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lüll Root cause analysis of the fusarium keratitis epidemic of 2004-2006 and prescriptions for preventing future epidemics Bullock JDTrans Am Ophthalmol Soc 2009[Dec]; 107 (ä): 194-204PURPOSE: A root cause analysis of the Fusarium keratitis epidemic of 2004-2006 was performed. METHODS: Three US Food and Drug Administration (FDA) documents were analyzed. Poisson and case-control studies were performed on outbreak data from Singapore. Irreversible thermochromic labels were applied to cartons of contact lens solution bottles, which were then subjected to elevated temperatures. RESULTS: The 1997 FDA guidance document concerning storage temperatures of contact lens care products predicted temperature-related solution instability. Bausch & Lomb (B&L) requested FDA approval for ReNu with MoistureLoc, claiming that it was substantially equivalent to other products. FDA Form 483 stated that cases of ReNu-related Fusarium keratitis from Asia had not been reported, the removal of the product from the Asian markets was unreported, and B&L had not performed biocidal testing on samples associated with Asian cases. The outbreak in Singapore could have been recognized after only 3 cases (Pr = .0067). The cause of the Singapore outbreak could have been determined after the recognition of only 3 (P = .0429), 5 (95% confidence interval [CI], 1.15-126.0), or 15 cases (95% CI, 1.60-14.1). Thermochromic labels can irreversibly change color when exposed to elevated temperatures, thus warning of potential antimicrobial failure. CONCLUSIONS: The worldwide Fusarium keratitis epidemic of 2004-2006 could, theoretically, have been prevented entirely, recognized much earlier, or mitigated by much more rigorous oversight by the FDA, by strict adherence by B&L to FDA guidelines and requirements, by the application of basic statistical methods, and/or by the use of temperature indication technology. The lessons learned from a root cause analysis of this pharmacologic catastrophy may help avert or mitigate future epidemics.|*Fusarium[MESH]|*Mycoses[MESH]|Asia/epidemiology[MESH]|Contact Lens Solutions/*adverse effects[MESH]|Disease Outbreaks/*prevention & control[MESH]|Drug Stability[MESH]|Drug Storage[MESH]|Global Health[MESH]|Guideline Adherence[MESH]|Hot Temperature/adverse effects[MESH]|Humans[MESH]|Keratitis/chemically induced/*epidemiology/*microbiology[MESH]|Primary Prevention/*methods[MESH]|Statistics as Topic/methods[MESH]|United States Food and Drug Administration[MESH]|United States/epidemiology[MESH] |