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.