Conception and validation of a protocol for reuse of non-irrigated electrophysiology catheters in a Brazilian teaching hospital.

Autor: Leichsenring ML; Infection Control Service, University of Campinas Hospital, Campinas, Brazil., Psaltikidis EM; Quality Improvement and Patient Safety Division, University of Campinas Hospital, Campinas, Brazil., de Oliveira Figueiredo MJ; Electrophysiology Service, University of Campinas Hospital, Campinas, Brazil.; Department of Internal Medicine, School of Medicine, University of Campinas, Campinas, Brazil., Moretti ML; Department of Internal Medicine, School of Medicine, University of Campinas, Campinas, Brazil., Trabasso P; Department of Internal Medicine, School of Medicine, University of Campinas, Campinas, Brazil. trabasso@fcm.unicamp.br.
Jazyk: angličtina
Zdroj: Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing [J Interv Card Electrophysiol] 2018 Jan; Vol. 51 (1), pp. 45-50. Date of Electronic Publication: 2017 Dec 11.
DOI: 10.1007/s10840-017-0301-3
Abstrakt: Purpose: Since the Brazilian current legislation permits the reuse of single-use devices under a validated processing protocol, the main purpose of our study was to develop and validate a method for reusing non-irrigated electrophysiology catheter (EC).
Methods: Manual and mechanical processing by ultrasonic washer was associated with the use of enzymatic solution and hydrogen peroxide with a final rinse with filtered water. Validation of the cleaning process, as well as catheter integrity, was done by observing the ECs in stereoscopic microscope at ×60 magnification, followed by HemoCheck-S® (HCS) test to monitor the presence of residual blood on their surfaces. Ethylene oxide (EO) was used for sterilization, and the final validations of the processing were performed by assays of sterility, pyrogenicity, and EO residuals. Lastly, a cost-minimization study was performed.
Results: Cleaning process demonstrated absence of organic material detectable by HCS at the surfaces of the ECs. Assays for sterility were negative, and assays of EO residuals and endotoxins showed levels under established standards. The number of reuses was settled to a maximum of seven uses for the ECs with handle and ten uses for ECS without handle. The cost-minimization study showed an 84% savings, when considering seven reuses.
Conclusions: Processing of ECs was validated at all stages. Therefore, reuse of ECs under the conditions that we designed was considered safe for patients and cost-effective for our institution.
Databáze: MEDLINE
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