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Philips Respironics issued a warning that some of its sleep therapy masks used with its respiratory machines could pose a “risk of serious injury” to patients.
Certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or straps “should not be used by or near patients and their household members, caregivers and bed partners who have metallic implanted devices or metallic objects in the body,” according to a notice posted by the U.S. Food and Drug Administration (FDA). The magnetic headgear clips attach the headgear straps to the masks, a method commonly used in the sleep therapy devices industry.
Overall, the notice impacts more than 17 million masks, according to federal health officials.
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This is not a notice to replace all masks with magnets that are in use, according to the company. Rather, the notice was issued to inform users that specific sleep therapy masks containing such magnetic clips have updated instructions and labels.
Philips said the masks already present warnings, but that the company just strengthened them and added contraindications as a safety measure.
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In its latest warning notice, Philips listed cases where patients or other members of the household, including caregivers, shouldn’t use the device. The list includes people with pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher, cerebral spinal fluid (CSF) shunts, ocular implants and certain contact lenses with metal.
The masks may continue to be used according to the updated instructions and labeling, according to the company.
“These masks may continue to be used according to the 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,” the warning notice said.
Royal Philips
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| Ticker | Security | Last | Change | Change % |
|---|---|---|---|---|
| PHG | KONINKLIJKE PHILIPS NV | 17.44 | +0.45 | +2.65% |
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David Ferguson, business leader for Philips Respironics, told FOX Business in a statement that the company is “committed to safe, effective and innovative products and solutions, as well as transparency,”
“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,” Ferguson said.
Ferguson also noted that the company launched an education campaign regarding the safety of masks containing magnetic headgear clips.
Philips Respironics is a subsidiary of Dutch multinational Royal Philips.
