Recall: Philips Respironics Breathing Assistive Devices (CPAPs) has been updated by the FDA on certain models.
Philips Respironics Breathing Assistive Devices (CPAPs) have been noted with health issues over the years but now severe health risks such as cancer have been cited. the Food and Drug Administration (FDA) in the United States has provided an update on the recall of certain Philips Respironics ventilators, CPAP machines, and BiPAP machines on June 14, 2021.
The FDA’s Center for Devices and Radiological Health’s director, Jeff Shuren, M.D., J.D., says that “ensuring patients and providers have the most up-to-date information regarding the recall of these critical devices is a top priority.” As a result, we are keeping a close eye on the company’s actions to ensure that any problems are resolved as quickly as possible for patients.
Recall status updates, including any new recommendations or actions regarding Philips Respironics devices, will continue to be provided to the public on a regular basis.”
Recalls of certain ventilators, CPAP, and BiPAP machines manufactured by Philips Respironics were issued earlier this year due to the possible health risks associated with polyester-based polyurethane sound abatement foam. The foam is prone to breaking down and causing serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent injury to users.
After the recall, the FDA inspected a Philips Respironics manufacturing facility to see if the foam problems were caused or contributed to by the facility’s adherence to FDA quality manufacturing requirements. During FDA inspections, records, training, facility operations, medical device production, and testing, the systems in place to ensure product quality are all reviewed and evaluated. FDA inspections are comprehensive.
The FDA investigator made several observations during the inspection, which are detailed in an “FDA Form 483,” which is also known as an “inspection closeout report.” The company received a list of observations from the FDA investigator. However, an FDA investigator’s list of inspection observations does nothing to determine whether a condition violates federal food, drug, and cosmetic laws or regulations. When determining the appropriate course of action, the FDA will take into account both the company’s response and all of the available information.
Breathing Machines from Philips Respironics May Cause Cancer
To repair the CPAP and BiPAP devices, Philips Respironics came up with a plan to replace the polyester-based polyurethane foam with a different, silicone-based foam following the initial recall. It was based in part on the company’s submission of a new foam test in June to the FDA.
A new piece of information was gleaned during FDA’s inspection of the manufacturing facility for silicone-based foam used in a single, similar device sold outside the United States that failed a safety test for the release of volatile organic compounds, a group of potentially hazardous chemicals (VOCs). On devices approved for use in the United States,
Philips Respironics provided the FDA with similar testing results. According to Philips Respironics, the FDA has requested that an independent laboratory conduct additional testing to determine whether or not the silicone-based foam poses any potential safety risks to patients.
Repair and replacement patients have already received silicone-based foam implants, and the FDA is aware of this fact. FDA hasn’t been able to determine whether the silicone-based foam used in the repaired devices poses any risk to patients in the United States at this time.”
Six years ago, Philips was made aware of the foam degradation issue.
According to the inspection closeout report, several observations were made by the FDA investigator during the most recent inspection of the company’s facility in Murrysville, Pennsylvania (also known as an FDA Form 483). Inspection findings reported by an FDA investigator do not represent FDA conclusions about whether or not a given condition is in violation of federal regulations. When it comes to deciding what to do next, FDA says it will look at the company’s response as well as all the information it has at its disposal.
No documented risk analysis or design failure mode effect analysis supports the company’s rationale for which polyester-based polyurethane foam-containing products were affected, included, or excluded from the ongoing device recall initiated by Philips in June. Because Philips did not provide sufficient evidence that other devices containing the same type of foam should not be included in the recall, the investigator made this finding:
Philips was made aware of a preventative maintenance procedure implemented by another Philips entity on Trilogy ventilator products regarding foam degradation issues and complaints in the field around November 25, 2015, according to the investigator’s report. There was no further investigation, health hazard evaluation, risk analysis, or design review of the issue by Philips Respironics. A preventative maintenance email sent by another Philips entity on November 25, 2015, was provided to the investigator by the company.
The investigator also noted in the report that Philips Respironics was aware of potential foam degradation problems with various sleep and respiratory care devices between April 1, 2016, and January 22, 2021, but the company did not perform adequate risk analysis within an appropriate time frame of at least 14 instances.
The Three Most Common CPAP Risks
This machine helps those who suffer from the condition of sleep apnea breathe more easily at night. It maintains positive airway pressure, preventing breathing passages from collapsing and interrupting your slumber as a result. Mask wearers are responsible for this. As the recipient breathes in the pressurized air, they can fall asleep.
The use of a CPAP mask is the first CPAP danger associated with this type of equipment. The mask is constantly in contact with all of your face’s dirt, oil, and debris. When wearing a mask, you run the risk of irritating your skin in a variety of ways.
Chronic illness is a possible side effect of using a CPAP machine. A lot of people who use breathing machines for sleep notice that they get sick far more frequently than before they started using the machine. This includes recurring issues such as sinus infections and strep throat. Your machine and other items may still harbor germs, even if they are regularly cleaned.
One of the most dangerous aspects of CPAP equipment is that it can develop mold or mildew if it isn’t cleaned out regularly. These particles can be inhaled every time you turn on your CPAP machine.
What CPAP Options Do You Have to Protect Yourselves?
To keep yourself safe, you were given information following your diagnosis of sleep apnoea. A lot of that advice probably included tips on how to open up your airways at night so you could sleep better. Your CPAP machine, of course, provided that benefit. Is there anything else you could have done before getting your CPAP machine? A lot of people don’t realize that there are healthier options for CPAP.
An oral appliance that keeps your teeth in a specific position while you sleep is a popular CPAP substitute. You simply place the device in your mouth and drift off to sleep as you normally would. It is easier for you to breathe while you sleep because your airway remains open. When you’re on the go, you can bring this appliance along with you, and it’s easy to clean. This makes it a viable alternative to CPAP for you.
In addition to these advantages, it’s also simple to get a low price on it. Traditional CPAP machines can be difficult to obtain, especially in rural areas. Insurers aren’t always on board with the idea of handing out expensive equipment, which can delay your treatment. Running the machine at night incurs additional expenses. You can get an oral appliance within a week or two of your dentist’s diagnosis.
FDA Advice on CPAPs
For the time being, the FDA does not advise patients who have taken part in the repair and replacement program to stop using its products. The FDA arrived at this conclusion after conducting an extensive benefit-risk analysis. Patients’ health and well-being may be jeopardized if they stop using one of these devices, according to the FDA.
The FDA will make the results of the independent testing available to the public as soon as they are available to determine whether the silicone-based foam used in the repaired devices poses any risks to patients. If a patient has any additional questions or concerns, they should speak with their doctor about them.
For those who are still using a recalled device that has not been repaired or replaced, the FDA recommends that they speak to a medical professional about whether or not they should continue using it, switch to another product, or discontinue using it altogether.