Aloufi Bader, Alshagathrah Fahad, Househ Mowafa
Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
College of Public Health and Health Informatics, King Saud Bin Abdulaziz University for Health Sciences, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
Stud Health Technol Inform. 2017;238:173-176.
Registries are an essential source of information for clinical and non-clinical decision-makers; because they provide evidence for post-market clinical follow-up and early detection of safety signals for biomedical implants. Yet, many of todays biomedical implants registries are facing a variety of challenges relating to a poorly designed dataset, the reliability of inputted data and low clinician and patient participation. The purpose of this paper is to present a best practice model for the implementation and use of biomedical implants registries to monitor the safety and effectiveness of implantable medical devices. Based on a literature review and an analysis of multiple national relevant registries, we identified six factors that address contemporary challenges and are believed to be the keys for building a successful biomedical implants registry, which include: sustainable development, international comparability, data reliability, purposeful design, ease of patient participation, and collaborative development at the national level.
注册登记系统是临床和非临床决策者的重要信息来源；因为它们为上市后临床随访以及生物医学植入物安全信号的早期检测提供证据。然而，当今许多生物医学植入物注册登记系统面临着各种挑战，包括数据集设计不佳、输入数据的可靠性以及临床医生和患者参与度低等问题。本文的目的是提出一个生物医学植入物注册登记系统实施和使用的最佳实践模型，以监测植入式医疗器械的安全性和有效性。基于文献综述和对多个国家相关注册登记系统的分析，我们确定了六个应对当代挑战的因素，这些因素被认为是建立成功的生物医学植入物注册登记系统的关键，包括：可持续发展、国际可比性、数据可靠性、有针对性的设计、患者参与的便利性以及国家层面的协作发展。
