Two‑piece Ostomy Bag – Only Drainable Bag (Integrated Type)

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The Two‑piece Ostomy Bag – Only Drainable Bag (Integrated Type) is a sterile, single‑use medical appliance intended for people with a permanent or temporary stoma (ileostomy, colostomy or urostomy). Unlike one‑piece systems, the two‑piece design separates the skin barrier (wafer/baseplate) from the collection pouch. The barrier remains adhered to the peristomal skin for several days, while the drainable pouch can be emptied frequently or replaced without disturbing the barrier.

The pouch body is constructed from a multi‑layer odour‑proof and leak‑proof film, covered on the body‑side by a soft, breathable non‑woven fabric that reduces friction and perspiration. An integrated activated‑carbon filter de‑odorises intestinal gases and prevents the pouch from ballooning. The drainable tail is equipped with a built‑in closure system – available as a self‑gripping soft clamp, a Velcro‑style fastener or a tap‑style drain valve – that allows the patient to empty the pouch hygienically without removing the entire appliance. Urostomy and high‑output models also incorporate an anti‑reflux valve to prevent back‑flow of urine or liquid stool, thereby reducing the risk of ascending infection.

Because the skin barrier is changed only every 2–4 days (depending on the individual’s output and skin condition), the two‑piece system is much gentler to the peristomal skin than daily applications of a one‑piece pouch. The technique also gives the patient more flexibility: the same barrier can be used with different pouch sizes or types (drainable vs. closed). The audible “click” of the coupling flange provides a clear confirmation of a secure connection, which is especially reassuring for the patient learning to self‑manage a new ostomy.

For the surgeon, the stoma nurse and the general practitioner, the two‑piece drainable system is the standard of care for most patients with a long‑term ostomy. It supports skin health, reduces the risk of leakage and infection, and enables the patient to return to daily activities, exercise and travel with confidence. For the patient, the ability to empty the pouch several times a day without touching the adhesive and to change the pouch without peeling off the barrier dramatically improves independence, comfort and quality of life.

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Categories: CONSUMABLES AND DISPOSABLES, Incontinence Products, Wound Care Tags: closed-end colostomy pouch, colostomy pouch closed, Esteem Symphony closed pouch, New Image two-piece closed, non-drainable ostomy bag, SenSura Mio Click Close, Two-piece closed ostomy bag, two-piece closed pouch, two-piece ostomy appliance closed

Description

Two‑piece Ostomy Bag – Only Drainable Bag (Integrated Type)

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Long‑Term Management of Ileostomy, Colostomy or Urostomy with Frequent Pouch Changes
Primary Use: Provides a sterile, single‑use two‑piece ostomy appliance that consists of a separate skin barrier (wafer/baseplate) and a detachable drainable collection pouch with an integrated closure (Velcro‑like fastener, soft clamp or tap). It is specifically designed for individuals with a permanent or temporary stoma (ileostomy, colostomy or urostomy) who have pasty, liquid or high‑volume output and need to change the pouch frequently without disturbing the skin barrier.

How it helps: For the ostomy nurse and the patient, the two‑piece design offers a more practical and skin‑gentle routine: the skin barrier remains in place for 2–3 days (or longer, depending on the product), while the drainable pouch is detached, emptied and cleaned, or replaced as often as necessary. The integrated closure (e.g. “Roll’up” soft clamp, Velcro hook‑and‑loop system or silicone plug) forms a leak‑proof seal that is comfortable to wear and does not bulge under clothing. For the patient, this system significantly reduces the number of adhesive removals per week, lowers the risk of peristomal skin irritation that can accompany daily barrier changes, and minimises the chance of pouch overload due to the weight of the contents.

2. Collection and Management of High‑Output Ileostomy or Post‑Operative Effluent
Primary Use: Especially suited for ileostomy patients or for the immediate post‑operative phase when stoma output is high, fluid and unpredictable. A high‑output two‑piece drainable pouch provides a large‑volume collection capacity (typically 500–1000 ml) to accommodate frequent liquid‑to‑pasty output. An anti‑reflux valve integrated into the pouch prevents output from flowing back towards the stoma, which helps to protect the peristomal skin and to reduce the risk of infection.

