Everyone wants a good night’s sleep and for those with sleep apnea (a condition with abnormal breathing which may cause poof sleep and lower oxygen levels) the solution is often a continuous positive airway pressure (CPAP) machine which is the most commonly prescribed device for treating sleep apnea disorders.
While CPAP machines have been around since the 1980’s, according to Grand View Research dated March 2021, the current global market size for sleep apnea devices is around $3.7 billion and expected to increase by 6.2% per year in the next few years. North America is the most lucrative market for sleep apnea machines and there are about a dozen manufactures of the machines among which the Philips company is one of the most prominent.
According to Philips first quarterly report of 2021 and dated April 26, 2021, there is noted possible risks to users related to the sound abatement foam used in certain of Philips’ sleep and respiratory care devices currently in use. This report references Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories: FDA Safety Communication Issued: February 27, 2020.
Philips issued a recall on June 14, 2021 for some of it’s Philips Respironics products due to potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices which can be a gas or particulate to be inhaled or ingested. These health risks include: cancer, respiratory issues, or other significant health issues. Ingesting or inhaling these particles is linked to:
- Carcinogenic effects
- Toxic effects
- Respiratory issues
- Chemical exposure risk
On June 30, 2021 the FDA issued a Safety Communication to alert users and providers regarding the Philips recall. In July, the FDA identified this device problem as a Class I recall, the most serious type of recall and posted frequently asked questions. A November 12, 2021 update from the FDA noted that Philips Respironics had not then provided the FDA with all the information needed for the FDA to evaluate the plan to repair and replace products across all the Philips Respironics’ recalled devices.
On March 14, 2022, the FDA updated its Frequently Asked Questions about the Philips Respironics CPAP, BiPAP, and ventilator recall to include information about Philips Respironics’ prioritization strategy for replacement devices. The FDA shared with Philips Respironics the concerns of health care providers and people who use these recalled devices, that for some patients, stopping use of the recalled device without an adequate alternative may involve significant risks to individual and public health. A first-come, first-served replacement strategy may not address these risks, or the risks from continued use of the recalled devices that such patients may face.
On March 10, 2022, the FDA issued a notification order to Philips Respironics requiring the company to notify patients and others of the company’s June 14, 2021, recall of certain Philips Respironics ventilators, CPAP and BiPAP machines, and the unreasonable risk of substantial harm to the public health posed by the degradation of the polyester-based polyurethane (PE-PUR) sound abatement foam used in those products. The FDA determined that this order was necessary to eliminate the unreasonable risk of harm posed by the recalled products, because the company’s notification efforts to that date have been inadequate. For more information about the order, see the FDA’s March 2022 press release.