Challenge load validation and assembly: from theory to practice
DOI:
https://doi.org/10.5327/Z1414-4425201600040007Keywords:
Esterilização, Condensação, Qualificação profissional, Paciente.Abstract
Objectives: The need to comply with the Collegiate Board Resolution (Resolução da Diretoria Colegiada – RDC) ANVISA No. 15/2012 presented
many challenges to the Material and Sterilization Center (Centro de Material e Esterilização – CME), among which, was determining the greatest challenge
load to be used during the sterilization validation process through moist heat in the performance qualification stage Methods: This article presents technical
regulations which support this activity, as well as the result of a thorough analysis regarding a common result when there is lack of determination of the
greatest challenge load: the problems with wet loads. Results: The many materials used as health products affect the performance of sterilizers and may
compromise the sterilization process. Conclusion: Considering this scenario, the use of national and international technical regulations references, the use
of devices to challenge the process, and validation of the sterilization are essential in order to ensure the quality of this activity and avoid risks to patients.
Keywords: Sterilization. Condensation. Credentialing. Patients.
References
A gencia Nacional de Vigilância Sanitária (Brasil). Resolução da
Diretoria Colegiada nº 15, de 15 de março de 2012. Dispõe sobre
requisitos de boas práticas para o processamento de produtos
para saúde e dá outras providências. [Portaria na internet] Diário
Oficial da União 15 mar. 2012 [acesso em 10 ago. 2016]. Disponível
em: http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2012/
rdc0015_15_03_2012.html
Sandle T. Ensuring Sterility: Autoclaves, Wet Loads, and Sterility
Failures. Journal of GXP Compliance. 2015;19(2) [acesso em: 10
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ensuring-sterility-autoclaves-wet-loads-and-sterility-failures
A ssociação Brasileira de Normas Técnicas. NBR ISO 17665-1.
Esterilização de produtos para Saúde - Vapor - Parte 1: Requisitos
para o desenvolvimento, validação e controle de rotina nos processos
de esterilização de produtos para saúde. Rio de Janeiro: ABNT; 2010.
I SO/TS 17665-3. Sterilization of health care products – most care –
Part 3: Guidance on the designation of a medical device to a product
family and processing category for steam sterilization. Geneva, 2013.
A ssociação Brasileira de Normas Técnicas. NBR 16328. Esterilização de
produtos para saúde – Procedimento de ensaios para medição de temperatura,
pressão e umidade em equipamentos. Rio de Janeiro: ABNT; 2014.
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