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How Will the CPAP Recall Affect People With COVID-19 Infections?
Sleep apnea is an issue that affects millions of people throughout the United States. Those who struggle to breathe correctly while sleeping may encounter a variety of health issues related to this condition. For those who have been infected by COVID-19, the effects of sleep apnea may become even more serious, and they may lead to life-threatening issues for those with severe cases. The concerns related to sleep apnea demonstrate the importance of proper treatment for those who suffer from this condition. Unfortunately, the recall of defective CPAP machines and ventilators that is currently being performed by Philips Respironics may make it more difficult for some to receive the treatment they need.
Study Links Sleep Apnea to More Severe COVID-19 Outcomes
A recent medical study looked at the role that sleep apnea may play in COVID-19 infections. Researchers found that those who suffer from sleep apnea are no more likely to be infected than the average person. However, for those with severe infections, sleep apnea is more likely to lead to more serious problems, including higher rates of hospitalization and death.
FDA Issues Notice Requiring Philips to Notify Consumers About CPAP Recall
Since June of 2021, Philips Respironics, a Dutch medical device manufacturer, has been undertaking a massive recall of CPAP devices and other types of ventilators. This recall was initiated because the devices used a sound abatement foam that could potentially cause harm to users. When this foam breaks down over time, “black debris” consisting of foam particles may be inhaled by those using the devices, and volatile organic compounds or other dangerous chemicals may also be released. Users of the devices may be at risk of lung injuries and other serious illnesses.
The CPAP recall involves around 2.6 million devices in the United States and 5.2 million devices worldwide. While Philips has made efforts to notify users about the recall, many people have been unable to receive replacement devices. The U.S. Food and Drug Administration (FDA) recently issued a notification stating that the company’s efforts to ensure that people are properly informed about the recall have been lacking, and it is requiring Philips to take certain actions to comply with its requirements.
What Do Doctors Recommend for Patients Who Use Recalled CPAP Machines?
Many people throughout the United States who rely on CPAP machines to treat sleep apnea have had their lives disrupted by a major recall of these devices. In 2021, Philips Respironics recalled millions of these products, including Dreamstation CPAPs and other CPAP, BiPAP, and ventilator devices. The recalled devices contained a polyester/polyurethane foam that has been found to degrade throughout the months and years of daily use, potentially exposing people to toxic substances that could cause serious health issues.
People who use devices that have been recalled may be wondering about their options. Since sleep apnea can be a serious issue that may affect a person’s overall health, stopping treatment could lead to a variety of problems. However, because there are millions of defective devices, replacements may not be available for some time. Philips is working to provide replacements, and the company expects this process to take a year or more. Other CPAP manufacturers are also struggling to meet demands and provide people with products that can offer the treatment they need. As CPAP users work to determine their options, they will want to understand the advice that doctors may give about how they can receive effective treatment for sleep apnea.
Can Treatments Other Than CPAP Machines Address Sleep Apnea?
Following a major recall of CPAP machines, many people are unsure about their options for treating sleep apnea. The recalled devices, which were manufactured by Philips Respironics, contained a type of foam that could break down, and when small foam particles or certain types of chemicals entered a device’s airways, they could be inhaled by a device’s user. This could put users at risk of multiple types of injuries, including lung cancer and other serious illnesses. Unfortunately, many people have struggled to receive replacements for defective CPAP devices, leaving them uncertain about whether they should discontinue their use of a recalled device or go without treatment for sleep apnea. Fortunately, other treatment options may be available.
Alternative Sleep Apnea Treatments
Being able to treat sleep apnea effectively can be crucial for a person’s health. Most people with this condition suffer from obstructive sleep apnea, and the position of their tongue and jaw will interrupt their ability to breathe correctly while sleeping. This can result in a significantly reduced quality of sleep and cause drowsiness and fatigue. It can also lead to additional health issues, such as increased risks of strokes or heart attacks.
More Ventilator Devices Added to Philips Respironics Recall
Philips Respironics, a medical device manufacturer, has released multiple different types of products used to provide breathing assistance or sleep apnea treatment, and these devices are used by medical facilities or in people’s homes. In June of 2021, the company initiated a massive recall of multiple types of devices, including CPAP and BiPAP machines and ventilators. This recall was done because the devices contained a polyester/polyurethane foam that has been found to degrade over time. When the foam breaks down, particles of the foam could be inhaled by a patient, and toxic chemicals may also be released that could endanger a person’s health. Recently, Philips recalled some additional ventilator devices for the same reason.
Recall of Trilogy Evo Ventilators
On December 12, 2021, Philips notified customers using its Trilogy Evo ventilators that the devices were being recalled, and the company sent an update on January 13, 2022 to provide additional safety information. These devices, which were not included in the June 2021 recall, had used the same foam as the other recalled devices. They were manufactured and distributed to customers in April and May of 2021.
How Do Ozone Cleaners Affect the Safety of CPAP Machines?
