Single-use Medical Devices Re-processing: Risk Assessment and Quality Control Technologies / 中国医疗器械杂志

The reuse of high-cost single-use medical devices (SUD) is permitted in many countries, such as the United States, Germany and the United Kingdom, but strict regulatory requirements must be met. In addition to regulatory policies and regulations, such as market access mode and special requirements on Good Manufacture Practice (GMP), there are strict technical requirements on the potential risk control and quality assurance system. Therefore, effective risk assessment and risk control technology are the keys to ensure effective quality control and safe use of SUDs. In this article, based on analyzing the technological requirements of the national regulatory on SUDs in the United States, Germany and Britain, and combined with the review from latest relevant literature, to discuss the strategies of how to carry out scientific risk assessment. Some risk control technologies on the reuse of SUDs are introduced, which will provide support for the further study on risk control strategies and regulatory decisions for the reuse of SUDs in China.

Aprovechamiento de cromo eliminado en aguas residuales de curtiembres (San Benito, Bogotá), mediante tratamiento con sulfato de sodio / Chromium rcovereed and re-sed from tannery residual water (located in sann benito, bogotá), by treatment with sodyum sulphate

El proceso de curtido consiste en transformar la piel de ganado vacuno u otros animales, en cuero, mediante la aplicación de taninos que son sustancias de origen vegetal, o también de cromo. Este elemento es un contaminante cuya concentración máxima permisible en vertimientos industriales es de 1 mg/L, según la Resolución 1074 de 1997 del Departamento Administrativo de Medio Ambiente (DAMA), para el Distrito Capital, por la cual se establecen estándares ambientales en materia de vertimientos. Se evaluó la factibilidad técnica para recuperar y reutilizar cromo de las aguas residuales del proceso de curtido de una curtiembre en San Benito (Bogotá), precipitándolo con soda cáustica 4 M y regenerándolo con sulfato de sodio y ácido fórmico grado industrial en reemplazo de ácido sulfúrico, regulado por estupefacientes, para reutilizar la sal de cromo en el mismo proceso de curtido. Su implementación minimiza contaminación de aguas con cromo y disminuye costos de producción. Se redujo el contenido de cromo del agua residual del proceso de curtido en 99,9% desde concentraciones promedio de 2.475 mg/L hasta niveles inferiores a 1,0 mg/L, permitiendo reutilización del agua para lavado de pieles saladas que ingresan al proceso, después de tratamiento con hidroxicloruro de aluminio e hipoclorito de sodio, disminuyendo significativamente su consumo. Se determinó la calidad del cuero obtenido mediante pruebas de encogimiento y resistencia a la flexión. Los procesos de reutilización de materiales producidos como desecho en procesos de curtiembres son fundamentales en la sostenibilidad ambiental de estas industrias.

The tan processes consist in the transformation of cattle or other animal skin in leather through the application of tannins which are substances from vegetal origin, or also with chromium. This element is a pollutant which maximum allowed concentration from industrial disposal is 1 mg/L, under Resolution 1074 of 1997 from the Administrative Department of the Environment (ADE) for the Capital District which establishes environmental standards on dumping. Technical feasibility for chrome recovery and reuse of wastewater from the tanning process in a tannery in San Benito (Bogotá) was evaluated, accelerating it with 4 M caustic soda and regenerating it with sodium sulfate and formic acid (industrial grade) in place of sulfuric acid, regulated by drugs, to reuse the chromium salt in the tanning process. Its implementation minimizes water pollution with chromium and decreases production costs. Chromium content of residual water in the tanning process decreased 99.9% from average concentrations of 2,475 mg / L to levels below 1,0 mg/L, allowing reuse water for salted skins wash that start the process after treatment with aluminum chloride hydroxide and sodium hypochlorite, reducing its consumption significantly. The quality of leather obtained was determined by shrinkage tests and bending strength. Processes of materials produced reuse as waste in tan processes are fundamental to the environmental sustainability of these industries.

Study on the Management Policy Situation of the Re-use of Single-use Device at Home and Abroad / 中国药房

OBJECTIVE:To provide reference for the management of re-use of single-use devices (SUDs) in China. METH-ODS:The management situation of SUDs use in China and the management policy of SUDs re-use in America and Germany were introduced,the published literature of SUDs re-use was researched and the safety and ethicality were analyzed and discussed. RE-SULTS:China had no regulation for the clear definition of the range,standards and requirements of SUDs re-use;America and Germany had well-management for the SUDs re-use with different modes. Literature analysis showed that there were 3 results for the SUDs re-use,including supporting,opposition and classified management. In terms of safety,SUDs re-use needs the base of specific species and disinfection operations;in terms of ethicality,SUDs re-use should focus on the right to know of patients and the effects on cost savings and environment. CONCLUSIONS:China should establish and improve the management policy of SUDs re-use,develop the classification assessment of re-use,encourage third-party organizations participating in the recycling of SUDs and strengthen the monitoring of adverse reactions,etc.

Densidade de estocagem no crescimento, composição e perfil lipídico corporal do jundiá / Stocking density in growth, composition and body lipid profile of jundiá

O objetivo do trabalho foi avaliar o crescimento, a composição e o perfil lipídico corporal de jundiás criados em diferentes densidades de estocagem (DE: 4,2; 6,4; 8,6 e 10,8kg m-3) em sistema com recirculação de água. Durante 120 dias, 420 peixes (peso inicial=182,95±2,96g) foram alimentados uma vez ao dia, até a saciedade aparente, com dieta peletizada formulada. Observou-se que, quanto maior a DE utilizada, menor é o peso individual dos peixes, entretanto a biomassa por tanque aumentou (P<0,05). Melhor conversão alimentar (1,69) e maior quantidade de gordura intraperitoneal (3,92) foram observadas nos peixes submetidos à densidade 4,2kg m-3. A proteína corporal foi afetada pelas DEs. Ocorreu diminuição dos ácidos graxos saturados e aumento dos insaturados nos peixes de acordo com o aumento das DEs. Conclui-se que a densidade de estocagem influência no peso final e na produtividade por volume do jundiá.

The aim of this research was to evaluate growth and body composition of jundiá farmed at different stocking densities (SD: 4.2, 6.4, 8.6 and 10.8kg m-3) in a water re-use system. During 120 days, 420 fish were fed near to satiation once a day. It was observed that in the highest SD, the individual fish weight was lower, however the biomass per tank increased (P<0.05). The best feed conversion ratio (1.69) and intraperitoneal fat (3.92 percent) were observed in fish subjected to density of 4.2kg m-3. The body protein was affected by SD. Saturated fatty acids decreased and unsaturated fatty acids increased according to the increase of SD. It was concluded that stocking density influences the final size and yield per volume of jundiá.

Study on the Condition of Cyclic Transformation of Ethanol Distilled Wastewater by Genetic Engineering Strain TR12 / 微生物学通报

Five grams of urea and two milliliters of corn syrup were added into 1 liter ethanoldistilled wastewater with 8% solid dregs The activity of acid resistant ? amylase and glucoamylase produced by inoculated Aspergillus kawachii genetic engineering strain TR12 in the transformed liquid reached a level of 13 42U/mL and 246U/mL respectively after fermentation at 32℃ by the shaking flask for 70 hours The transformed liquid was circularly applied to the ethanol ingredient process without cooking room, not only it didn't influence the ethanol output and quality, but also it could efficiently reduce the pollution of ethanol distilled wastewater and the cost of ethanol production