Philips CPAP Recall Breaking News Update
Philips produces millions of ventilator devices used across the globe. For many decades, the company has been a trusted brand name in many industries, including medical. That’s why the recent breaking news recalling multiple types of the company’s BiPAP and CPAP machines for potential health hazards is alarming.
The CEO of Royal Philips, Frans van Houten, apologized publicly in the recall announcement. He emphasized the deployment of an immediate resolution and a plan to replace the impacted devices. The company delivered the recall report with a solution for patients, indicating its focus on patient safety.
Here’s What You Need to Know About the Philips Respironics Recall
The U.S. Food and Drug Administration (FDA) issued the recall in June 2021. The devices listed on the recall were manufactured between April 11, 2007, and April 26, 2021. If you have a ventilator, CPAP, or BiPAP machine, you must carefully check to see if it is on this list.
The FDA wants the community to be aware of the potential health risks associated with the continued use of these machines. It was discovered that a specific polyester-based polyurethane called PE-PUR is used to construct these devices. PE-PUR is a foam used to reduce vibration and sound. It has been recently discovered that this material can break down over time. The patient can inhale harmful black debris or swallow it when this happens.
Potential Health Hazards
The health impact of the breakdown of this material can be severe. Studies have shown that exposure to this debris or its chemicals can cause adverse health effects. Per the FDA, doctors have noted more than 1,200 complaints that include over 100 specific injuries tied directly to this issue. The following are the harmful health effects that result from inhaling or ingesting this material:
- Respiratory infection
- Skin irritation
- Nausea and vomiting
- Toxic, carcinogenic effects
- Impacts on the kidneys and liver
If These Devices Are Being Recalled, Why Should I Still Use Mine?
The Philips recall states that patients should immediately stop using these products, which is also a health risk for many patients. Patients need their devices. It is possible to obtain new appliances or try alternative treatments, but this is something you should address immediately with a physician.
This decision should be made individually between the patient and the physician based on a current medical condition and alternative options. If you are using an affected device, you should contact your health care provider to discuss your options. Philips also provides information about the recall of its sleep and respiratory care devices on its website.
Based on the seriousness of your medical condition, it may be best to temporarily stop using your Bi-Level PAP or CPAP device and try the new therapy while waiting for a reconditioned or new machine. Your physician may switch you to another similar sleep ventilator treatment not included in the recall.
Recall Notification Advises You to Talk to Your Physician
Your health is the priority, and you will be on the list to receive a new machine as quickly as possible. Physicians are working to triage patients so that those with the most need for the equipment receive it first. You and your doctor may determine that the risk of stopping your use of the CPAP device is greater than the risk of infection.
You should follow your primary care provider’s medical advice. If you are unsure, Philips’ news release outlines some options but advises you to discuss all choices clearly with your physician.
Patients Using Bi-Level PAP and CPAP Machines
For patients using BiPAP or CPAP devices, you should work with your primary medical provider to determine if there are any temporary alternative solutions. Discuss if continuing therapy temporarily outweighs the risks identified in the notifications listed in the recall data. This information was also given to medical providers.
Patients Using Life-Sustaining Mechanical Ventilators
If you or your loved one is using a life-sustaining mechanical ventilator, do not stop or alter your therapy until you have cleared it with your doctor. Philips is aware that other options may be limited. This is something the patient and their family and clinical team will have to talk about so that the decision made benefits the patient. In most cases, therapy disruption will not be an option.
What Is the Risk Associated With Recalled Philips CPAP and Ventilator Machines?
As part of the ongoing recall, Philips monitors patient reports for any potential safety issues. The company compiles reports on these results for the public as local and federal regulations require. No deaths have been reported due to the potential health risks associated with the Philips ventilator machines.
Patients have reported exposure to foam particulate. Particle detection was found to cause chemical exposure to off-gassing, which has the potential risk of carcinogenic effects. The vulnerability can lead to severe medical symptoms, such as headaches, irritations, respiratory issues, and other impacts from hypersensitivity. Though the sign reflects toxic and carcinogenic results, Philips has noted it has no reports of chemical emissions impacting patient health.
Repair and Replacement Program
Philips understands the critical nature of the equipment that patients use. Therefore, to protect patients’ health and the announcement of the recall, Philips is also working directly with regulatory agencies to launch and implement the necessary corrections as quickly as possible.
The sound abatement foam, which is currently used in the devices, will be replaced with a new material that meets higher standards. In addition, Philips has worked to obtain all regulatory clearances to address the repairs needed for all affected patient devices. First-generation products, like DreamStation, will be modified with an entirely different sound abatement foam. Once the regulatory clearances are received, these modified and refurbished products will be shipped.
The newly launched DreamStation 2, the next-generation CPAP platform, has not been impacted by these recall issues. However, to add support to the recall program and patients who will need to switch to new devices, Philips will increase the DreamStation 2 CPAP production. The additional boost in supply will help ease the strain for those life-dependent patients on their ventilator systems while the repair and replacement program is in place.
