Clinical Performance +
Why FX Dialyzers make a difference
FX Dialyzers have been used in more than 500 million treatments worldwide. As the world’s leading provider of dialysis products, Fresenius Medical Care aims to make a difference — for patients and healthcare professionals.
Continuous innovation combined with our commitment to the highest level of quality standards, ensure that our FX Dialyzers portfolio is built to address the individual needs of patients.
All FX Dialyzers have the capacity to remove a broad range of uremic toxins, effectively retain endotoxins, and provide intrinsic biocompatibility.1
A smooth treatment is the difference that allows us to focus more on the patient.
FX properties that make a difference
Several state-of-the-art technologies have been combined to create the distinctive functional properties of the FX Dialyzers. Together they make a difference in terms of beneficial patient outcomes, smooth handling and cost savings potential.
The blue header with its laterally placed blood inlet port is designed to reduce the risk of kinked bloodlines, aiming at smooth handling and allowing healthcare professionals to focus on what really matters — the best care for patients.
The FX Dialyzers are developed for system compatibility, perfectly fitting into automatic priming procedures with low rinsing volumes and short preparation times. In addition, there is no need to turn any FX Dialyzer during the priming procedure. Moreover, the FX Dialyzers have a removable label that can easily be attached to patient records, allowing for quick documentation.
Simplified workflows, user-friendly handling and short preparation time support the nursing staff’s daily work — freeing up resources to focus more on patients.
Fresenius Medical Care’s Nano Controlled Spinning (NCS™) technology creates fibers with a highly defined membrane architecture. Precise nanoscale modulation of pore size, structure and distribution favors minimal resistance to solute transfer across the membrane and contributes to improved clearances compared to macro-design membranes.10,11
Additionally, the microwave fiber structure enables the homogenous distribution of dialysis fluid, supported by the inner housing’s pinnacle design of the FX Dialyzers. It prevents the channelling of the dialysis fluid and ensures that each fiber within the bundle is perfectly surrounded by the dialysis fluid.11,12,13
The optimized header design of the FX Dialyzers ensures a homogenous blood flow path. Its geometry allows a spiral distribution of blood in the dialyzer header, preventing low velocity stagnation zones and resulting in an enhanced performance.11
Setting the standard
Each FX Dialyzer is individually sterilized by the unique INLINE steam sterilization method. Both the blood and the dialysate compartments of the dialyzer are rinsed continuously with steam at a minimum temperature of 121° C.
Rinsing with hot steam assures a gentle sterilization — without the need for chemicals or irradiation, which may lead to increased cytotoxic14 and carcinogenic residuals.15,16
Optimal use of resources
The INLINE steam sterilization process allows for the efficient use of resources during preparation as well as a reduction of costs, since only 500 mL rinsing volume is required. The process
- includes a 100% fiber integrity test, aimed at minimizing the risk of blood leakages due to fiber ruptures
- ensures that all FX Dialyzers are already pre-rinsed and ready to use upon arrival, resulting in short rinsing time and low rinsing volumes.
Best choice for high biocompatibility
Cytotoxicity is minimal after steam sterilization, whereas it increases with gamma irradiation.14 Studies have shown that with steam sterilized dialyzer membranes, less oxidative stress is induced to the patient’s blood compared to gamma sterilization.17,18,19
Performance characteristics remain intact
Changes of the material properties can be observed after sterilization with gamma irradiation, while the material remains intact in this respect when using steam sterilization.20
Increased losses of albumin during dialysis sessions have been observed with gamma sterilized dialyzers which were stored for a longer time.14,21
Adding value across the entire life cycle
Fresenius Medical Care has implemented an approach based on the Life Cycle Assessment (LCA) methodology, which follows the structure and requirements of EN ISO 14040/44: 2006:
- Comprehensive assessment of a product’s environmental impact across its full life cycle, from materials supply to manufacturing, distribution, use and final disposal
- Identification of improvement opportunities through environmentally sound processes, materials and design choices.
Lightweight material is essential for environmental sustainability
The advanced housing material of any FX Dialyzer is made of environmentally friendly and lightweight polypropylene. Due to the advanced material, FX Dialyzers up to 50% lighter (before treatment) than dialyzers made of polycarbonate22
This may result in improved end-of-life management by producing less waste23 and contributing to cost savings.
