Responding to Your Needs: Two Decades of Flexi-Seal™ Innovation in Fecal Management

The history of Flexi-Seal™

Let's take a look at the history of modern fecal management and on how Convatec decided to make fecal management our priority, so it doesn’t have to be yours.

Fecal incontinence is a well-known nursing challenge that can be both uncomfortable and embarrassing for patients¹. Traditionally, the management of fecal incontinence has consisted of addressing the patient's hygiene needs, changing bed linens and using incontinence pads, etc.¹ most of which are considered inadequate by the medical profession.² In 2005, the challenge of managing fecal incontinence changed significantly with the introduction of the first Flexi-Seal™ Fecal Management System; A product developed to assist clinicians in the management of fecal incontinence, infection control, associated skin damage², and rectal medication delivery. In fact, this was just the beginning. The feedback on Flexi-Seal™ - suggestions and ideas from clinicians around the world – has led to our continued development on a whole portfolio of Flexi-Seal devices throughout the years:

Flexi-Seal Signal™

By listening to nurses' clinical needs, we introduced a groundbreaking product update in 2010: the Flexi-Seal Signal™. Flexi-Seal Signal™ stood out with its unique fill indicator designed to minimize over-inflation and create a custom fit, reducing the risk of tissue damage and leakage. The product was also updated with a sampling port for easy collection of stool samples and a blue finger pocket to ease insertion of the device. In 2015, we added Zeolite to the catheter's silicone which significantly improved the product's odor protection³. We also demonstrated that Flexi-Seal Signal™ can contain C. diff and minimize its spread into the environment⁴. You can read more about C.diff and how it strikes here.

Flexi-Seal™ PROTECT

In 2017, with Flexi-Seal PROTECT, we answered your questions about how to control and monitor filling even more precisely, with an even simpler, more intuitive option. Flexi-Seal™ PROTECT offers all of this with its two colored indicators. When the green dome pops, it means the optimal fill level has been reached, while when the red indicator pops, it means the patient needs less volume for an optimal fit. Feedback from the domes goes beyond inserting the product, because the two indicators let the user know how the optimal fill may change during use. For example, after mobilization, the filling volume may need to be adjusted. This information may not be distinguishable if it were not for the indicator domes.

Read more about the importance of individual fit here.

Fortunately, you have not stopped challenging us at this point …

Flexi-Seal™ PROTECT PLUS

How can Flexi-Seal™ help prevent the spread of infection even more? We were also able to answer this question in 2019 with the latest version: Flexi-Seal™ PROECT PLUS. Here, you have a fecal management system with a self-closing catheter to help reduce the risk of leakage and cross contamination⁵, and a collection bag with Diamonds™ gelling and odor control sachets to help reduce spills and leaks, and to help prevent the spread of infection. To learn more about the Diamonds™ sachets, you can click here.

You've also asked how to prevent misconnections. That is why we developed Flexi-Seal™ PROTECT PLUS with ENFit™. The ENFit™ connector helps reduce the risk of balloon overinflation by preventing misconnection of medication or irrigation to the inflation port.

Thanks to your cooperation, we can now provide patients with a product that meets high standards of safety and hygiene. What's next? One thing is certain: The innovation journey will continue as long as we strive to improve the lives of the people we touch and care for patients together!

*) Maximum fill volume is ≤45 ml. Filling should stop when the green indicator pops out and stays out which should happen before 45 ml if the rectal space is smaller than maximum balloon size. Never add more than 45 ml in total.