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CPAP Recall
In June, Philips Respironics voluntarily recalled millions of ventilators, BiPAP, and CPAP machines because the sound reduction foam breaks down and can be inhaled or swallowed by the device user. It is unclear exactly how many systems were recalled, but the estimates range in the millions.
In July, the FDA announced the Philips Respironics recall a class I, meaning it may cause serious injury or death. There is general concern about the safety of these systems along with the recall process. The Attorney General for Connecticut, William Tong released his letter to the FDA dated October 5, 2021. The letter starts with “I am writing to request that the FDA take more aggressive regulatory action pertaining to the voluntary recall by Philips Respironics of certain Continuous Positive Airway Pressure (“CPAP”), Bilevel Positive Airway Pressure (“BiPAP”) and ventilator devices, which contain a degrading foam that has been determined by the FDA to be potentially life threatening.”
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According to the FDA website, users of these systems have several options, including “Using alternative treatments for sleep apnea, such as positional therapy or oral appliances, which fit like a sports mouth guard or an orthodontic retainer.” Properly treating sleep apnea is critical for maintaining and improving patient health. The FDA urges anyone using one of these recalled devices to work with their medical provider for a suitable solution.
CPAP
Positional therapy would include products like slumberBUMP™ Positional Sleep Belt. According to snoringHQ.com, the slumberBUMP is a lightweight sleep belt that trains individuals to sleep in a non-supine position and consists of an inflated air pouch around the chest. They further indicate that positional therapy can supplement CPAP or BiPAP.
The pandemic and this recall have stressed the supply chain for the types of devices recalled. The FDA fully supports oral appliances for the treatment of sleep apnea, and dentists teamed with medical doctors successfully treat patients with oral appliances every day.
ASBA’s mission is to educate health professionals on all treatment strategies for sleep apnea. Consider joining ASBA today.
