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

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.