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Doctoral Thesis
DOI
https://doi.org/10.11606/T.9.2005.tde-02092013-181037
Document
Author
Full name
Alzira Maria da Silva Martins
E-mail
Institute/School/College
Knowledge Area
Date of Defense
Published
São Paulo, 2005
Supervisor
Committee
Penna, Thereza Christina Vessoni (President)
Albuquerque, Cristina Northfleet de
Kaneko, Telma Mary
Lopes, Patricia Santos
Salgado, Hérida Regina Nunes
Title in Portuguese
Reprocessamento e reutilização de cânulas de perfusão
Keywords in Portuguese
Higiene e segurança industrial
Monitorização biológica
Toxicologia industrial
Abstract in Portuguese
Os procedimentos utilizados para reprocessamento e reuso de artigos médicos de uso único não estão normalizados nem avaliados quanto a segurança. Os objetivos deste estudo foram: (i) determinar o tempo de esterilização e aeração de cânulas de perfusão em ambiente industrial; (ii) avaliar os níveis de resíduos de óxido de etileno, concentração de endotoxinas e resistência a tração de cânulas de perfusão após reprocessamento e reuso em ambiente hospitalar. No ambiente industrial as cânulas foram submetidas á esterilização com 450mg/L de 10% de óxido de etileno e 90% de CO2 por um período de 2 horas a uma temperatura de 45 a 55° C, umidade entre 30 e 90% aeração com 26 trocas de ar por hora com temperatura de 35°C. No ambiente hospitalar a cânula aramada TF 36460 foi utilizada em procedimento cirúrgico com circulação extracorpórea; lavada com água potável, desinfecção com detergente enzimático, enxague com água potável, embalada em papel grau cirúrgico e reprocessada por óxido de etileno com concentração de 500mg/L de 12% de óxido de etileno e 88% de Freon com tempo de exposição de 240 minutos, temperatura de 53°C, umidade entre 40-60% e aeração em temperatura ambiente. No ambiente industrial o tempo necessário para redução de 12 ciclos logarítmicos (SAL 10-6), foi de 120 minutos, no ambiente hospitalar foi de 240 minutos. O tempo de aeração variou de 19 a 28 horas na área industrial; e no ambiente hospitalar foi de 28 horas. No segundo reuso a cânula apresentou residual de óxido de etileno de 83,09 ppm; acima do limite especificado (≤_25ppm). Os testes de resistência a tração e determinação da concentração de endotoxinas foram realizados até o quarto reuso não apresentando resultados fora dos limites especificados. O procedimento de reuso nas condições atuais realizado em ambiente hospitalar foi reprovado, pois não atendeu aos requisitos de residual de óxido de etileno descritos na portaria Brasileira Interministerial n° 482.
Title in English
Reprocessing and reuse of perfusion cannulas
Keywords in English
Biological monitoring
Industrial hygiene and safety
Industrial Toxicology
Abstract in English
The procedures used during reprocessing of disposables have not been normalized, nor assessed for safety. The objective of this study is to assess sterility, residual rate of ethylene oxide, pyrogenicity and resistance to traction results observed in perfusion cannulas after the sterilization process in industrial environments and after reprocessing and reuse in the hospital environment. In the industrial environment, the cannulas were submitted to sterilization with 450mg/L of EtO and 90% of CO2 during a period of 2 hours and at a temperature of 45-55°C, humidity ranging from 30 to 90% and aeration of 26 air changes per hour at a temperature of 35°C. For the hospital environment, we selected the TF 36460 wired cannula, and after using it on a surgical procedure with extracorporeal circulation, it was washed with clean water, disinfected with enzymatic detergent, rinsed with clean water, wrapped in surgical paper and reprocessed in 500mg/L ethylene oxide of 12% EtO and 88% Freon and exposed for 240 minutes at a temperature of 53°C, humidity ranging from 40 to 60% and aeration at room temperature. In the industrial environment, the time needed for decreasing 12 logarithm cycles (10-6) was 120 minutes, while in the hospital environment it was 240 minutes. The aeration time ranged between 19 and 28 hours in the industrial area, while in the hospital environment it took 28 hours. In the second reuse the cannula presented residual of ethylene oxide of 83,09 ppm; above of the specified limit (≤25_ppm). The physical test and endotoxins concentration had been carried through until for reuse not presented results out of specified. The currently procedure of reuse in the hospital is disapproved therefore does not take care of the limits of ethylene oxide residues, recommended by Interministerial Brazilian regulation 482.
 
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Publishing Date
2013-09-02
 
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