Eventos adversos e motivos de descarte relacionados ao reuso dos produtos médico-hospitalares em pacientes submetidos a angioplastia coronária

Abstract

The reuse of health care products [medical and supply hospital products] is a practice carried out by several countries. The hemodynamic catheters, which are used for diagnosis examination and cardiac procedures, such as coronary angioplasty, are the most reutilized ones. The technical difficulties to reprocess the products and the adverse events are important issues for those who decide for the reutilization of these products. Objectives: To describe the adverse events presented by the patients during and after the coronary angioplasty possibly related to the reuse of health care products [medical and supply hospital products], and to quantify and identify the reasons to discard the products in relation to both the first use and to the reuse. Casuistic and Method: Of 60 patients who were submitted to coronary angioplasty, 33 (55%) were men. The age ranged from 42 to 88 years-old, 63 ± 10 years [mean ± SD]. According to the anamnesis, 22 patients (36.7%) presented hypertension, and 10 (16.7%) had diabetes. Of this group, 15 patients (25%) were smokers, and 8 (13.3%) were alcoholics. Of the 60 patients, 29 (48.3%) presented unstable angina, 27 (45%) had AMI (acute myocadial infarction), and 4 (6.6%) other diagnoses. During the procedure and the permanence in the Intensive Care Unit (ICU) the occurrences of adverse events, such as fever, hypertension, hypotension, chills, sudoresis, bleeding, nausea, and vomit presented by the patients have been observed. Seven medical devices have been evaluated: introductor, guiding catheter, guidewire 0.35, guidewire 0.014, balloon catheter for angioplasty, a syringe with manometer to insufflate the balloon (indeflator), and a three-way (3) stopcock (manifold). Of these, 76 were first-use products and 410 reprocessed products. It was verified if the same products were discarded before or during the procedure, and which were the reasons that led these products to be discarded. The categorical variables have been analyzed with the chi-square test (χ2 test). The discrete quantitative variables have been analyzed with a nonparametric statistical test for ordinal data (Mann-Whitney test). A type I error of 5% was admitted. Results: The results have highlighted that 26 patients presented adverse events. Hypotension was the most clinically significant adverse event and occurred in 11 (18.3%) of the patients. There was not, however, a statistical significance between the hypotension adverse event and the reuse of the products. Four first-use products and 80 reused products have been discarded. Three first-use products and 55 reused products have been discarded because they were damaged. We want to emphasize that all the syringes used to insufflate the balloon, which have been discarded, have been so for this reason. Conclusions: The adverse events presented by the patients submitted to angioplasty are not related to the reuse of the health care products. The medical devices integrity and functionality have been the main reason of the discards.