How it helps: For the surgical team and the stoma nurse, a high‑output two‑piece system simplifies the management of ileostomy or post‑cystectomy urostomy patients during the initial weeks of recovery when output volumes are highest. The separate skin barrier stays on the skin while the pouch is exchanged, which is less intrusive and reduces the risk of damaging healing tissue or newly formed stoma mucosa. The anti‑reflux valve (sometimes called a non‑return valve) is essential for urine‑collecting pouches: it prevents urine from travelling back to the stoma and therefore reduces the risk of ascending urinary tract infections. The audible “click” when the pouch is locked onto the baseplate gives the patient and the caregiver clear tactile and auditory confirmation of a secure fit.

3. Protection of Peristomal Skin from Aggressive Output
Primary Use: For patients whose stoma output is highly liquid and/or strongly enzymatic (e.g. ileostomy or urostomy), the two‑piece system allows the skin barrier to be selected from a range of adhesives (standard, extended‑wear, aloe‑infused or convex) that best resist erosion and moisture. The drainable pouch has a flexible, low‑profile coupling ring and a soft, breathable back‑cover that reduces friction and perspiration.

How it helps: For the WOC nurse, the choice of a suitable skin barrier is paramount. In a two‑piece system the barrier can be kept in place for up to 72 hours or longer, which is much gentler to the peristomal skin than daily removal and re‑application. Extended‑wear adhesives are specifically formulated to withstand aggressive output (urine, pancreatic enzymes, bile) that would quickly break down standard adhesives. Convex barriers can be used to treat flush or retracted stomas by applying gentle pressure around the stoma, thereby reducing leakage. For the patient, a well‑fitted, durable barrier means less risk of skin excoriation, fewer urgent changes and greater overall comfort.

SECONDARY & SUPPORTIVE USES

1. Overnight drainage connection (urostomy and high‑output ileostomy): Many drainable two‑piece pouches are equipped with a universal connector that can be attached to a bedside drainage bag or a leg bag. This allows gravity drainage during the night, giving the patient uninterrupted sleep while reducing the risk of pouch overload and leakage.

2. Flexible pouch changes for active lifestyles or travel: The two‑piece design allows the patient to keep the skin barrier in place and simply snap on a clean pouch when needed. This is especially useful during physical activities, swimming or travelling, where carrying several complete one‑piece systems would be impractical.

3. Stoma irrigation – temporary protection for colostomates: Some people with a descending or sigmoid colostomy perform regular irrigation to train the bowel to empty on a schedule. After irrigation, a stoma cap or a small covering system may be used. A two‑piece drainable pouch can be adapted as a protective cover during the irrigation procedure.

4. Long‑term care in nursing homes: In assisted living facilities where ease of management by caregivers is a priority, a two‑piece drainable pouch simplifies the daily routine. The skin barrier can be left in place for several days while the pouch is emptied or replaced as necessary, reducing the number of complete system changes and lowering the risk of inadvertent skin damage.

5. Temporary post‑surgical diversion following trauma or pelvic surgery: A two‑piece drainable system is also used for temporary urinary or faecal diversion after pelvic trauma, radiation injury or complicated pelvic surgery. The ability to change the pouch without removing the barrier is particularly valuable when the peristomal area is tender or when the patient’s mobility is limited.

6. Paediatric ostomy care: Smaller‑sized two‑piece drainable pouches are available for children with congenital anomalies (e.g. bladder exstrophy, imperforate anus). The gentle adhesive and low‑profile coupling help protect delicate skin while enabling frequent pouch changes when the child is active.

7. Palliative care for advanced pelvic malignancies: For patients with advanced, inoperable pelvic cancers (cervical, prostate, bladder) that cause urinary obstruction, a diverting urostomy or colostomy may be created to relieve symptoms and improve the quality of life. The drainable two‑piece system is preferred because it is simple to manage and places less strain on the patient.

