Editorial
Copyright ©2012 Baishideng. All rights reserved.
World J Clin Infect Dis. Apr 25, 2012; 2(2): 13-27
Published online Apr 25, 2012. doi: 10.5495/wjcid.v2.i2.13
Medical errors, infection-control breaches and the use of adulterated and misbranded medical devices
Lawrence F Muscarella
Lawrence F Muscarella, Custom Ultrasonics, Inc., 144 Railroad Drive, Ivyland, PA 18974, United States
Author contributions: Muscarella LF solely contributed to this paper.
Supported by Custom Ultrasonics, Inc.
Correspondence to: Lawrence F Muscarella, PhD, Custom Ultrasonics, Inc., 144 Railroad Drive, Ivyland, PA 18974, United States. editor@myendosite.com
Telephone: +1-215-3648577
Received: July 12, 2011
Revised: February 25, 2012
Accepted: March 10, 2012
Published online: April 25, 2012
Abstract

Several well-publicized cases of improper cleaning, disinfection or sterilization of contaminated reusable medical equipment that posed an increased risk of patient-to-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 healthcare-associated infections.

Keywords: 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