安全公告和登记异常值数据衡量全膝关节植入物安全性和性能的不同方面:安全公告和登记异常值的比较研究。

IF 2.5 2区 医学 Q1 ORTHOPEDICS
Lotje A Hoogervorst, Yijun Ren, Tom Melvin, Ashley A Stratton-Powell, Anne Lübbeke, Robert E Geertsma, Alan G Fraser, Rob G H H Nelissen, Enrico G Caiani, Perla J Marang-van de Mheen
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引用次数: 0

摘要

背景和目的:全膝关节置换术 (TKA) 植入物等医疗器械的安全公告可能表明其设计或性能存在问题,需要采取纠正措施以防止对患者造成伤害。安全公告通常发布在国家卫生部或监管机构的网站上。目前还不清楚触发安全公告的问题是否与登记处确定为 "离群 "的植入物相同。我们的目的是评估登记处的安全通告和离群识别在多大程度上显示了相同或不同的 TKA 植入物: 我们使用 CORE-MD 工具(一种自动网络搜索工具)在 13 个国家的卫生部网站和监管机构中收集与 TKA 植入物相关的安全通告。根据《医疗器械管理条例》(MDR),安全公告被定义为 "制造商向用户或客户发送的与现场安全纠正措施有关的通信"。从登记报告中提取已识别的 TKA 异常值,其定义为翻修风险明显高于其他同类 TKA 植入物: 结果:共确定了 38 个 TKA 植入体和 35 个 TKA 异常值的 787 份安全通知,共确定了 47 个独特的 TKA 植入体。26个(55%)TKA植入体有安全通告,同时也是异常值,12个(26%)TKA植入体只有安全通告,9个(19%)只有异常值。仅有安全通告的 TKA 植入物的问题类型与有安全通告的 TKA 异常值相似,其中 "制造/包装/运输 "问题最为常见(44%)。结论:55%有安全通告的TKA在登记册中被认定为异常值,而约25%的TKA异常值不是公开发布的安全通告的对象,安全通告指出登记册未认定的TKA植入物可能有更高的失败风险。这表明安全通告和登记处异常值数据衡量的是安全和性能的不同方面。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Safety notices and registry outlier data measure different aspects of safety and performance of total knee implants: a comparative study of safety notices and register outliers.

Background and purpose:  Safety notices for medical devices such as total knee arthroplasty (TKA) implants may indicate problems in their design or performance that require corrective action to prevent patient harm. Safety notices are often published on national Ministries of Health or regulatory agencies websites. It is unknown whether problems triggering safety notices identify the same implants as those identified by registries as "outlier." We aimed to assess the extent to which safety notices and outlier identification in registries signal the same or different TKA implants.

Methods:  The CORE-MD tool, an automated web scraper tool, was used to collect safety notices related to TKA implants on 13 national Ministries of Health websites and regulatory agencies. Safety notices were defined according to the Medical Device Regulation (MDR) as "a communication sent by a manufacturer to users or customers in relation to a field safety corrective action." Identified TKA outliers, defined as having a significantly higher revision risk than other comparable TKA implants, were extracted from registry reports.

Results:  787 safety notices for 38 TKA implants and 35 TKA outliers were identified, together identifying 47 unique TKA implants. 26 (55%) TKA implants had safety notices and were also outliers, 12 (26%) TKA implants had only safety notices, and 9 (19%) were outliers only. TKA implants with safety notices only had similar types of problems to TKA outliers with safety notices, with "Manufacturing/Packaging/Shipping" problems being most frequent (44%). Cumulative revision risks (1/5/10 years) were lower for TKA implants with safety notices only than for TKA outliers with safety notices.

Conclusion:  55% of the TKA with a safety notice were identified as outliers in the registry, whereas around 25% of TKA outliers are not the subject of publicly released safety notices, with safety notices pointing to TKA implants not identified by registries as potentially having a higher risk of failure. This suggests that safety notices and registry outlier data measure different aspects of safety and performance.

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来源期刊
Acta Orthopaedica
Acta Orthopaedica 医学-整形外科
CiteScore
6.40
自引率
8.10%
发文量
105
审稿时长
4-8 weeks
期刊介绍: Acta Orthopaedica (previously Acta Orthopaedica Scandinavica) presents original articles of basic research interest, as well as clinical studies in the field of orthopedics and related sub disciplines. Ever since the journal was founded in 1930, by a group of Scandinavian orthopedic surgeons, the journal has been published for an international audience. Acta Orthopaedica is owned by the Nordic Orthopaedic Federation and is the official publication of this federation.
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