{"id":14310,"date":"2022-06-01T10:13:02","date_gmt":"2022-06-01T14:13:02","guid":{"rendered":"https:\/\/staging.somnomed.com\/en\/?p=14310"},"modified":"2022-06-02T12:57:36","modified_gmt":"2022-06-02T16:57:36","slug":"the-cpap-machine-recall-what-you-need-to-know","status":"publish","type":"post","link":"https:\/\/staging.somnomed.com\/restassuretest\/the-cpap-machine-recall-what-you-need-to-know\/","title":{"rendered":"The CPAP Machine Recall: What You Need To Know"},"content":{"rendered":"\t\t
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The CPAP Machine Recall: What You Need To Know<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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In June 2021, Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines due to potential health risks. The recall was classified as Class I – the most serious type of recall.\u00a0<\/span><\/i><\/p>

Since its announcement, the recall has impacted approximately 2 million people in the United States. Below, we dive into more detail about the associated health risks and what you can do about the recall as a practicing physician and\/or as an Obstructive Sleep Apnea (OSA) patient.<\/i><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Why CPAP Machines Have Been Recalled<\/b><\/p>

The polyester-based polyurethane (PE-PUR) foam used in many of the Philips ventilators, bi-level positive airway pressure (Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines utilized to lessen sound and vibration were found to be able to break down.\u00a0<\/span><\/p>

If this foam breaks down, black pieces of foam or certain chemicals that are invisible to the naked eye could be breathed in or swallowed by the person using the device. Breathing in chemicals or swallowing small pieces of broken-apart foam has the potential to result in serious injury, cause permanent impairment, and\/or require medical intervention to prevent permanent injury.<\/p>

The FDA classified the June 2021 recall as Class I, which involves a reasonable probability that \u201c\u2026the use of, or exposure to, a violative product will cause serious adverse health consequences or death.\u201d1<\/p>

What Do You Do If Your CPAP Machine Has Been Recalled?<\/b><\/p>

Stopping use of a CPAP device can, in some cases, be riskier than continuing its use. Patients should speak with their healthcare providers on whether the benefits of using the device outweigh the risks – especially if a patient\u2019s Obstructive Sleep Apnea (OSA) is severe.<\/p>

Unfortunately, at the time of this writing, Philips has not yet provided the FDA with all information needed for the FDA to evaluate the plan to repair and replace all recalled Philips devices. If patients have a health issue and are currently using or have used a recalled or replaced device – or have any problem with their device – it\u2019s recommended by the FDA for patients to speak with their health care provider about it and\u00a0report the problem through the MedWatch Voluntary Reporting Form<\/span><\/a>.<\/p>

What Is An Alternative To A CPAP Device?<\/b><\/p>

If a patient has been diagnosed with mild or moderate Obstructive Sleep Apnea (OSA), SomnoDent\u00ae<\/sup><\/span>\u00a0therapy may be just as effective as CPAP. A SomnoMed sleep apnea oral appliance is an FDA-cleared, custom-fitted dental device specially designed to be an effective, comfortable, and durable alternative to CPAP therapy. Plus, it\u2019s insurance and Medicare approved! The appliance works by moving the lower jaw forward, clearing the airway and giving patients a safe and soundless sleep.<\/p>

How Is SomnoMed\u00ae<\/sup> Helping Physicians, Dentists, and Patients During the Recall?<\/b><\/p>

At SomnoMed\u00ae<\/sup>, we understand that in many markets, patients receive CPAP as first-line therapy for OSA treatment. However, CPAP isn\u2019t an option or a preferred first choice for everyone. Our\u00a0Medical\u00a0Initiative\u00a0looks to address the reasons why oral appliance therapy is not prescribed as first-line treatment – and strives to change that.\u00a0<\/span><\/p>

We work equally with dentists and sleep physicians to help them treat their patients and address the ever-increasing burden of OSA utilizing oral appliance therapy as an effective CPAP alternative.\u00a0<\/span><\/p>

Where To Go From Here<\/b><\/p>

The FDA provided an update on the\u00a0medical device reports (MDRs) received<\/span><\/a>\u00a0on May 19, 2022. The FDA continues to review and assess MDRs and has pledged to keep the public informed as new information becomes available.<\/p>

In the meantime, there are so many challenges that come into play when diagnosing and treating Obstructive Sleep Apnea (OSA), from the OSA screening process to therapy. These include but are not limited to access, education, and awareness. That\u2019s why, here at SomnoMed, we\u2019re rolling up our sleeves in pursuit of a common, universal commitment: to bring more patients into more successful OSA treatment, regardless of therapy.\u00a0<\/p>

Have more questions? <\/span>Sleep physicians, contact us here:\u00a0https:\/\/somnomed.co\/en\/physicians\/physicians-contact\/<\/span><\/a><\/span><\/p>

Dentists, reach out to us here:\u00a0https:\/\/somnomed.co\/en\/dentists\/dentists-contact\/<\/span><\/a><\/span><\/p>

Compare CPAP and oral appliances over a whole night\u2019s sleep here:\u00a0https:\/\/effectivenessequation.com\/<\/span><\/a><\/p>

Patients, contact us here: https:\/\/somnomed.co\/en\/find-a-clinic\/<\/span><\/a><\/span><\/p><\/div>


Sources:
<\/b>1 https:\/\/www.fda.gov\/medical-devices\/safety-communications\/faqs-philips-respironics-ventilator-bipap-machine-and-cpap-machine-recalls<\/span><\/a><\/span><\/p>

2 https:\/\/www.healthline.com\/health-news\/philips-cpap-machines-are-being-recalled-what-to-know#What-to-know-about-the-recall<\/span><\/a><\/span><\/p><\/div>


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The CPAP Machine Recall: What You Need To Know In June 2021, Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines due to potential health risks. The recall was classified as Class I – the most serious …<\/p>\n","protected":false},"author":3,"featured_media":14316,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[21],"tags":[],"class_list":["post-14310","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sleep-health"],"acf":[],"_links":{"self":[{"href":"https:\/\/staging.somnomed.com\/restassuretest\/wp-json\/wp\/v2\/posts\/14310","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/staging.somnomed.com\/restassuretest\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/staging.somnomed.com\/restassuretest\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/staging.somnomed.com\/restassuretest\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/staging.somnomed.com\/restassuretest\/wp-json\/wp\/v2\/comments?post=14310"}],"version-history":[{"count":3,"href":"https:\/\/staging.somnomed.com\/restassuretest\/wp-json\/wp\/v2\/posts\/14310\/revisions"}],"predecessor-version":[{"id":14320,"href":"https:\/\/staging.somnomed.com\/restassuretest\/wp-json\/wp\/v2\/posts\/14310\/revisions\/14320"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/staging.somnomed.com\/restassuretest\/wp-json\/wp\/v2\/media\/14316"}],"wp:attachment":[{"href":"https:\/\/staging.somnomed.com\/restassuretest\/wp-json\/wp\/v2\/media?parent=14310"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/staging.somnomed.com\/restassuretest\/wp-json\/wp\/v2\/categories?post=14310"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/staging.somnomed.com\/restassuretest\/wp-json\/wp\/v2\/tags?post=14310"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}