Project: Implant Study 2017-2019
In three consecutive SEM studies conducted by the University Hospital of Cologne and the Charité University Hospital in Berlin, over 250 implants in sterile packaging were analyzed using the same protocol over the past ten years [Duddeck, 2009: Duddeck et al., 2013; Duddeck et al., 2015]*. Results from the most recent study with135 implants and their comparison with previous studies have shown a significant increase in the number of implants with conspicuous residues — despite the fact that it is technically quite possible to produce residue-free implants, which many of the examined implants had proven.
Residue-free medical devices are invariably the result of considerable technological efforts during production and consistent quality management. If, by contrast, adequate quality assurance testing is not performed during production, inferior medical devices are the inevitable result — a fact no formal marketing authorization can ignore..
As a continuation of the three studies cited above, the aim of this study was to investigate any improvements in manufacturing and quality management as well as to determine any increases in the quality level of the participating manufacturers and implant companies.
What´s new in the setup for the Implant Study 2017-2019?
In order to provide a setup which complies with the highest standards of scientific research, the process of analysis will be performed according to DIN EN ISO/IEC 17025. This accreditation not only includes the DIN EN ISO 9001:2015 quality standard but also assessment and monitoring by means of regular inspections carried out by an independent accreditation body in compliance with DIN EN ISO/IEC 17011.
The unpacking of the implants themselves, and the loading of the specimen holders as well as insertion into the SEM will take place in an environment that meets class 100 cleanroom requirements according to United States Federal Standard (US FS) 209 and ISO class 5 according to DIN EN ISO 14644-1. A digitally composed high-resolution SEM image (FSHR) shows the complete surface of an implant at a 120° angle. Thus, the detailed report of every implant shows not only single sections of the sample but always a precise overview of the implant´s surface.