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Vigilancia automatizada para detectar señales de seguridad posteriores al procedimiento de dispositivos
Frederic S Resnic1, Thomas P Gross, Danica Marinac-Dabic
1BrighamandWomen’s Hospital and Harvard Medical School, Boston, Massachusetts 02115, USA. fresnic@partners.org
JAMA
|November 11, 2010
Resumen
La vigilancia automatizada de los registros clínicos puede detectar problemas de seguridad con nuevos dispositivos cardiovasculares. Este método identificó con éxito el aumento de los riesgos para los stents específicos de liberación de fármacos y los dispositivos de cierre vascular.
Área de la Ciencia:
- Medicina Cardiovascular La medicina cardiovascular es una especialidad de la salud.
- Seguridad de los Dispositivos Médicos.
- Informática de la salud Informática de la salud.
Sus antecedentes:
- La vigilancia actual de dispositivos médicos se basa en la notificación voluntaria de eventos adversos, que tiene limitaciones.
- La vigilancia automatizada de los registros clínicos ofrece una solución potencial para la evaluación temprana de la seguridad posterior a la comercialización.
Objetivo del estudio:
- Evaluar la viabilidad de la vigilancia automatizada de la seguridad utilizando registros clínicos para nuevos dispositivos cardiovasculares.
- Para determinar si este enfoque automatizado puede proporcionar advertencias tempranas de problemas de seguridad relacionados con el dispositivo.
Principales métodos:
- Se realizó un análisis de cohorte prospectivo y emparejado de propensión.
- Se analizaron datos de 7 dispositivos cardiovasculares recientemente introducidos utilizando el Registro CathPCI (abril de 2003-septiembre de 2007).
- Las alertas de seguridad se desencadenaron al exceder el intervalo de confianza superior del 95% (IC) de los dispositivos de comparación.
Principales resultados:
- La vigilancia automatizada desencadenó alertas para 2 de los 7 dispositivos cardiovasculares evaluados.
- El stent liberador de fármacos Taxus Express2 mostró un aumento en los riesgos de infarto de miocardio y eventos cardíacos adversos importantes.
- El dispositivo de cierre vascular Angio-Seal STS indicó un mayor riesgo de complicaciones vasculares importantes.
Conclusiones:
- La vigilancia prospectiva automatizada de los registros clínicos es un método factible para el monitoreo de la seguridad de los dispositivos médicos.
- Este enfoque puede identificar efectivamente las señales de seguridad de baja frecuencia para nuevos dispositivos cardiovasculares, mejorando la vigilancia posterior a la comercialización.
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