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Journal of Interventional Cardiac Electrophysiology

Erschienen in:

11.12.2017

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

verfasst von: Mirtes Loeschner Leichsenring, Eliane Molina Psaltikidis, Márcio Jansen de Oliveira Figueiredo, Maria Luiza Moretti, Plínio Trabasso

Erschienen in: Journal of Interventional Cardiac Electrophysiology | Ausgabe 1/2018

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Abstract

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.

Zipes DP, Akhtar M, Denes P, DeSanctis RW, Garsm Jr. A, Gettes LS, et al. Guidelines for Clinical Intracardiac Electrophysiologic Studies. A report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Subcommittee to Assess Clinical Intracardiac Electrophysiologic Studies). Circulation. 1989;80(6):1925-39. https://doi.org/10.1161/01.CIR.80.6.1925.

Lindsay BD, Kutalek SP, Cannom DS, Hammill SC, Naccarelli GV. Reprocessing of electrophysiology catheters: clinical studies, regulations and recommendations. A repor of the naspe task force on reprocessing of electrophysiological catheters. Pacing Clin Electrophysiol. 2001;24(8):1297–305. https://doi.org/10.1046/j.1460-9592.2001.01297.x.CrossRefPubMed

Popp W, Rasslan O, Unahalekhaka A, Brenner P, Fischnaller E, Fathy M, et al. What is the use? An international look at reuse of single-use medical devices. Int J Hyg Environ Health. 2010 July;213(4):302–7. https://doi.org/10.1016/j.ijheh.2010.04.003.CrossRefPubMed

Ministry of Health of Brazil Agência Nacional de Vigilância Sanitária (ANVISA) Resolução - RE N° 2.606 de 11 de agosto de 2006. Avaliable from: http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2006/res2606_11_08_2006.html. Accessed October 20, 2013.

Tessarolo F, Disertori M, Caola I, Guarrera GM, Capri S, Nollo G. Reprocessing single-use cardiac catheters for interventional cardiology. A cost-minimization model for estimating potential saving at departmental scale and national level. Ital J Public Health. 2009;6(2):140–9.

Ferrell M, Wolf CE, Ellenbogen KA, Wood MA, Clemo HF, Gilligan DM. Ethylene oxide on electrophysiology catheters following resterilization: implications for catheter reuse. Am J Cardiol. 1997;80(12):1558–61. https://doi.org/10.1016/S0002-9149(97)00785-6.CrossRefPubMed

Alfa MJ. Monitoring and improving the effectiveness of cleaning medical and surgical devices. Am J Infect Control. 2013;41:556–9.

Druce JD, Russell JS, Birch CJ, Yates LA, Harper RW, Smolich JJA. Decontamination and sterilization protocol employed during reuse of cardiac electrophysiology catheters inactivates human immunodeficiency virus. Infect Control Hosp Epidemiol. 2003;24(03):184–90. https://doi.org/10.1086/502190.CrossRefPubMed

Druce JD, Russell J, Birch CJ, Vickery K, Harper RW, Smolich JJ. Cleaning and sterilization protocol for reuse cardiac electrophysiology catheters inactivates hepatitis and coxsackie viruses. Infect Control Hosp Epidemiol. 2005;26:721–5.CrossRef

10.

Tessarolo F, Caola I, Nollo G, Antolini R, Guarrera GM, Caciagli P. Efficiency in endotoxin removal by a reprocessing protocol for electrophysiology catheters based on hydrogen peroxide plasma sterilization. J Hyg Environ Health. 2006;209:557–65.CrossRef

11.

Grabsch EA, Grayson ML, Johnson PDR, Yates LA, Harper RW, Smolich JJ. Bactericidal efficacy of sterilizing protocol for reused cardiac electrophysiology catheters. Am J Cardio. 2002;89(6):770–2. https://doi.org/10.1016/S0002-9149(01)02353-0.CrossRef

12.

Lester BR, Boser NP, Miller K, Schnapf M, Jacques BA, Sullivan BF, et al. Reprocessing and sterilization os single-use electrophysiological catheters: removal of organic carbon and protein surface residues. J AOAC Int. 2009;92(4):1165–73.PubMed

13.

Lester BR, Alexander AA, Miller K, Boser NP, Sullivan BF, Brucker GG. Comparasion of performance characteristics between new and reprocessed electrophysiology catheters. J Interv Card Electrophysiol. 2006;17(2):77–83. https://doi.org/10.1007/s10840-006-9055-z.CrossRefPubMed

14.

Ministry of Health of Brazil. Agencia Nacional de Vigilancia Sanitária (ANVISA). Resolução - RDC n°15 de 15 de março de 2012. Avaliable from: www.anvisa.gov.br/hotsite/segurançadopaciente/documentos/rdcs/RDC%20N°%2015-2012.pdf. Accessed September 10, 2013.

15.

Tessarolo F, Caola I, Caciagli P, Guarrera GM, Nollo G. Sterility and microbiological assessment of reused single-use cardiac electrophysiology catheters. Infect Control Hosp Epidemiol. 2006;27(12):1385–92. https://doi.org/10.1086/508829.CrossRefPubMed

16.

Ministry of Health of Brazil. Portaria Interministerial MS/MET n° 482 de 16 de abril de 1999. Aviable from: www.prosaude.org.br/legislação_2013/legislação_textos/portaria_482.pdf.. Accessed September 12, 2013.

17.

Lerouge S, Guinot G, Tabrizian M, Ferrier D, Yagoubi N, Yahia L. Plasma-based sterilization; effect on surface and bulk properties and hydrolytic stability of reprocessed polyurethane electrophysiology catheters. Int J Biomater Res Eng. 2000;52(4):774–82.

18.

Tessarolo F, Ferrari P, Silvia B, Motta A, Migliaresi C, Zennaro L, et al. Evaluation and quantification of reprocessing modification in single-use devices in interventional cardiology. Appl Surf Sci. 2004;238(1-4):341–6. https://doi.org/10.1016/j.apsusc.2004.05.223.CrossRef

19.

Ayzman I, Dibs SR, Goldberger J, Passman R, Kadish A. In Vitro performance characteristics of reused ablation catheters. J Interv Card Electrophysiol. 2002;7(1):53–9. https://doi.org/10.1023/A:1020820200112.CrossRefPubMed

20.

Lerouge S, Tabrizian M, Wertheimer MR, Marchand R, Yahia L. Safety of plasma-based sterilization: surface modifications of polymeric medical devices induced by Sterrad and Plazlyte processes. Biomed Mater Eng. 2002;12(1):3–13.PubMed

Titel: Conception and validation of a protocol for reuse of non-irrigated electrophysiology catheters in a Brazilian teaching hospital
verfasst von: Mirtes Loeschner Leichsenring
Eliane Molina Psaltikidis
Márcio Jansen de Oliveira Figueiredo
Maria Luiza Moretti
Plínio Trabasso
Publikationsdatum: 11.12.2017
Verlag: Springer US
Erschienen in: Journal of Interventional Cardiac Electrophysiology / Ausgabe 1/2018
Print ISSN: 1383-875X
Elektronische ISSN: 1572-8595
DOI: https://doi.org/10.1007/s10840-017-0301-3

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