Learn how to prevent particle contamination from your recalled CPAP machine.
According to the FDA, “Philips Respironics has voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP), and continuous positive airway pressure (CPAP) machines due to potential health risks” (1). The reason for the recall is due to “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” (1). Philips issued a statement that they plan to repair or replace the products in approximately 12 months (2). Unfortunately, not all CPAP users are able to find a solution or replacement to their CPAP machine. Many users are unable to go 12 months without the use of their device due to serious health concerns.
CPAP users are left to decide which risk is greater: the harmful effects of not using their CPAP machine or potential harmful effects from inhaled particles.
According to Mayo Clinic, sleep apnea is a serious medical condition that can lead to further complications such as high blood pressure or heart problems, type 2 diabetes, metabolic syndrome, liver problems, daytime fatigue, and more (3). A study in the Journal of Clinical Sleep Medicine concluded that moderate-to-severe sleep apnea is a risk factor for mortality, stroke, and cancer (4). Because of these dangerous risks, many physicians are advising their patients to continue to use their CPAP machine despite the risk the ventilator itself may pose.
Which options do CPAP users have when they are unable to replace their machine, but need to continue to use CPAP at night?
One solution is to place a Pall Breathing Circuit Filter between the machine and the CPAP tubing. We recommend that the BB50T filter should be used under the supervision of a clinician or respiratory therapist and the filter should be placed at machine side on the CPAP machine. These filters have been demonstrated to effectively remove particles of even the most critical size (5) and the company assumes that the filter is an effective way to prevent particulate contamination (6). Contact a representative today to obtain machine side breathing filters.
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- United States Food and Drug Administration. FAQs on Philips Respironics CPAP, BiPAP, and Ventilator Recalls. [Published 2021 Sep 10]. [Updated 2022 Dec 22]. https://www.fda.gov/medical-devices/safety-communications/philips-respironics-cpap-bipap-and-ventilator-recall-frequently-asked-questions.
- Philips. Philips starts repair and replacement program of first-generation DreamStation devices in the US in relation to earlier announced recall notification. 2021 Sep 01. https://www.philips.com/a-w/about/news/archive/standard/news/press/2021/20210901-philips-starts-repair-and-replacement-program-of-first-generation-dreamstation-devices-in-the-us-in-relation-to-earlier-announced-recall-notification.html.
- Mayo Clinic. Sleep apnea. Mayo Foundation for Medical Education and Research. 2020 Jul 28. CON-20377615. https://www.mayoclinic.org/diseases-conditions/sleep-apnea/symptoms-causes/syc-20377631.
- Marshall NS, Wong KKH, Cullen SRJ, Knuiman MW, Grunstein RR. Sleep Apnea and 20-Year Follow-up for All-Cause Mortality, Stroke, and Cancer Incidence and Mortality in the Busselton Health Study Cohort. J Clin Sleep Med. 2014;10(4):355–362. https://doi.org/10.5664/jcsm.3600.
- International Organization of Standards. ISO 23328-1:2008 Breathing system filters for anesthetic and respiratory use — Part 1: Salt test method to assess filtration performance. [Published 2003 Aug 15].
- Pall Corporation. Pall BB50T Breathing Circuit Filter. 2019.
Author bio
Catherine Kane, RN, BSN – Clinical Specialist ICU
Catherine provides clinical support to sales and marketing teams at Cytiva on a full range of products including filters for mechanical ventilation, surgical and medical gas applications, and IV drug delivery systems. Catherine holds a Bachelor of Science in Nursing from the University of St. Francis in Joliet, IL with a background in inpatient nursing and clinical research.