Aecization of medical devices sterilized to ethylene oxide: considerations about Brazilian regulation
DOI:
https://doi.org/10.5327/Z1414-4425202100030008Keywords:
Equipamentos e provisões. Esterilização. Óxido de Etileno. Resíduos tóxicos.Abstract
Objectives: To describe acceptable residual levels of ethylene oxide in medical devices, analyze recommended aesther processes and compare them with
the Brazilian regulation. Method: Integrative literature review, with specific descriptors, without year of publication restriction. Data search between October and
November 2019, which resulted in 34 studies included in the study. Results: Current Brazilian regulation is outdated in relation to product classification, the determination
of waste values ethylene oxide toxic in medical devices and the recommended processes for the aecization of these products, and may contribute to risks
of adverse events for patients users of inappropriately aenated devices, and consequently urge their update. Conclusion: The shortcomings of this regulatory framework
indirectly benefit companies that outsource ethylene oxide sterilization by omitting essential controls for safety of the patient exposed to possible toxic residues
of ethylene oxide, unsafe practices of sterilization of health products, in addition to hindering the control of health service by the country’s health surveillance.
References
Mansur JM. Reuse of single use devices. Understanding risks and strategies for decision-making for healthcare organizations. Joint Comission International. 2017. [acessado 2018 Dez 26]. Disponível em: http://www.jointcomissioninternational.org
Jacobs P., Akpinar I. Single use medical devices: economics issues. Heart Asia 2018;10:e011034.doi:10.1136/heartasia-2018-011034
Unger S, Landis A. Assessing the environmental, human health, and economic impacts of reprocessed medical devices in a Phoenix hospital’s supply chain. Journal of Cleaner Production 2016;112:1995-2003.doi:10.1016/j.jclepro.2015.07.144
Kapoor A, Vora A, Nataraj G, Mishra S, Kerka P, Manjunath CN. Guidance on reuse of cardio-vascular catheters and devices in India: a consensus document. India Heart Journal 2017;69:357-63.doi:10.1016/j.ihj.2017.04.003
World Health Organization. Global Guidelines for The Prevention of Surgical Site Infection. Geneva: WHO; 2016.
Costa EAM, Santos QNF, Dantas IS. Risco em processamento de produtos para saúde em unidade básicas de Salvador, Ba. Vigil. Sani.debate. 2018;6(2): 38-43.doi:10.22239/2317-269x.00991
Costa EAM. Panorama internacional do reprocessamento de produtos para saúde de uso único. Rev SOBECC. 2016;21(4): 203-209.doi:10.5327/Z1414-44252016000400005
Rutala WA, Webwe DJ. Sterilization, high-level disinfection an environmental cleaning. Infect Dis Clin N Am. 2011; 25:45-76.doi:10.1016/j.idc2010.11.009
Rutala WA, Weber DJ. Healthcare Infection Control Practices Advisory Committee. Guidelines for Disinfection and Sterilization in Helathcare Facilities. Center for Disease Control and Prevention. HICPAC, 2008.
Goveia VR, Pinheiro SMC, Graziano KU. Métodos de esterilização por baixa temperatura e novas tecnologias. Rev Latino-am Enferm 2007;15(3).doi:10.1590/S0104-11692007000300002
De Souza RQ, Graziano KU, Ikeda TI, Gonçalves CR, Cruz AS. Citotoxicidade de tubos de PVC esterilizados em óxido de etileno após exposição à radiação gama. Rev Esc Enferm USP 2013:47(2):494-9. Doi:10.1590/S0080-62342013000200031
Abdo N, Rodrigues DB, Freitas MIP. Métodos físico-químicos de esterilização. Óxido de Etileno. In: Associação Paulista de Epidemiologia e Controle de Infecção Relacionada à Assistência à Saúde (APECIH). Limpeza, Desinfecção e Esterilização de Artigos em Serviços de Saúde. São Paulo: APECIH, 2010.
Sundim M S, Riscos na reutilização de produtos médicos esterilizados em óxido de etileno. Dissertação de Mestrado em Engenharia Biomédica. Universidade Tecnológica Federal do Paraná. Curitiba, 2014, 76f..
Abdo, N. Aeração de artigos odonto-médico-hospitalares reprocessados a òxido de etileno: a prática em empresas prestadoras de serviço terceirizado. Dissertação de Mestrado. Faculdade de Ciências Médicas. Universidade Estadual de Campinas. Campinas. 2006.
Rodrigues RH, Fernández VMC, Despaigne SC, Betacourt OV. Dispositivos médicos de uso único reprocesados por esterilización química mediante óxido de etileno. Rev Cubana Hig. Epidemiol. 2002;40(2):89-94.
Shintani H. Ethylene oxide gas sterilization on medical devices. Biocontrol Science 2017;22(1):1-16.doi:10.4265/bio.22.1
Lucas Ad, Forrey C, Saylor DM, Vorvolakos K. Solvent on thermal extraction of ethylene oxide from polymeric materials: medical device considerations. J Biomed Mater Res Appl Biomater. 2018;106(6):2455-63.doi:10.1002/jbm.b.34052
Lucas AD, Merritt K, Hitchins VM, Woods TO, McNamec SG, Lyle DB. et al. Residual ethylene oxide in medical devices and device material. J Biomed Mater Res Part B: Appl Biomater 2003;66B:548-552. doi:10.1002/jbm.b.10036
Mendes GCC, Brandão RS, Silva CLM. Ethylene oxide sterilization of medical devices: a review. Am J Infect Control 2007;35:574-81.doi:10.1016/j.ajic.2006.10.014
ANSI/AAMI/ ISO 10993-7:2008(R)2012. Biological evaluation of medical devices – Part 7. Ethylene oxide sterlization residuals. AAMI: Arlington, 2012.
