SP474
IMPLEMENTATION OF A COMPACT HAEMODIALYSIS SYSTEM IN A REAL-WORLD ENVIRONMENT: ASSESSMENT OF USER UPTAKE, SAFETY, PERFORMANCE AND USABILITY Free

INTRODUCTION AND AIMS: SC+ is a cartridge-based haemodialysis system. It provides a small, simple and powerful technical solution to support user-led care and in parallel delivers performance equivalent to in-centre machines. This study assessed the safety, performance and usability of the system in-centre and in the subject’s home.

METHODS: A single-arm, prospective, multi-centre, observational study on the haemodialysis-dependent, end-stage renal disease (ESRD) patient population. Subjects who met a broad inclusion/exclusion criteria (aged >18 years, meeting intended use statement for SC+ and good functioning vascular access) were approached by the clinic’s Principal Investigator to participate. Each dialysis therapy was performed on an outpatient basis in line with each subjects’ prescription using a bicarbonate-based dialysate at a flow rate of 500 mL/min and blood flow rates of between 300 and 450 ml/min. During the final phase of the study a sub-set of users (patients and Health Care Professionals) were identified to undergo training, competency sign-off and subsequently conduct treatments using SC+ independently. Within this ‘user led’ phase, participants were monitored to assess training comprehension and what, if any, support was required from technical experts following competency sign-off.

RESULTS: Clinical and technical performance of SC+ was assessed by subject urea reduction ratio (URR), standardised weekly Kt/V and the percentage of scheduled dialysis treatments completed without premature termination. The average StdKt/V for the study population was >2.1. No significant differences were observed in the safety and performance of SC+ between the overall patient population and user led sub-set. Usability issues identified whilst transitioning to the user led phase largely related to training flow and have been incorporated into future training material revisions. No significant usability issues relating to device operation were observed. Two Adverse Device Effects were reported during the study, all other reported Adverse Events & Device Deficiencies were assessed to be non-serious or not device related.

CONCLUSIONS: SC+ functioned safely with acceptable clinical and technical performance in the ESRD subject population. There was no measured loss of therapy time, UF error was acceptable, no significant usability issues were noted, and there were no safety issues in the subject population. Clinical performance was demonstrated by subjects attaining a weekly StdKt/V of greater than 2.1, recommended as a weekly adequacy equivalence by Gotch. Combined with previous usability studies the user led phase validates that SC+ can be used independently by patients and Health Care Professionals in a real-world environment.