Assessment of the benefit of medical devices in surgical practice. Problems and possible solutions

作者：Seidel D; Brass P; Sehnke N; Jakob V; Eglmeier W; Neugebauer E A M^*

来源：Chirurg, 2014, 85(5): 407-415.

DOI：10.1007/s00104-013-2654-1

• Clinical trial
• Medical devices
• Benefit assessment
• Multicenter studies
• Surgical trial network

The market approval of medical devices in Germany does not yet require a benefit assessment. Thus, there is a lack of high quality studies that clearly prove the benefit of medical innovations. In the past, the Federal Joint Committee in Germany (G-BA) did not have the opportunity to adequately address this issue of lacking evidence. A law for the improvement of the care structure in the statutory health insurance offers the possibility for the G-BA to obtain evidence for the benefit of medical practice. With an integrated regulation for testing of medical devices the manufacturers have the option to apply for an assessment of new and established treatment methods and to provide scientific evidence for the benefit of medical devices as a requirement for inclusion in the catalogue of services of the statutory health insurance. However, this expanded scope of action is also a challenge for clinicians. The already existing problem of integrating multicenter clinical trials in the surgical routine will remain. The Surgical Study Network Germany (CHIR-Net) offers an ideal way to cope with the increased requirements on studies in the field of medical devices through established partnerships with methodological institutions and practitioners in clinical settings.

• 出版日期2014-5