Innovative testing solutions for Ostomy bags

Ostomy surgery can be a necessary and, potentially, life-saving procedure for patients with various gastrointestinal or urological conditions and traumas including colorectal cancer, diverticular disease, incontinence, ulcerative colitis and Crohn's disease. 

 

The availability of well-fitting and functional ostomy product solutions is crucial for the health, well-being, and general health-related quality of life of people living with a stoma.


Considerable advances have been made in the design of ostomy bags to overcome the challenges of ballooning and leakage. A UK based survey of pouch users ranked pouch leak problems as the most important research priority to aid in improving their quality of life.

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The Challenge

 

RSSL were approached due to our in-house expertise, to assist in the development of bespoke methods to mechanically test a range of Ostomy products for burst strength, retention of an open-ended bag closure and freedom from leakage of bags with flanges to ISO 8670-2 standards.

Our approach

 

The client submitted a range of Colostomy, Urostemy and Ileostomy products for testing. To improve accuracy and efficiency, RSSL developed bespoke attachment designs for each bag type which were built by the instrument manufacturer (Figures 1 & 3). The bespoke plate attachments enabled each product to be securely fastened and tested using the texture analyser.

Figure 1.  Setup to compress ostomay bags between two plates (retention of an open-ended bag closure and burst strength tests). 

 

The ostomy bags were attached to the rigid, transparent plates and filled with a solution dyed red to allow clear visibility of any leakage (see Figure 2). A series of Macros were then developed to carry out controlled mechanical testing of the bags. These controls carried out analysis which tested the propensity to leak and determine burst strength across the range of different Ostomy products submitted for testing.

 

To further test the durability of the bags, particularly for ‘freedom from leakage’ which forms Part 2 of the ISO 8670-2, a separate attachment was designed and built to assess the flanges. This allowed the bag to be successfully clamped and ‘freedom from leakage’ assessment carried out as demonstrated in Figure 3.

 

Figure 2. Ostomy bag showing leakage during testing

Figure 3. Set up of a bag clamped for freedom of leakage of bags with flanges test.

Outcome

 

Using a combination of in-house expertise, innovative solutions and close collaboration with the instrument manufacturer, RSSL was able to develop suitable methods for the client that were not previously available. This ensured the client could demonstrate that all the ostomy bags tested were tested against and shown to comply with the ISO 8670-2 specification.

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