Sheng Wu Yi Xue Gong Cheng Xue Za Zhi. 2026 Apr 25;43(2):221-226. doi: 10.7507/1001-5515.202511040.
ABSTRACT
Compared to non-absorbable medical devices, the design and evaluation of repeated exposure systemic toxicity tests for absorbable medical devices present unique challenges. This article discusses the special considerations for conducting such tests on absorbable medical devices. Based on regulatory documentation, scientific literature and practical experience, and focusing on the degradation and metabolic characteristics of absorbable medical devices, the analysis summarizes personalized test design strategies from key aspects such as test duration and data collection points, exposure routes, dose design, sample preparation, and pathological examination. This article proposes the following points: ① the test duration should cover the in vivo degradation and absorption process of the medical device material, with multiple data collection points established according to the product’s degradation kinetics to reveal the time-effect relationship of toxic responses; ② the exposure route must closely simulate clinical use, as it directly affects the metabolic pathways and toxicological manifestations of degradation products; ③ dose group design should move beyond the traditional “limit test” approach by employing multiple dose groups to uncover potential dose-response relationships; and ④ result evaluation requires appropriate statistical methods to integrate pathological data from different dose groups, determine the relationship between toxic responses and the test samples, and analyze the relevance of toxic responses to clinical applications to guide clinical practice. This article provides a specific and practical reference for the accurate and objective assessment of repeated exposure systemic toxicity risks associated with absorbable medical devices.
PMID:42037323 | DOI:10.7507/1001-5515.202511040
