Microbiological evaluation of the steam sterilization of assembled laparoscopic instruments.

Objective: assess the safety of steam sterilization of assembled laparoscopic instruments with challenge contamination. Method: a laboratory experimental study, using as test samples trocars and laparoscopic graspers. Geobacillus stearothermophillus ATCC-7953 was used, with a microbial population of 106UFC/Filter paper substrate, removed from the biological indicator. Three of them were introduced into each instrument at the time of assembly, and sterilized at pressurized saturated steam, 134oC for 5 minutes. After sterilization, the instrument was disassembled and each filter paper substrate was inoculated in soybean casein culture and incubated at 56oC for 21 days. In case of absence of growth, they were subjected to heat shock of 80oC, for 20 minutes and re-incubated for 72 hours. Sample size: 185 graspers and 185 trocars, with 95% power. We paired the experiments with comparative negative control groups (5 graspers and 5 trocars with challenge contamination, sterilized disassembled) and positive control (30 filter paper supports, unsterilized), subject to the same incubation procedures. Results: there was no microbial growth in experimental and negative control. The results of the positive control were satisfactory. Conclusion: this study provided strong scientific evidence to support the safety of steam sterilizing of the assembled laparoscopic instrument.

Microbiological evaluation of the steam sterilization of assembled laparoscopic instruments / Avaliação microbiológica da esterilização a vapor do instrumental laparoscópico montado / Evaluación microbiológica de la esterilización a vapor de instrumental laparoscópico montado

ABSTRACT Objective: assess the safety of steam sterilization of assembled laparoscopic instruments with challenge contamination. Method: a laboratory experimental study, using as test samples trocars and laparoscopic graspers. Geobacillus stearothermophillus ATCC-7953 was used, with a microbial population of 106UFC/Filter paper substrate, removed from the biological indicator. Three of them were introduced into each instrument at the time of assembly, and sterilized at pressurized saturated steam, 134oC for 5 minutes. After sterilization, the instrument was disassembled and each filter paper substrate was inoculated in soybean casein culture and incubated at 56oC for 21 days. In case of absence of growth, they were subjected to heat shock of 80oC, for 20 minutes and re-incubated for 72 hours. Sample size: 185 graspers and 185 trocars, with 95% power. We paired the experiments with comparative negative control groups (5 graspers and 5 trocars with challenge contamination, sterilized disassembled) and positive control (30 filter paper supports, unsterilized), subject to the same incubation procedures. Results: there was no microbial growth in experimental and negative control. The results of the positive control were satisfactory. Conclusion: this study provided strong scientific evidence to support the safety of steam sterilizing of the assembled laparoscopic instrument.

RESUMO Objetivo: avaliar a segurança da esterilização a vapor, do instrumental laparoscópico montado com desafio da contaminação. Método: estudo experimental laboratorial, cujo corpo de prova foram trocarte e pinça laparoscópica. Utilizou-se esporos Geobacillus stearothermophillus ATCC-7953, com população microbiana de 106UFC/suporte de papel filtro, removidos do indicador biológico. Três deles foram introduzidos no interior de cada instrumento, no momento da montagem, sendo esterilizados a vapor saturado sob pressão, 134oC por 5 minutos. Depois da esterilização, o instrumental foi desmontado, e cada suporte de papel filtro foi inoculado em meio de cultura de caseína soja, incubado a 56oC por 21 dias. Não havendo crescimento, foram submetidos a um choque térmico de 80oC, por 20 minutos e reincubados por 72 horas. Tamanho da amostra, 185 pinças e 185 trocartes, com poder de 95%. Os experimentos foram acompanhados dos grupos controle negativo comparativo (5 pinças e 5 trocartes com contaminação desafio, esterilizados desmontados) e positivo (30 suportes de papel filtro, não esterilizados), submetidos aos mesmos procedimentos de incubação. Resultados: não houve nenhum crescimento microbiano nos grupos experimental e controle negativo. Os resultados do controle positivo foram satisfatórios. Conclusão: este estudo forneceu fortes evidências científicas para sustentar a segurança da prática de esterilização a vapor do instrumental laparoscópico montado.