BRASIL. Portaria Interministerial No. 482 de 16 de abril de 1999. Aprova Regulamento Técnico contendo disposições sobre os procedimentos de instalações de Unidade de Esterilização por Óxido de Etileno e de suas misturas e seu uso. Brasília: Ministério da Saúde e Ministério do Trabalho e Emprego, 1999. Diário Oficial da União de 19 de abril de 1999.
Mendes KDS, Silveira RCCP, Galvão CM. Revisão Integrativa: método de pesquisa para a incorporação de evidências na saúde e na enfermagem. Texto Contexto Enferm 2008;17(4):758-64
Gimeno P, Auguste ML, Handlos V, Nielson AM, Schmidt S, Lassu N, et al. Identification and quantification of ethylene oxide in sterilized medical devices using multiple headspace GC/MS measurement. Journal of Pharmaceutical and Biomedical Analysis 2018:119-127. Doi:10.1016/jpba.2018.05.035
El Helaly M, Balkhy H, Vallenius L, Khan W. Occupational exposure and work practices among ethylene oxide sterilization workers. Egyption Journal of Occupational Medicine 2017; 41(2): 157-174.doi:10.21608/EJOM.2017.2849
Luttrell W, Brotherton EE. Ethylene oxide. Division of Chemical Health and Safety of The American Chemical Society. Doi:10.1016/j.jchas.2008.09.010.
Gibson C, Mattheus IP, Sanuel AH. Computerized model for accurate determination of ethylene oxide diffusion in sterilized medical supplies. Biomaterials 1989;10:343-48.doi:10.1016/O142-9612(89)90076-8
Center for Disease Control and Prevention. The National Institute for Occupational Safety and Health (NIOSH). Ethylene oxide sterilizers in helath care facilities: engeneering controls and workpractices. Atlanta: NIOSH, 1989.
Bogen KT, Sheehan PJ, Valdez Flores C, Li AA. Reevaluation of historical exposures to ethylene oxide among US sterilization workers in The National Institute of Occupational Safety and Health (NIOSH) study cohort. Int. J. Environ Res Public Health 2019; 1738.
Andrade Júnior FP, Romano TKF, Lima BTM, Souza EKM, Alves TWB, Silva IB et al. Òxido de etileno como agente esterilizante: características gerais, toxicidade e comparação com outros saneantes e métodos de esterilização. Periódico Tchê Química 2019;16(31):175-85
Mendes GC, Brandão TRS, Silva CLM. Kinetics of ethylene oxide desorption from sterilized materials. Journal of AOAC International 2013;96(1):33-36.doi:10.5740/jaocint.11-506
Santos HCO. Validação do processo de esterilização por óxido de etileno para determinar tempo de aeração em frascos enterais. Dissertação de Mestrado. Universidade Federal do Goiás. Faculdade de Farmácia. 2010.
Nakata S, Umeshita K, Ueyama H, Takashina M, Noguchi S, Murata A, et al. Aeration time following ethylene oxide sterilization for reusable rigid sterilization containers: concentration of gaseous ethylene oxide in containers. Biomedical Instrumentation & Technology. 2003;34:121-4.PMID:10820640
Anaya LPL. Óxido de etileno, utilización como agente esterilizante y riesgos para la salud del personal sanitário. CES Salud Publica 2014;5:154-162.
Boiano JM, Steege AL. Ethylene oxide and hidrogen peroxide gas plasma setrilization: precautionary practices in US Hopsitals. Zentralsterilisation (Wiesb) 2015;23(4):262-68.PMID:26594097
Steelman V M. Ethylene oxide. The importance of aeration. AORN Journal.1992;55(3):773-87.doi:10.1016/s0001-2092(07)69447-2
Rodriguez RH, Fernández CG, Despaigne SC. Análisis cuantitavo y efecto de resíduos em processos esterilización química a bajas temperaturas. Ver Cubana Invest Biomed 2006;25(2).
Hernádez-Navarrete MJ, Celorrio-Pascual JM, Moros CL, Bermad VMS. Fundamentos de antissepsia, desinfeccion y esterilización. Enfem Infec Microbiol Clin 2014;32(10):681-688.doi:10.1016/j.eimc.2014.04.003
Savaris M, Carvalho GA, Falavigna A, Santos V dos, Brandalise RN. Avaliação química e térmica da esterilização PEEK comercial e médica por óxido de etileno. Esteira. Res.2016; 19(4).
US Environmental Protection Agency. Ethylene oxide: Hospitals and healthcare facilities must use a single chamber where sterilizing medical equipment with ethylene oxide. March, 2010.
Dias FN, Ishin M, Nogaroto SL, Piccini B, Penna TCV. Sterilization of medical devices by ethylene oxide, determination of the dissipation of residues and use of green fluorescent protein as an indicator of process control. Journal of Biomedical Mater Res Part B. 2009;629-30.doi:10.1002/jbm.b.31438
Bogen KT, Sheehan PJ, Valdez-Flores C, Li AA. Reevaluation of historical exposures to ethylene oxide among US sterilization workers in The National Institute of Occupational Safety and Health (NIOSH) study cohort. Int. J. Environ Res. Public Healthy 2019;16:1738. Doi:10.3390/ijerph16101738
US Food and Drug Administration. Federal Register. 1987. 43:122;27474-2748210.
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