How Can I Learn if My Device Has Been Recalled?
After discovering the potential health risk of its devices, Philips issued a voluntary recall notification. Suppose you are concerned about whether your CPAP, BiPAP, or another mechanical ventilator device could be a part of the recall. In that case, you should first check with the Affected Device List that the company has posted on its site.
CPAP and BiPAP Devices
- E30: Emergency use authorization only.
- DreamStation ASV: This device is known as the DreamStation BiPAP auto SV.
- DreamStation ST, AVAPS: This machine has two widely known names, the DreamStation BiPAP AVAPS and DreamStation BiPAP S/T.
- SystemOne ASV4: This ventilator is sometimes known as System One BiPAP Auto SV (advanced).
- C Series S/T, AVAPS: Check your machine. These machines are known as C-Series, System One BiPAP AVAPS, or System One BiPAP S/T.
- OmniLab Advanced Plus: This device may be known as the In-lab Titration Device.
- System One 50 series CPAP, Auto CPAP, or BiPAP
- System One 60 series CPAP, Auto CPAP, or BiPAP
- DreamStation CPAP, Auto CPAP, or BiPAP
- DreamStation GO CPAP, APAP, or Auto CPAP
- Dorma 400, 500 CPAP, or Auto CPAP
If your device is listed above, then your machine has been recalled. However, the list is not extensive. It would help if you referred to Philips’ latest affected device list to ensure your device is safe and not on any recall list.
What Should You Do if Your Machine Has Been Recalled?
If you find that your respiratory device is on the list of machines that have been recalled, the first thing to do is register your device. When you fill out the registration form, you will be given a confirmation number. This number will be sent to your email address if you have one, so be sure not to delete it.
If you think you have an issue with a CPAP, BiPAP, or mechanical ventilator, the FDA encourages you to report the difficulty through its MedWatch Voluntary Reporting Form. Health care personnel who work at a facility subject to the FDA’s user facility reporting requirements should follow the reporting procedures that their facility has established.
When Can I Replace My Recalled Device?
This is a tricky question. The recall isn’t strictly handled through Amazon’s next-day service. Instead, this is a remediation program. Philips is working with patients to take their current devices to manufacturers, have the foam removed, the new replacement product installed, and the device sterilized and returned.
As a shopper, you may have noted products that were discounted because they were labeled as “remanufactured.” While there is no exact definition, many times, this means the product was returned, and it was repaired, checked, and determined to be in working order. Recalls on medical equipment work similarly, except they are also subject to being triaged, much like when patients are admitted to the ER (emergency room). But again, those who must be seen first are treated first.
Philips wants to work with patients and doctors to ensure that patients receive their replacement devices as quickly as possible. The company has chosen to comply with requests by the FDA and the medical community to prioritize remediation efforts for those patients who may have elevated health risks. Philips has worked to put together a fair prioritization system that includes some of the following data points:
- The severity of sleep obstruction
- Occupation (public service)
What Happens After I Register My Philips Device?
Once you have registered your device and are following through on other processes to have your machine repaired, that’s it. You can check back now and then to see if there is anything more you can do on your end. Philips is working hard to help every patient as quickly as possible and help those who need it soonest.
Durable Medical Equipment Providers, Distributors, or Medical Institutions
Many patients are enrolled in a fee-for-service health plan or obtain their CPAP through durable medical equipment (DME) providers. According to the recall notice, DMEs and other providers must submit authorization for patient-owned devices. Providers should instruct their patients to continue using an impacted ventilator only if they use an inline bacteria filter.
A Certificate of Medical Necessity (CMN) is not required at this time. This authorization is being waived to help streamline the process for both patients and medical providers.
You should seek a specialist if your breathing is due to ongoing illness. A specialist can help you understand the cause of your breathing distresses and know more about the types of ventilators that will work best for you. In addition, a specialist can check the age of your current machine, get you registered if needed, and help process your recall.
Primary Care Physician
If you see a primary care physician, you should feel confident knowing that the repair process will benefit your overall health. You will continue to get better sleep, but with cleaner, healthier air. If your system is older than five years, replace it. If it needs to be refurbished through the recall process, get registered.
You can register for the recall, but you may find the process is more straightforward if you have your medical provider walk you through it. It could also be an excellent time to discuss a plan for what options are now available for better sleep and breathing going into your future.
What You Need to Do
As a patient, don’t get stressed about this recall. It is essential, and you do need to address it. Take a moment to review the facts about the recall and how it will impact you. Does this recall even affect you? Will you need to register your machine? Once you know how this recall affects you, you can make some decisions about your health and future. It is a personal decision.
Remember, too, that the recommended life span of a CPAP or other ventilator is about five years. If you have had your machine for four and a half years, you may want to call your provider and arrange for a new device. Skip the hassle of the recall.
If you still expect to get a few years out of your machine, then first check the recall details and follow the instructions. It won’t take long. Once registered, you will obtain the instructions to follow. If you have any other questions, you should contact your physician.