2009 OMIG, Abstract 5

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Improper Storage / Transport Temperatures, Defective Plastic Bottles, and the Worldwide Fusarium Keratitis Epidemic of 2004-2006.
J.D. Bullock, L. Elder, R.E. Warwar
Departments of Community Health, Mathematics and Statistics, Ophthalmology, and Pathology, Wright State University Boonshoft School of Me Medicine, Dayton, OH  

Background:  In early March 2006, the first U.S. cases of ReNu-related Fusarium keratitis were reported from Newark, NJ and Dayton, OH (JDB/REW). Per a Food and Drug Administration (FDA) inspection report, Bausch & Lomb (B&L) had maintained ReNu with MoistureLoc (ReNuML) without temperature controls in their Greenville, SC plant, one four production sites for ReNuML, and the only facility to which Fusarium  keratitis cases had been traced.  Bullock et al (Arch Oph, Nov. 2008) later reported  loss of fungistatic capability of ReNuML when stored in its original plastic container at 60^oC, while boiling ReNuML in a glass tube for 10 minutes did not diminish its fungistatic properties.
Purpose: To demonstrate the effect of temperature and container properties on the ability of ReNuML to inhibit growth of Fusarium species.
Methods: The solution was divided into six aliquots and stored separately for four weeks at room temperature (RT/23^oC/73oF), 42^oC (108^oF), and 60^oC (140^oF), in both their original plastic bottles and similarly-sized glass containers, then tested in triplicate for their ability to inhibit the growth of seven Fusarium isolates previously associated with the worldwide Fusarium keratitis epidemic of 2004-06.
Results: ReNuML stored in glass containers demonstrated no fungistatic deterioration at all three temperature levels. However, in its original plastic container at 60^oC, a highly statistically significant fungistatic deterioration of the  solution  was  noted compared to those stored in the original plastic bottle at either RT (P=4.00x10^-7), 42^oC (P=2.10x10^-6), or in a glass container at 60^oC (P=1.29x10^-6).
Conclusions:  When stored in its original plastic bottle and exposed to temperature elevation, ReNuML loses its in vitro fungistatic capability. The temperature required for fungistatic failure is >42^oC and ≤60^oC. These findings, together with the FDA inspection findings of improper temperature control of B&L’s products at their Greenville, SC facility, suggest that defective plastic containers in combination with excessive storage and/or transport temperatures degraded ReNuML’s antifungal properties and may have contributed to the Fusarium keratitis epidemic of 2004-06.
Financial Disclosure:  N      Financial Support:  None