KEY PRODUCT FEATURES

1. BASIC IDENTIFICATION ATTRIBUTES

Device Type: A sterile, single‑use two‑piece ostomy appliance composed of a separate skin barrier (wafer/baseplate) and a detachable, drainable collection pouch.
Designation: Two‑piece drainage ostomy bag – integrated type; drainable two‑piece colostomy/ileostomy/urostomy pouch with integrated closure; open‑ended two‑piece pouch.
Key Components:
- Pouch body: Odour‑proof, leak‑proof multi‑layer plastic film (often including a gas‑permeable breathable membrane). The film is soft, non‑rustling and covered on the patient‑side with a comfortable non‑woven fabric.
- Skin barrier (wafer/baseplate): A separate, detachable medical‑grade hydrocolloid adhesive disc with a coupling ring (flange). The barrier may be flat or convex, standard‑wear or extended‑wear, and can be supplied pre‑cut or cut‑to‑fit.
- Coupling mechanism: A mechanical snap‑on/‑off flange system (often a plastic locking ring) that securely connects the pouch to the skin barrier. An audible “click” confirms correct engagement.
- Integrated closure: The drainable tail of the pouch is fitted with a built‑in closure to prevent accidental spillage. Options include a self‑gripping soft clamp (Roll’up), a Velcro‑like hook‑and‑loop fastener (e.g. EasiClose), or a tap‑style drain valve for urostomy bags.
- Anti‑reflux valve (for urostomy and high‑output pouches): A non‑return valve integrated into the pouch to prevent back‑flow of urine or liquid stool towards the stoma, thereby reducing the risk of ascending infection.
- Gas filter: An integrated activated‑carbon filter (often protected by a moisture‑proof membrane) that de‑odorises intestinal gases and prevents the pouch from ballooning.
- Outlet (drainable tail): A wide‑mouth opening (typically 5–7 cm wide) that allows easy and hygienic emptying of the pouch without removing it from the barrier.

2. TECHNICAL & PERFORMANCE PROPERTIES

Capacity (volume as per ISO 8670‑2): Varies by size and manufacturer. Examples:
- Midi (colostomy/ileostomy): 520–665 ml, depending on flange diameter.
- Maxi (colostomy/ileostomy): 715–805 ml.
- Urostomy pouch: typically 620–675 ml.
Flange diameters (coupling size): Common sizes are 25 mm (1″), 35 mm (1 3⁄8″), 45 mm (1 3⁄4″), 55 mm (2 3⁄16″), 65 mm (2 9⁄16″), 70 mm (2 3⁄4″) and 80 mm (3 1⁄8″). The selected barrier and pouch must have matching diameters.
Stoma opening (cut‑to‑fit): For most two‑piece systems the skin barrier is cut‑to‑fit by the user; the recommended opening is 1–1.5 mm larger than the stoma diameter to avoid pressure necrosis.
Material: Pouch – multi‑layer odour‑proof plastic film with a soft, breathable non‑woven fabric on the skin‑side. Barrier – hydrocolloid adhesive (may be aloe‑infused or formulated for extra erosion resistance). The pouch is free of natural rubber latex and phthalates (DEHP).
Closure types: Integrated self‑gripping soft clamp (Fold‑over/Roll’up); Velcro‑style hook‑and‑loop fastener (EasiClose); tap‑style drain valve (urostomy); traditional clip seal (available as an option).
Gas filter: High‑performance activated‑carbon filter; may be protected by a moisture‑repellent membrane (e.g. Moisture Protect Composition) to preserve function when the pouch is wet.
Sterility: Non‑sterile (clean) for general use. Intended for external application to clean, intact peristomal skin. Single‑patient, single‑use device; the pouch should be discarded after emptying (urostomy) or after one use (colostomy/ileostomy) – typically after 1–2 days of use.
Storage life (shelf life): 3 years when stored in a cool, dry place, away from direct sunlight and extremes of temperature.
Latex‑free: Yes.
Primary standards compliance: ISO 8670‑2 (Ostomy collection bags – Requirements and test methods); ISO 12505‑1 and ‑2 (Skin barrier test methods); CE marked (Medical Device Regulation), and registered with the FDA (Class I medical device, product code EXB for colostomy/ileostomy and EXG for urostomy).

3. PHYSICAL & OPERATIONAL PROPERTIES

Configuration: Two‑piece system – the skin barrier and the pouch are separate components. The barrier is first applied to the peristomal skin; the pouch is then snapped onto the barrier via a rigid or flexible plastic coupling ring.
Pouch appearance: Available in transparent, opaque (fabric‑covered) or “split” designs (a viewing window covered by a fabric flap). Opaque pouches increase discretion; transparent pouches allow easy monitoring of stoma colour and output volume.
Pouch softness and noise: The pouch film is made of a low‑rustle, soft material, and the body‑side cover is a breathable non‑woven fabric that reduces friction and perspiration.
Wear time (skin barrier): Standard‑wear barriers: 1–2 days; extended‑wear barriers: 2–4 days. The exact wear time depends on the individual’s skin condition, stoma output and the specific product.
Pouch change frequency (drainable models): The drainable pouch can be emptied several times a day without being removed. The entire pouch is usually replaced every 1–2 days (or sooner if a leak develops).
Outlet width: Wide‑mouth opening (e.g. 7 cm) to facilitate easy cleaning and to accommodate semi‑solid output.
Connector for night drainage (urostomy/high‑output pouches): A universal adapter is supplied with many urostomy and high‑output pouches; it allows the drainable outlet to be connected to a bedside drainage bag or a leg bag.
Belt attachment: Many two‑piece barriers have tabs or slots for a stoma belt. A belt can be used to increase the security of the barrier during physical activity or to apply gentle convex pressure.
Disposal: The used pouch should be emptied into a toilet. The empty pouch, together with the skin barrier (when it is removed), must be wrapped and discarded in the general household waste (not flushed).
Storage: Store in a cool, dry place away from direct sunlight, heating appliances and excessive moisture. Do not store near organic solvents or adhesives.

