Better Patient Care: It's in the Bag

Originally Published MDDI June 2002

MEDICAL DESIGN EXCELLENCE AWARDS 2002

Assura EasiClose Colostomy/Ileostomy Pouch

Submitted and manufactured by Coloplast (Marietta, GA)

Human factors science plays an increasingly important role in excellent product design, and Coloplast's Assura EasiClose colostomy/ ileostomy pouch with its integrated Velcro closure system scores high in that area. MDEA jurors cited the company's close attention to patient concerns in developing new product characteristics that would make life more comfortable for people who must wear an ostomy pouch.

The Assura EasiClose drainable pouch consists of a pouch, pouch filter, adhesive, outlet, soft cloth panels, and, in the case of the two-piece version, coupling lockrings.

"Our innovation comes from approaching product development with a consumer mind-set," says Jamie Handler, marketing support manager for Coloplast. The company, he adds, has spoken with hundreds of clinicians to learn what issues their patients wanted to see addressed in drainable ostomy products.

"First and foremost, patients want the pouch to be secure. It must stick to their skin and not peel off," Handler notes. "Second, the outlet port must not leak or cause skin irritation. They also want a pouch that is comfortable and discreet."

The aforementioned Velcro closure system distinguishes EasiClose from other ostomy pouches, all of which use a clamp or a clip to close the pouch. Patients have complained that clamps are uncomfortable and bulky, and show through clothing. Coloplast added a Velcro closure to alleviate those concerns while providing a secure seal.

To further address patients' worries about leaks, Coloplast positioned two foam plates on either side of the outlet. The two plates fold over each other to create a leakproof outlet, and the plates' "memory" returns them to their position after the pouch is opened for emptying. The plates also create some stiffness so that the user can maintain better control of the bag while it's being emptied and cleaned.

To ensure that the pouch doesn't slip during wear and that patients don't experience the skin irritation that can accompany the often daily removal of ostomy pouches, Coloplast developed a special formula and design for its adhesive. "The adhesive itself leaves little or no residue, and the flange is spiral shaped and layered with two different components—one promotes security and adhesion, and the other promotes absorbency," Handler explains. "The design of the flange makes it nearly impossible for it to be reapplied to exactly the same spot of skin it rested against previously, which reduces the risk of skin irritation."

Two other qualities speak to Assura EasiClose's close attention to the needs of colostomy and ileostomy patients: The pouch is covered on both sides with soft polyester so that the device can rest comfortably against the patient's skin without triggering perspiration, and it won't rustle when the patient moves, calling attention to the pouch. Second, the pouch includes an odor-eliminating filter composed of a proprietary, semipermeable membrane that lets gas pass through but retains moisture and averts leaks. The pouch's chambered design also prevents the filter from clogging.

For additional patient comfort, Coloplast offers the product in small, medium, and large sizes that hang at different lengths. Patients may wear the pouches up to 48 hours.

"Our intention was to create a product that would be a confidence builder for ostomates—that they could wear comfortably, securely, and discretely," Handler explains. By putting this kind of priority on the needs of patients, Coloplast has transformed what could have been a routine product into an award winner.

Copyright ©2002 Medical Device & Diagnostic Industry