Device regulation and surveillance in vascular care: Challenges and opportunities.
Catheter Cardiovasc Interv
; 104(1): 84-91, 2024 Jul.
Article
en En
| MEDLINE
| ID: mdl-38639136
ABSTRACT
Cardiovascular devices are essential for the treatment of cardiovascular diseases including cerebrovascular, coronary, valvular, congenital, peripheral vascular and arrhythmic diseases. The regulation and surveillance of vascular devices in real-world practice, however, presents challenges during each individual product's life cycle. Four examples illustrate recent challenges and questions regarding safety, appropriate use and efficacy arising from FDA approved devices used in real-world practice. We outline potential pathways wherein providers, regulators and payors could potentially provide high-quality cardiovascular care, identify safety signals, ensure equitable device access, and study potential issues with devices in real-world practice.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Vigilancia de Productos Comercializados
/
Aprobación de Recursos
Límite:
Humans
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Catheter Cardiovasc Interv
Asunto de la revista:
CARDIOLOGIA
Año:
2024
Tipo del documento:
Article
País de afiliación:
Estados Unidos