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Abstract: FR-PO521

Human Factors Validation of the Tablo Hemodialysis System in Home Patients

Session Information

Category: Dialysis

  • 702 Dialysis: Home Dialysis and Peritoneal Dialysis

Authors

  • Lim, Brittany, Outset Medical, San Jose, California, United States
  • Schumacher, Josh, Outset Medical, San Jose, California, United States
  • Edson, Elise, Outset Medical, San Jose, California, United States
  • D'Alessandri-Silva, Cynthia J., Outset Medical, San Jose, California, United States
  • Aragon, Michael A., Outset Medical, San Jose, California, United States
Background

Home hemodialysis (HHD) is a complex, lifesaving therapy for patients with end-stage kidney disease (ESKD). As such, the high level patient interaction needed to use devices safely and effectively while educating patients and care partners to administer dialysis at home requires significant training and can be facilitated by using more intuitive, patient-centered technology. The Tablo® Hemodialysis System (“Tablo”) is an all-in-one, easy-to-learn system indicated for clinic, hospital, and home settings. Features include a simplified user interface touchscreen GUI, coupled with images to assist with system operation. Prior validation testing of Tablo, showed a user error rate of 1.2%. Here we report simulated use human factors validation testing of a recent software version of Tablo in the home setting.

Methods

Patients and their care partners (one pair considered a “participant”) were recruited to test the Tablo user interface in a simulated use home environment. Participants underwent two days of hands-on training to learn device setup, takedown, monitoring of treatments, maintenance, and alarm resolution. After a decay of at least 24 hours, participants performed all tasks without assistance from the trainer. Task performance (including use errors, close calls, and difficulties) were recorded, along with subjective interview and knowledge task assessments.

Results

Fifteen (15) participants were recruited and consisted of 6 who held prior HHD experience and 9 with no prior HHD or self-care experience. A total of 5400 tasks were assessed across all participants, with 98.4% completed without difficulty and 0.7% completed with minor difficulty noted. The remaining 0.9% were classified as use errors, with none of these posing an unacceptable level of residual risk. Following completion of testing,100% of participants reported confidence they could use Tablo safely and effectively.

Conclusion

This human factors study demonstrates that Tablo is safe and easy to use in a simulated home environment regardless of prior experience with self-care. More recent software further reduces Tablo’s already lower user error rate. This data endorses prior reports of Tablo being easy to learn and use for patients and care partners and may contribute to the high adoption and retention rates observed with the Tablo Hemodialysis System for home use.