Microbiologist Discusses Best Practices For Bacterial Control on Medical Devices

This case involves a middle-aged male patient who suffered complications following gallbladder surgery. The patient required an endoscopic retrograde cholangio-pancreatography (ERCP) to determine proper treatment course. Within days of receiving the ERCP, the patient became infected with E. Coli. A microbiologist familiar with biofilm prevention, multi-drug resistant organism outbreaks, and with a working knowledge of automated endoscope reprocessors was sought to discuss best practices for infection control.

Question(s) For Expert Witness

1. Please briefly describe your work with automated endoscope reprocessors.

Expert Witness Response E-088513

I am well qualified to serve as an expert on biofilms, medical equipment disinfection, and tracing infection sources using molecular epidemiological tools. I conducted research at the FDA on mixed-species biofilm and served as a reviewer of food additive petitions filed before the FDA for 6 years. The approximately 60 petitions I reviewed all dealt with the use of antimicrobial agents to control microbes in foods, on food processing machinery, in poultry chiller tanks, and clean-in-place disinfections. I was often called on by the petitioner to help them design the experiments to generate the data needed for the FDA to grant them approval for the intended use. I worked closely with FDA's general counsel and was prepped to serve as the agency's expert witness on compliance actions initiated against companies implicated in foodborne illnesses. I also served as the lead scientist for a national network of public health and food regulatory laboratories at the FDA for 13 years. In this capacity, I was involved with the outbreak analyses and traceback efforts of a number of pathogens, including pathogenic E. coli strains. During my years as a senior program officer at a major medical research center, I dealt extensively with research projects on multi-drug resistant organisms and nosocomial infections. I have received multiple awards for teaching and training from the Department of Health and Human Services, the FDA, and the Department of Agriculture. I have published on this topic and was invited to present findings at an international microbiology conference.