Across 15 environmental impact categories24, the overall eco-performance of an FX Dialyzer (FX classix 80) is notably better — on average by 42 % — compared to a reference dialyzer made from polycarbonate (HF 80S).25
The difference is feeling confident throughout the entire treatment.
Reliability and experience make a difference when seeking the best solutions.
1 Wagner S. et al., Nephrology Dialysis Transplantation (2017); 32 (3): iii615.
2 Bock A. et al., J Am Soc Nephrol (2013); 24: SA-PO404.
3 Maduell F. et al., Blood Purif. (2014); 37(2): 125-130.
4 Lim P. S. et al., Artif Organs (2017); Nov 27. doi: 10.1111/aor.13011.
5 Schindler R. et al., Clin. Nephrology (2003); 59: 447–454.
6 Weber V. et al., Artif Organs (2004); 28(2): 210-217.
7 Chazot C. et al., Nephron (2015); 129: 269-275.
8 Tsai I.J. et al., Pediatr Nephrol (2014); 29: 111–116.
9 Data from Fresenius Medical Care Deutschland GmbH: Comparison clearance values F8 HPS (effective surface area 1.8 m2) versus FX 8 (effective surface area 1.4 m2).
10 Ronco C., Nissenson A. R., Blood Purif (2001); 19: 347-352.
11 Ronco C. et al., Kidney International (2002); 61 (80): 126-142.
12 Külz M. et al., Nephrol Dial Transplant (2002); 17: 1475-1479.
13 Mandolfo S. et al., The International Journal of Artificial Organs (2003); 26 (2): 113-120.
14 Allard B. et al., Le Pharmacien Hospitalier et Clinicien (2013); 48 (4): 15-21.
15 Shintani H., Biomedical instrumentation & technology (1995); 29 (6): 513–519.
16 Hirata N. et al., Radiation Physics and Chemistry (1995); 46 (3): 377–381.
17 Golli-Bennour E. E. et al., International urology and nephrology (2011); 43 (2): 483–490.
18 Azzabi A. et al., Néphrologie & Thérapeutique (2014); 10 (5): 318.
19 Golli-Bennour E.E et al., World J Nephrol Urol (2017); 6 (1-2): 14-17.
20 da Silva Aquino K. A., INtechOpen (2012); www.intechopen.com/books/gamma-radiation/sterilization-by-gamma-irradiation (27.04.2018).
21 Dawids S., Handlos V. N., Developments in hematology and immunology (1989); 347–368.
22 Unpublished data from Fresenius Medical Care Deutschland GmbH: Internal calculation based on weight measurements before treatment of FX Dialysers versus F-series dialysers.
23 Unpublished data from Fresenius Medical Care Deutschland GmbH: Internal calculation based on weight measurements of FME FX classix 80 versus FME HF 80S. The typical number of treatments in most clinics is approximately 10,000 per year; this results in about 1,600 kg less waste being produced annually with FX classix 80 when used on FME 5008 CorDiax machine.
24 EC-JRC-IES (2011): ILCD handbook – Recommendations for LCIA in the European context. Source: publications.jrc.ec.europa.eu/repository/handle/JRC61049 (all 15 environmental impact categories with recommendation in table 1 of this ILCD handbook have been evaluated).
25 Unpublished data from Fresenius Medical Care Deutschland GmbH internal study (2018): Comparative life cycle assessment of selected FME dialysers. Eco-performance is always calculated versus baseline product (FME HF 80S); long distance scenario illustrated.
26 Melchior, P. et al. (2021). Complement activation by dialysis membranes and its association with secondary membrane formation and surface charge. Artificial Organs, 00, 1-9. https://doi.org/10.1111/aor.13887
27 Zawada, A. et al. (2021). Polyvinylpyrrolidone in hemodialysis membranes: Impact on platelet loss during hemodialysis. Hemodialysis International, 25, 1– 9. https://doi.org/10.1111/hdi.12939
28 Ehlerding, G. et al. (2021). Performance and hemocompatibility of a novel polysulfone dialyzer: a randomized controlled trial. Kidney360, 2(6), 937-947 https://doi.org/10.34067/KID.0000302021
29 Ehlerding, G. et al. (2021). Randomized comparison of three high-flux dialyzers during high volume online hemodiafiltration – the comPERFORM study, Clinical Kidney Journal; sfab196. doi.org/10.1093/ckj/sfab196