Rastreio e manejo de pacientes com cabos-eletrodos de cardiodesfibriladores Riata com condutores externalizados: revisão da literatura / Screening and management of patients with Riata implantable cardioverter-defibrillator eads with externalized conductors: literature review

Os cabos-eletrodos de cardiodesfibriladores com revestimento de silicone Riata e Riata ST foramextensamente implantados entre os anos de 2003 e 2010. Sua distribuição, porém, foi interrompida após aobservação de exteriorização dos condutores por falha do isolante em diversos casos de mau funcionamento.Esses cabos-eletrodos foram classificados como classe I de recall pelo Food and Drug Administration. Diversosestudos foram realizados desde então para se determinar a incidência e a prevalência de extrusão dos condutores epara avaliar sua correlação com falha elétrica. Também tem sido estudado o melhor método de rastreio e como seconduzir os pacientes portadores desses cabos-eletrodos.

The cardioverter-defibrillator leads with Riata silicone coating and Riata ST were widely deployed between 2003 and 2010. Its distribution, however, was discontinued after observation of externalization of conductors due to insulation failure in several cases of malfunction. These leads were classified as Class I Recall by the Food and Drug Administration. Several studies have been performed since then to determine the incidence and prevalence of extrusion of the conductors and to evaluate their correlation with electrical failure. The best screening method and how to conduct patients with these leads have also been investigated.

Analysis of FDA medical device recall in 2005-2006 / 中国医疗器械杂志

<p><b>OBJECTIVES</b>To analyze medical device recall information of FDA U.S. and to address the safety issue of medical device.</p><p><b>METHOD</b>For each report, the recall class, product name, product class and recall reason were recorded and classified for analysis.</p><p><b>RESULTS</b>3093 reports were identified; the recalling reasons of the three classes were significantly different. It is found that the main recall reason for medical material is package problems (39%) and design defectiveness (19%), for medical tools are design defectiveness (27%) and package problems (26%), and for medical equipment are design defectiveness (45%) and system failures (39%). The number of software recalled is 109. The main recall reason for high risk equipment is design defectiveness, and the I class level of high risk equipment recalled was decline in 2006 compared to that in 2005.</p><p><b>CONCLUSION</b>Monitoring and application of medical device recall information should be strengthened, and the objective law of medical device safety issue should be summed up, in order to provide reference for supervision of medical device.</p>