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Environmental exposure scenario for reagents used in in-vitro diagnostics.
Water Research ( IF 11.4 ) Pub Date : 2020-01-23 , DOI: 10.1016/j.watres.2020.115521 Véronique Stark-Rogel 1 , Karina Urmann 2 , Amandine Courdouan Merz 2 , Jan Backmann 1
Water Research ( IF 11.4 ) Pub Date : 2020-01-23 , DOI: 10.1016/j.watres.2020.115521 Véronique Stark-Rogel 1 , Karina Urmann 2 , Amandine Courdouan Merz 2 , Jan Backmann 1
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In-vitro diagnostic assays involve various substances that may be released into the environment via a sewage treatment plant if the effluent from diagnostic instruments is discharged into the drains. Because the release of liquid waste into the public sewer system is regulated at national and/or local levels, a risk assessment per site should be performed to determine whether the release of the effluent from in-vitro diagnostic equipment is compliant with applicable regulations. To facilitate the assessment, we developed a screening tool to generate exposure scenarios for chemical substances used in in-vitro diagnostic assays. This screening tool helps in determining a) whether release of the effluent into the sewer system would be allowed from a regulatory point of view and b) whether such release would result in potential risks to surface water. The screening tool is based on conditions encountered at typical usage sites in Switzerland and Germany, with the option to adapt them to other local settings. In addition, measured analytical results of liquid waste together with typical operational parameters of diagnostic equipment were defined as default input parameters. The resulting concentrations in liquid waste and predicted environmental concentrations (PEC) are compared with regulatory limit values for release into the sewer system and predicted no-effect concentrations (PNEC) for surface water for risk estimation. The functioning of the presented screening tool is demonstrated by two assessments performed for fictitious but typical hospitals in Switzerland and Germany. It identified substances that cause potential concern for which a more advanced assessment is required.
中文翻译：
体外诊断中使用的试剂的环境暴露场景。
体外诊断测定涉及各种物质，如果诊断仪器产生的废水排放到排水管中，则这些物质可能会通过污水处理厂释放到环境中。由于液体废物向公共下水道系统的排放是在国家和/或地方级别进行监管的，因此应对每个站点进行风险评估，以确定从体外诊断设备中排放的废水是否符合适用法规。为了促进评估，我们开发了一种筛选工具，以生成体外诊断测定中所用化学物质的暴露场景。该筛查工具有助于确定a）从监管角度看是否允许将污水排放到下水道系统中，以及b）这种排放是否会对地表水造成潜在的风险。筛选工具基于在瑞士和德国的典型使用场所遇到的条件，并可以选择使其适应其他本地设置。此外，将液体废物的测量分析结果以及诊断设备的典型操作参数定义为默认输入参数。将液体废物中的最终浓度和预测的环境浓度（PEC）与排放到下水道系统的法规限值和地表水的预测无影响浓度（PNEC）进行风险评估。通过对瑞士和德国的虚拟医院和典型医院进行的两次评估，证明了所提供的筛查工具的功能。它确定了引起潜在关注的物质，需要对其进行更高级的评估。
更新日期：2020-01-23
中文翻译：
体外诊断中使用的试剂的环境暴露场景。
体外诊断测定涉及各种物质，如果诊断仪器产生的废水排放到排水管中，则这些物质可能会通过污水处理厂释放到环境中。由于液体废物向公共下水道系统的排放是在国家和/或地方级别进行监管的，因此应对每个站点进行风险评估，以确定从体外诊断设备中排放的废水是否符合适用法规。为了促进评估，我们开发了一种筛选工具，以生成体外诊断测定中所用化学物质的暴露场景。该筛查工具有助于确定a）从监管角度看是否允许将污水排放到下水道系统中，以及b）这种排放是否会对地表水造成潜在的风险。筛选工具基于在瑞士和德国的典型使用场所遇到的条件，并可以选择使其适应其他本地设置。此外，将液体废物的测量分析结果以及诊断设备的典型操作参数定义为默认输入参数。将液体废物中的最终浓度和预测的环境浓度（PEC）与排放到下水道系统的法规限值和地表水的预测无影响浓度（PNEC）进行风险评估。通过对瑞士和德国的虚拟医院和典型医院进行的两次评估，证明了所提供的筛查工具的功能。它确定了引起潜在关注的物质，需要对其进行更高级的评估。
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