Several well-publicized cases of improper cleaning,disinfection or sterilization of contaminated reusable medical equipment that posed an increased risk of patientto-patient disease transmission were reported within t...Several well-publicized cases of improper cleaning,disinfection or sterilization of contaminated reusable medical equipment that posed an increased risk of patientto-patient disease transmission were reported within the past few years,resulting in the notification of approximately 20 000 patients.These medical errors,the specific infection-control standards they breached,and assessments of the risk of infection associated with each are discussed.Other topics discussed include the Food and Drug Administration’s(FDA)regulation of medical devices and infection-control products;the use of adulterated,misbranded,and investigational devices;consent decrees and associated Certificates of Medical Necessity;and informed patient consent.Focus is placed on liquid chemical sterilization,its history,and the FDA’s recent censure and discontinuation of a medical device labeled with this claim,namely,the STERIS System 1 processor.Recommendations are provided for healthcare facilities,regulatory agencies,manufacturers of reusable medical devices,and professional healthcare organizations and administrations to improve public health and prevent healthcareassociated infections.展开更多
基金2023年度教育部人文社会科学研究青年基金项目(23YJCZH303):交通和用地协同发展背景下城市轨道站域传染病传播的影响机制和风险识别研究世界银行全球环境基金GEF国际合作项目(7204890):Consultancy for Summary Reports and Multimedia Dissemination for GEF6 China SCIAP Project(TOD中国可持续城市发展试点项目总结报告)中国博士后科学基金面上资助项目(2020M680332):基于复杂适应系统理论的城市适灾景观勘测模型与规划响应研究。
文摘Several well-publicized cases of improper cleaning,disinfection or sterilization of contaminated reusable medical equipment that posed an increased risk of patientto-patient disease transmission were reported within the past few years,resulting in the notification of approximately 20 000 patients.These medical errors,the specific infection-control standards they breached,and assessments of the risk of infection associated with each are discussed.Other topics discussed include the Food and Drug Administration’s(FDA)regulation of medical devices and infection-control products;the use of adulterated,misbranded,and investigational devices;consent decrees and associated Certificates of Medical Necessity;and informed patient consent.Focus is placed on liquid chemical sterilization,its history,and the FDA’s recent censure and discontinuation of a medical device labeled with this claim,namely,the STERIS System 1 processor.Recommendations are provided for healthcare facilities,regulatory agencies,manufacturers of reusable medical devices,and professional healthcare organizations and administrations to improve public health and prevent healthcareassociated infections.
