Validation of a Dialyzer Reprocessing Device

About the Research Group
This project is part of ESCH-R and KitNewCare, two leading initiatives driving sustainable healthcare in Europe. At UMC Utrecht, the Department of Nephrology serves as one of the clinical sites, focusing on accelerating circular practices by reducing single-use medical consumables and promoting systemic change to transform kidney care into a model for environmental sustainability. Our interdisciplinary research group, composed of engineers, designers, and healthcare professionals, plays a central role in developing sustainable medical technologies, circular workflows, and stakeholder-driven solutions. By designing reusable medical devices and optimizing hospital processes, we contribute to a more sustainable and circular healthcare system.

dialyzer 1

Project Description
Patients with kidney failure typically undergo hemodialysis treatment three times a week. A crucial component in this process is the dialyzer, also known as an artificial kidney, which filters waste products, excess fluids, and toxins from the blood when the kidneys can no longer perform this function. To reduce medical waste in hemodialysis, the practice of reprocessing, which involves cleaning and preparing dialyzers for safe reuse, is practiced in countries such as the United States and India. As part of this effort, we are evaluating a dialyzer reprocessing unit developed by NovaFlux in the United States, which has already received FDA approval.Before this technology can be introduced in Europe, two key challenges must be addressed. The first challenge concerns regulatory differences, since all dialyzers in Europe are currently labeled as single use devices, whereas reusable dialyzers are marketed and permitted in the United States. The second challenge arises from differences in clinical practice. While the NovaFlux device has been validated for hemodialysis, the standard treatment in Europe is Hemodiafiltration. This method applies additional pressure to the dialyzer to improve treatment efficiency, which introduces a higher risk of membrane fouling during reuse. As part of the validation process, the device will be tested using dialyzers that have been used by patients as well as with simulated blood in order to closely replicate real world clinical conditions. In addition, the integrity and performance of the dialyzers will be thoroughly evaluated after multiple reprocessing cycles to ensure that safety, functionality, and treatment efficacy are maintained throughout repeated use. In collaboration with NovaFlux, this project focuses on validating the reprocessing unit to ensure its safety, effectiveness, and compliance with European standards. The ultimate goal is to support future CE marking and enable the adoption of this technology within Europe.

Student Requirements– Medical Engineering, Technical Medicine, Biomedical Engineering, Clinical Technology, or a related field- Interested in testing and validation of medical devices- Passionate about sustainability in healthcare- Familiarity with laboratory work and experimental setups- Basic understanding of medical device regulations and standards- Analytical mindset with an interest in data collection and performance evaluation

Project Length
Internship/ Graduation Project (3 to 6 months)

Location
UMC Utrecht

Contact Information
Jan Tsai- PhD Student
c.tsai@umcutrecht.nl

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