SFDA Issues Safety Alert for Masks Used with BiPAP and CPAP Devices2022-10-05
The Saudi Food and Drug Authority (SFDA) issued a warning regarding the safety of devices Implanted medical devices which are affected by masks containing magnets (face and nasal masks) used with Bilevel Positive Airway Pressure (BiPAP) and Continuous Positive Airway Pressure (CPAP) medical devices, produced by the Philips Respironics factory.
SFDA indicated that the safety alert includes all batch numbers in Saudi Arabia for the Amara View Minimal Contact Full-Face Mask, DreamWear Full Face Mask, DreamWisp Nasal Mask with Over the Nose Cushion, Wisp Nasal Masks, and Wisp Youth Nasal Masks.
The Authority advised patients who use this model who have interventional medical devices implanted in their bodies, to stop using the affected mask, and to consult a doctor about the appropriate alternative, and if an alternative is available, the affected mask can be destroyed.
The Authority called on consumers to report any accidents or problems suspected of being related to medical devices or supplies through the SFDA’s unified call center on the number 19999, the National Center for Medical Devices Reporting (NCMDR), or through Saudi Vigilance System.
It is noteworthy that the masks are for single patient use in the home or multi-patient use in the hospital environment. The masks are to be used on patients for whom CPAP or bi-level therapy has been prescribed.