Millions of people have been affected by the recall of CPAP and BiPAP machines performed by Philips Respironics in 2021. These devices were recalled because of a foam that was used in the machines for noise-dampening purposes. The degradation of the foam, which could occur throughout the life of a device, could potentially lead to small foam particles and toxic chemicals being inhaled by users while they were receiving treatment for sleep apnea. One issue that was raised by Philips in its recall notice was the use of certain types of cleaning devices that purified CPAP parts through the use of ozone. CPAP users who also used ozone cleaners will want to understand how this may have affected their health and safety.
Manufacturer of Ozone Cleaners Sues Philips Respironics
When it issued its notice recalling multiple different types of CPAP and BiPAP devices, as well as medical ventilators, Philips stated that the use of unapproved cleaning methods, including cleaning devices that use ozone, may have exacerbated the degradation of the foam in the devices, increasing the likelihood that users could be exposed to harmful particles and chemicals. In October of 2021, SoClean Inc, a manufacturer of ozone cleaners, filed a lawsuit against Philips, claiming that the company had made false and misleading claims about the causes of foam degradation. The lawsuit stated that SoClean’s sales have fallen and its brand’s reputation has suffered as a result of the statements made by Philips. It also stated that Philips is attempting to divert blame for injuries suffered by CPAP users, when the true reasons for these issues are design flaws and a poor choice of materials. SoClean believes that the use of ozone when cleaning CPAP machines does not lead to the breakdown of foam, but degradation is actually caused by high humidity and contact with water.
Recalled CPAP Machines May Have Caused Exposure to Dangerous Chemicals
Since the medical equipment manufacturer Philips Respironics began recalling millions of CPAP and BiPAP machines and ventilators in 2021, users of these devices have been concerned about the potential health risks that may have affected them. The recalled devices contained a polyurethane foam that could break down during regular, daily use, and the inhalation of particles and chemicals may have led to multiple types of health issues. By understanding the specific substances that people may have been exposed to and their potential effects, CPAP users can determine whether they have suffered harm, and they can work with an attorney to determine their legal options.
Potentially Harmful Chemicals That May Affect CPAP Users
Testing performed by Philips determined that the breakdown of the foam used in CPAP machines and other devices may have caused users to inhale small foam particles. These particles contained multiple types of toxic chemicals, including:
Are Replacements for Recalled CPAP Machines Also Dangerous?
In June of 2021, the medial device manufacturer Philips Respironics recalled more than 15 million CPAP machines and similar devices. This recall was performed because the devices contained a foam that could degrade, causing users to experience health risks because of the inhalation of tiny foam particles or toxic chemicals. While the recall has left many users without the treatments needed to address issues related to sleep apnea, Philips has begun making replacement CPAP devices available. However, some concerns have also been raised about the potential health risks of using the replacement machines.
FDA Asks for Testing to Determine Safety Risks of New CPAP Machines
As part of the recall, the U.S. Food and Drug Administration (FDA) has been investigating Philips’ manufacturing practices, including reviewing records and visiting the company’s facilities. During these investigations, the FDA uncovered potentially troubling information about the plans to replace the noise-abatement foam in the recalled devices.
Health Issues May Have Been Known Years Before Recalling CPAP Machines
CPAP machines provide effective treatment for people who have been diagnosed with sleep apnea. However, many of the users of these devices may have been placed at risk of injuries or illnesses. In 2021, the medical device manufacturer Philips Respironics issued a recall of millions of CPAP and BiPAP devices. This recall was performed because the devices contained a noise-dampening foam that could break down, putting users at risk of harm when they inhaled tiny particles and toxic chemicals. This recall has caused difficulty for many users who have had to decide whether to continue using potentially harmful devices or go without treatment for sleep apnea or other conditions until replacement devices are available. Many people are also troubled by recent findings that Philips may have known about the issue for years before deciding to perform a recall.
FDA Investigation Uncovers Details Showing that Philips May Have Known About Health Risks to CPAP and BiPAP Users
Can Recalled CPAP Machines Cause Serious Lung Diseases?
Devices used to treat medical conditions are meant to improve people’s quality of life and help them avoid serious health issues. Unfortunately, these devices may be defective, potentially leading to injuries or illnesses. Millions of people in the United States may face this possibility because they have used CPAP machines that have been recalled due to the presence of harmful substances. Those who have used the recalled CPAP or BiPAP devices may experience multiple types of health concerns, including serious lung injuries.
Interstitial Lung Diseases That May Be Caused by Defective CPAPs
The recalled devices contained a type of foam that could break down over time, causing a person to breathe in microscopic particles and harmful chemicals. In addition to putting users at risk of different forms of chronic obstructive pulmonary disease (COPD), the devices may also cause interstitial lung disease that affects the tissue inside the lungs that support the air sacs and pathways. Interstitial lung disease may include multiple different disorders, including: