Table 2: Comparative attributes of conventional FI management options versus closed-loop automated stool management.
|
Attribute |
Adult diapers |
Absorbent pads |
IBCs (e.g., Flexi-Seal) |
Qoramatic ASM |
|
System type |
Open |
Open |
Semi-closed (balloon-anchored) |
Closed-loop |
|
Containment of liquid stool |
Poor |
Poor to moderate |
Variable; balloon migration common |
High |
|
Reported leakage |
Frequent |
Frequent in high-output FI |
40-78% |
1.8% (≤1% post-implementation) |
|
Mucosal injury risk |
None (skin only) |
None (skin only) |
7-28% device-related injury |
None reported |
|
Nursing time per patient per day |
High (frequent changes) |
174-348 minutes |
~66-120 minutes (per IBC literature) |
~6.8 min initial; ~0.4 min follow-up |
|
Use in anticoagulated / fragile patients |
Permitted |
Permitted |
Cautionary or contraindicated |
Permitted (zero radial pressure) |
|
Environmental contamination footprint |
High |
High |
Moderate |
Low |
IBC: indwelling balloon catheter. Qoramatic ASM data are from the pivotal 20-patient single-center evaluation and post-market surveillance (data on file). IBC parameters reflect peer-reviewed literature [6].