输液泵产品说明书存在的若干问题和风险分析

Some Problems and Risk Analysis of Infusion Pump Instructions

目的分析输液泵使用说明书中存在的问题,保障临床使用安全。方法对所获取的10个输液泵产品说明书的适用范围、使用的输液器要求、清洁维护保养方法和周期、电池使用情况和产品使用期限等内容进行比对、分析。结果10个产品说明书中有5个产品的说明书未阐述输液泵禁忌症,9个说明书有相应输液器推荐,1个产品仅提供了输液器管壁厚薄范围;清洁维护保养方面,9个产品明确了清洁保养的方法,但清洁产品存在不同,且清洁周期从2个月到12个月不等。结论建议企业完善产品使用说明书,保障输液泵产品使用安全。

Objective 10 instructions of infusion pumps were contrasted and analyzed in order to explore the problems of instructions,furthermore improve the product safety.Methods Analyzed the scopes of application,requirements of infusion apparatus,maintenance methods and cycles,battery maintenance,and service life,etc.Results There were 5 products in 10 which did not indicate contraindications.One product only provided the thickness range of the tube wall of the infusion apparatus instead of specific brands.The cleaning cycles of 9 products varied from 2 to 12 months.One product did not clarify the service life.Conclusion It is recommended that manufactures should improve the product instructions to ensure the safety of infusion pumps.