Esterilizadores pequeños de vapor

La comunidad médica mundial en voz de diversas sociedades científicas (AAMI, AORN, APIC, ASC, AST y IAHCSMM) definió que la aplicación del término “flash” a los esterilizadores rápidos es anticuada porque no representa una definición técnica a los diversos ciclos que cumple un sistema de esterilizador pequeño siendo más adecuado la definición de “esterilizadores de vapor para uso inmediato” cuya función es esterilizar elementos que no deben ser usados para su uso posterior.

La normativa internacional normalmente hace referencia a la norma canadiense (CAN/CSAZ314.3- 09) o norteamericana (ANSI/AAMI ST79) y otros centros clínicos que proporcionan información recomendada para la esterilización de emergencia definiendo que debe existir un ciclo que tiene un tiempo mínimo de 3 minutos y una temperatura por encima de los 132 grados. La nueva versión tiene un software con un tiempo de secado de 15 minutos.

El Statim 5000 fabricado por Scican de Canadá está autorizado por la Health Canadá y FDA de Estados Unidos y otros organismos reguladores internacionales y vendido en más de 90 países de todo el mundo desde los años 90 cumple con la normativa internacional exigida (CaN/CSA Z-314, ANSI/ST79 y otras) teniendo estos esterilizadores pequeños a vapor un tiempo de 3 ½ minutos y una temperatura sobre 135 grados para elementos que no se almacena contando además con una impresora de registro. Están fabricados con cámaras pequeñas de extracción de aire mediante impulsos de presión permitiendo trabajar con cargas más pequeñas.

La normativa técnica en Chile es muy antigua y está definida en manual de ”Normas Técnicas sobre Esterilización y Desinfección de Elementos Clínicos” decretada mediante Resolución Exenta No. 1665 del 27 de noviembre del año 2001 del Ministerio de Salud y que establece:

  • Se use en casos de emergencia cuando no se puede concurrir a métodos tradicionales y nunca en elementos implantables.
  • Casos de extrema urgencia y no es posible contar con material esterilizado a tiempo.
  • Cuando la central de esterilización está cerrada.

De la sola lectura y definición técnica de la normativa chilena sobre la esterilización rápida de los pequeños esterilizadores a vapor está muy atrasada en razón al continuo avance de la tecnología, donde la normativa aplicada es del año 2001 por lo que se hace necesario adecuar. Entre los aspectos a considerar se detalla:

  1. Por definición se debe hablar de la esterilización flash como la esterilización de los “pequeños esterilizadores a vapor” los cuales deben cumplir un ciclo mínimo de 3 minutos y una temperatura mínima de 132 grados.
  2. Se debe contar con un protocolo de uso de los pequeños esterilizadores a vapor que considere:
  • Debe existir siempre una persona responsable a cargo del procedimiento (enfermera supervisora de pabellón y/o enfermera jefe de pabellón) que controle los procedimientos y revise el cumplimiento del protocolo.
  • Estos equipos deben ser usados para esterilizar instrumental en caso de emergencia, entre cirugía y cirugía cuando se requiere su uso como el caso de la oftalmología y nunca como un sistema de esterilización periódica.
  • Todo el instrumental, previo a la esterilización debe ser lavado, estar muy limpio y sin materia orgánica. El instrumental clínico que sea necesario esterilizar debe ser autorizado por enfermera supervisora (Capítulo III, Técnicas sobre Esterilización y Desinfección de Elementos Clínicos).
  • Debe existir un registro histórico de cada ciclo anotándolo en la hoja de carga. El control químico debe quedar adosado a la hoja de carga. Una vez a la semana se colocará un control biológico y enviado a la Central de Esterilización.
  • El equipo debe ser manejado sólo por personal paramédico y/o enfermera capacitada y entrenada responsable.
  • El mantenimiento técnico debe ser efectuado por servicios técnicos oficiales, reconocidos y certificados por el fabricante de acuerdo protocolo pre-establecido en cumplimiento de la normativa internacional. El mismo se debe efectuar semestralmente y/o cada 500 ciclos manteniendo una hoja de vida del equipo indicando intervenciones, mantenimientos efectuados e incorporada al registro histórico.
  • El equipo se debe instalar en el área limpia cerca del pabellón y/o en el pabellón mismo que permita entregar el cassette al área quirúrgica adecuadamente.
  • Estos equipos están acogidos a la normativa internacional de acreditación que de acuerdo al acuerdo de libre comercio entre Chile y Canadá, Chile está obligado a cumplir. Cualquier transgresión a la normativa debe ser comunicada a las autoridades del hospital.

En suma, los pequeños esterilizadores a vapor pueden ser usados como elemento de apoyo extraordinario en un pabellón quirúrgico en cumplimiento de las Normas Técnicas sobre Esterilización y Desinfección de Elementos Clínicos existente en Chile del año 2001, que se hace necesario actualizar dado el avance de la tecnología, cumpliendo estrictamente los protocolos de uso controlados por la enfermera de esterilización y/o enfermera jefe de pabellón. Esta tecnología es un importante aporte a la medicina nacional que disminuye costos y maximiza recursos.

 

Ing. Jaime Calderón Riveros
Santiago, Octubre de 2012

 

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