The Food and Drug Administration (FDA) is warning health care providers involved with organ and tissue transplantation, patients considering organ or tissue transplantation, and recipients of organs or tissues that a preservation solution manufactured by Organ Recovery Systems Inc., may be contaminated with an antibiotic-resistant bacteria that can cause serious infections in patients.
The issue involves Organ Recovery Systems Inc.’s SPS-1 Static Preservation Solution, a clear to light yellow sterile solution intended for the flushing and cold storage of kidneys, livers, and pancreases at the time of organ removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.
On Dec. 4, 2016, staff at a health care facility notified the FDA that an uncharacteristic odor from SPS-1 was identified during an organ procurement operation. Laboratory tests on fluid samples and cultures from the SPS-1 used for this operation confirmed contamination with Pantoea and Enterococcus bacteria, a contaminant that is intrinsically resistant to the antibiotic vancomycin. It is not known how the SPS-1 used in this operation became contaminated.
Organ Recovery Systems immediately issued a recall of two lots of SPS-1. However, on Jan. 12, 2017, the company notified customers of another report of uncharacteristic order from a different lot of SPS-1. Organ Recovery Systems temporarily suspended production and distribution of all SPS-1 products and expanded the recall.
On March 8, 2017, the company informed customers that it was voluntarily removing SPS-1 and that additional sterility testing on randomly selected bags of SPS-1 should be completed by month’s end. To date, there have been no reports of post-operative infections or other adverse events related to this this issue.
The FDA is working with the Centers for Disease Control and Prevention (CDC), the Health Resources and Services Administration (HRSA), and state public health departments to actively investigate the potential for contamination in Organ Recovery Systems’ SPS-1.
Any adverse events that may be related to contamination of SPS-1 should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Safety Communication