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Patient Safety Alert - Report of Contaminated Organ Preservation Solution


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Stephanie Pouch, MD
The Ohio State University
Columbus, OH, USA
Stephanie.Pouch@osumc.edu



he Centers for Disease Control (CDC), Healthcare Resources and Services Administration (HRSA), Food and Drug Administration (FDA), and the Iowa Department of Public Health (IDPH) are actively investigating a report of bacterial contamination of the organ preservation solution, SPS-1, produced by Organ Recovery Systems (ORS). On December 12, 2016, surgeons observed a foul odor emanating from the organ preservation solution. The CDC and IDPH were notified on December 14, 2016, and samples of SPS-1 from several opened bags grew Pantoea agglomerans, Enterococcus casseliflavus, and Streptococcus mitis/oralis group. The bags with microbial growth were reported from two lots of SPS-1, PBR-0074-330 (expiration 07/01/2018) and PBR-0060-392 (expiration 06/01/2018), and ORS has recalled both lots. All organ procurement organizations (OPOs) and transplant centers need to be aware of the potentially contaminated solution. SPS-1 from the aforementioned lots should not be utilized, and centers have been instructed to recover and return any unused product to ORS.

At present, there have been no known adverse events among patients who received organs treated with the affected SPS-1 lots; however, such patients require close monitoring. Any quality issues or post-transplant adverse events must be reported to local or state health authorities and the FDA's Adverse Event Reporting Program (www.fda.gov), and the Organ Procurement and Transplantation Network (reports may be filed under the Disease Transmissions section of the Improving Patient Safety portal in UNet).

The impact of contaminated organ preservation solution is not entirely clear. However, previous studies suggest that contamination rates range from 27.9% to 38.7% and that infection due to preservation solution contaminants is rare, likely due to the use of perioperative antimicrobial prophylaxis [1-3]. Nonetheless, a malodorous product labelled as sterile must be considered microbiologically contaminated. As illustrated in the current alert, this must trigger an abundance of caution and prompt microbiological testing, evaluation for the mechanism of contamination, close clinical monitoring, and rapid reporting to the appropriate agencies, the manufacturer, and other OPOs and transplant centers. ■

Disclosure Statement: The author has no conflicts of interest to disclose.


References:

  1. Mattana AM, Marra AR, Machado AM, et al. Evaluation of the presence of microorganisms in solid-organ preservation solution. Braz J Infect Dis 2011; 15(6): 528-32.
  2. Audet M, Piardi T, Panaro F, et al. Incidence and clinical significance of bacterial and fungal contamination of the preservation solution in liver transplantation. Transpl Infect Dis 2011; 13: 84-8.
  3. Veroux M, Corona D, Scriffignano V, et al. Contamination of preservation fluid in kidney transplantation: single-center analysis. Transplant Proc 2010; 42(4): 1043-5.



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