Eventos adversos e motivos de descarte relacionados ao reuso de produtos médicos hospitalares em angioplastia coronária

Abstract

Eventos adversos e motivos de descarte relacionados ao reuso de produtos médicos hospitalares em angioplastia coronária Adverse events and reasons for discard related to the reuse of cardiac catheters in percutaneous transluminal coronary angioplasty Abstract Objective: To describe the adverse effects that occur during and after percutaneous transluminal coronary angioplasty (PTCA) possibly related to the reuse of medical equipment. An additional objective is to quantify and identify the reasons of discard in respect to the brand-new and reuse of medical equipment. Method: Sixty patients were studied (48.3% with unstable angina, 45% with acute myocardial infarction and 6.7% with other diagnoses). During the procedure and stay in the Intensive Coronary Unit, the occurrence of fever, hypotension or hypertension, chills, sudoresis, bleeding, nausea and vomits were observed. Seven products were evaluated: catheter introducer, catheter guides (0.35 and 0.014), catheter balloons for angioplasty, indeflator inflation device and manifolds. In total, 76 brand-new and 410 reused apparatuses were studied to verify the occurrence of discard, whether this happened before or during the procedure and for what reason. P-values = 0.05 were considered significant. Results: Twenty-six patients presented adverse effects. Hypotension was the most common seen in 11 (18.3%) cases. There was no significant association between this adverse effect and reuse or not of the equipment. Three brand-new products and 55 of the reused products were discarded as they were incomplete. Conclusion: The adverse effects presented by patients submitted to coronary vessel angioplasty were not associated to the reuse of medical equipment. The integrity and functionality were the main reasons of discard.

Avaliação das propriedades físicas e funcionais dos dispositivos de insuflação de cateteres de angioplastia submetidos a processo para reutilização

“…Poucos hospitais seguem de fato protocolos sistemáticos para limpeza, esterilização e controle de qualidade relacionados à reutilização de cateter. Procedimentos claros e rígidos para prevenir possíveis eventos clínicos aos pacientes, como risco de infecções, reações pirogênicas, toxicidade e contaminações, devem ser urgentemente estabelecidos 11 .…”

Esterilización por baja temperatura y sus aplicabilidades

“…Batista 18 describió los problemas de contaminación que podrían ocurrir durante y después de hacer una Angioplastia Coronaria (ATC) con la reutilización de catéteres. La probabilidad de no mantener la integridad de los catéteres utilizados en angioplastias después de esterilizados con óxido de etileno es alta, pues este proceso puede cambiar las características físicas del polímero, que es la materia prima del catéter.…”