Konsequenzen des Evidenzberichts und der Einzelfallbewertung der Methode Robodoc® für die Begutachtungspraxis des MDK, das Behandlungsfehlermanagement der Krankenkassen und den grundsätzlichen Umgang mit Innovationen

摘要

PURPOSE: Robots in Total Hip Replacement were introduced to utilize the precision of an industrial robot for reaming the femur. This method has been discussed controversially from the beginning of its clinical application in Germany. Criticism increased recently especially in respect of alleged malpractice. Aim of this study was to describe the consequences of the results of a systematic review and the evaluation of malpractice accusations for statutory health insurance and medical advisory services. METHOD: Robot-assisted total hip replacement was evaluated by a Health Technology Assessment report, especially concerning proof of clinical benefit and specific complications of this method. 44 cases of alleged malpractice reported to health insurance were assessed as well and compared with the results of the systematic review. RESULTS: The HTA report showed no proof of clinical benefit but pointed to increased rates of complications. In the 44 evaluated cases the entire range of endoprosthesis- but no robot-specific complications could be identified. CONCLUSION: Patients must be informed about risks, complications, benefits and especially alternatives to a robot-assisted operation. The prospective procedure of management of assumed malpractice concerning Robodoc can not be standardised, but each case must be evaluated individually. Consequently, implementation of a structured malpractice management system for health insurance and medical advisory services should be useful. Additionally, health service should implement an "early warning system" for innovative procedures.