Abstract | ||
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Registries are an essential source of information for clinical and nonclinical 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. |
Year | DOI | Venue |
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2017 | 10.3233/978-1-61499-781-8-173 | Studies in Health Technology and Informatics |
Keywords | DocType | Volume |
Surveillance,Post-market,Biomedical,Saudi Arabia | Conference | 238 |
ISSN | Citations | PageRank |
0926-9630 | 0 | 0.34 |
References | Authors | |
0 | 3 |
Name | Order | Citations | PageRank |
---|---|---|---|
Bader Aloufi | 1 | 0 | 0.34 |
Fahad Alshagathrah | 2 | 0 | 0.34 |
Mowafa S. Househ | 3 | 116 | 31.32 |