Thursday, 25 June 2020

Additional safety protections relating to COVID-19 for faecal microbiota transplant (FMT) products


The Australian TGA has issued a document titled “Additional safety protections relating to COVID-19 for faecal microbiota transplant (FMT) products.”

The Therapeutic Goods Administration (TGA) is providing advice on safety protections to faecal microbiota transplant (FMT) providers since there is the potential to transmit the SARS-CoV-2 virus via FMT through shedding in stool.


FMT products comprise, contain, or are derived from donated human stool and are introduced into a recipient person for a therapeutic use. Human stool is collected from a screened donor by defaecation. This stool is then processed into an FMT product and provided to the recipient via enema, colonoscopy, nasoenteric tube, or orally (e.g. capsules).

This advice follows a recent safety alert from the US FDA that highlighted the additional safety precautions that should be in place for COVID-19 disease screening of potential stool donors for FMT products in order to prevent the spread of the SARS-CoV-2 virus.

See: https://www.tga.gov.au/alert/additional-safety-protections-relating-covid-19-faecal-microbiota-transplant-fmt-products

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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