手术植入物 - 手术植入物的最小数据集

[中文适用范围]： 本文件定义了植入物的最小数据集，以促进植入物跟踪系统的数据记录和国际交换。 该数据还可用于支持检索分析和种植体注册。 本文件适用于通过外科手术植入的医疗器械的制造商和经销商，以及进行植入或外植体手术的医院和其他医疗机构。 它规定了植入物制造商和经销商以及医院和其他医疗机构在植入物事件和任何后续外植体事件时记录的数据项的要求。 本文件旨在定义要记录的所有植入物和外植体事件的最小数据集，并提供及时检索与已接受特定识别设备或指定范围内的设备的特定患者子集相关的最小植入物数据批号、批号或序列号，用于患者随访。 本文档的目的不是提供与特定医疗从业者、医疗机构或制造商相关的数据恢复方法，用于在发生不可预见的设备故障时进行患者随访或产品召回以外的目的。 [外文原描述]： This document defines minimum data sets for implants to facilitate recording and international exchange of data for the purposes of implant tracking systems. This data can also be used to support retrieval analysis and implant registry. This document is applicable to the manufacturers and distributors of medical devices intended for implant via a surgical procedure and to those hospitals and other medical facilities which carry out implant or explant procedures. It specifies requirements for data items to be recorded by the manufacturers and distributors of implants and by hospitals and other medical facilities at both the time of implant event and at the time of any subsequent explant event. This document is intended to define a minimum data set to be recorded for all implant and explant events, as well as providing for the timely retrieval of minimum implant data related to specific subsets of patients who have received specific identified devices or devices within a specified range of lot, batch or serial codes, for the purpose of patient follow up. It is not the intent of this document to provide a means of data recovery which is related to specific medical practitioners, medical facilities or manufacturers for purposes other than patient follow up or product recall in the event of unforeseen device malfunction.