4. SAFETY & COMPLIANCE ATTRIBUTES

Regulatory status: Class I medical device. CE marked under the Medical Device Regulation (EU) 2017/745. Registered with the FDA as a 510(k) exempt device (Product Code EXB for colostomy/ileostomy pouches and EXG for urostomy pouches). Manufactured under ISO 13485 quality management systems.
Biocompatibility: The hydrocolloid adhesive is formulated to be skin‑friendly, hypoallergenic and free from common sensitisers. Aloe vera‑infused barriers are available for particularly sensitive skin.
Latex‑free: All components contain no natural rubber latex, making them suitable for patients with latex allergy.
Odour control: The multi‑layer film is certified to be 100 % odour‑proof. The integrated activated‑carbon filter de‑odorises intestinal gases and prevents pouch ballooning.
Back‑flow prevention (urostomy and high‑output models): An integrated anti‑reflux valve reduces the risk of ascending infection by preventing liquid output from flowing back toward the stoma.
Wet‑out protection for filter (MPC technology): On many drainable pouches, the carbon filter is protected by a moisture‑repellent membrane that prevents liquid from entering the filter when the patient bathes or swims. The accompanying filter sticker can be applied over the filter for additional protection during water activities.

5. STORAGE & HANDLING ATTRIBUTES

Storage: Keep in a clean, dry place at room temperature (15–30 °C). Protect from dust, direct sunlight and sources of high heat. The pouch should be used before the expiry date printed on the box.
Pre‑use preparation: Wash hands thoroughly with soap and water. Clean the peristomal skin with lukewarm water and pat it completely dry. Do not use lotions, oils or alcohol‑based wipes, as these may impair the adhesion of the barrier.
Cutting the barrier: Measure the stoma size with the measuring guide supplied. Cut the opening in the skin barrier 1–1.5 mm larger than the stoma diameter to ensure a comfortable fit without pressure or trauma. Scissors with curved blades are recommended.
Application: Remove the protective liner from the skin barrier. Apply the barrier directly onto the dry peristomal skin, centring the cut opening on the stoma. Press firmly for 30 seconds to ensure proper adhesion. Snap the pouch onto the barrier until an audible “click” is heard.
Emptying the drainable pouch: For ileostomy/colostomy pouches: hold the tail over the toilet, open the integrated closure, and gently squeeze the pouch to empty the contents. Clean the inside of the tail with toilet paper or a moist wipe if necessary. Fold the tail and secure the integrated closure. For urostomy pouches: open the tap‑style valve and allow the urine to drain; close the valve when finished.
Night drainage (urostomy/high‑output pouches): Connect the universal adapter to the drainable outlet. Attach the bedside drainage tube and ensure the drainage bag is positioned lower than the bladder to allow gravity drainage.
Pouch replacement (without removing the barrier): Gently unsnap the used pouch from the barrier, taking care not to pull the barrier away from the skin. Clean the coupling ring of the barrier if necessary, then snap on a fresh pouch.
Barrier removal: Gently peel the skin barrier away from the skin, supporting the skin with one hand as you remove the barrier. Use an adhesive remover wipe if necessary to reduce discomfort.
Disposal: Wrap the used pouch and/or barrier in the provided disposal bag or newspaper and place it in the general waste. Do not flush the pouch or its components.

6. LABORATORY & CLINICAL APPLICATIONS

Primary application: Post‑operative and long‑term management of intestinal or urinary stoma (colostomy, ileostomy, urostomy) where frequent pouch changes are required and where protection of the peristomal skin is a high priority.
Clinical role: An essential device in colorectal surgery, urology, oncology (post‑cystectomy), paediatric surgery and long‑term care. Indispensable for the daily independence and quality of life of patients with a permanent or temporary ostomy.

