Preventing Particle Contamination from Your Recalled CPAP Machine
Learn how to prevent particle contamination from your recalled CPAP machine!
February 28, 2022
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 device1”. Phillips issued a statement that they plan to repair or replace the products in approximately 12 months2. 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 more3. A study in the Journal of Clinical Sleep Medicine, concluded that moderate-to-severe sleep apnea is a risk factor for mortality, stroke and cancer4. 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. Pall recommends 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. Pall filters have been demonstrated to effectively remove particles of even the most critical size5 and Pall assumes that the filter is an effective way to prevent particulate contamination6. Contact a Pall representative today to obtain machine side breathing filters.
- “Philips Respironics CPAP, BiPAP, and Ventilator Recall: FAQs.” U.S. Food and Drug Administration, FDA, 10 Sept. 2021, https://www.fda.gov/medical-devices/safety-communications/philips-respironics-cpap-bipap-and-ventilator-recall-frequently-asked-questions.
- “Philips Starts Repair and Replacement Program of First-Generation Dreamstation Devices in the US in Relation to Earlier Announced Recall Notification.” Philips, Philips, 1 Sept. 2021, 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.
- “Sleep Apnea.” Mayo Clinic, Mayo Foundation for Medical Education and Research, 28 July 2020, https://www.mayoclinic.org/diseases-conditions/sleep-apnea/symptoms-causes/syc-20377631.
- Marshall, Nathaniel S., et al. “Sleep Apnea and 20-Year Follow-up for All-Cause Mortality, Stroke, and Cancer Incidence and Mortality in the Busselton Health Study Cohort.” Journal of Clinical Sleep Medicine, vol. 10, no. 04, 2014, pp. 355–362., https://doi.org/10.5664/jcsm.3600.
- ISO 23328-1:2008 Breathing system filters for anesthetic and respiratory use — Part 1: Salt test method to assess filtration performance
- “Pall BB50T Breathing Circuit Filter” Pall Corporation, 2019
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Catherine Kane, RN, BSN – Clinical Specialist ICU
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