUR foam include headache; dizziness; irritation in the eyes, nose, respiratory tract, and skin; hypersensitivity; nausea/vomiting; and toxic and carcinogenic effects.

The foam degradation may be exacerbated by high heat and high humidity environments, and by use of unapproved cleaning methods, such as ozone.
To date, there have been no reports of death as a result of these issues.

Source: fda.gov

RECOMMENDATIONS FOR PEOPLE WHO USE AFFECTED BIPAP OR CPAP MACHINES

Talk to your health care provider to decide on a suitable treatment for your condition, which may include:

-Stopping use of your device.

-Using another similar device that is not part of the recall.

-Continuing to use your affected device, if your health care provider determines that the benefits outweigh the risks identified in the recall notification.

-Using alternative treatments for sleep apnea, such as positional therapy or oral appliances, which fit like a sports mouth guard or an orthodontic retainer.

-Initiating long term therapies for sleep apnea, such as losing weight, avoiding alcohol, stopping smoking, or, for moderate to severe sleep apnea, considering surgical options.

Source: fda.gov