Advanced Medical Balloons (#4660)
Managing fecal incontinence in the critical care units within an acute care hospital is challenging at the best of times. It is an underestimated issue and is a common problem throughout hospitals in the USA. Fecal incontinence in the ICU can be a significant problem, as it can lead to skin breakdown, infections, additional caregiver burden, and substantial economic burden. 1-5* Fecal incontinence affects up to 30-42% 6-7* of all critical care patients.
In 2005, the first-generation fecal management systems were introduced and quickly became a standard of care throughout the majority of hospitals in the U.S.A.
Fecal management systems (FMS) prevent infections and complications in intensive care. They help to:
- Prevent infections
- Reduce the incidence of dermatitis and pressure ulcers (IAD/HAPI)
- Maintain patient comfort and dignity
- Facilitate nursing care
- Prevent cross-contamination (HAI)
- Minimize cleaning and treatment costs
These water filled silicone-based 1st generation devices did provide some clinical relief to caregivers and patients and, over time, became well accepted as an integral part of fecal management protocols of care. However, the stool leakage rates of these designs remain very high. In the 2015 study by the Cleveland Clinic9, they reported leakage rates for the two market-leading FMS products to be 70% with a reported anal erosion rate of 13.8%. Thus, the clinical and health-economic relevance of continuing to reduce stool leakage in the ICU and other critical care units remains high.
Advanced Medical Balloons (AMB) is a highly innovative medical technology specialty company that designs, develops, and markets catheter technology based on microscopically thin, complex-shaped balloon films made of polyurethane (PUR) that are filled with air rather than water. They deduced that the key to unlocking superior outcomes in reducing stool leakage was understanding and reimagining the material and shape of the catheter balloon to create a true, trans anal canal seal that aligns with the natural functions/movement of the colon.
Hygh-tec® FMS is the next-generation FMS, employing a different and softer material with a more flexible intra-rectal balloon design for better adjustment to the anatomical situation. The balloon of the device head is dumbbell-shaped and filled with air. Its design provides an improved sealing efficiency and has been shown clinically to lower the incidence of device-related adverse events, in particular when used for longer time periods and up to its approved usage time (30 days) 9-10*.
Hygh-tec® FMS is indicated for continuous trans-anal drainage and collection of liquid or semi-liquid stool and provides separate access for cleaning and medication administration.
Hygh-tec® FMS is an adaptable, dynamic fecal management system, setting a new standard in Critical Care with a conforming design that dramatically reduces patient leakage. In 2024, The Heidelberg (Germany) Univ. Hospital reported that the hygh-tec® FMS leakage rate was 10.3% and the rate of anal erosion was under 1% in a clinical study 10* that modeled the clinical protocol used in the 2015 Cleveland Clinic study looking at the leakage rates and anal erosion of two 1st generation fecal management systems.
*Footnote information available upon request. Please contact Stephen Forden, General Manager, [email protected] or (908) 247-0781.
CONTRACT SUMMARY
AGREEMENT #4660
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Products:
Fecal Management System
Ordering Information:
All Customer Orders placed at [email protected]
Price Protection:
No – Maximum Increase Not to Exceed 5% Annually
Shipping Terms:
Freight is pre-paid and added to invoice or shipped using the facility’s shipping number and carrier. No processing, handling, or minimum order fees unless facility order is under $100. Products shall be shipped FOB Shipping Point unless expressly agreed upon between Vendor and Individual Customer.
Payment Terms:
Net 30
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