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September 27, 2021
Paustenbach and Asssociates
On June 30, 2021, the U.S. Food and Drug Administration (FDA) issued a safety communication regarding the voluntary recall of specific Philips Respironics ventilators, BiPAP (Bi-Level Positive Airway Pressure), and CPAP (Continuous Positive Airway Pressure) machines manufactured between 2009 and April 26, 2021. This was due to potential breakdown and inhalation, or ingestion of polyester-based polyurethane sound abatement foam used in these devices.
Philips Respironics received complaints about the presence of black debris or particles in device air pathways. Based on reports by various news services, though it is unclear if the alleged symptoms are related to the reported problem, Philips Respironics has also received reports of headache, upper airway irritation, cough, chest pressure, and sinus infections. According to the FDA, the potential risks of particulate and chemical exposures from the use of these machines include asthma; skin, eye, and respiratory tract irritation; dizziness, hypersensitivity, nausea/vomiting; and “toxic and carcinogenic effects” to organs such the kidneys and liver (FDA, 2021).
Based on our experience, we would recommend evaluating these claims using a systematic approach based on risk assessment methods. Based on initial analysis, some aspects of the reported adverse effects seem illogical based on the toxicology of polyurethane foam. Of course, case reports are usually poor predictors of the actual cause of a person’s specific illness or symptoms. To understand if there is a likelihood of any adverse effects, a characterization of the airborne particulates, if any are produced by the devices, will be necessary. After that, this information needs to be combined with the appropriate toxicity data to allow the completion of a scientifically based risk assessment.
Paustenbach and Associates scientists have extensive experience in conducting consumer product safety assessments and evaluating the potential health risks of possible leachable contaminants from consumer products. Specifically, we have assessed the presence of trace quantities of metals in medical devices and identified potential long-term health hazards due to those metals. Our scientists have 50+ years of experience characterizing these hazards and offering a range of possible solutions. Our scientists have published more than 300 papers on relevant topics. Please contact us for more information regarding Paustenbach and Associates’ capabilities.
FDA. (2021). Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. Retrieved 8/18/2021, from https://www.fda.gov/medical-devices/safety-communications/certain-philips-respironics-ventilators-bipap-and-cpap-machines-recalled-due-potential-health-risks