SAFETY HANDLING PRECAUTIONS

1. SAFETY PRECAUTIONS

Proper fit is critical for skin protection: The skin barrier opening must be cut to the correct size – no larger than 1–1.5 mm of the stoma. An opening that is too large will expose the peristomal skin to corrosive stool or urine, leading to maceration, excoriation and fungal infection.
Pouch change frequency: For colostomy/ileostomy, the pouch should be emptied before it becomes more than half‑full to prevent the extra weight from pulling the barrier away from the skin. For urostomy, empty the pouch when it is one‑third to one‑half full to avoid back‑pressure.
Monitor for signs of skin breakdown: Discontinue use and consult a stoma nurse if the peristomal skin becomes red, moist, itchy or painful. This may indicate contact dermatitis (allergy) or a fungal infection (candidiasis) requiring a different adhesive or medical treatment.
Do not cut the pouch outlet: The drainable outlet is pre‑formed; never attempt to enlarge the opening with scissors, as this will destroy the integrity of the closure mechanism.
Anti‑backflow valve integrity (urostomy/high‑output models): Do not insert any object into the anti‑reflux valve, as this can damage the one‑way mechanism and increase the risk of infection.
Night drainage safety: When connecting to a bedside drainage bag, ensure the tubing is not kinked and that the drainage bag is placed at a level lower than the bladder to enable gravity flow. Do not raise the bag above the level of the stoma.
Allergy and sensitivity: Although the materials are hypoallergenic, a small number of patients may develop contact dermatitis. If irritation occurs, discontinue use of that product and try a different brand or a barrier with a different formulation.
Prevent filter clogging (bathing/swimming): Cover the gas filter with the supplied filter sticker before showering or swimming. This prevents water from entering the filter and blocking its deodorising function. Remove the sticker after bathing.
Do not reuse: The pouch and the skin barrier are single‑use devices only. Reuse compromises sterility, adhesive performance and leak‑proof properties, and increases the risk of infection.
Do not flush: The pouch, its components and any wipes must not be flushed down the toilet (they will block plumbing). Dispose of them in the household waste.
Hydration monitoring (urostomy patients): Urostomates lose more water and electrolytes than the general population. Encourage adequate fluid intake and monitor for signs of dehydration, especially during hot weather or when output is very high.
Training requirement: All patients and caregivers must receive thorough instruction from a stoma nurse or other qualified healthcare professional before using a two‑piece ostomy system. This includes proper measurement and cutting of the barrier, correct application of the pouch, emptying technique, and recognition of complications.

2. FIRST AID MEASURES

Skin irritation or allergy: If a rash, redness or severe itching develops at the adhesive site, remove the appliance immediately. Gently cleanse the skin with warm water and pat dry. Discontinue use of that device and consult a stoma care nurse. An alternative system (e.g. a different adhesive or a one‑piece pouch) may be required.
Bleeding stoma: A small amount of bleeding from the stoma mucosal surface when cleaning is common. Apply gentle pressure with a clean, dry gauze pad for a few minutes. Seek medical advice if bleeding is profuse, persists for longer than 5 minutes, or if the stoma changes colour to dark purple/black.
Leakage or skin excoriation: If a leak occurs, remove the appliance immediately. Gently cleanse the peristomal skin with warm water (a mild pH‑balanced cleanser can be used). Dry thoroughly. Apply a skin barrier powder or protective wipe if needed, then apply a new skin barrier and pouch.
Signs of urinary tract infection (urostomy): If the patient develops fever, chills, flank pain, cloudy or foul‑smelling urine, or increased leakage, evaluate for urinary tract infection and consult a clinician promptly. Prompt antibiotic treatment may be needed.
Parastomal hernia: If a bulge appears around the stoma (especially when coughing or straining), advise the patient to consult a clinician. A hernia support belt may be required. Do not increase the size of the barrier opening; a larger opening could strangulate the hernia.
Pouch ballooning (gas accumulation): If the pouch inflates because the gas filter is blocked, open the drainable outlet slightly (or use the integrated gas‑release valve if present) to decompress the pouch. Identify and treat any cause of excessive gas (diet, swallowing air).
Clogged overnight drainage tubing: If the bedside drainage tubing becomes clogged with mucus or thick output, gently irrigate with a small amount of warm water using a bulb syringe. If clogging recurs, replace the drainage set.

