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Colombia adopta manual técnico obligatorio para IPS: Buenas prácticas en reprocesamiento de dispositivos médicos
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La Resolución 914 de 2025, vigente desde el 1.º de julio de 2025, adopta el Manual de Requisitos para la Implementación de las Buenas Prácticas de Reprocesamiento de Dispositivos Médicos y Elementos Reutilizables (DMER) como estándar normativo obligatorio. Este manual detalla los criterios que deben cumplir las instituciones de salud que reprocesan equipos o instrumentos reutilizables, tales como cánulas, pinzas, endoscopios, electrodos, entre otros.
La normativa se dirige a IPS públicas y privadas, de baja, mediana y alta complejidad, que realicen directamente estas prácticas dentro de sus instalaciones. El enfoque del Ministerio es garantizar que las actividades de reprocesamiento sean seguras, eficaces y trazables, reduciendo riesgos de infecciones asociadas a la atención en salud (IAAS) y mejorando los estándares de habilitación y vigilancia.
Requisitos técnicos y científicos exigidos por la norma – dispositivos médicos
El manual anexo a la resolución define de forma detallada los componentes clave del sistema de reprocesamiento, incluyendo:
- Infraestructura física adecuada: con zonas separadas para limpieza, desinfección, esterilización y almacenamiento.
- Equipos validados: lavadoras ultrasónicas, autoclaves, termo-desinfectadoras, sistemas de secado, entre otros, deben contar con mantenimientos, calibración y validaciones documentadas.
- Protocolos escritos: todas las etapas del reprocesamiento deben seguir Procedimientos Normalizados de Operación (PNO) y contar con evidencia de su cumplimiento.
- Personal capacitado y competente: se exige que el personal involucrado tenga formación específica y permanente en el manejo de los DMER, así como acreditación de competencias.
Uno de los pilares de la Resolución 914 de 2025 es la exigencia de que todas las IPS cuenten con un Sistema de Gestión de Calidad específico para el reprocesamiento. Esto incluye auditorías internas, análisis de causas raíz ante hallazgos críticos, planes de mejora continua, y una estructura organizacional clara con responsables técnicos designados.
Asimismo, se exige un sistema integral de trazabilidad, que permita conocer el ciclo completo de cada DMER desde su uso clínico hasta su reprocesamiento y reuso. Esto implica la documentación y seguimiento de:
- Identificación del dispositivo.
- Registro del procedimiento realizado.
- Fecha de cada ciclo de reprocesamiento.
- Nombre del profesional que realizó el procedimiento.
- Servicio o área donde se reutilizó.
Este sistema debe permitir reconstruir completamente el historial de cada dispositivo médico reprocesado, lo que fortalece la seguridad del paciente y la responsabilidad institucional.
Medidas de bioseguridad y control del riesgo
La nueva resolución pone especial énfasis en la implementación de medidas de bioseguridad tanto para el talento humano como para la infraestructura física. Las áreas deben cumplir con normas de ventilación, flujo unidireccional, señalización de zonas sucias y limpias, y barreras físicas cuando se requiera. De igual forma, se establece la obligación de implementar un programa de gestión del riesgo que permita:
- Identificar peligros asociados al reprocesamiento.
- Evaluar eventos adversos potenciales.
- Establecer indicadores de seguimiento.
- Implementar acciones preventivas y correctivas.
Estas medidas buscan evitar fallas en la desinfección o esterilización que podrían derivar en infecciones nosocomiales, daños a los pacientes o responsabilidades legales.
Período de transición y vigilancia por parte de las autoridades sanitarias
Aunque la Resolución 914 de 2025 entró en vigor el 1.º de julio, las instituciones que ya cuenten con servicios de reprocesamiento habilitados tienen un plazo de doce (12) meses para adecuarse completamente a los nuevos requisitos. Durante este período de transición, las IPS deberán:
- Elaborar y presentar un Plan de Adecuación ante las secretarías de salud o entidades territoriales competentes.
- Implementar progresivamente los estándares exigidos en el manual.
- Coordinar procesos de autoevaluación, capacitación y actualización documental.
El incumplimiento de los requisitos una vez vencido el plazo podrá dar lugar a sanciones administrativas, suspensión temporal del servicio o pérdida de la habilitación del componente funcional correspondiente.
Derogatoria y articulación con otras normas
Con esta resolución, el Ministerio de Salud deroga los siguientes apartados de la Resolución 3100 de 2019: Artículo 2.5.5.3 (del Capítulo 5, Título 5, Parte 2 del Libro 2), Numerales 2 y 3 del artículo 2.5.5.4., y Numeral 5 del artículo 2.5.5.6.
También se derogan o modifican otras disposiciones previas sobre reprocesamiento que resulten incompatibles con el nuevo manual. Esta decisión busca consolidar en un solo cuerpo técnico las buenas prácticas del sector y unificar criterios para las actividades de inspección, vigilancia y control.
Esta resolución representa una apuesta del Estado colombiano por fortalecer la calidad técnica y sanitaria de los procedimientos que, aunque no visibles al paciente, tienen un impacto directo en su seguridad y en los resultados clínicos.
El nuevo estándar no solo responde a compromisos con organismos internacionales, sino que refuerza la cultura de seguridad, la trazabilidad y la responsabilidad institucional. Su cumplimiento será clave para garantizar prácticas hospitalarias más seguras y sostenibles en Colombia.
Descargue aquí la resolución completa:
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