Actualización de la Normativa de los pequeños esterilizadores a vapor (Statim 2000 y Statim 5000)

De acuerdo al manual de aplicación de las “Normas Técnicas sobre Esterilización y Desinfección de Elementos Clínicos” publicada en Resolución Exenta No. 1665 del 27 de noviembre del 2001 del Ministerio de Salud de Chile, el uso de los sistemas de esterilización rápida está autorizado y normado en las siguientes condiciones:

  • Se use en casos de emergencia cuando es imposible incurrir a los métodos tradicionales y nunca con artículos implantables.
  • Cuando la necesidad del equipo es de extrema urgencia y no es posible contar a tiempo con el material esterilizado por los sistemas convencionales.
  • Material solicitado en horas que la Central de Esterilización está cerrada o no puede responder a los requerimientos.

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:

  • 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 134 grados.
  • Se debe contar con un protocolo de uso de los pequeños esterilizadores a vapor.
  • 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.
  • 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 (los nuevos equipos G4 vienen con sistema de conexión en red al sistema computacional).
  • 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 casette al área quirúrgica adecuadamente.
  • Estos equipos están acogidos a la Normativa Internacional de acreditación que en convenio al acuerdo de libre comercio entre Chile y Canadá que 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.

Los esterilizadores rápidos Statim 2000G4 y 5000G4, fabricados por Scican de Canadá, son considerados líderes mundiales en este tipo de tecnología y son usados en los principales centros mundiales de salud (más de 92 países). Clínicas y hospitales, lo usan en sus unidades de odontología, oftalmología y pabellones quirúrgicos. Estos equipos cumplen con toda la Certificación Internacional, que entre la que destacamos:

  • Certificado TUV Nº G1030412160011, de cumplimiento de los equipos esterilizadores fabricados por SciCan, de las directivas del Annex II, clause 3 of Council Directive 93/42/EEC relativo a equipos médicos (Directivos y Standard de la Comunidad Económica Europea).
  • Licencias K962179 y K910241 & K915054 respectos a los equipos STATIM 2000 y 5000 respectivamente, autorizando su comercialización por el Departament of Healt and Human Services division of the Food and Drug Administration (FDA).
  • Certificado TUV, de implementación de las normas de calidad ISO 13485:1996: TUV Management Services es una empresa alemana certificadora de calidad y cumplimientos de normas internacionales.
  • Certificado del fabricante relativo a la exportación de equipos médicos, los que a través de la licencia 4580 declara que los equipos cumplen con los requerimientos de la Canada’s Food and Drugs Act and regulastions.
  • Declaration of Conformity. Especifica que los equipos STATIM cumplen los requerimientos de la directiva del “Council Directive 93/42/EEC of 14 June 1993”, respecto a equipos médicos.
  • En Chile está autorizado su uso de acuerdo a las “Normas Técnicas sobre Esterilización y Desinfección de Elementos Clínicos” editado por el Ministerio de Salud, Gobierno de Chile. En Chile hay equipos instalados en hospitales y clínicas de Arica a Punta Arenas.

El Protocolo recomendado de mantenimiento técnico de acuerdo a la normativa vigente para el cumplimiento de normas internacionales (ISO 13485: 1996, EN 61010-1/A2:1995, EN 61010-2-041:1996, EN 60601-1-2:1993). Es sustantivo para el fabricante el cumplimiento de esta normativa.

El mantenimiento técnico debe ser efectuado por el servicio técnico oficial del fabricante, con repuestos originales del fabricante, de acuerdo a un protocolo pre-establecido.

Se debe efectuar un mantenimiento semestral y/o 500 ciclos completo del equipo revisando su funcionamiento, cambiando filtros, etc.

Se debe mantener un registro/hoja de vida de cada equipo indicando intervenciones, mantenimientos efectuados, registro de repuestos utilizados, etc. con la firma del técnico responsable.

La intervención de terceros no autorizados obliga al fabricante a presentar la notificación legal a las autoridades.

Ing. Jaime Calderón Riveros
Santiago, Marzo de 2015

26 comentarios en “Actualización de la Normativa de los pequeños esterilizadores a vapor (Statim 2000 y Statim 5000)

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