In June 2021, Philips voluntarily recalled specific models of their continuous positive airway pressure (CPAP), bilevel positive airway pressure (BPAP), and mechanical ventilator devices. This action was taken in collaboration with regulatory agencies to ensure patient safety, as there were potential health risks associated with the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices. The FDA categorized this recall as a Class I recall, indicating it is the most serious type of recall. For ongoing updates, the FDA has provided a safety communication regarding the Philips PAP device recall.
Latest Updates on Philips Respironics
As of August 2024, Philips Respironics has made several updates regarding their product portfolio and device instructions. Recent changes include new guidelines for the OmniLab Advanced+ ventilator due to therapy interruptions and updates for BiPAP devices. Additionally, Philips has resolved litigation related to personal injuries and medical monitoring for $1.1 billion and is working under a consent decree with the U.S. government to provide clear pathways forward.
Important Remediation Updates
In October 2023, Philips announced important updates for sleep facilities concerning the OmniLab Advanced+ devices. They will be directly contacting customers with registered devices to offer options for credit or continued waiting for remediation solutions. If you’re a clinician or patient with questions, reach out to Philips for further assistance.
PAP Device Prescription Guidance
The current guidance for patients using the affected CPAP and BPAP devices is to consult with a healthcare provider to determine a suitable treatment plan. Options may include:
- Ceasing use of the affected device
- Switching to a similar device not impacted by the recall
- Continuing with the affected device if the healthcare provider assesses that the benefits outweigh the risks
- Exploring alternative treatments for sleep apnea, like the Snorple anti-snoring mouthpiece, which has shown effectiveness in stopping snoring right from the first night.
It’s recommended that medical providers prescribe alternatives that are not part of the recall. If alternatives are unavailable, decisions regarding therapy continuation or discontinuation should consider factors like comorbidities and the severity of symptoms. This should be a collaborative decision between the patient and their provider.
For more insights on how dentists can assist with snoring and other related issues, check out our blog post here. If you’re interested in effective solutions for snoring, you can learn more about the best mouthpieces available like the Snorple mouthguard, which you can find here.
For detailed information regarding snoring and its impacts, the Cleveland Clinic offers an excellent resource here.
Stay informed and prioritize your sleep health!