Philips (NYSE:PHG) is warning users of certain therapy masks about potential issues with implanted devices.
The company’s Respironics subsidiary alerted users of CPAP or BiPAP therapy masks with magnetic headgear clips or straps that could negatively interact with implantable, metallic medical devices.
Respironics has distributed more than 17 million masks containing magnetic clips. As of Aug. 30, the company received 14 reports suggesting that the masks may have impacted implanted devices.
Philips is advising against using the masks 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 said it is a commonly used method in the sleep therapy devices industry.
Mounting troubles at Philips Respironics
It’s the latest addition to the mounting troubles for Philips Respironics. The company has been dealing with a massive, deadly recall of CPAP and BiPAP ventilators and other respiratory devices and has been in talks with federal prosecutors over its handling of the recall. Respiratory device problems stem from polyester-based polyurethane sound abatement foam that could break down. Foam particles could enter a device’s air pathway and cause a range of potential health problems and toxic, carcinogenic effects for the use
Philips has already been out of the respiratory devices market for a year as it deals with the recall. Roy Jakobs, the company’s Connected Care chief businesses leader who has been in charge of the recall, is slated to become CEO next month.
More about the latest recall
The newest voluntary notification tells patients to stop using the affected masks if the implant/device is contraindicated against the magnets. Patients should consult physicians to determine if it’s possible to use another mask for their therapy. In the 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.
Reports of problems 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.
The masks include magnets with a magnetic field strength of 400 mT, Philips said. With the exception of the devices identified in the contraindication, ensure that the mask is kept at least 6 in. (approximately 15 cm) away from any other medical implants or medical devices potentially 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.
“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,” said David Ferguson, business leader for Philips Respironics, in a prepared statement. He added that the company is launching a broad awareness and education campaign regarding the safety of masks containing magnetic headgear clips.
Implanted devices that may be affected:
- Implantable cardioverter defibrillators (ICDs)
- Magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (i.e., neck and head)
- Cerebral spinal fluid (CSF) shunts, for example, ventriculo peritoneal (VP) shunts
- 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