Recall of Potentially Contaminated Organ Preservation Solution
The Food and Drug Administration (FDA) is increasing awareness about the potential for bacterial contamination of Static Preservation Solution (SPS-1; Organ Recovery Systems), which is intended for the flushing and cold storage of kidney, liver, and pancreas at the time of organ removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.
The FDA has also highlighted the Company's recall of specific lots of SPS-1 and the temporary suspension of production and distribution of all SPS-1 products.
In December 2016, the FDA was first notified of an unusual odor from SPS-1 by staff at a healthcare facility during an organ procurement operation. Lab results from fluid samples and cultures from the specific SPS-1 confirmed contamination with Pantoea and Enterococcus (intrinsically vancomycin-resistant) bacteria. The Company immediately withdrew two lots (PBR-0060-392 and PBR-0074-330).
Then in January 2017, the Company informed customers of another report of uncharacteristic odor from a different lot of SPS-1 (PBR-0074-337), suggestive of possible contamination. Another lot of SPS-1 was reported as being present when an odor was noticed but the odor was not reported to come directly from this product.
Organ Recovery Systems has temporarily stopped production and distribution of all SPS-1 products and has added Lot# PBR-0074-337 and PBR-0060-386 to their recall. A voluntary removal of SPS-1 was announced on March 8, 2017 and additional sterility testing of random bags of SPS-1 is anticipated to be completed by March 31, 2017.
The following is recommended for organ and tissue procurement organizations and transplant facilities:
- 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.
- Consider quarantining existing lots of SPS-1 not included in the recall and use an alternative FDA-cleared product until Organ Recovery Systems provides additional assurance of product safety through additional sterility testing.
- If your facility does not have an alternative organ preservation solution immediately available, the FDA does not believe that organs exposed to SPS-1 should be excluded from transplantation. Rather, the small risk of infection should be balanced with the benefits of transplantation in each potential recipient.
- Pay attention to the quality of any organ preservation solution used. If there are concerns about odor, cloudiness, precipitation, or any other physical characteristics that could indicate contamination, carefully consider the benefits and risks.
- Report any adverse events or suspected contamination of organ preservation solution to the FDA and the manufacturer.
The FDA has not received reports of any post-operative infections or other adverse events directly related to the identified products. The Agency is working with the Centers for Disease Control and Prevention (CDC), the Health Resources and Services Administration (HRSA), and state public health departments to investigate the potential for contamination in SPS-1.
For more information call (847) 824-2421 or visit FDA.gov.