Fresenius Medical Care, International Quality and Regulatory Affairs Email: wolfgang.kuemmerle{at}fmc\|[hyphen]\|ag.de
Sir,
Subsequent to the recent Editorial Comment by Prof. Canaud [1], Fresenius Medical Care wishes to respond to concerns and questions from patients and dialysis care personnel and hereby expressively confirm that perfluorocarbon-based fluids are not used in the manufacturing process of Fresenius Medical Care dialysers. Moreover, Fresenius Medical Care dialysers that fail the inline integrity test in the production process are rejected and are not reprocessed.
Furthermore, according to our market surveillance we do not share the opinion that perfluorohydrocarbons are well-known products that are widely used in the dialyser manufacturing industry ....
In the interest of all parties currently using Fresenius Medical Care dialysers we once again state that Fresenius Polysulfone® differs distinctly from the dialysers in question based on the raw materials used, the polymer, the manufacturing process, sterilization process and clinical performance characteristics.
Today, and in the future, every effort will be undertaken by Fresenius Medical Care to comply rigorously with the highest quality and safety guidelines and ensure the well being of our patients and all served by our company.
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