Philips Respironics issued a voluntary notification recently, recalling some specific masks used with bilevel positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines produced by the company, citing a serious health concern. According to the U.S. Food and Drug Administration, which issued an alert for patients, healthcare providers, and caregivers following the issuance of the notification, over 17 million masks are part of this recall. If you or someone you know uses any Phillips mask, here is everything you need to know about this recall.
The Issue With The Masks
Many patients with respiratory issues like obstructive sleep apnea or respiratory failure often depend on machines like ventilators, CPAP devices, or BiPAP devices. These devices are fitted with a mask to help deliver constant pressurized air to the patient to make it easier for them to breathe.
However, the recalled masks have been identified to pose a serious concern to the health of the patient or anyone near them. These are designed with magnets connecting the components of the mask to hold them in place, and these magnets can cause adverse effects in people who have metallic medical devices implanted in their bodies. The same is true for people with certain metallic objects in their bodies.
As per the official notification released by Philips, patients or anyone in close vicinity to them may be affected by the magnets present in the masks if they have any of the following devices in their bodies.
- Pacemakers
- Neurostimulators
- Implantable cardioverter defibrillators (ICD)
- Cerebral spinal fluid (CSF) shunts (e.g., ventriculoperitoneal (VP) shunt)
- Magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (i.e., neck and head)
- Aneurysm clips
- Embolic coils
- Metallic splinters in the eye
- Intracranial aneurysm intravascular flow disruption devices
- Certain contact lenses with metal
- Metallic cranial plates, screws, burr hole covers, and bone substitute devices
- Ocular implants (e.g., glaucoma implants, retinal implants)
- Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing devices, and auditory brainstem implants)
- Metallic stents (e.g., aneurysm, coronary, tracheobronchial, biliary)
- Metallic gastrointestinal clips
- Implantable ports and pumps (e.g., insulin pumps)
- Magnetic denture attachments
- Hypoglossal nerve stimulators
- Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field
- Devices labeled as MR (Magnetic Resonance) unsafe
However, this list is by no means exhaustive. Therefore people with any other metallic implants may also need to be careful around these masks to avoid any adverse effects.
Possible Health Risks
People with implanted metallic medical devices or even metallic shrapnel or splinters in their bodies may be affected by these masks. The magnetic field produced by the masks can hinder the normal functioning of certain metallic medical devices or may even cause them to move from their position. This can lead to injuries or sometimes even death. While the patient using the mask is the one most likely to be affected by this issue, anyone in close proximity to the patient can also face adverse issues. This may include family members, bed partners, caregivers, or even medical personnel.
Here are some of the ways in which the magnets in the mask may affect you:
- People with cerebral spinal fluid and ventriculoperitoneal shunts may experience increased pressure in their brain or eyes - and this may be fatal.
- The magnets may disrupt suture lines or even cause clip separation in patients with aneurysm clips, leading to death.
- It may interfere with the functioning of pacemakers, resulting in irregular heartbeat or heart block, which may be fatal.
- It may affect the functioning of cardioverter defibrillators, resulting in their failure to deliver electric shocks to restore a regular heartbeat.
- It may affect the functioning of neurostimulators, which may be fatal in some cases.
Philips, as well as other manufacturers, are required to submit medical device reports or MDRs in case there is enough evidence that any device manufactured by them has caused or contributed to any serious injury or death. Philips reported 14 serious injuries caused by the recalled masks till the end of August 2022, none of which were fatal. The serious injuries included pacemaker failure and the need for subsequent replacement, convulsions, tachycardia, bradycardia, arrhythmia, irregular blood pressure, cognitive changes, headaches, resetting of an automatic implantable cardioverter defibrillator, as well as a requirement for shunt adjustment.
Till 9th September 2022, FDA received around 43 complaints associated with this particular issue, although no deaths were reported.
Which Masks Are Part Of This Recall?
The recall is applicable to 7 Philips masks at present. These include the following:
- Amara Full Face Mask
- DreamWisp Nasal Mask
- DreamWear Full Face Mask
- Wisp Nasal Mask
- Wisp Youth Nasal Mask
- Therapy Mask 3100 NC
- Therapy Mask 3100 SP
These masks are designed to be worn by patients using BiPAP or CPAP machines to support their breathing ability. These may be utilized for both single-patient use in a home environment or multi-patient use in a clinical or hospital environment. While the majority of the recalled masks are for use by adults, the Wisp Youth Nasal Mask and the Therapy Mask 3100 NC/SP are designed for younger patients.
It should also be noted that the usage of these masks is not limited to only BiPAP and CPAP devices manufactured by Philips. These are also compatible with machines manufactured by other companies. Therefore, if you use any BiPAP or CPAP device, it is recommended that you recheck the mask you are using with your ventilator device to identify whether it's among the ones recalled to avoid the risk of injury.
What To Do If You Are Using One Of The Recalled Masks
In an official notification, FDA has put forward some recommendations for patients using any of the recalled masks or their caregivers. In case you find that you are using any of the recalled masks, the first step is to discontinue use immediately and shift to a non-magnetic mask (if available). This recommendation should be followed without fail if the patient or anyone near them has any metallic objects or metallic medical devices implanted in their body, as they can be affected by the magnetic field of the mask.
Make sure to keep the mask at a distance of at least 6 inches from a person with any such metallic implants or metallic objects in their bodies. The same should be followed for any medical devices that can be impacted by the magnets.
Discuss with your healthcare provider to decide whether you need any changes in your treatment plan due to this safety issue. They will also be able to determine if there is an alternative mask available that suits your condition and recommend the same. Make sure to also reach out to them in case you experience any problems with your medical device. You can also report the issue through the FDA’s MedWatch Online Voluntary Reporting Form.
Once you have another alternative mask, make sure to dispose of the recalled mask properly. In case you have any questions or queries related to non-magnetic mask options, you can reach out to Philips Respironics’ customer service at 1-800-345-6443 or visit their official website for information on the same.
However, youcan continue using the recalled masks only if you or anyone near you doesn't have any such metallic medical implants or metallic objects in their bodies that the magnets can impact.
Apart from these, the FDA has also put forward some recommendations for healthcare providers. They are encouraged to discuss the health risks posed by these masks with their patients. This is especially if they are at risk of injury or death due to any such metallic object or device in their body that can be affected by the magnets in the mask. In addition, they should refrain from prescribing any of the recalled masks to their patients if they or anyone near them has any metallic device or object in their body.
Is This Associated With The Earlier Recalls Announced By Philips?
This isn't the first time Philips is recalling any of its devices. The company had recalled several ventilator machines and BiPAP devices earlier this year for different reasons. As a result, it's normal for users to be concerned about the safety of Philips devices. However, this recall is not connected to the earlier issue related to the polyester-based polyurethane (PE-PUR) foam used in certain ventilators and BiPAP devices.
The recall notification was issued by the company following the receipt of several reports of adverse effects caused by the magnets in the masks. At present, the FDA is working closely with the company to ensure that this issue is resolved at the earliest.