RESUMEN Objetivo: evaluar la seguridad de la esterilización a través de vapor, de instrumental laparoscópico previamente montado con desafío de contaminación. Método: estudio experimental en laboratorio, cuyo cuerpo de prueba fueron trócarte y pinza laparoscópica. Se utilizó esporas Geobacillus stearothermophilus ATCC-7953, con población microbiana de 106UFC/soporte de papel filtro, removidos del indicador biológico. Tres de ellos fueron introducidos en el interior de cada instrumento, en el momento del montaje, los que fueron esterilizados a vapor saturado bajo presión, 134oC por 5 minutos. Después de la esterilización, el instrumental fue desmontado y cada soporte de papel filtro fue inoculado en medio de una cultura de caseína y soya, incubado a 56oC por 21 días. No habiendo crecimiento, fueron sometidos a un choque térmico de 80oC, por 20 minutos y nuevamente incubados por 72 horas. La muestra estuvo constituida por 185 pinzas y 185 trócartes, con poder de 95%. Los experimentos fueron acompañados en los grupos: control negativo comparativo (5 pinzas y 5 trócartes con contaminación desafío, esterilizados desmontados) y positivo (30 soportes de papel filtro, no esterilizados), sometidos a los mismos procedimientos de incubación. Resultados: no se encontró crecimiento microbiano en los grupos experimental y control negativo. Los resultados del control positivo fueron satisfactorios. Conclusión: este estudio suministra fuertes evidencias científicas para sustentar que la práctica, de esterilización a vapor del instrumental laparoscópico montado, es segura.

A review of 130 humans enrolled in transgastric NOTES protocols at a single institution.

BACKGROUND: The methodology of Natural Orifice Translumenal Endoscopic Surgery (NOTES) has been validated in both human and animal models. Herein is a discussion of our experience gained from the initial 130 patients enrolled in transgastric pre-NOTES and NOTES protocols at our institution. METHODS: A retrospective review of our research database was performed for all patients enrolled in NOTES protocols. The infectious risk of a gastrotomy with and without a NOTES procedure was assessed in 100 patients. Eighty patients completed a true NOTES protocol looking at staging, access, and insufflation with select patients evaluating the potential for bacterial contamination of the abdominal compartment. RESULTS: A total of 130 patients have completed pre-NOTES and NOTES protocols at our institution. We observed no clinically significant contamination of the abdomen secondary to transgastric procedures in 100 patients. Diagnostic transgastric endoscopic peritoneoscopy (DTEP) was completed in 20 patients with pancreatic head masses and found to have a 95% concordance with laparoscopic exploration for assessment of peritoneal metastases. Blind endoscopic gastrotomy and DTEP were evaluated in 40 patients who underwent laparoscopic Roux-en-Y gastric bypass procedures (LSRYGB) and were found to be safe, reliable, and without a clinically significant risk of contamination. Endoscopic peritoneal insufflation was successfully established and correlated with standard laparoscopic insufflation in 20 patients. CONCLUSIONS: Transgastric NOTES is a safe alternative approach to accessing the peritoneal cavity in humans. The risk of bacterial contamination secondary to peroral and transgastric access is clinically insignificant. A device for the facile closure of the gastric defect is the sole factor limiting institution of this methodology as a standalone technique.

Carga microbiana de trocartes reprocessáveis após laparoscopias ginecológicas / Microbial load of reprocessable trocars after gynecological videolaparoscopy

