Prepared by: Jessica Bertram M3 (University of Tennessee Health Science Center)
Reviewed by: M. Boyd Gillespie, MD, MSc, FACS
Philips Respironics Recall: Why It Occurred
In June, Phillips Respironics recalled certain devices because of health and safety concerns. Phillips Respironics stated that some of their machines contain a harmful foam substance which is located in the air pathway and extends from the device outlet into the patient’s mask.
The foam is manufactured from polyester-based polyurethane (PE-PUR) and is used to help reduce sound and vibrations caused by the machine. Reports have shown that this noise suppressing foam has the potential to deteriorate and release harmful particles or chemicals which can be swallowed or inhaled by the person using the device.
The FDA stated that exposure to chemicals released from the PE-PUR foam have been linked to potential health concerns including:
- irritation in the eyes, nose, respiratory tract, and skin
- toxic and carcinogenic (cancer causing) effects
Furthermore, if exposed to the particles released from the PE-PUR foam, potential health risks include:
- irritation to the skin, eye, and respiratory tract
- inflammatory response
- toxic or carcinogenic (cancer causing) effects to organs, such as kidney and liver
Which devices are involved?
So far, Phillips Respironics has voluntarily recalled their Bi-Level Positive Airway Pressure (Bi-level PAP, BiPAP, or BPAP), their Continuous Positive Airway Pressure (CPAP), and Mechanical Ventilator devices that were manufactured prior to April 26, 2021.
They also stated that the likelihood of the foam to break down increases in devices that, are more than three years old, are used in high heat (greater than 95 degrees) and high humidity environments or that were routinely cleaned with an ozone cleaning device. Included is a link listing all affected models.
CPAP Alternatives for Patients:
The FDA and Phillips Respironics recommends that patients first confirm that their device is included in the recall.
In addition, Phillips Respironics asks patients to register their device online or register by phone at 877-907-7508 in order to stay informed of updates regarding instructions or other corrective fixes.
For patients using affected BiPAP and CPAP devices: Phillips Respironics recommends for you to discontinue use and contact your health care provider to determine whether the benefits outweigh the risks identified in the recall.
However, for patients using Mechanical Ventilator devices to sustain life: DO NOT discontinue use until after you have consulted with a physician to determine appropriate next steps. Fortunately there are currently a number of treatment options for patients with OSA who are struggling with CPAP or are having difficulty obtaining a safe CPAP device.
How can UT’s Dream Team help?
Led by our department chair Dr. M. Boyd Gillespie, the UT Baptist Sleep Surgery Clinic is available to consult with patients with regard to the safety of their CPAP devices as well as discuss alternatives to CPAP for patients who struggle to use the device.
Please call (901) 737-3021 for an appointment with Dr. Gillespie.