The first national technical standard for fecal microbiota transplantation has been released.

On October 12, 2022, the State Administration for Market Regulation and the National Standardization Administration jointly announced that the national standard GB/T 41910-2022 "Quality Control of Washed Fecal Microbiota and Classification of Fecal Microbiota Samples," led by Professor Zhang Faming and participated by Li Pan and others, has been approved for implementation.

This is the first national technical standard published in the field of fecal microbiota transplantation, and also the first national technical standard for washed fecal microbiota transplantation.

The value of national technical standards

The standard clearly specifies the laboratory conditions and technical requirements needed for washed fecal microbiota, establishing the dosage unit for washed fecal microbiota transplantation.

• The collection and processing of fecal microbiota samples should be carried out in a clean laboratory within a nationally approved hospital, and treatment should be decided and executed by registered practicing physicians in the hospital.

• Laboratory technical personnel should have an educational background in clinical medicine, microbiology, pharmacy, or biotechnology.

• The laboratory's biosafety level should reach at least level two, and the indoor air cleanliness level should meet at least the cleanliness Class C standard required by the "Design Standards for Clean Rooms in the Pharmaceutical Industry."

• Dedicated equipment, instruments, and related facilities for fecal microbiota separation should be used.

• A quality management system should be established to manage and control the quality of the entire process of washed fecal microbiota.

The standard establishes the "measurement" for washed fecal microbiota transplantation: 1.0 × 10^13 bacteria as one basic unit dose (unit, U). As a unified measurement unit for transplant microbiota dosage, this plays a foundational role in clearly informing clinical diagnosis and treatment and in scientific research reproducibility. It provides a basis for technical supervision, quality control, and research reporting.

In ancient times, there were "uniform writing," "uniform tracks for vehicles," and "uniform measurements," which reflects the value of today's national standards.

More importantly, this national standard clearly specifies the safety levels of fecal microbiota samples. Based on laboratory preparation methods and safety levels, fecal microbiota are classified into original level, coarse filtration level, and washed level. This provides classification standards for national regulation and industry research.

The release of this standard helps ensure laboratory safety for washed fecal microbiota transplantation technology and promotes the safe application of washed fecal microbiota transplantation technology.

Safety assurance is the primary requirement of medical technology. As a core project of the National Clinical Research Center for Digestive Diseases, data from the Chinese Fecal Microbiota Transplantation Platform shows that the incidence of adverse events from fecal microbiota transplantation was about 20% in 2012. Real-time data on October 18, 2022, shows that using washed fecal microbiota transplantation has reduced the overall incidence of adverse events from fecal microbiota transplantation to 5.15%, a decrease of over 70%.