Recent US FDA Warning over Fecal Transplants.


Medical news from America recently has featured the sad death of an immune-compromised patient receiving a “fecal transplant” as part of a clinical trial in America. We wish to add our condolences to the patient’s family at this difficult time. It is emerging that US clinicians supplying the “fecal transplant” material failed to adequately screen the donor(s) for antibiotic-resistant strains of the pathogenic ESBL-producing E. coli bacteria. Whilst infection with ESBL E coli species frequently has little effect on a healthy person, when a patient whose immune system is grossly compromised is exposed to it it can lead to fatal results.

Taymount wishes to make a comment on this situation: Firstly the Taymount Laboratories screening process has always screened for the pathogens associated with this tragic event. Taymount Laboratories also do not make “fecal transplants” instead they manufacture Faecal Microbiota Transplant (FMT) implant material for medical order. Since 2015 the Taymount Laboratory elected to migrate away from using outside contractor testing laboratories and instead they have heavily invested in sophisticated state-of-the-art DNA/RNA PCR testing equipment to ensure in-house screening for pathogenic species.

Unlike many suppliers, our sophisticated screening procedures mean that each of our implants is screened for pathogens before being released. There is no reliance on just a regular periodic screening of each donor. It is directly because of a lack of a global standardised approach to donor testing and procedures that Taymount Group has been urging regulators to standardise all aspects of Faecal Microbiota Transplantation to improve patient safety standards.

To help to illustrate the safety of Taymount Laboratories procedures, we are currently in the process of making a video on testing procedures and standards which will include the Taymount Laboratories’ BioFire® FilmArray® PCR analysis equipment that targets detection of specific pathogens. This video will be released shortly.

In summary, all Taymount Laboratories FMT implants are screened in-house by molecular analysis of DNA and RNA for the pathogens that led to the untimely passing of the patient in the American trial program. We also wish to make very clear that Taymount Laboratories were not involved in the US clinical trial.

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