Long-term biocompatibility evaluation strategy for new biomaterials in medical products and equipment accessories
Publish Time: 2024-12-11
At a time when medical technology is developing rapidly, new biomaterials are increasingly used in medical products and equipment accessories. However, ensuring their long-term biocompatibility is a key link in ensuring patient safety and treatment effectiveness, and a rigorous and comprehensive evaluation strategy is required.
First, in vitro cell experiments are an important means of preliminary screening. Select a variety of cell lines related to human tissues, such as fibroblasts and endothelial cells, and co-culture new biomaterials with these cells. By observing the morphology, proliferation rate, apoptosis of cells, and related factors secreted by cells, evaluate the toxicity, irritation, and potential cell function effects of the materials on cells. This stage can quickly obtain basic information on the interaction between materials and cells, providing an important reference for subsequent experiments, but it cannot completely simulate the complex environment in the body.
Animal in vivo implantation experiments are the core step for further in-depth exploration. According to the actual use scenarios of medical products and equipment accessories, select appropriate animal models, such as mice, rats, rabbits, and even large animal models. The new biomaterial is made into a corresponding accessory shape or implant, implanted in a specific part of the animal's body, and observed at different time points (short-term can be weeks, long-term can be months or even years). Monitoring indicators include inflammatory response of local tissues, degree of fibrosis, angiogenesis, material degradation rate and distribution of degradation products in tissues. At the same time, the overall physiological indicators of the animal, such as hematological indicators, liver and kidney function, etc., are tested to evaluate whether the material causes systemic adverse reactions.
In addition, special functional evaluation experiments are required. If the material has specific biologically active functions, such as drug sustained release, tissue induced regeneration, etc., special experiments need to be designed to verify its effectiveness and stability in a long-term in vivo environment. For example, for drug sustained-release materials, the release rate and cumulative release amount of the drug at different times should be tested to ensure that the drug can be released at an appropriate dose within the expected time, and the material carrier will not lose its controlled release ability due to the long-term in vivo environment.
Long-term follow-up observation is also an indispensable part. Even if no obvious problems are found in the animal experiment stage, patients still need to be followed up for a long time after the new biomaterial is applied in clinical practice. Collect patients' clinical symptoms, imaging materials and related biomarker data to timely detect possible delayed adverse reactions or changes in material properties, provide real-world basis for continuous optimization and improvement of evaluation strategies, and ultimately ensure the safe and effective application of new biomaterials in the medical field and promote the continuous advancement of medical technology.
