Microbiologist Discusses Best Practices For Bacterial Control on Medical Devices

ByVictoria Negron

Updated on

Microbiologist Discusses Best Practices For Bacterial Control on Medical Devices

Case Overview

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.

Questions to the Food Safety expert and their responses

Q1

Please briefly describe your work with automated endoscope reprocessors.

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.

About the expert

This highly qualified expert is a microbiologist with 27+ years of experience in his field. He earned his B.Sc. in Chemistry & Microbiology and his M.Sc. in Biochemistry from the University of Bombay before coming to the United States and completing some post-graduate coursework in Food Science and Technology at Virginia Tech. He then went on to earn his Ph.D. in Microbiology from the University of South Carolina. He joined the FDA in 1989 and served as a Microbiologist and the PulseNet Lead Scientist until eventually becoming the Chief of the Microbial Hazards Research Branch. After leaving the FDA in 2006, the expert joined the NIH. He has received 34 awards at the center, agency, or department level over the course of his career and was entrusted to present numerous high profile briefings. The expert currently works as a consultant with startups and nonprofit organizations.

Expert headshot

E-088513

Specialties:

About the author

Victoria Negron

Victoria Negron

Victoria Negron is a seasoned professional with extensive experience in journalism and thought leadership within the legal space. She specializes in crafting high-impact content, including whitepapers, webinars, and current event articles that explore the pivotal role of expert witnesses in complex litigation matters. With a robust focus on B2B product marketing and content marketing, Victoria has continually demonstrated her ability to drive effective communication strategies.

During her tenure at Expert Institute, she progressed from a Marketing Writer to Senior Content Marketing Manager, ultimately serving as the Associate Director of Content & Product Marketing. In these roles, she refined her expertise in digital marketing, search engine optimization (SEO), content strategy, and thought leadership. Her contributions have significantly enhanced the organization's content offerings and marketing initiatives, positioning the Expert Institute as a trusted resource in the legal field.

Victoria holds a Master of Business Administration (MBA) from the University of Florida - Warrington College of Business and a Bachelor of Arts (BA) in Literature, Art, and Hispanic Studies from Hamilton College.

Find an expert witness near you

What State is your case in?

What party are you representing?

background image

Subscribe to our newsletter

Join our newsletter to stay up to date on legal news, insights and product updates from Expert Institute.