Panel Discussion

An outbreak of fungal meningitis and other infections during late 2012 and early 2013 occurred due to injection of a contaminated product, distributed widely throughout the United States, into more than ten thousand patients. The primary pathogen identified, Exserohilum rostratum, had been rarely described previously as a human pathogen. Due to the serious nature of fungal meningitis, the response, once the contaminated product was identified, had to be rapid and to reach all exposed persons. In addition, CDC, FDA, and state partners needed to ensure that only one product was contaminated and causing disease, and generate clinical guidelines in real-time based on limited data for a previously rarely-reported infection. At CDC, the Emergency Operations Center was activated to facilitate the variety of actions required to effectively respond. The teams responding to the outbreak elected to collect case reports from anyone ill who was exposed to any product from the implicated company, work with FDA to test multiple products, collaborate with multiple groups to ensure direct contact of all exposed persons, and collect available clinical data to develop treatment guidelines. Each of these required extensive collaboration on a scale previously unfamiliar to most people staffing the outbreak. The scope and nature of the response were different from other outbreaks, and multiple lessons were learned that could be applied to similar large outbreaks in the future.

Session Objectives: Session Objectives: Attendees will gain an understanding of: 1. How CDC, FDA, and state partners interface to approach outbreaks, and the tools available at each level to facilitate outbreak response and regulate medical products 2. Challenges in decision-making during such a response, such as determining how to treat people with suspect infection without a good diagnostic test, and how to balance the risk of treatment with the risk of infection sequelae 3. Lessons learned with regard to communication with the public, effective data collection and dissemination, and statistical needs to demonstrate important epidemiologic metrics such as attack rates