OpenBiome update on recent FDA safety alert
OpenBiome screens for antibiotic-resistant bacteria, including the bacteria involved in a recent safety alert from FDA. OpenBiome did not provide the FMT material linked to this event and our service remains uninterrupted.
On Thursday, June 13, 2019, the FDA issued a safety alert regarding two fecal microbiota transplant (FMT) recipients who acquired Extended Spectrum Beta-Lactamase (ESBL)-producing Escherichia coli infections following FMT, resulting in one death. The material used in these cases was not from OpenBiome. We are continuing to service clinical providers and clinical researchers as usual.
OpenBiome screens donors for several antibiotic-resistant bacteria, including ESBL-producing organisms, carbapenem-resistant enterobacteriaceae (CRE), methicillin-resistant Staphylococcus aureus (MRSA), and Vancomycin-resistant enterococci (VRE), as well as evaluating for risk factors associated with acquisition of these microbes. In response to this event, the FDA has introduced new screening requirements for FMT material. We already meet these requirements as part of our routine donor assessments.
You can learn more about our full safety and quality program at www.openbiome.org/safety
This event underscores the importance of robust safety and quality infrastructure for FMT, and of informing patients of the risks associated with FMT and alternatives. Although OpenBiome has provided more than 45,000 treatments with no reported infections or deaths definitively resulting from FMT material, vigilant management of safety is our highest priority. We are here to support patients and the community of healthcare providers and clinical researchers who serve them. Please do not hesitate to use us as a resource.
FOR PATIENTS: If you have questions or concerns about your FMT, please reach out to your doctor. You may also find additional resources at www.openbiome.org/patients or you may reach us at firstname.lastname@example.org
FOR PROVIDERS: You may reach us at email@example.com and you may review our Quality and Safety Program, including our donor screening criteria, at www.openbiome.org/safety
OpenBiome is the first public stool bank, founded to expand safe access to fecal transplantation for patients with recurrent C. difficile infections and to catalyze research on the microbiome’s role in human health. OpenBiome provides clinicians with rigorously screened, ready-to-use preparations and supports researchers with a suite of tools to discover how gut bacteria might treat diseases beyond C. difficile. Since 2013, OpenBiome has partnered with over 1,200 healthcare institutions across all 50 states and internationally to deliver more than 45,000 treatments for recurrent C. difficile. Its research portfolio includes 34% of all active and completed trials in the United States exploring the use of fecal transplants to treat disease. For more information, visit http://www.openbiome.org.