Even as personal health company Philips announces repairs and replacements of its sleep apnea machines, millions of customers have been left with few alternatives for a safe night's sleep.
The company voluntarily recalled millions of sleep apnea machines in June, due to possible health risks associated with a polyester-based polyurethane foam used to reduce device sound.
According to the Food and Drug Administration, there were more than 1,200 complaints and more than 100 injuries related to the machines by July 22, 2021. It subsequently warned the public that continued use of the devices could cause serious injury or death.
According to both Philips and the FDA, the foam in the devices could degrade into small particles during use.
"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 device," the FDA said in its recall notice. "Exposure to debris or chemicals could cause serious adverse events in patients such as irritation (skin, eye, and respiratory tract), inflammation, headache, asthma, hypersensitivity, nausea/vomiting, adverse effects to other organs (e.g., kidneys and liver) and toxic carcinogenic effects."
An estimated 22 million Americans have sleep apnea, a condition of abnormal breathing during sleep. Many of them depend on devices like those recalled by Philips and have been waiting for recommendations on what to do next.
While Philips has since announced the company has been approved by the FDA to repair and replace the recalled products, the work is likely to continue through September of next year. A timeline that has left some customers wondering what should be used in the meantime.
When it comes to some patients, an expert with Dignity Health said the health benefits of continued usage could outweigh the health costs of waiting for a new one.
"At this point, for the time being, people with the severe form of the disease probably should continue using the machine because their health is in more jeopardy," said Dr. Nariman Saddad, a pulmonologist with Dignity Health. "The people with a milder form, especially if they have concerns, they can hold [off] on using it."
In a statement shared by the company, Philips said, in part: "We are mobilized to deliver a solution to them as fast as possible. We have significantly increased our production, service and rework capacity, and further intensified our outreach to our customers and their patients. We urge patients with affected active devices to register these on the dedicated recall notification website."
Recalled products include:
-Continuous Ventilator, Minimum Ventilatory Support, Facility Use: Philips Respironics E30 with Humidifier
-Continuous Ventilator, Non-life Supporting devices: DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+, and
-Noncontinuous Ventilators: SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, and REMstar SE Auto)
Product codes included BZD and MNS, with manufacturing dates between April 11, 2007 and April 22, 2021 and distribution dates between July 21, 2009 and April 22, 2021.
More information on the recall notification, as well as instructions for customers, users, and physicians can be found here. Philips has advised anyone with an affected device to register the product and begin a case in the replacement program.
