Reprocessamento de dispositivos médicos de uso único em cardiologia: revisão sistemática da literatura sobre características de segurança e desempenho aplicadas à eletrofisiologia cardíaca

Resumo original em inglês

O que aconteceu

The rising burden of cardiovascular diseases, especially atrial fibrillation, has increased demand for electrophysiology (EP) procedures in Europe, driving greater reliance on disposable devices like diagnostic and ablation catheters. Reprocessing single-use medical devices offers potential economic and environmental benefits, yet concerns persist regarding device integrity and safety. Under the European Union Medical Device Regulation, reprocessing is permitted if national laws allow it; however, implementation varies across Member States. This systematic literature review evaluates the safety and performance of reprocessed cardiac EP catheters originally intended for single use.

O que encontraram

Following PRISMA guidelines, literature searches of PubMed and Embase identified in vitro and in vivo studies that examined the safety and functionality of reprocessed EP catheters. Key outcomes included infection risk, device sterility, mechanical and electrical integrity, and adverse events. Twelve studies (four in vivo and eight in vitro) involving >1200 patients and multiple catheter brands were included. Under stringent reprocessing protocols, reprocessed EP catheters showed comparable safety and mechanical performance to new devices. However, gaps remain in evidence regarding prion and fungal contamination, the maximum number of safe reprocessing cycles, and the detection of rare complications.

Por que isso importa

The absence of adverse events and reliable performance associated with reprocessed EP catheters reported in this study may encourage European countries that have not yet authorized single-use medical device reprocessing to consider its adoption. However, the broader implementation of this practice remains contingent on its applicability and logistical feasibility within each national context.

Resumo publicado sob licença CC BY. A tradução para o português ainda não chegou a este estudo.