ConvaTec, a developer of medical technologies, has launched the enhanced Flexi-Seal Signal fecal management system (FMS) in the US.
The nurse-inspired enhancements from the Flexi-Seal FMS family of fecal management systems include a sampling port, a medication delivery process and an extended catheter.
The sampling port is designed for safe stool collection and to help reduce risk of exposure to infectious stools, while the medication delivery process enables prescribed medication rectally via the irrigation port.
The extended catheter can adapt to a range of bed sizes and accommodate a variety of patient heights and weights, according to the company.
Other features of Flexi-Seal Signal FMS include the SIGNAL indicator, which indicates when the device's retention balloon is filled to an appropriate volume, and a low-pressure balloon, which allows simple insertion and removal.
A closed-end, charcoal-filtered collection bag will contain and lock in odour and act as a barrier to C. difficile transmission, while a versatile strap will securely lock onto an open bed frame.
A 42-patient clinical study evaluated the safety and performance of Flexi-Seal FMS in subjects with liquid or semi-liquid diarrhoea and incontinence.
The study data reported that Flexi-Seal FMS improved faecal incontinence control, was efficacious and was time efficient in 83% of caregivers. Skin conditions were maintained or improved in 92% of patients.
Healthy rectal mucosa was observed in patients who had baseline and follow-up endoscopy, after using Flexi-Seal FMS.
The temporary containment device does not contain natural rubber latex components.