Abstract: SA-PO0411
Human Factors (HF) Testing in a Novel Automated Peritoneal Dialysis (PD) Cycler Designed for Easy Patient Use
Session Information
- Home Dialysis: Science and Cases, from Lab to Living Room
November 08, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 802 Dialysis: Home Dialysis and Peritoneal Dialysis
Authors
- Gupta, Nupur, Indiana University, Bloomington, Indiana, United States
- Miller, Brent W., Indiana University, Bloomington, Indiana, United States
- Aggarwal, Vikram, Northwestern Memorial HealthCare, Chicago, Illinois, United States
- Pendergraft, Rick, Simergent LLC, Oklahoma City, Oklahoma, United States
- Lindo, Steve J., Simergent LLC, Oklahoma City, Oklahoma, United States
- Sloand, James A., The George Washington University, Washington, District of Columbia, United States
Background
Summative HF usability testing was performed for an innovative new APD cycler among 15 prevalent PD patients/carepartners and 15 nurses (RNs) in Chicago and Indianapolis. This APD cycler was developed to improve patient quality of life compared to features present in existing APD cyclers.
Methods
Two “supertrainer” RNs individually trained all participants for < 2 hrs followed by a decay period. Participants then completed safety-critical Simulated Use (SU) tasks and Knowledge Tasks (KT). An independent consultant observed each participant perform the following 5 SU categories, each with multiple tasks: Device Assembly, Program Prescriptions / Nurse’s Menu (RNs), Disposables Setup, Run Therapy/Respond to Alarms using a dummy patient simulator, & Post-Therapy Teardown. Task outcomes were classified as "success", "close call", "use difficulty", or "use error" (Table 1).
Results
Of 4,279 SU tasks evaluated, 97.3% were deemed Success across all users (96.8% for patients, 97.8% for RNs). Of the 1,767 KTs, 98.6% were deemed as Success across all users (99.3% for patients, 98.0% for RNs).
Conclusion
Given the high Success rate for patients and nurses and a subsequent risk analysis of Use Difficulties, Close Calls, and Use Errors, the patient-centric APD cycler was thus found to be safe and effective for intended users & use environments in this summative HF usability study suggesting that trained patients & RNs could operate the cycler without unacceptable risks that could result in harm. Results have been submitted for FDA review as part of the 510(k) application process.
Definitions of Simulated Use Task Performance
| Success | Task correctly performed without aid from moderator; for KTs, provided the correct answer or found information in user manual. |
| Close Call | User had difficulty or made a use error that could result in harm, but took action to “recover”, preventing harm from occurring |
| Use difficulty | Any observed difficulty by user while using the device not resulting in use error, pointing to an underlying usability concern with device’s design, accompanying documentation, labeling, packaging, or training. |
| Use Error | User action/lack of action that was different from that expected by manufacturer, causing a result that (1) was different from the result expected by the user, (2) was not caused solely by system failure, & (3) did or could result in harm. |
Funding
- Other NIH Support