VALIDATION OF SEALING PROCESS FOR MEDICAL DEVICES REPROCESSED IN CENTRALSUPPLIES STERILIZATION DEPARTMENTS
Keywords:
Validation Studies, Service lndicators, Equipment and Hospital Supplies, Sterilization.Abstract
Due to the complexity and need to establish routines and standard operational procedures, which are linked from the cleaning to the storage of medical devices in Central Supplies, the sealing process validation seems to be something not known and in some way an act that goes unnoticed.In this scenario, the present article aims to provide aguideline for nurses in sterilization centers regarding the knowledge of packaging validation process andobtaining a simplified guide for sealing validation of sterilized materiais. It was realized from experience report, combined with literature review. The disclosure of serie ISO 11607 from international Organization for Standardization (Packaging for terminally sterilized medical devices) and its main guide lines, as well asexpected results and orientation are outlined and detailed in this review.References
WoIf H. Safety through packaging: packing pro-cess trends in CSSD. Zentral Sterilisation. CentralServices [serial on the Internet] 2002 [cited 2011 Jul07];1 0(suppl.2):38-40. Available from: http:Ilwww.hawo.com/documents/Publications/hmhawoju-bilaeum_zsen.pdf
Carter A, Jones A, Wiese K, Johmann A, Ludtke-Handjery H C, Kiebling T, et ai. Guideline for thevalidation of the sealing process according to DINEN ISO 11607-2, revision 01, july 2008: foreword tothe guideline [Internet]. [cited 2011 JuI 07]. Availablefrom: http:!/www.wfhss.com/html/educ/recommen-dations/sealing-process-validation-guideline_en.pdf
International Organization for Standardization.ISO 11607-2:2006: packaging for terminally sterilizedmedical devices. Part 2 - Validation requirements forforming, sealing and assembly processes [Internet].[cited 2011 Jul 07] Available from: http:/!www.iso.org/iso/isocatalogue/cataloguetc/cataloguedetail.htm?csnumber=3871 3
Polit DF, Beck CT. Fundamentos da pesquisa emenfermagem: avaliação de evidências para a prá-tica de enfermagem. 7a ed. Porto Alegre: Artmed;2011.
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