title: Facing regulatory challenges of on-line hemodiafiltration.
abstract: On-line hemodiafiltration (on-line HDF) is the result of a vision that triggered multifarious changes in very different areas. Driven by the idea to offer better medical treatment for renal patients, technological innovations were developed and established that also constituted new challenges in the field of regulatory affairs. The existing regulations predominantly addressed the quality and safety of those products needed to perform dialysis treatment which were supplied by industrial manufacturers. However, the complexity of treatment system required for the provision of on-line fluids demanded a holistic approach encompassing all components involved. Hence, focus was placed not only on single products, but much more on their interfacing, and the clinical infrastructure, in particular, had to undergo substantial changes. The overall understanding of the interaction between such factors, quite different in their nature, was crucial to overcome the arising regulatory obstacles. This essay describes the evolution of the on-line HDF procedure from the regulatory point of view. A simplified diagram demonstrates the path taken from the former regulatory understanding to the realization of necessary changes. That achievement was only possible through 'management of preview' and consequent promotion of technical and medical innovations as well as regulatory re-evaluations.
authors.affiliation: Fresenius Medical Care Deutschland GmbH, Bad Homburg, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Kümmerle
mesh_terms: D018795:Device Approval; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D017583:Hemodiafiltration / Q000295:instrumentation / Q000592:standards*; D006801:Humans; D011786:Quality Control; D051437:Renal Insufficiency / Q000628:therapy; D012926:Social Control, Formal