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Transplant Organ Preservation Solution Recall, Contamination


On March 9, 2017, the FDA warned that SPS-1 Static Preservation Solution (SPS-1) manufactured and distributed by Organ Recovery Systems, Inc., may be contaminated with infectious bacteria.

 

SPS-1 is a clear to light yellow, sterile solution intended for the flushing and cold storage of the kidney, liver, and/or pancreas at the time of organ removal from a donor in preparation for storage, transportation, and eventual transplantation into a recipient.

 

The FDA received a report on December 14, 2016, from staff at a health care facility who notified the FDA of an uncharacteristic odor from SPS-1 encountered during an organ procurement operation. Laboratory results from fluid samples and cultures from the SPS-1 used for this operation confirmed contamination with Pantoea, a genus of Gram-negative bacteria of the family Enterobacteriaceae, and Enterococcus, a genus of Gram-positive bacteria known at vancomycin-resistant enterococci (VRE) that have developed resistance to many antibiotics, especially vancomycin.

 

While it is not yet known how the SPS-1 used for this operation became contaminated, Organ Recovery Systems immediately initiated a voluntary removal of two lots of SPS-1: Lot Numbers PBR-0060-392 and PBR-0074-330.

 

On January 12, 2017, Organ Recovery Systems notified customers of another report of an uncharacteristic odor suggestive of potential contamination from SPS-1 from a different lot, Lot Number PBR-0074-337. Additionally, SPS-1 from Lot Number PBR-0060-386 was reported as being present when an odor was noticed, although the report did not identify any odor coming directly from this product.

 

Since January 12, 2017, Organ Recovery Systems has temporarily suspended production and distribution of all SPS-1 products, and added Lot Numbers PBR-0074-337 and PBR-0060-386 to the recall.

 

On March 8, 2017, Organ Recovery Systems updated customers on the voluntary removal of SPS-1 and stated that additional sterility testing of randomly selected bags of SPS-1 should be completed by March 31, 2017.

 

The FDA is working with the 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.

 

In addition to following the standard precautions, the FDA made additional recommendations for facilities and staff which use organ preservation solutions. First, facilities and staff should be aware that Organ Recovery Systems has recalled SPS-1 Lot Numbers PBR-0060-392, PBR-0074-330, PBR-0074-337, and PBR-0060-386. Second, facilities and staff should consider quarantining existing lots of SPS-1 not included in the recall and using an alternative FDA-cleared product until Organ Recovery Systems provides additional assurance of product safety through additional sterility testing. Third, facilities and staff should be aware that while contaminated SPS-1 to date has been associated with an uncharacteristic odor, the absence of an odor does not rule out the potential for bacterial contamination.

 

The FDA explained that, it is not its position that organs exposed to SPS-1 should be excluded from transplantation if a facility does not have an alternative organ preservation solution immediately available. Rather, the small risk of infection should be balanced with the benefits of transplantation in each potential recipient.

 

See the FDA Safety Alert

 

See the FDA Safety Communication

 

See also Medical Law Perspectives, July 2015 Report: Organ Transplants: Saving Lives, Facing Risks, Minimizing Complications

 

 

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