K Osmanski-Zenk1, H Haas2, W Mittelmeier3, D Kluess3. 1. Orthopädische Klinik und Poliklinik, Universitätsmedizin Rostock, Doberaner Straße 142, 18057, Rostock, Deutschland. katrin.osmanski-zenk@med.uni-rostock.de. 2. Zentrum für Orthopädie und Unfallchirurgie, Gemeinschaftskrankenhaus Bonn, 53113, Bonn, Deutschland. 3. Orthopädische Klinik und Poliklinik, Universitätsmedizin Rostock, Doberaner Straße 142, 18057, Rostock, Deutschland.
Abstract
BACKGROUND: Although investigations of retrieved medical implants can provide valuable information about the cause of the revision, there is a lack of information, which could be avoided by consequent failure analyses. In the framework of the EndoCert certification system it is obligatory to record and report incidents. OBJECTIVES: The present work examines how the willingness to report has developed in certified arthroplasty centers and which method of handling retrievals is preferred and actually used. MATERIALS AND METHODS: On the basis of a questionnaire for handling retrievals, all 508 arthroplasty centers that were certified till June 1, 2016, were included (return rate = 97.2%). RESULTS: A total of 93.3% of the centers have established an algorithm for handling of retrievals and 83.0% of the centers prefer to hand out the retrieval to the patient, while only 25.7% wish to store it in the center for research purposes. In the case of a potential incident as the cause of revision, centers prefer to forward the retrieval to damage analysis, whereby the centers act in different ways, depending on the case. An implant fracture is, e.g., considered a reportable event in most cases without temporal limitation. On the other hand, breakage or failure of surgical instruments is considered not to be reported in the case of more than half of the centers. In 2014 and 2015, approximately 71% of EPZs reported no incidents. CONCLUSIONS: According to our survey, many certified arthroplasty centers are sensitized to careful handling of retrievals. The treatment of the explanted components is conducted in different ways. The assessment of whether an incident is to be reported shows large differences. In view of the relatively high number of revision surgeries, the number of reports to the authorities appears to be low.
BACKGROUND: Although investigations of retrieved medical implants can provide valuable information about the cause of the revision, there is a lack of information, which could be avoided by consequent failure analyses. In the framework of the EndoCert certification system it is obligatory to record and report incidents. OBJECTIVES: The present work examines how the willingness to report has developed in certified arthroplasty centers and which method of handling retrievals is preferred and actually used. MATERIALS AND METHODS: On the basis of a questionnaire for handling retrievals, all 508 arthroplasty centers that were certified till June 1, 2016, were included (return rate = 97.2%). RESULTS: A total of 93.3% of the centers have established an algorithm for handling of retrievals and 83.0% of the centers prefer to hand out the retrieval to the patient, while only 25.7% wish to store it in the center for research purposes. In the case of a potential incident as the cause of revision, centers prefer to forward the retrieval to damage analysis, whereby the centers act in different ways, depending on the case. An implant fracture is, e.g., considered a reportable event in most cases without temporal limitation. On the other hand, breakage or failure of surgical instruments is considered not to be reported in the case of more than half of the centers. In 2014 and 2015, approximately 71% of EPZs reported no incidents. CONCLUSIONS: According to our survey, many certified arthroplasty centers are sensitized to careful handling of retrievals. The treatment of the explanted components is conducted in different ways. The assessment of whether an incident is to be reported shows large differences. In view of the relatively high number of revision surgeries, the number of reports to the authorities appears to be low.
Authors: Wolfgang Lauer; E Stößlein; A Brinker; K Broich Journal: Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz Date: 2014-12 Impact factor: 1.513
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