Asunto(s)
Aprobación de Recursos/legislación & jurisprudencia , Regulación Gubernamental/historia , Accesibilidad a los Servicios de Salud/tendencias , Defensa del Paciente/tendencias , Aprobación de Recursos/normas , Equipos y Suministros/provisión & distribución , Europa (Continente)/epidemiología , Sector de Atención de Salud/economía , Sector de Atención de Salud/normas , Accesibilidad a los Servicios de Salud/estadística & datos numéricos , Historia del Siglo XX , Humanos , Legislación de Dispositivos Médicos/historia , Defensa del Paciente/estadística & datos numéricos , Atención al Paciente/normas , Atención al Paciente/estadística & datos numéricos , Médicos/estadística & datos numéricos , Estados Unidos/epidemiologíaRESUMEN
Medical devices are of increasing importance in cardiovascular disease and have made important contributions to patient care. These devices continue to evolve with increasing complexity. FDA regulation of medical devices involves increased stringency for higher risk and novel devices. However, there are some current opportunities to strengthen the FDA's pre-approval regulatory process and improve post-marketing surveillance. This article reviews FDA regulation of cardiovascular devices and offers suggestions for strengthening the process while focusing on examples relevant to cardiac electrophysiologists.
Asunto(s)
Cardiología/instrumentación , Enfermedades Cardiovasculares/terapia , Desfibriladores Implantables , Legislación de Dispositivos Médicos , Marcapaso Artificial , United States Food and Drug Administration , Procedimientos Quirúrgicos Vasculares/instrumentación , Ensayos Clínicos como Asunto , Aprobación de Recursos/legislación & jurisprudencia , Diseño de Equipo/normas , Seguridad de Equipos/tendencias , Historia del Siglo XX , Humanos , Legislación de Dispositivos Médicos/historia , Recall de Suministro Médico , Vigilancia de Productos Comercializados , Estados Unidos , United States Food and Drug Administration/historiaRESUMEN
During the relatively short history of class proceedings in Canada, developers and manufacturers of medical devices and pharmaceuticals ("medical products"), including medical products designed for patients with diabetes, have found themselves at the receiving end of a significant number of class action claims. As a result, medical products litigation has become the battleground for some of the most significant developments in Canadian class actions law. This article provides a broad overview of some of the most significant developments. The authors pay particular attention to developments regarding the test for class action certification and consider whether high-profile dismissals of certification motions represent a trend toward raising the threshold for plaintiffs seeking to obtain certification of a proposed class action. The authors also consider a decision arising out of a lengthy class action common issues trial in which the medical device company was victorious. In the authors' view, the class action pendulum in Canada, particularly as it relates to medical products claims, remains in motion. It behooves all affected players to keep their eye on this ball with rapt attention to see where it may move next.