Introduction: Uptake rates of home hemodialysis are the lowest among all modality types, despite providing patients with clinical and quality of life benefits at a lower cost to providers. Currently, there is a need to develop dialysis systems that are appealing to patients while also being suitable for use across the continuum of care. The SC+ hemodialysis system was developed by Quanta Dialysis Technologies Ltd. to provide patients with a dialysis system that is small, simple to use, and powerful enough to deliver acceptable dialysis adequacy. Methods: As part of the SC+ design validation, human factors testing was performed with 17 Healthcare Professionals (nephrology nurses and healthcare assistants) and 15 Home Users (patients and caregivers). To assess usability and safety, the human factors testing involved between 4.5 and 6 hours of training and, after a period of training decay, a subsequent test session in which participants independently performed tasks on SC+. Findings: Between the two user groups, there were only 29 errors observed out of 1216 opportunities for errors, despite minimal training. Errors that did occur were minor and attributed to an initial lack of familiarity with the device; none were safety related. Discussion: Among prevalent dialysis patients and healthcare professionals, the SC+ hemodialysis system was easy to use, even with minimal training and a learning decay period, and had a high level of use safety. By taking into account human factors to optimize the user experience, SC+ has the potential to address systemic and patient barriers, allowing for wider self‐care and home hemodialysis adoption.
Background and objective The SC+ haemodialysis system developed by Quanta Dialysis Technologies is a small, easy-to-use dialysis system designed to improve patient access to self-care and home haemodialysis. A prototype variant of the standard SC+ device with a modified fluidic management system generating a pulsatile push-pull dialysate flow through the dialyser during use has been developed for evaluation. It was hypothesized that, as a consequence of the pulsatile push-pull flow through the dialyser, the boundary layers at the membrane surface would be disrupted, thereby enhancing solute transport across the membrane, modifying protein fouling and maintaining the surface area available for mass and fluid transport throughout the whole treatment, leading to solute transport (clearance) enhancement compared to normal haemodialysis (HD) operation. Methods The pumping action of the SC+ system was modified by altering the sequence and timings of the valves and pumps associated with the flow balancing chambers that push and pull dialysis fluid to and from the dialyser. Using this unique prototype device, solute clearance performance was assessed across a range of molecular weights in two related series of laboratory bench studies. The first measured dialysis fluid moving across the dialyser membrane using ultrasonic flowmeters to establish the validity of the approach; solute clearance was subsequently measured using fluorescently tagged dextran molecules as surrogates for uraemic toxins. The second study used human blood doped with uraemic toxins collected from the spent dialysate of dialysis patients to quantify solute transport. In both, the performance of the SC+ prototype was assessed alongside reference devices operating in HD and pre-dilution haemodiafiltration (HDF) modes.
Rationale & Objective Most kidney failure patients receive hemodialysis three times-per-week in a facility. More frequent and longer-duration dialysis prescriptions improve a number of key outcome measures. These prescriptions are best suited to self-care and home regimens. The Quanta SC+ hemodialysis system is a novel device with demonstrated ease of use for patients and healthcare practitioners through Human Factors Testing. The primary objective of this study is to report the efficacy and safety of the SC+ system using conventional hemodialysis prescriptions. Study Design Non-randomized, observational study Setting & Participants: Prevalent hemodialysis patients in 4 sites in the United Kingdom were recruited to switch from their current device to the SC+ system with no other changes to their prescription. Interventions SC+ hemodialysis system Outcomes Efficacy data were collected in terms of dialysis adequacy, urea reduction ratios, and net fluid removal accuracy. Results 60 patients were enrolled in the study resulting in 1,333 evaluable treatments. The threshold spKt/V of 1.2 was exceeded in 96.6 percent of treatments in patients receiving three-times weekly regimens, while the threshold stdKt/V of 2.1 was exceeded in 94% of treatments and 97.6% of treatments in patients without significant residual kidney function. Ultrafiltration accuracy was determined by measuring net fluid removal and validated to be within acceptable limits. The adverse event profile during treatment was typical of hemodialysis. There were no serious adverse events. Limitations Few patients on high-frequency treatment regimens were enrolled. Conclusions The SC+ system delivers safe and effective hemodialysis across a range of patients and dialysis prescriptions. It is one of the smallest systems available and has validated usability for patients to perform self-care safely with minimal training. This device may encourage patients to feel empowered to take on home hemodialysis, unlocking beneficial clinical and patient-reported outcome associated with these modalities.
Background and Aims Fluid management is an integral component for managing patients to correct abnormalities in plasma composition and maintain fluid balance. Consequently, accurate fluid removal during treatment is a critical design element of haemodialysis machines. The SC+ haemodialysis system developed by Quanta Dialysis Technologies, is a small, simple-to-use dialysis system designed to improve patient access to self-care and home haemodialysis. This paper describes the design, evaluation and performance of the flow balance and ultrafiltration module of SC+ to deliver specified fluid removal in accordance with the international technical standards for haemodialysis defined in IEC 60601-2-16 using a number of unique proprietary technologies. Method SC+ uses volumetric flow balancing chambers which are contained within a single use disposable cartridge. During normal operation of SC+, dialysis fluid flows through the cartridge in discrete packets. This is achieved by the application of pneumatic pressure and vacuum to manipulate a flexible PVC membrane that, in turn, opens and closes a sequential series of valves and pump cavities that constitute the flow balance chambers. Proof of system performance was undertaken using a range of dialysers and venous pressures, with and without ultrafiltration, to quantify the net fluid removal error, in order to simulate a range of patient conditions in typical clinical practice. Results In total, the tests comprised 22 separate runs on multiple machines, with 88 individual 30-minute measurement samples, taken over a range of environmental conditions, dialyser types (with differing KuF), dialysate flowrates, and venous pressures. Across all results, there was a mean error of 7.4g/hour rate error, (max allowed is 100g/hr) of positive flow from the blood to the dialysate side with a standard deviation of 19.88g/hr. The maximum permissible rate stated in IEC 60601-2-16 is +/-100g/hr. In specific detail, without ultrafiltration the flow balance error was measured as 2.2g/hr with a deviation of 19.0g/hr, and with ultrafiltration the mean error was 12.8g/hr with a standard deviation of 19.5g/hr. Conclusion It has been demonstrated that flow balance error and fluid removal attainable with the SC+ haemodialysis system lies well within the acceptable standards permitted for haemodialysis machines. This essential performance parameter as defined within IEC 60601-2-16 has been demonstrated across a range of clinically relevant parameters at dialysate flow rates of up to 500ml/min
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