Results of human factors testing in a novel Hemodialysis system designed for ease of patient use

Wilcox, Stephen; Carver, Michelle; Yau, May; Sneeringer, Peter; Prichard, Sarah; Álvarez, Luis Octavio Martínez; Chertow, Glenn M.

doi:10.1111/hdi.12430

Cited by 13 publications

(13 citation statements)

References 13 publications

(24 reference statements)

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“…14 There are a number of possible reasons for the limited uptake of home hemodialysis in the United States, including (1) gaps in nephrologist training and experience; (2) generally low levels of patient engagement and activation; (3) fear of self-cannulation; (4) lack of 1 or more trained dialysis partners or caretakers; and (5) technical challenges brought on by nonintuitive machine design. 18 Studies conducted in the self-care hemodialysis setting indicate that patients can independently, accurately, and rapidly manage treatments with Tablo including setup and resolution of any alarms that may occur. [15][16][17] The Tablo ® Hemodialysis system was designed to address several of the barriers to home hemodialysis through a consumer-centric design focused on increasing patient engagement with a system that is easy to learn and use ( Figure 1).…”

Section: Introductionmentioning

confidence: 99%

“…Human factors studies have shown that the Tablo system is easy to learn. 18 Studies conducted in the self-care hemodialysis setting indicate that patients can independently, accurately, and rapidly manage treatments with Tablo including setup and resolution of any alarms that may occur. 19 The objective of the current investigational device exemption (IDE) trial was to evaluate the safety and efficacy of Tablo when used in-center managed by trained health professionals and in-home by trained patients or a care partner.…”

Section: Introductionmentioning

confidence: 99%

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Safety and efficacy of the Tablo hemodialysis system for in‐center and home hemodialysis

Plumb

Álvarez

Ross³

et al. 2019

Hemodialysis International

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Introduction: Home hemodialysis remains underutilized despite observational data indicating more favorable outcomes with home compared with in-center hemodialysis. The Tablo Hemodialysis system is designed to be easy to learn and use and to facilitate adoption of home hemodialysis. The objective of the current investigational device exemption (IDE) study was to evaluate the safety and efficacy of Tablo managed in-center by health care professionals and in-home by patients and/or caregivers.Methods: A prospective, multicenter, open-label, crossover trial comparing in-center and in-home hemodialysis using Tablo. There were 4 treatment periods during which hemodialysis was prescribed 4 times per week: 1-week Run-In, 8-week In-Center, 4-week Transition, and 8-week In-Home. The primary efficacy endpoint was weekly standard Kt/V urea ≥ 2.1. The secondary efficacy endpoint was delivery of ultrafiltration (UF) within 10% of prescribed UF. We collected safety and usability data.Findings: Thirty participants enrolled and 28 completed all trial periods. Adherence to the protocol requirement of 4 treatments per week was 96% in-center and 99% in-home. The average prescribed and delivered session lengths were 3.4 hours for both the In-Center and the In-Home periods. The primary efficacy endpoint for the intention-to-treat cohort was achieved in 199/200 (99.5%) of measurements during the In-Center period and 168/171 (98.3%) In-Home. The average weekly standard Kt/V urea was 2.8 in both periods. The secondary efficacy UF endpoint was achieved in the ITT cohort in 94% in both in-center and in-home.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Safety and efficacy of the Tablo hemodialysis system for in‐center and home hemodialysis

Plumb

Álvarez

Ross³

et al. 2019

Hemodialysis International

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“…Similar methodologies have been employed for other HHD systems to assess the clinical safety and performance of the systems within controlled clinical environments prior to roll‐out in home settings. For example, HFT was conducted for the recently developed Tablo hemodialysis system with Healthcare Professionals and patients …”

Section: Discussionmentioning

confidence: 99%

“…For example, HFT was conducted for the recently developed Tablo hemodialysis system with Healthcare Professionals and patients. 27 This HFT study does have certain limitations; although the home is the principle target environment for use of SC +, usability testing is difficult to execute in the home. However, our simulated home environment was deemed an adequate representation, particularly because it included similar distractions that would be found in a home, such as televisions, noise from patients and staff, and variation in lighting conditions (i.e., bright sunlight hitting the screen, as well as low ambient lighting conditions).…”

Section: Discussionmentioning

confidence: 99%

Human factors testing of the Quanta SC+ hemodialysis system: An innovative system for home and clinic use

Harasemiw

Day

Milad³

et al. 2019

Hemodialysis International

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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.

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“…Although some have been adapted for home use, more recently manufacturers have begun focusing on machines specifically developed for home therapy use and patient operation [11,12]. Such an approach has necessitated an improved understanding of industrial design, human factors and ergonomics to ensure that the burden of undertaking treatment in the home is reduced for the patient and their care partner [13,14].…”

Section: Plos Onementioning

confidence: 99%

Enhancement of solute clearance using pulsatile push-pull dialysate flow for the Quanta SC+: A novel clinic-to-home haemodialysis system

Buckberry¹,

Hoenich

Krieter

et al. 2020

PLoS ONE

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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.

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Results of human factors testing in a novel Hemodialysis system designed for ease of patient use

Cited by 13 publications

References 13 publications

Safety and efficacy of the Tablo hemodialysis system for in‐center and home hemodialysis

Safety and efficacy of the Tablo hemodialysis system for in‐center and home hemodialysis

Human factors testing of the Quanta SC+ hemodialysis system: An innovative system for home and clinic use

Enhancement of solute clearance using pulsatile push-pull dialysate flow for the Quanta SC+: A novel clinic-to-home haemodialysis system

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