The U.S. Food and Drug Administration (FDA) has issued a safety alert to patients, caregivers, and healthcare professionals concerning Philips Respironics (Philips) new breathing machine mask recall. The safety recall involved masks that are used with certain Philips continuous positive airway pressure (CPAP) machines and bilevel positive airway pressure (Bilevel PAP, BiPAP, or BPAP) machines. The recalled masks contain magnets that can cause injury or death when the magnets interfere with some implanted metallic objects and metallic medical devices in the patient’s body. These adverse possibilities can happen in patients who use the affected masks or in people who are near a person using the recalled masks. The recalled Philips masks can be used with other manufacturers’ CPAP and BiPAP breathing machines. Those who use BiPAP or CPAP machines should look to see if their mask has been recalled.
The recalled masks have magnetic headgear clips that hold the mask in place and are for single-patient use in the home or clinical environments. These recalled Philips masks are used by patients who weigh more than 66lbs (30kg) except for the Therapy Mask 3100 NC/SP and the Wisp Youth Nasal Mask. These two masks are used for patients seven years of age and older.
The recalled breathing machine masks include:
- Amara View Full Face Mask
- DreamWisp Nasal Mask
- DreamWear Full Face Mask
- Wisp and Wisp Youth Nasal Mask
- Therapy Mask 3100 NC/SP
The news report states that the recalled masks have magnets that can cause injury or death if the user or a person near the patient has one of the following metallic objects in the body or implanted metallic medical devices:
- Aneurysm clips
- Embolic coils
- Cerebral spinal fluid shunts (such as ventriculoperitoneal shunts)
- Implantable cardioverter defibrillators
- Magnetic metallic implants, valves, and electrodes, placed in upper limbs, head, neck, or torso.
- Metallic stents (such as aneurysm, coronary, tracheobronchial, and biliary)
- Neurostimulators (like hypoglossal nerve stimulators)
- Intracranial aneurysm intravascular flow disruption devices
- Metallic cranial plates, burr hole covers, screws, and bone substitute devices
- Certain contact lenses containing metal
- Ocular implants (like glaucoma implants and retinal implants)
- Magnetic denture attachments
- Implants to restore hearing or balance that have an implanted magnet (like cochlear implants, auditory brainstem implants, and implanted bone conduction hearing devices)
- Metallic gastrointestinal clips
- Implantable pumps and ports (like insulin pumps)
- Metallic joint replacements
- Magnetic metallic implants not labeled for M.R. or not evaluated for safety in a magnetic field
- Devices labeled as Magnetic Resonance (M.R.) Unsafe
- Metallic shrapnel
- Metallic splinters in the eye
Should these magnets induce movement or affect the functioning of particular metallic objects in the body or implanted metallic medical devices, the possible risks could include:
- For ventriculoperitoneal shunts and cerebral spinal fluid: increased pressure on the brain or eye could become fatal.
- For pacemakers: irregular heartbeat or heart block could become fatal.
- For cardioverter defibrillators: the defibrillator could fail to shock, resulting in death.
- For aneurysm clips: disrupted clip separation or suture lines can be fatal.
- For neurostimulators: compression of the brain, lead migration, or seizures resulting in deaths.
According to the FDA, Philips is required to provide medical device reports (MDRs) when there is reason to believe that their medical devices may have contributed or caused serious injury or death or malfunctioned and a similar device they make could cause or contribute to serious injuries or death if a similar malfunction were to happen. Patients, healthcare professionals, and consumers are able to submit device adverse events and malfunction reports to the FDA.
Philips has reported that there have been at least fourteen serious injuries related to the use of these recalled masks. The reports included a need for shunt adjustment, pacemaker failure leading to pacemaker replacement, arrhythmia, automatic implantable cardioverter defibrillator reset, headaches, cognitive changes, and changes in the heart rate (bradycardia, tachycardia), seizures, convulsions, and irregular blood pressure.
However, it is possible that there is an under-reporting of adverse medical events, a lack of verification that the device caused the reported event, inaccuracies in reports, and missing information concerning important details such as the frequency of device use. These limitations are the reason why MDRs comprise only a portion of the FDA’s important postmarket surveillance data sources. MDRs, along with other data sources, contribute important details to a medical device’s benefit-risk assessment. The FDA reviews and assesses the MDRs to keep the public informed when new information is available.
Recommendations for Caregivers and Patients
- Immediately stop the use of the recalled mask and change to a non-magnetic mask if you or someone close to you is using the recalled mask and they have any of the implanted metallic medical devices or objects in their body, explain the issue, and have them keep their distance.
- Keep the recalled mask at least six inches away from any metallic objects in the body, metallic medical implants, and medical devices.
- Contact your healthcare provider to decide if a different mask can be used for therapy and if the treatment needs to be changed due to this safety issue.
- Call your healthcare provider immediately should you or a loved one experiences any issues related to their medical device and report the issues via the FDA’s MedWatch Voluntary Reporting Form.
- Properly throw away the affected masks once you have a different mask.
- You can use the mask as long as you or someone near you have any of the metallic objects in the body or implanted metallic medical devices that are listed above.
Recommendations for Health Care Providers
- Warn patients to stop using of the recalled mask and switch to a non-magnetic mask.
- Make sure the recalled mask is at least 6 inches away from metallic objects in the body, metallic medical implants, or medical devices that the magnetic fields might impact.
- Properly dispose of the recalled mask.
- Discuss the negative health risks connected with the recalled masks.
- Do not prescribe these recalled masks to patients with implanted metallic medical devices or metallic objects in their bodies.
The FDA acknowledges that patients depend on these medical devices, and the agency is closely monitoring Philips’ actions to make sure that the issue is resolved. The FDA will work with Philips to make certain that the company takes proper steps to rectify the recalled devices.
The FDA is evaluating the health hazard raised by using the recalled devices, reviewing Philip’s strategy to address the issue, and taking additional measures when appropriate. The FDA is also evaluating the safety of these magnets used in masks or similar interfaces used in sleep medicine and their impact on patient safety. The FDA plans to caution these manufacturers and take critical measures to manage any issues. According to the FDA, the agency will keep the public updated.
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