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 : 2024-10-26 DOI:10.1016/j.yrtph.2024.105725
Chad P. Satori , Catherine D. Christensen , Stephanie M. Street , Mikaelle Giffin , Christopher M. Pohl , Whitney V. Christian
{"title":"The analytical evaluation threshold for inorganic metal extractables and leachables analysis of medical devices","authors":"Chad P. Satori ,&nbsp;Catherine D. Christensen ,&nbsp;Stephanie M. Street ,&nbsp;Mikaelle Giffin ,&nbsp;Christopher M. Pohl ,&nbsp;Whitney V. Christian","doi":"10.1016/j.yrtph.2024.105725","DOIUrl":null,"url":null,"abstract":"<div><div>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.</div></div>","PeriodicalId":20852,"journal":{"name":"Regulatory Toxicology and Pharmacology","volume":"154 ","pages":"Article 105725"},"PeriodicalIF":3.0000,"publicationDate":"2024-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Regulatory Toxicology and Pharmacology","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0273230024001661","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, LEGAL","Score":null,"Total":0}
引用次数: 0

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.
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
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。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 去求助
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)
期刊最新文献
Considerations and derivations of permitted daily exposure limits for impurities from intravitreal pharmaceutical products. Carcinogenicity Assessment of Inotersen in Tg.rasH2 Mice and Sprague-Dawley Rats: Implications for 2'-MOE Antisense Oligonucleotides. Enhancing reliability of embryo-fetal developmental toxicity studies: A proposed design of replicate studies. Target organ toxicity in Sprague Dawley rats following oral exposure to complex groundwater mixture: Assessment of dose-response relationships using histopathological and biochemical alterations Minimizing the Risk of Ethylene Glycol and Diethylene Glycol Poisoning in Medications: A Regulatory and Pharmacopoeial Response.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1