En julio de 2021, la FDA de EEUU alertó sobre el retiro de Clase 1 de algunos equipos CPAP de la marca Philips del mercado. Esto es, el retiro inmediato de estos productos ante el riesgo comprobado de lesiones graves o la muerte. Cerca del 80% de este catálogo afectado corresponde a equipos CPAP Y el 20% a ventiladores mecánicos utilizados ampliamente en las hospitalizaciones por Covid.
La misma empresa con sede en Ámsterdam aportó que este riesgo radica en que la espuma aislante de ruido utilizada en los aparatos tendía a degradarse hasta producir partículas que pueden entrar en el flujo de aire del dispositivo y ser inhaladas por el usuario. La alerta recogida por el Instituto de Salud Pública chileno señala que la espuma de poliuretano a base de poliéster puede emitir gases químicos que potencialmente también provocan irritación en la piel y vías respiratorias, además de cefalea, asma o sucesos adversos en otros órganos como el hígado o los riñones y cáncer. Por su parte, la FDA agrega que los dispositivos de más de tres años de uso o que han estado expuestos a altas temperaturas y ambientes húmedos, tienen más probabilidades de tener espuma degradada. Otros efectos reportados incluyen irritación de ojos, tos, sinusitis, presión en el pecho y asma.
Si bien en EEUU, país donde radica la alerta, el retiro ha sido total, en Chile los usuarios de equipos CPAP sólo cuentan con un protocolo de recambio de las piezas consideradas cancerígenas. Radio Bio Bío informó que en una reunión realizada “entre representantes de Philips, el ISP, sociedades médicas y proveedores de los dispositivos, se observó poca claridad, falta de información y coordinación con los proveedores” sobre este tema. El organismo revisor asegura que, pese a realizarse dos reuniones posteriores, no se obtuvo mayor precisión sobre el plan de acción. Finalmente el Ministerio de Salud solicitó a su División Jurídica identificar una medida que permitiera dejar en antecedentes la situación. “Hasta la fecha, asegura el Ministerio de Salud, no existe claridad respecto al plan de contingencia de Philips”, asegura el medio.
Mientras en Chile la venta de estos equipos no está sujeta a control sanitario obligatorio (es decir, no requieren de una autorización para su comercialización pues su calidad, seguridad y desempeño es responsabilidad de quienes los fabrican, importan, distribuyen y comercializan), la FDA en EEUU, en tanto, publicó un formulario web donde recopila los datos de usuarios de equipos Philips y quienes sospechen haberse visto afectados por esta riesgo técnico.
¿Cuáles son los equipos que fueron retirados del mercado en EEUU?
La mayoría de los dispositivos corresponden a la línea DreamStation de la marca con sede en Ámsterdam y la totalidad de los números de serie de los equipos fabricados entre 2009 y el 26 de abril de 2021. Más de la mitad de los dispositivos afectados se encuentran en EEUU, según Philips, mientras que en Chile se estiman unos 12 mil de ellos. Las marcas de dispositivos Philips retiradas del mercado incluyen:
- Aeris
- Modelos de dispositivos de la serie BiPAP A30 / A40
- BiPAP V30
- ASV de la serie C
- Dorma 400 y 500
- DreamStation
- E30
- Garbin Plus
- LifeVent
- REMstar SE Auto
- SystemOne (Serie Q)
- Trilogía 100
- Trilogía 200
Más en Somnodromo: ¿Qué es un CPAP?
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