Cohen Medical Associates is a family medical center and research center located in Delray Beach, FL.
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cpap recall

Was Your CPAP Device Recalled?

Our primary care doctors in Delray Beach have received several calls from our patients regarding the recent recall of CPAP devices used to treat sleep apnea. We’re also concerned that others using these devices haven’t yet heard about last month’s recall.

So we want to share what to do if you are using one of these devices.

The CPAP recall

On June 30, the U.S. Food and Drug Administration (FDA) issued an alert to all users of certain Philips Respironics Ventilators, Bi-Level Positive Airway Pressure (BiPAP), and Continuous Positive Airway Pressure (CPAP) machines. This alert occurred because Philips Respironics has voluntarily recalled certain of these devices due to potential health risks.

The recall includes an estimated three million to four million devices sold globally. Over half of the devices were sold in the U.S. Most of the devices involved the first-generation DreamStation products. The recall excludes DreamStation 2 products.

A list of the affected devices can be found here.

The cause

The problem with the devices stemmed from foam used to muffle the sound made by these machines. Philips found that the foam could begin to deteriorate and release tiny particles and gases with prolonged use. According to the company, inhaling or swallowing these materials can irritate airways, cause headaches, and possibly be toxic.

“These issues can result in serious injury which can be life-threatening, cause permanent impairment, and/or require medical intervention to preclude permanent impairment,” the company said in a statement.

Since April, Philips has been investigating the problem prompted by reports from some consumers. Reports said that they had found black debris in the air path tube. Some also reported experiencing such symptoms as coughing, chest pressure, sinus infection, and upper airway irritation.

No deaths are reported in connection with the recalled devices, but some of the particles could potentially cause cancer. According to Philips, other possible risks with exposure include irritation of the skin, eyes, asthma, headache, nausea, and vomiting, and adverse effects on other organs such as the liver and kidneys.

“We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measure we are announcing today to ensure patient safety,” Philips CEO Frans van Houten said in a statement accompanying the recall.

What to do about the CPAP recall

If you have one of these machines, it’s because you’ve been diagnosed with a common condition called sleep apnea. Left untreated, sleep apnea—the sudden, often undetectable impairment or stopping of breathing during sleep—can lead to daytime fatigue, high blood pressure or heart problems, type 2 diabetes, and even memory issues. So you must address the problem.

The FDA recommends the following for those who are currently using one of these devices.

Talk to your health care provider to decide on a suitable treatment for your condition, which may include:

  • stopping use of your device
  • using another similar device that is not part of the recall
  • using alternative treatments for sleep apnea, such as positional therapy or oral appliances, which fit like a sports mouth guard, or an orthodontic retainer
  • initiating long-term therapies for sleep apnea, such as losing weight, avoiding alcohol, stopping smoking, or, for moderate to severe sleep apnea, considering surgical options
  • continuing to use your affected device, if your health care provider determines that the benefits outweigh the risks identified in the recall notification

More recommendations

The FDA also recommends that users follow the manufacturer’s recommended cleaning and replacement guidelines for their device. Improper or “off-label” cleaning methods accelerate the foram deterioration, according to findings by the agency and manufacturer. These methods include ozone cleaners and ultraviolet (UV) light products.

You should also use an inline bacterial filter the help reduce particles in the air path tube. These filters, however, will not help reduce exposure to certain chemicals that the foam may release. They may also affect the device’s performance, because they may increase airflow resistance through the device.

Finally, the FDA warns consumers not to stop or change ventilator use until they have talked to their health care provider. This is because “alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable.”

Register your CPAP device

Philips is working to fix the issues with these devices. So if you haven’t yet registered your device on the recall website, do so here. This will allow the company to notify you when they’ve found a solution.

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