OBJETIVO: identificar a carga microbiana presente em trocartes reprocessáveis usados nas laparoscopias ginecológicas. MÉTODOS: estudo exploratório descritivo. Um total de 57 trocartes, sendo 30 com 10 mm de diâmetro e 27 com 5 mm, foram recolhidos na sala de operação, imediatamente após o ato cirúrgico, e colocados em recipiente esterilizado onde foram adicionados 250 mL de água destilada estéril. Foi feita agitação dos trocartes para desprendimento de partículas e obtenção do lavado a ser analisado. Realizou-se filtração por meio de membrana de celulose 0,22 µm, colocadas, com pinça esterilizada, em placas ágar sangue. Após incubação, foi feita a análise microbiológica para contagem de unidades formadoras de colônias e posterior identificação do micro-organismo, usando-se técnicas laboratoriais padronizadas. RESULTADOS: a carga microbiana foi recuperada em 47,4 por cento dos trocartes analisados. Destes, 45,6 por cento apresentou crescimento de 1 a 100 unidades formadoras de colônias. Foram identificados 14 tipos de micro-organismos, dentre os quais, Staphylococcus coagulase negativo (28 por cento) e Bacillus sp (21 por cento) foram isolados com maior frequência. Identificou-se também Aeromonas hydrophila, Alcaligenes sp, Candida parapsilosis e enterobactérias. CONCLUSÕES: o estudo demonstrou que o desafio microbiano enfrentado pelos operadores responsáveis pela limpeza e esterilização dos trocartes é baixo quando comparado com o desafio imposto pelos indicadores biológicos; no entanto, não se pode inferir que os riscos de complicações infecciosas sejam mínimos para pacientes.

PURPOSE: to identify the microbial charge present in reusable trocars used in gynecological laparoscopies. METHODS: a descriptive exploratory study. An amount of 57 trocars, 30 with 10 mm of diameter and 27 with 5 mm, have been collected from the surgical unit, immediately after the surgery and placed in a sterilized recipient, in which 250 mL of sterile distilled water was added. Then, the trocars were agitated for the drainage of particles and to obtain a wash-out fluid to be analyzed. After being filtered through 0.22 µm cellulose membrane, the residue was placed on blood agar plates with a sterilized forceps. Following incubation, microbiological analysis has been done to count the number of colonies and further identify the microorganisms, using standard laboratorial techniques. RESULTS: microbial charge was recovered from 47.4 percent of the trocars analyzed. Among those, 45.6 percent presented 1 to 100 growing colonies. Fourteen types of microorganisms have been identified, among which the more frequently isolated were coagulase-negative Staphylococcus (28 percent) and Bacillus sp (21 percent), Aeromonas hydrophila, Alcaligenes sp, Candida parapsilosis, and enterobacteries were also identified. CONCLUSIONS: the study has demonstrated that the microbial challenge faced by the technician responsible for the cleaning and sterilization of trocars is low, as compared to the challenge imposed by biological markers. Nevertheless, it may be not inferred that the risks for infectious complications for patients are minimal.

[Microbial load of reprocessable trocars after gynecological videolaparoscopy]. / Carga microbiana de trocartes reprocessáveis após laparoscopias ginecológicas.

PURPOSE: to identify the microbial charge present in reusable trocars used in gynecological laparoscopies. METHODS: a descriptive exploratory study. An amount of 57 trocars, 30 with 10 mm of diameter and 27 with 5 mm, have been collected from the surgical unit, immediately after the surgery and placed in a sterilized recipient, in which 250 mL of sterile distilled water was added. Then, the trocars were agitated for the drainage of particles and to obtain a wash-out fluid to be analyzed. After being filtered through 0.22 microm cellulose membrane, the residue was placed on blood agar plates with a sterilized forceps. Following incubation, microbiological analysis has been done to count the number of colonies and further identify the microorganisms, using standard laboratorial techniques. RESULTS: microbial charge was recovered from 47.4% of the trocars analyzed. Among those, 45.6% presented 1 to 100 growing colonies. Fourteen types of microorganisms have been identified, among which the more frequently isolated were coagulase-negative Staphylococcus (28%) and Bacillus sp (21%), Aeromonas hydrophila, Alcaligenes sp, Candida parapsilosis, and enterobacteries were also identified. CONCLUSIONS: the study has demonstrated that the microbial challenge faced by the technician responsible for the cleaning and sterilization of trocars is low, as compared to the challenge imposed by biological markers. Nevertheless, it may be not inferred that the risks for infectious complications for patients are minimal.