Suggestions for Additional Qualifying Pathogens Sample Clauses

Suggestions for Additional Qualifying Pathogens. (Comment 15) Bacteroides, Fusobacterium, and Prevotella Species One comment suggested adding Bacteroides, Fusobacterium, and Prevotella species to the list of qualifying pathogens. (Response) For the reasons that follow, FDA will not add these species to the list of qualifying pathogens. A discussion of these three bacterial pathogens is provided together for the following reasons: (1) These bacterial pathogens are representative of a group of medically-important gram-negative anaerobic rods (see Ref. 7 at pp. 3111– 3120) and (2) common taxonomic characteristics (Ref. 8 at pp. 179–194). These bacterial pathogens are commonly found in the mucous membranes (Ref. 9), particularly in the mouth (Bacteroides, Fusobacterium, and Prevotella), intestines (Bacteroides), and female urogenital tract (Bacteroides, Fusobacterium, and Prevotella) (Ref. 7 at p. 3112). Each of these bacterial pathogens can cause the same infectious diseases and are often implicated in odontogenic infections (particularly for those with poor dental hygiene or periodontal disease, as these bacteria populate dental plaque), peritonsilar infections, and polymicrobial abdominal infections, among others. Particularly when introduced into compromised tissue (e.g., via a wound or break in mucous membranes), these pathogens can cause abscesses that may require drainage or debridement in addition to antimicrobial therapy (Ref. 7 at p. 3117). Infection prevention is often the focus for these pathogens—either via ‘‘avoiding conditions that reduce the redox potential of the tissues’’ or preventing the bacteria from entering wounds, often by administering prophylactic antimicrobial agents prior to surgery or dental work (Ref. 9). In general, infections from these pathogens are not transmitted from one person to another or acquired from the environment, but rather occur from a person’s own mucosal flora (id.). These infections, once established, are generally able to be treated successfully with surgical incision and drainage as well as administration of antimicrobial agents and treatment of underlying comorbid conditions (Ref. 7 at pp. 3111–3119 and Ref. 10). There have been reports of increases in the incidence of bacteremia caused by anaerobic pathogens (a classification that includes Bacteroides, Fusarium, and Prevotella species) (Ref. 11). However, these increases appear more likely to reflect the complex patient populations studied (id. at p. 898) rather than, for example, underlying changes in the...