3. FIRE FIGHTING MEASURES

Flammability: The plastic pouch and the non‑woven fabric are combustible. Keep the appliance away from open flames, cigarettes and direct heat sources. The primary fire hazard in the clinical setting is the flammable solvents that might be present; the pouch itself does not increase the hazard beyond that of other plastic medical disposables.
Extinguishing media: Use water, foam, CO₂ or a dry chemical extinguisher for fires involving combustible materials. The pouch presents no special fire hazard beyond typical plastics.

Two‑piece Ostomy Bag – Only Drainable Bag (Integrated Type)

Two‑piece Ostomy Bag – Only Drainable Bag (Integrated Type)

PRIMARY CLINICAL & DIAGNOSTIC USES

SECONDARY & SUPPORTIVE USES

1. BASIC IDENTIFICATION ATTRIBUTES

Device Type: A sterile, single‑use two‑piece ostomy appliance composed of a separate skin barrier (wafer/baseplate) and a detachable, drainable collection pouch.

Designation: Two‑piece drainage ostomy bag – integrated type; drainable two‑piece colostomy/ileostomy/urostomy pouch with integrated closure; open‑ended two‑piece pouch.

Key Components:

Pouch body: Odour‑proof, leak‑proof multi‑layer plastic film (often including a gas‑permeable breathable membrane). The film is soft, non‑rustling and covered on the patient‑side with a comfortable non‑woven fabric.

Skin barrier (wafer/baseplate): A separate, detachable medical‑grade hydrocolloid adhesive disc with a coupling ring (flange). The barrier may be flat or convex, standard‑wear or extended‑wear, and can be supplied pre‑cut or cut‑to‑fit.

Coupling mechanism: A mechanical snap‑on/‑off flange system (often a plastic locking ring) that securely connects the pouch to the skin barrier. An audible “click” confirms correct engagement.

Integrated closure: The drainable tail of the pouch is fitted with a built‑in closure to prevent accidental spillage. Options include a self‑gripping soft clamp (Roll’up), a Velcro‑like hook‑and‑loop fastener (e.g. EasiClose), or a tap‑style drain valve for urostomy bags.

Anti‑reflux valve (for urostomy and high‑output pouches): A non‑return valve integrated into the pouch to prevent back‑flow of urine or liquid stool towards the stoma, thereby reducing the risk of ascending infection.

Gas filter: An integrated activated‑carbon filter (often protected by a moisture‑proof membrane) that de‑odorises intestinal gases and prevents the pouch from ballooning.

Outlet (drainable tail): A wide‑mouth opening (typically 5–7 cm wide) that allows easy and hygienic emptying of the pouch without removing it from the barrier.

2. TECHNICAL & PERFORMANCE PROPERTIES

Capacity (volume as per ISO 8670‑2): Varies by size and manufacturer. Examples:

Midi (colostomy/ileostomy): 520–665 ml, depending on flange diameter.

Maxi (colostomy/ileostomy): 715–805 ml.

Urostomy pouch: typically 620–675 ml.

Flange diameters (coupling size): Common sizes are 25 mm (1″), 35 mm (1 3⁄8″), 45 mm (1 3⁄4″), 55 mm (2 3⁄16″), 65 mm (2 9⁄16″), 70 mm (2 3⁄4″) and 80 mm (3 1⁄8″). The selected barrier and pouch must have matching diameters.

Stoma opening (cut‑to‑fit): For most two‑piece systems the skin barrier is cut‑to‑fit by the user; the recommended opening is 1–1.5 mm larger than the stoma diameter to avoid pressure necrosis.

Material: Pouch – multi‑layer odour‑proof plastic film with a soft, breathable non‑woven fabric on the skin‑side. Barrier – hydrocolloid adhesive (may be aloe‑infused or formulated for extra erosion resistance). The pouch is free of natural rubber latex and phthalates (DEHP).

Closure types: Integrated self‑gripping soft clamp (Fold‑over/Roll’up); Velcro‑style hook‑and‑loop fastener (EasiClose); tap‑style drain valve (urostomy); traditional clip seal (available as an option).

Gas filter: High‑performance activated‑carbon filter; may be protected by a moisture‑repellent membrane (e.g. Moisture Protect Composition) to preserve function when the pouch is wet.

Sterility: Non‑sterile (clean) for general use. Intended for external application to clean, intact peristomal skin. Single‑patient, single‑use device; the pouch should be discarded after emptying (urostomy) or after one use (colostomy/ileostomy) – typically after 1–2 days of use.

Storage life (shelf life): 3 years when stored in a cool, dry place, away from direct sunlight and extremes of temperature.

Latex‑free: Yes.

