Dutch Breast Implant Registry (DBIR) annual report 2020

The scientific board of the DBIR believes that properly designed clinical quality registries can provide important evidence and can play an important role in patient and implant safety. These registries facilitate quality monitoring and therefore improve ways to innovate and to measure and reduce ad...

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Bibliographic Details
Main Author: Vrolijk, J. J.
Corporate Author: Dutch Institute for Clinical Auditing
Format: eBook
Language:English
Published: Leiden (NL) Dutch Institute for Clinical Auditing October 2021, 2021
Edition:Version 2021.01
Online Access:
Collection: National Center for Biotechnology Information - Collection details see MPG.ReNa
Description
Summary:The scientific board of the DBIR believes that properly designed clinical quality registries can provide important evidence and can play an important role in patient and implant safety. These registries facilitate quality monitoring and therefore improve ways to innovate and to measure and reduce adverse events. This is important, for example, in the pre- and post-approval monitoring of breast implants. The data in our registry have established a mature and reliable dataset. Of course, each dataset has its drawbacks and limitations. However, with our evolution and growth, new roles develop. DBIR is independent of industry and funded by patients and healthcare insurance. Independence of industry is vital to our existence and will always remain one of our core values. On the other hand, registry data are increasingly important to support innovation and adverse event reporting as required by the new Medical Device Regulation (MDR) that came into effect in May 2021. In other words, our registry data are becoming of vital importance to our patients in order to ensure breast implants remain on the market. This is why different forms of collaboration are considered part of the responsibility we have towards our patients, surgeons, and legislators
Physical Description:1 PDF file (60 pages) illustrations