Late last fall, the FDA issued a press release that Philips Respironics, the manufacturer of CPAP (Continuous Positive Airway Pressure) devices had recalled certain products due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.
According to the FDA, “These devices are used to provide breathing assistance. Specifically:
- A bilevel positive airway pressure (also known as BiPAP, BiLevel PAP, or BPAP) machine pumps air under pressure into the airway of the lungs. BiPAP machines have a higher pressure when you breathe in and lower pressure when you breathe out.
- A continuous positive airway pressure (CPAP) machine keeps your airway open by providing a continuous stream of air through a mask. CPAP machines are devices prescribed to people with obstructive sleep apnea to keep their airways open during sleep.
- A continuous ventilator device is intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.”
Since these machines have been prescribed by physicians in increasing numbers in the last decade, many people may be affected adversely by this recall. The noise abatement foam was included in the device to address complaints that the machines were so noisy it prevented users and family members from sleep.
However, the foam has been the source of a number of significant health issues and led to the recall. According to the FDA, “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.
Another vital issue concerning these devices concerns the registration of the CPAP Memory Cards and well as the retrieval of data recorded on the device. Nearly all CPAP machines store data that indicate whether the patient is complying with CPAP therapy. This includes the total number of hours the machine has been on, as well as the total number of days in which the machine has operated for the minimum amount of time required for compliance. Using compatible software, the clinician can see what percentage of days in any given period the patient has used the machine. CPAP devices typically record the times the patient has stopped breathing (apnea) or has breathed too slowly or irregularly (hypopnea). In addition, they can also classify apnea events as obstructive (due to a blocked airway), central (due to the fact that the patient is not even attempting to breath) or unknown. This data can indicate whether the patient needs a greater prescribed air pressure, or whether CPAP therapy is appropriate for the patient.
The registration of the Memory Cards and the data retrieval are of the utmost importance in terms of monitoring your health as well as taking legal action against the manufacturer if the CPAP machines causes any of the above-mentioned problems. This could be a matter of life and death for CPAP users so it is vitally important you comply with the registration and retrieval of the Memory Card and its data.
Rheingold, Giuffra, Ruffo & Plotkin represent CPAP clients that have been adversely affected by this recall. We can also help with issues concerning the CPAP Memory Card. If you or a loved one has been injured by one of these devices, please contact us today.