3. PHYSICAL & OPERATIONAL PROPERTIES

Configuration: Two‑piece system – the skin barrier and the pouch are separate components. The barrier is first applied to the peristomal skin; the pouch is then snapped onto the barrier via a rigid or flexible plastic coupling ring.

Pouch appearance: Available in transparent, opaque (fabric‑covered) or “split” designs (a viewing window covered by a fabric flap). Opaque pouches increase discretion; transparent pouches allow easy monitoring of stoma colour and output volume.

Pouch softness and noise: The pouch film is made of a low‑rustle, soft material, and the body‑side cover is a breathable non‑woven fabric that reduces friction and perspiration.

Wear time (skin barrier): Standard‑wear barriers: 1–2 days; extended‑wear barriers: 2–4 days. The exact wear time depends on the individual’s skin condition, stoma output and the specific product.

Pouch change frequency (drainable models): The drainable pouch can be emptied several times a day without being removed. The entire pouch is usually replaced every 1–2 days (or sooner if a leak develops).

Outlet width: Wide‑mouth opening (e.g. 7 cm) to facilitate easy cleaning and to accommodate semi‑solid output.

Connector for night drainage (urostomy/high‑output pouches): A universal adapter is supplied with many urostomy and high‑output pouches; it allows the drainable outlet to be connected to a bedside drainage bag or a leg bag.

Belt attachment: Many two‑piece barriers have tabs or slots for a stoma belt. A belt can be used to increase the security of the barrier during physical activity or to apply gentle convex pressure.

Disposal: The used pouch should be emptied into a toilet. The empty pouch, together with the skin barrier (when it is removed), must be wrapped and discarded in the general household waste (not flushed).

Storage: Store in a cool, dry place away from direct sunlight, heating appliances and excessive moisture. Do not store near organic solvents or adhesives.

4. SAFETY & COMPLIANCE ATTRIBUTES

Regulatory status: Class I medical device. CE marked under the Medical Device Regulation (EU) 2017/745. Registered with the FDA as a 510(k) exempt device (Product Code EXB for colostomy/ileostomy pouches and EXG for urostomy pouches). Manufactured under ISO 13485 quality management systems.

Biocompatibility: The hydrocolloid adhesive is formulated to be skin‑friendly, hypoallergenic and free from common sensitisers. Aloe vera‑infused barriers are available for particularly sensitive skin.

Latex‑free: All components contain no natural rubber latex, making them suitable for patients with latex allergy.

Odour control: The multi‑layer film is certified to be 100 % odour‑proof. The integrated activated‑carbon filter de‑odorises intestinal gases and prevents pouch ballooning.

Back‑flow prevention (urostomy and high‑output models): An integrated anti‑reflux valve reduces the risk of ascending infection by preventing liquid output from flowing back toward the stoma.

5. STORAGE & HANDLING ATTRIBUTES

Storage: Keep in a clean, dry place at room temperature (15–30 °C). Protect from dust, direct sunlight and sources of high heat. The pouch should be used before the expiry date printed on the box.

Pre‑use preparation: Wash hands thoroughly with soap and water. Clean the peristomal skin with lukewarm water and pat it completely dry. Do not use lotions, oils or alcohol‑based wipes, as these may impair the adhesion of the barrier.

Cutting the barrier: Measure the stoma size with the measuring guide supplied. Cut the opening in the skin barrier 1–1.5 mm larger than the stoma diameter to ensure a comfortable fit without pressure or trauma. Scissors with curved blades are recommended.

Application: Remove the protective liner from the skin barrier. Apply the barrier directly onto the dry peristomal skin, centring the cut opening on the stoma. Press firmly for 30 seconds to ensure proper adhesion. Snap the pouch onto the barrier until an audible “click” is heard.

Night drainage (urostomy/high‑output pouches): Connect the universal adapter to the drainable outlet. Attach the bedside drainage tube and ensure the drainage bag is positioned lower than the bladder to allow gravity drainage.

Pouch replacement (without removing the barrier): Gently unsnap the used pouch from the barrier, taking care not to pull the barrier away from the skin. Clean the coupling ring of the barrier if necessary, then snap on a fresh pouch.

Barrier removal: Gently peel the skin barrier away from the skin, supporting the skin with one hand as you remove the barrier. Use an adhesive remover wipe if necessary to reduce discomfort.

Disposal: Wrap the used pouch and/or barrier in the provided disposal bag or newspaper and place it in the general waste. Do not flush the pouch or its components.

