FDA Updates on FMT Donor Screening Recommendations
Regulatory News | 19 June 2019 |
After warning healthcare providers and patients of the risk of potentially deadly infections following fecal transplants last week, the US Food and Drug Administration (FDA) on Wednesday provided more details on its recommendations for donor screening and handling fecal microbiota for transplantation (FMT) procedures.
Background
FMT is often used to treat patients with Clostridium difficile (C.difficile) infections who have not responded to standard therapy. In a 2013 guidance, FDA explained that it would exercise enforcement discretion with regard to FMT for this use so long as the treating physician obtains adequate informed consent that includes, “at a minimum, a statement that the use of FMT to treat C. difficile is investigational and a discussion of its potential risks.”
Last week, FDA revealed that two patients who were immunocompromised developed severe multi-drug resistant infections caused by extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E.coli) after receiving FMT, one of whom died from the infection.
At the time, FDA advised that donor screening and testing for multi-drug resistant organisms (MDROs) should be carried out to reduce the risk of infection in patients receiving FMT.
Screening and Testing Recommendations
While FDA initially shared its recommendations with companies developing FMT products under an investigational new drug (IND) application, the agency says it has received requests from non-IND holders using FMT under the agency’s enforcement discretion policy for the additional screening and testing recommendations.
Now, FDA has published its full recommendations for donor screening and testing, which include screening questions addressing individuals who have a higher risk of colonization with MDROs who should be excluded from donation.
Those individuals include healthcare workers, recently hospitalized patients, people who regularly attend outpatient medical or surgical clinics and individuals “who have recently engaged in medical tourism.”
FDA also provided a list of the MDROs that donor stool should be tested for, which at a minimum should include ESBL-producing Enterobacteriaceae, vancomycin-resistant enterococci (VRE), carbapenem-resistant Enterobacteriaceae (CRE) and methicillin-resistant Staphylococcus aureus (MRSA).
FDA says that all existing FMT products that have not undergone screening and testing for MDROs should be quarantined until their donors have been screened and the FMT products have been tested.
Lastly, FDA says that the informed consent process for FMT procedures should describe both the risk for MDRO transmission and the donor screening and testing measures that have been implemented.
FDA
Background
FMT is often used to treat patients with Clostridium difficile (C.difficile) infections who have not responded to standard therapy. In a 2013 guidance, FDA explained that it would exercise enforcement discretion with regard to FMT for this use so long as the treating physician obtains adequate informed consent that includes, “at a minimum, a statement that the use of FMT to treat C. difficile is investigational and a discussion of its potential risks.”
Last week, FDA revealed that two patients who were immunocompromised developed severe multi-drug resistant infections caused by extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E.coli) after receiving FMT, one of whom died from the infection.
FDA said that both patients received FMT from the same donor, and that “the donor stool and resulting FMT used in these two individuals were not tested for ESBL-producing gram-negative organisms prior to use.” Subsequent testing found the samples to be positive for ESBL-producing E.coli that matched samples from the patients.
At the time, FDA advised that donor screening and testing for multi-drug resistant organisms (MDROs) should be carried out to reduce the risk of infection in patients receiving FMT.
Screening and Testing Recommendations
While FDA initially shared its recommendations with companies developing FMT products under an investigational new drug (IND) application, the agency says it has received requests from non-IND holders using FMT under the agency’s enforcement discretion policy for the additional screening and testing recommendations.
Now, FDA has published its full recommendations for donor screening and testing, which include screening questions addressing individuals who have a higher risk of colonization with MDROs who should be excluded from donation.
Those individuals include healthcare workers, recently hospitalized patients, people who regularly attend outpatient medical or surgical clinics and individuals “who have recently engaged in medical tourism.”
FDA also provided a list of the MDROs that donor stool should be tested for, which at a minimum should include ESBL-producing Enterobacteriaceae, vancomycin-resistant enterococci (VRE), carbapenem-resistant Enterobacteriaceae (CRE) and methicillin-resistant Staphylococcus aureus (MRSA).
FDA says that all existing FMT products that have not undergone screening and testing for MDROs should be quarantined until their donors have been screened and the FMT products have been tested.
Lastly, FDA says that the informed consent process for FMT procedures should describe both the risk for MDRO transmission and the donor screening and testing measures that have been implemented.
FDA
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