ConvaTec, a developer and marketer of medical technologies for community and hospital care, announced an upgrade of Flexi-Seal SIGNAL Fecal Management System (FMS) that includes a SIGNAL indicator that pops to assist clinicians in determining when the device’s retention balloon is filled to an appropriate volume, creating a safe and effective seal for their patients’ protection and preventing embarrassing leakage.
Inspired by nurses, Flexi-Seal SIGNAL FMS is for those with little or no bowel control and liquid or semi-liquid stool, and can be used for up to 29 consecutive days, according to the press release.
The product now includes a sampling port designed for safe and easy stool collection and to help decrease risk of exposure to infectious stool; a simple medication delivery process to allow prescribed medication rectally via the irrigation port, without complicating the use of the device, and an extended catheter that adapts to a range of bed sizes and accommodates a variety of patient heights and weights.
Fecal incontinence occurs in patients in critical care situations, where applying fecal management devices can cause skin breakdown (and infection), inhibiting healing. If fecal matter is not contained properly, it can result in a range of complications, including superficial skin irritation, perineal dermatitis and serious infection, and affect a patient’s comfort and dignity. Effective fecal containment reduces the risk of wound infection.
The container, to be used on a temporary basis, is for “patients with acute fecal incontinence,” designed to “safely and effectively divert fecal matter, protect patients’ wounds from fecal contamination, and reduce the risk of skin breakdown and spread of infection,” according to the press release.
Flexi-Seal SIGNAL FMS also includes:
- A soft, low-pressure balloon designed to aid easy insertion and removal and minimizes the chance of tissue necrosis
- A closed-end charcoal-filtered collection bag which is designed to contain and lock in odor, and provides an effective barrier to C. difficile transmission, a dangerous infection increasingly spreading through healthcare facilities, helping to minimize the risk of cross-contamination (the press release notes that the seal has been scientifically proven to reduce C.difficile)
- A blue easy-to-locate finger pocket for simple single-finger insertion and an increased irrigation lumen to aid in the administration of fluid to facilitate irrigation.
- A strap that securely locks onto an open bed frame, also helping to minimize the risk of contamination that might result from spillage
More than 90 percent of the 40 patients involved in a clinical study to evaluate the safety and performance of Flexi-Seal FMS were found to have their skin condition maintained or improved, according to the press release.
Clearly, this is something that’s uncomfortable to think about, but when the need is there, containing these fluids safely and cleanly is, of course, paramount.
Edited by
Brooke Neuman
