Philips (NYSE:PHG) announced that its Respironics subsidiary warned users of certain therapy masks of potential issues with implanted devices.
The company alerted users of certain CPAP or BiPAP therapy masks with magnetic headgear clips or straps. Such devices should not be used by or near patients and their household members, caregivers and bed partners who have metallic implanted devices or metallic objects (such as metallic splinters) in the body.
Philips said the magnetic headgear clips attach headgear straps to the masks. The company noted that this is a “commonly used” method in the sleep therapy devices industry.
This represents the latest addition to the mounting troubles for Philips Respironics. The company has been dealing with a massive recall of CPAP and BiPAP ventilators and other respiratory devices and has been in talks with federal prosecutors over its handling of the recall.
Last week, Philips Respironics settled with the U.S. Department of Justice for $24.8 million over kickback allegations.
The new voluntary notification told patients to stop using the affected masks if the implant/device is contraindicated against the magnets. Patients should consult physicians to determine if another mask can be used for their therapy. In teh meantime, they should switch to a non-magnetic mask if available.
Patients may continue to use the masks according to Philips’ updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body. Respironics distributed more than 17 million masks containing magnetic clips to date.
As of Aug. 30, 2022, the company received 14 reports suggesting that mask agents may have impacted their medical devices. Reports included suggestions of pacemaker interference, pacemaker failure leading to replacement, the need of shunt adjustment, resetting of an automatic implantable cardioverter defibrillator (AICD), seizures, defibrillator shutting off periodically, arrhythmia, irregular blood pressure, change in heartbeats, and cognitive issues.
The affected masks include the Amara View full face mask, the DreamWisp nasal mask, the DreamWear full face mask, the Wisp and Wisp Youth nasal mask and the Therapy Mask 3100 NC/SP.
“We are committed to safe, effective and innovative products and solutions, as well as transparency,” said David Ferguson, business leader for Philips Respironics. “We have stepped up our actions to further improve patient safety and quality, and we have taken the initiative to further strengthen the warnings and add contraindications specifically related to the magnetic headgear clips in certain of our sleep therapy masks, that are commonly used in the sleep therapy devices industry. We are also launching a broad awareness and education campaign regarding the safety of masks containing magnetic headgear clips.”
Implanted devices that may be affected:
- Pacemakers
- Implantable cardioverter defibrillators (ICD)
- Neurostimulators
- Magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (i.e., neck and head)
- Cerebral spinal fluid (CSF) shunts (e.g., ventriculo peritoneal (VP) shunt)
- Aneurysm clips
- Embolic coils
- Intracranial aneurysm intravascular flow disruption devices
- Metallic cranial plates, screws, burr hole covers, and bone substitute devices
- Metallic splinters in the eye
- Ocular implants (e.g., glaucoma implants, retinal implants)
- Certain contact lenses with metal
- Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing devices, and auditory brainstem implants)
- Magnetic denture attachments
- Metallic gastrointestinal clips
- Metallic stents (e.g., aneurysm, coronary, tracheobronchial, biliary)
- Implantable ports and pumps (e.g., insulin pumps)
- Hypoglossal nerve stimulators
- Devices labeled as MR (Magnetic Resonance) unsafe
- Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field
Philips issued a warning saying that magnets with a magnetic field strength of 400 mT are used in the mask. With the exception of the devices identified in the contraindication, ensure that the mask is kept at least 6 inches (approx. 15 cm) away from any other medical implants or medical devices that can be impacted by the magnetic fields to avoid possible effects from localized magnetic fields. This includes household members, caregivers, and bed partners that may be in close vicinity to patients that use the masks.