Importance to FDA

A major public health safety concern is the risk of transmissible infectious diseases associated with the use of FDA-regulated medical products, consumption of food, or reuse or sharing of medical devices. In the medical product space, this is a challenge because many medical products cannot be terminally sterilized (meaning they’re sterilized in their final holding container) since some are composed of biological materials that may lose their ability to work as intended. Examples of biological materials include human blood and blood components, therapeutic proteins, monoclonal antibodies, live virus vaccines, certain gene therapy products, and cell-based therapies.

To address these issues, FDA encourages the development of tools designed to evaluate innovative technologies to reduce, inactivate, or eliminate pathogens from FDA-regulated products. The Agency combines typically used methods in conjunction with novel tool development to prevent transmission of infectious disease through FDA-regulated product use. Typical and novel methods incorporate one or more of the following:

• Prevention, e.g., using carefully sourced raw materials; or
• Reduction, inactivation, or elimination, e.g., irradiating devices and certain foods, terminally sterilizing drugs, removing, or inactivating methods applied to traditional biotechnology products or to certain foods; or
• Detection, e.g., screening of the blood supply to remove units carrying human pathogens, sampling and testing foods and removing those containing foodborne pathogens from the marketplace.

Examples

• FDA has regulatory oversight for the safety of human blood and tissues. The risk of transfusion-transmitted diseases in blood products has decreased significantly, and there continues to be low rates of transfusion-transmitted infectious diseases associated with the blood supply due to the development of specific assays for detection of known human pathogens and donor deferral policies. FDA evaluates and encourages development of simple and innovative technologies for effective pathogen reduction of whole blood and red blood cells and encourages improvement of existing technologies developed for platelets and plasma to continue improving the safety of the blood supply.
• Investigating whether the application of nanopore technology makes it easier to detect and trace the Clostridium botulinum (C. botulinum) toxin and Escherichia coli (E. coli). New immune-based methods are being developed to enable rapid and sensitive detection of toxins in food substrates, such as C. botulinum, ricin, and abrin.
• FDA has regulatory oversight for the safety of foods other than meat, poultry and processed egg products. FDA conducts research on the use of technologies such as high--pressure processing, non-thermal plasma, and thermal inactivation of pathogens in various food matrices. FDA also conducts research on new detection methods and the application of whole genome sequencing of microbial pathogens to identify outbreaks of illness and new sources of contamination and encourages industry to adopt new measures to control foodborne pathogens.
• FDA has been working with industry to identify microbial contamination in tattoo inks and address ways to eliminate this problem. Some of these activities have included regulatory meetings to address issues of sterility and manufacturing processes, as well as working to identify the different types and quantity of microbes present in the inks using BAM chapter 23, USP 71 and are beginning to look at other methods to reduce time for testing.