The Centers for Disease Control and Prevention (CDC) has issued an additional Epi-X update regarding reports of potentially contaminated organ preservation solution. This is an additional update to information posted on January 12.
The text of the update is as follows:
Brief Summary of Report: CDC, HRSA, and FDA are investigating bacterial contamination of SPS-1, an organ preservation solution distributed by Organ Recovery Systems (ORS).
Description: This is an update to an Epi-X posted on January 12, 2017, which reported potential bacterial contamination in SPS-1 lots PBR-0074-337, PBR-0060-386, PBR-0074-330, and PBR-0060-392.
FDA’s investigation of potential contamination of several lots of SPS-1, manufactured by Organ Recovery Systems (ORS) is on going. We recommend that Organ Procurement Organizations (OPO) and transplant facilities should consider transitioning to alternate, FDA-cleared organ preservation fluid products from other manufacturers.
Please take the following actions to report adverse events occurring on or after April 1, 2016, in patients who received organs or tissues from organ recovery procedures using SPS-1 from any manufacturing lot:
- Submit a report to the Organ Procurement and Transplantation Network in the Disease Transmissions section of the Improving Patient Safety
Portal in UNet.
- File a report with FDA’s MedWatch Safety Information and Adverse Event Reporting Program either online (www.fda.gov), by regular mail or FAX to 1-800-FDA-0178 if you suspect contaminated organ preservation products at your facility.
- Notify local or state health authorities.