Abstract: FR-PO527
Point of Care Peritoneal Dialysis: Initial Usability Assessments
Session Information
- Home Dialysis, Policy, Novel Approaches
November 04, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 702 Dialysis: Home Dialysis and Peritoneal Dialysis
Authors
- Talbot, Ben, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia
- Lynch, Sue Robyn, MedTech Pathways, Sydney, New South Wales, Australia
- Burman, Jenny Ann, Ellen Medical Devices, Sydney, New South Wales, Australia
- Garvey, Vincent Joseph, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia
- Kaur, Navneet, Ellen Medical Devices, Sydney, New South Wales, Australia
- Knight, John, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia
Background
The Ellen Medical Devices Point-Of-Care (EM-POC) system can be used by patients and care-givers to produce PD fluid from potable water at the point-of-care.
Early identification of potential use errors is important within the medical device design process. IEC 62366-1 is a medical device human factors engineering process standard used to establish the safety of medical devices with respect to usability. Formative evaluations are completed iteratively, early and often throughout an optimal design process, with feedback used to improve device design.
We present results from early formative evaluations which have informed the ongoing design and development of the EM-POC system.
Methods
Formative human factors evaluations compliant to IEC 62366-1 were completed with an experienced PD patient, PD nurses and internal company personnel:
1. Participants assessed usability of a prototype device when used to to complete PD bag fills with sterile water produced by the EM-POC system at home. (n=4)
2. Participants completed tasks and provided opinions regarding aspects of design and usability through online evaluations using images of the prototype and software simulation of the user interface. (n=3)
Results
The most common potential harm identified was concern over contamination risk leading to peritonitis.
Resulting design adjustments have included:
1. Tactile and auditory feedback during connection of the PD bag
2. Improved geometry and visibility of the connection port
3. A single step connection process
4. Prohibited distilling if the connection is incomplete or incorrect
Conclusion
Early formative evaluations have successfully identified potential use errors enabling design refinement and improvement prior to further clinical evaluation.
Funding
- Commercial Support – Ellen Medical Devices