We have been seeing more requests than ever for bacterial endotoxin testing on tissue and tissue based products. Currently the FDA does not require endotoxin testing of tissue, but there are relevant USP documents. The primary focus of USP <1046> Cellular and Tissue-Based Products is on cellular therapies, but much of the document could be interpreted to apply to other tissue-based products. Highly processed tissues and combination products that are considered medical devices may already require endotoxin testing according to USP <161> Transfusion and Infusion Assemblies and Similar Medical Devices. USP <161> indicates that a device with direct or indirect contact with the circulatory system, lymphatic system, or cerebrospinal fluid should be evaluated for endotoxin.
There are two important aspects for manufacturers to consider when determining the need for endotoxin testing of their product. First, manufactures have an obligation to ensure patient safety regardless of regulations or label claims. Given the contact many of these products would have with the circulatory or lymphatic system endotoxin testing should be considered. There would be a significant risk to human health if these products were contaminated with high levels of endotoixn. Second, the FDA could start requiring endotoxin testing for tissues and tissue based products. Having a testing procedure in place now will be a great proactive step. Being prepared for upcoming regulations will make the transition easier on manufacturers if additional regulations are implemented.
Nelson Labs provides full microbiological testing services. Manufacturers who currently produce, or plan to produce, tissue based or combination products can contact Nelson Labs for additional information.