2022-10-05

The Saudi Food and Drug Authority issued a warning regarding the safety of devices implanted in the body, including masks containing magnets that are used with continuous positive pressure devices to treat sleep apnea, produced by the Philips Respironics factory.

The Food and Drug Administration indicated that the safety alert includes all operating numbers in Saudi Arabia for the Amara View face mask model with a head support, the Dreamwear face mask, the Dream Wisp nasal mask with a head support, the Wisp nose mask with a transparent frame or cloth frame, and the Wisp Youth nose mask. .

The authority advised patients who use this model, who have interventional medical devices implanted in their bodies, to stop using the mask containing magnets, and to consult a doctor about the appropriate alternative, and if an alternative is available, the affected mask can be destroyed.

The Authority explained that the face and nose mask for continuous positive pressure devices are masks intended for use by one patient at home or for several patients in a healthcare provider environment, and the mask is used for patients with continuous positive airway pressure (CPAP) respirators or bi-level therapy.

The Authority called on users to report any incidents or problems suspected to be related to medical devices or supplies through the Authority’s unified call center at (19999), the National Center for Medical Devices and Supplies Reports (NCMDR), or through the Tayqaat reporting platform.