Medical errors,infection-control breaches and the use of adulterated and misbranded medical devices

• 作者: Lawrence F Muscarella
• 来源期刊: 世界临床传染病学杂志
• 学科: 医学
• 关键词: INFECTION CONTROL STERILIZATION Disinfection DISEASE NOTIFICATION Infectious DISEASE transmission Communicable DISEASE CONTROL Decontamination Medical errors Government regulation Equipment and supplies hospital ASEPTIC technique Liquid chemical STERILIZATION
• 年，卷（期）: sjlccrbxzz,（2）
• 页码范围: 13-27
• 页数: 15页
• 分类号: R

摘要

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.