Evaluation of reprocessing medical devices in 14 German regional hospitals and at 27 medical practitioners' offices within the European context - consequences for European harmonization.

Safe reprocessing of medical devices through cleaning, disinfection, and sterilization is essential for the prevention of health care associated infections (HAI) and to guarantee patient safety. Several studies detected residual contamination and even severe infections of patients, despite carrying out reprocessing. To develop appropriate solutions, the existing situation in Germany and selected European countries was analyzed. Additionally, in 27 medical practitioners' offices and 14 hospitals, the true practice of reprocessing was analyzed using a questionnaire, a checklist, and inspection on site. A structured analysis of potential alternatives to the internal reprocessing was conducted within the German and European context. The results indicate that the conditions for the execution of the reprocessing process in the analyzed health facilities in southern Hesse (Germany) do not satisfy legal requirements. The detected deficiencies were consistent with other reports from Germany and Europe. The analysis gave insight into several reasons for the detected deficiencies. The three main reasons were the high costs for proper implementation, the subjective value assigned to the reprocessing unit in health care facilities, and deficits in monitoring by the health authority. Throughout the European Union, a similar regulatory framework for the performance of the reprocessing process exists, while the environment, structures of the health systems and administrative supervision vary significantly. The German states as well as selected European countries are currently discussing the challenges of increased quality-assured execution of the reprocessing process. For instance, the same supervisory system for hospitals and medical practitioners should be established at an equal standard. Alternatives such as the use of single-use medical devices, outsourcing the decontamination processes, or the cooperation of health facilities may be considered. This paper also discusses economic and ecological aspects. Finally, different options are recommended to ensure the exclusive use of reliable medical devices for surgical procedures that guarantee an adequate standard of patient safety within economic constraints.