The analytical evaluation threshold for inorganic metal extractables and leachables analysis of medical devices.

IF 3 4区 医学 Q1 MEDICINE, LEGAL Regulatory Toxicology and Pharmacology Pub Date : 2024-10-25 DOI:10.1016/j.yrtph.2024.105725
Chad P Satori, Catherine D Christensen, Stephanie M Street, Mikaelle Giffin, Christopher M Pohl, Whitney V Christian
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Abstract

Chemical characterization of medical devices uses the analytical evaluation threshold (AET) to determine reportable organic extractables, as these chemicals may be of toxicological concern and should be addressed via toxicological risk assessment. The AET is not applicable to metal extractables due to the exclusion of toxicity data on inorganics from the dataset used to derive dose-based threshold (DBT) values. This results in minimal guidance for reporting metal extractables. Herein, an AET for metals, or mAET, is proposed as a reporting threshold for individual metal extractables. The mAET can ensure metals are reported that are at quantities that may present a patient safety risk. This may reduce the number of metals reported in a chemical characterization report, improving the efficiency of the overall biocompatibility evaluation by removing unneeded effort and resource time. Conversely, an analytical method's ability to report all metals at toxicologically relevant levels can be confirmed by comparing method sensitivity to mAET values. DBTs were developed for 70 metals, permitting mAET values to be determined. These mAET values were then compared to metal reporting limits from 13 previously conducted chemical characterization studies, which used varying extraction designs and analytical methods, to determine the impact of the mAET.

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医疗器械无机金属萃取物和浸出物分析的分析评估阈值。
医疗器械的化学特征描述使用分析评估阈值 (AET) 来确定可报告的有机萃取物,因为这些化学品可能会引起毒理学关注,应通过毒理学风险评估来解决。由于用于推导基于剂量的阈值 (DBT) 的数据集中不包含无机物的毒性数据,因此 AET 并不适用于金属萃取物。这导致对金属萃取物报告的指导极少。在此,建议将金属的 AET 或 mAET 作为单个金属萃取物的报告阈值。mAET 可确保报告的金属数量可能会对患者安全构成风险。这可以减少化学特性报告中报告的金属数量,通过减少不必要的工作量和资源时间来提高整个生物相容性评估的效率。相反,通过比较方法灵敏度和 mAET 值,可以确认分析方法是否有能力报告毒理学相关水平的所有金属。针对 70 种金属开发了 DBT,从而确定了 mAET 值。然后将这些 mAET 值与之前进行的 13 项化学特性研究(采用不同的提取设计和分析方法)中的金属报告限值进行比较,以确定 mAET 的影响。
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来源期刊
CiteScore
6.70
自引率
8.80%
发文量
147
审稿时长
58 days
期刊介绍: Regulatory Toxicology and Pharmacology publishes peer reviewed articles that involve the generation, evaluation, and interpretation of experimental animal and human data that are of direct importance and relevance for regulatory authorities with respect to toxicological and pharmacological regulations in society. All peer-reviewed articles that are published should be devoted to improve the protection of human health and environment. Reviews and discussions are welcomed that address legal and/or regulatory decisions with respect to risk assessment and management of toxicological and pharmacological compounds on a scientific basis. It addresses an international readership of scientists, risk assessors and managers, and other professionals active in the field of human and environmental health. Types of peer-reviewed articles published: -Original research articles of relevance for regulatory aspects covering aspects including, but not limited to: 1.Factors influencing human sensitivity 2.Exposure science related to risk assessment 3.Alternative toxicological test methods 4.Frameworks for evaluation and integration of data in regulatory evaluations 5.Harmonization across regulatory agencies 6.Read-across methods and evaluations -Contemporary Reviews on policy related Research issues -Letters to the Editor -Guest Editorials (by Invitation)
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