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METHOD AND SYSTEM FOR VALIDATING CHANGES IN MEDICAL PRACTICE, PROCEDURES AND PRODUCT CHOICE

机译:验证医学实践,程序和产品选择变化的方法和系统

摘要

A system and method for assessing the statistical and clinical acceptance of a new medical service or changes in products used by a clinical laboratory or hospital, and providing documentation of validation. The system and method includes an information exchange mechanism, such as an internet, extranet, compact disc (e.g., CD-ROM) or text-based mechanism to establish a systematic approach between a provider and client for collecting, reviewing and providing information to demonstrate the clinical validity of new or modified products. The collected information and user requests are evaluated using tools such as an analytical array to determine required protocols, limits and subsequent tests needed to demonstrate the clinical validity of products, and thereafter, to provide a report to show validation of the change.
机译:一种系统和方法,用于评估新医学服务或临床实验室或医院使用的产品变化的统计和临床接受度,并提供验证文档。该系统和方法包括信息交换机制,例如因特网,外联网,光盘(例如,CD-ROM)或基于文本的机制,以在提供者和客户之间建立用于收集,查看和提供信息以展示信息的系统方法。新产品或改良产品的临床有效性。使用诸如分析阵列之类的工具评估收集到的信息和用户要求,以确定所需的方案,限值和后续测试,以证明产品的临床有效性,然后提供报告以显示变更确认。

著录项

  • 公开/公告号US2016196395A1

    专利类型

  • 公开/公告日2016-07-07

    原文格式PDF

  • 申请/专利权人 BECTON DICKINSON AND COMPANY;

    申请/专利号US201614989381

  • 发明设计人 SOL F. GREEN;

    申请日2016-01-06

  • 分类号G06F19;

  • 国家 US

  • 入库时间 2022-08-21 14:32:47

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