Nutzenbewertung von Medizinprodukten in der chirurgischen Praxis

Abstract

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.

Barriers and facilitators of patient access to medical devices in Europe: A systematic literature review

“…Three articles were the result of meetings. Data from publications was organized on: market access (n = 9) [6,8,10,[22][23][24][25][26][27], patient access (n = 17) [12,13,[28][29][30][31][32][33][34][35][36][37][38][39][40][41][42], effective patient access (n = 0) or a combination (n = 14) [9,16,[43][44][45][46][47][48][49][50][51][52][53][54]. Depending on the type of access, the included publications provided data about France, Germany, Italy, Spain, the United Kingdom (UK), the Netherlands, Sweden and/or Poland (see 3.2.1., 3.2.2. and 3.2.3. for the specification of reported countries by access type).…”

“…Most of the publications were in English. However, publications in German (n = 5) [27,29,35,47,49] and Italian (n = 1) [33] were also included. Fig.…”

“…Market approval procedures. Market access to MDs was the main objective in nineteen publications, and concerned five countries: France (n = 3) [16,50,51], Germany (n = 4) [27,43,47,49], the UK (n = 11) [6,8,10,[22][23][24]26,43,[52][53][54], Sweden (n = 2) [48,53], and/or Poland (n = 1) [25].…”

“…Low-risk devices (class I) can be self-certified by the manufacturer on the basis of safety and performance. Class II and III devices' applications are supported by a literature review or clinical data that can either originate from the device itself or equivalent devices [8,22,23,27,47,49,52]. For class III devices, effec- tiveness data is required [51].…”

Komplikationen in der Chirurgie

“…Schon immer aber waren auch die unerwünschten Operationsfolgen Bestandteil der Chirurgie, die Demut erzeugende [1] andere Seite der ansonsten vielfach glänzenden Medizinmedaille, gleichsam das Yin und Yang des Chirurgen. [4][5][6][7][8][9][10][11][12][13][14].…”