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

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 ap proximately 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.