Methods: A 12 month retrospective review of donor corneal rim cultures was performed from July 2015 to July 2016, with continual prospective monitoring of donor corneal rim cultures. The protocols used to prepare corneal donor tissues were reviewed. The standard protocol included flooding the tissue with povidone iodine followed by rinsing with a sterile saline solution and then placement in a sterile container with Opitsol GS (a preservative solution with gentamycin and streptomycin). The sterile saline rinse that was normally used for processing had been on back order and had been replaced with an alternative brand from March 2016-July 2016. Unopened bottles of the alternative brand of sterile saline fluid and Optisol GS were sent to an outside lab for bacterial culture and remaining product was temporarily quarantined.
Results: Microbiology review revealed seven donor corneal rim cultures positive for NLF gram negative bacilli from May to July 2016. Organisms isolated from the donor corneal rim tissue included Achromobacter xylosoxidans (4), Burkholderia cepacia (3), Stenotrophomonas maltophilia (2) and Elizabethkingia meningoseptica (1). Sterility cultures of Opitsol GS demonstrated no growth. Sterility cultures of the sterile saline rinse grew gram positive and gram negative bacteria from all samples. A FDA MedWatch was submitted in July 2016, and on September 6, 2016 a FDA recall notice was published. The quarantined saline was permanently removed. No clinical infections associated with the positive donor corneal rim cultures were identified.
Conclusion: Microbiologists are the front line for IC surveillance. Close partnership between the IC team and the microbiology lab can help identify potential outbreaks by alerting them of the growth of atypical organisms or clusters.
L. Pisney, None
M. Barron, None