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Minsalud actualiza regulación para equipos con radiación ionizante y servicios de protección radiológica – Proyecto de resolución
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El Ministerio de Salud y Protección Social de Colombia (Minsalud) publicó un proyecto de resolución que reglamenta de manera integral el uso de equipos generadores de radiación ionizante y la prestación de servicios de protección radiológica y control de calidad, derogando la Resolución 482 de 2018. Esta propuesta normativa se alinea con los estándares del Organismo Internacional de Energía Atómica (OIEA), y busca garantizar la seguridad de los pacientes, los trabajadores expuestos y el público general frente a los riesgos asociados a las radiaciones ionizantes.
La resolución se apoya en la Ley 9 de 1979, que en su artículo 151 establece que toda persona natural o jurídica que preste servicios de protección radiológica o haga uso de equipos generadores de radiación ionizante debe contar con licencia.
Además, incorpora modificaciones del Decreto Ley 2106 de 2019, que transfiere la competencia de expedir dichas licencias a las secretarías de salud departamentales o distritales. Se suma a esto la Ley 100 de 1993 y el Decreto 2090 de 2003, que reconocen la exposición a radiaciones ionizantes como un factor de riesgo laboral. Colombia, como miembro del OIEA, también acoge las normas internacionales de seguridad (GSR parte 3), promovidas mediante la Ley 16 de 1960 y el Acuerdo Suplementario (Ley 296 de 1996).
Licencia para prestación de servicios de protección radiológica y control de calidad
El proyecto de resolución busca reglamentar el uso de equipos generadores de radiación ionizante en las prácticas médica, veterinaria, industrial y de investigación, así como los servicios de protección radiológica y control de calidad. No aplica para actividades con materiales radiactivos. Se introducen definiciones fundamentales como “control de calidad”, “director técnico”, “oficial de protección radiológica”, “equipo generador de radiación ionizante” y “nivel de referencia para diagnóstico (NRD)”, entre otros, que delimitan las obligaciones y perfiles necesarios para operar bajo esta regulación.
De otro lado, el proyecto de resolución detalla que toda persona o entidad que preste servicios de protección radiológica deberá obtener licencia con validez nacional. Para ello, deberá contar con un director técnico con posgrado en física médica (u otros requisitos académicos según el caso), infraestructura adecuada y cumplimiento de protocolos internacionales (TECDOC, Task Group AAPM, etc.). Los informes de control de calidad tendrán una vigencia de dos años. Esta licencia será válida por cuatro años y su renovación deberá solicitarse con al menos 60 días hábiles de anticipación.
Licencias para prácticas médicas
Los prestadores de servicios de salud con equipos de radiación ionizante deberán obtener licencia según el nivel de riesgo:
- Categoría I (riesgo bajo): incluye radiología odontológica periapical, densitometría ósea, entre otras. Vigencia: 5 años.
- Categoría II (riesgo medio): radiodiagnóstico de alta, media y baja complejidad. Vigencia: 4 años.
- Categoría III (riesgo alto): radioterapia básica, intermedia y avanzada. Vigencia: 4 años.
Cada categoría tiene requisitos diferenciados sobre el tipo de profesional responsable (encargado u oficial de protección radiológica), control de calidad, protección dosimétrica, tecnovigilancia y protocolos de capacitación.
Licencias para prácticas industriales, veterinarias o de investigación
Estas prácticas también deberán ser licenciadas y clasificadas como:
- Categoría I: radiografía industrial de baja complejidad (escáneres de paquetes, body scanners).
- Categoría II: radiografía industrial de alta complejidad, veterinaria o en investigación.
Las licencias tendrán vigencia de seis años. Se exige constancia de capacitación, programa de protección radiológica, estudio ambiental, y en el caso de body scanners, información al público sobre riesgos y alternativas.
Por otro lado, el artículo 40 establece incompatibilidades para evitar conflictos de interés. Por ejemplo, un titular de licencia para servicios de protección radiológica no podrá prestar servicios si también es usuario de equipos. Además, los titulares estarán sujetos a visitas de inspección cada dos años. Hasta el 31 de diciembre de 2025, podrán aplicarse las disposiciones de la Resolución 482 de 2018, si el solicitante así lo desea.
Transformaciones clave del modelo regulatorio
- Centralización de funciones en secretarías de salud territoriales.
- Exigencia de personal altamente cualificado.
- Licencias diferenciadas según nivel de riesgo.
- Adopción de protocolos internacionales.
- Digitalización de formatos y trámites.
- Refuerzo de la tecnovigilancia.
- Separación entre proveedores y usuarios de servicios.
La entrada en vigencia de esta resolución se dará a partir de su publicación en el Diario Oficial, momento en el que quedará derogada la normativa anterior. Su implementación busca elevar los estándares de calidad, seguridad y transparencia en el uso de tecnologías que implican radiación ionizante en el país.
Descargue aquí el proyecto de resolución:
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