6. LABORATORY & CLINICAL APPLICATIONS

Primary application: Post‑operative and long‑term management of intestinal or urinary stoma (colostomy, ileostomy, urostomy) where frequent pouch changes are required and where protection of the peristomal skin is a high priority.

Clinical role: An essential device in colorectal surgery, urology, oncology (post‑cystectomy), paediatric surgery and long‑term care. Indispensable for the daily independence and quality of life of patients with a permanent or temporary ostomy.

1. SAFETY PRECAUTIONS

Proper fit is critical for skin protection: The skin barrier opening must be cut to the correct size – no larger than 1–1.5 mm of the stoma. An opening that is too large will expose the peristomal skin to corrosive stool or urine, leading to maceration, excoriation and fungal infection.

Pouch change frequency: For colostomy/ileostomy, the pouch should be emptied before it becomes more than half‑full to prevent the extra weight from pulling the barrier away from the skin. For urostomy, empty the pouch when it is one‑third to one‑half full to avoid back‑pressure.

Monitor for signs of skin breakdown: Discontinue use and consult a stoma nurse if the peristomal skin becomes red, moist, itchy or painful. This may indicate contact dermatitis (allergy) or a fungal infection (candidiasis) requiring a different adhesive or medical treatment.

Do not cut the pouch outlet: The drainable outlet is pre‑formed; never attempt to enlarge the opening with scissors, as this will destroy the integrity of the closure mechanism.

Anti‑backflow valve integrity (urostomy/high‑output models): Do not insert any object into the anti‑reflux valve, as this can damage the one‑way mechanism and increase the risk of infection.

Night drainage safety: When connecting to a bedside drainage bag, ensure the tubing is not kinked and that the drainage bag is placed at a level lower than the bladder to enable gravity flow. Do not raise the bag above the level of the stoma.

Allergy and sensitivity: Although the materials are hypoallergenic, a small number of patients may develop contact dermatitis. If irritation occurs, discontinue use of that product and try a different brand or a barrier with a different formulation.

Prevent filter clogging (bathing/swimming): Cover the gas filter with the supplied filter sticker before showering or swimming. This prevents water from entering the filter and blocking its deodorising function. Remove the sticker after bathing.

Do not reuse: The pouch and the skin barrier are single‑use devices only. Reuse compromises sterility, adhesive performance and leak‑proof properties, and increases the risk of infection.

Do not flush: The pouch, its components and any wipes must not be flushed down the toilet (they will block plumbing). Dispose of them in the household waste.

Hydration monitoring (urostomy patients): Urostomates lose more water and electrolytes than the general population. Encourage adequate fluid intake and monitor for signs of dehydration, especially during hot weather or when output is very high.

2. FIRST AID MEASURES

Leakage or skin excoriation: If a leak occurs, remove the appliance immediately. Gently cleanse the peristomal skin with warm water (a mild pH‑balanced cleanser can be used). Dry thoroughly. Apply a skin barrier powder or protective wipe if needed, then apply a new skin barrier and pouch.

Signs of urinary tract infection (urostomy): If the patient develops fever, chills, flank pain, cloudy or foul‑smelling urine, or increased leakage, evaluate for urinary tract infection and consult a clinician promptly. Prompt antibiotic treatment may be needed.

Parastomal hernia: If a bulge appears around the stoma (especially when coughing or straining), advise the patient to consult a clinician. A hernia support belt may be required. Do not increase the size of the barrier opening; a larger opening could strangulate the hernia.

Pouch ballooning (gas accumulation): If the pouch inflates because the gas filter is blocked, open the drainable outlet slightly (or use the integrated gas‑release valve if present) to decompress the pouch. Identify and treat any cause of excessive gas (diet, swallowing air).

Clogged overnight drainage tubing: If the bedside drainage tubing becomes clogged with mucus or thick output, gently irrigate with a small amount of warm water using a bulb syringe. If clogging recurs, replace the drainage set.

3. FIRE FIGHTING MEASURES

Extinguishing media: Use water, foam, CO₂ or a dry chemical extinguisher for fires involving combustible materials. The pouch presents no special fire hazard beyond typical plastics.

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Outlet (drainable tail): A wide‑mouth opening (typically 5–7 cm wide) that allows easy and hygienic emptying of the pouch without removing it from the barrier.

Capacity (volume as per ISO 8670‑2): Varies by size and manufacturer. Examples:

Midi (colostomy/ileostomy): 520–665 ml, depending on flange diameter.

Maxi (colostomy/ileostomy): 715–805 ml.

Urostomy pouch: typically 620–675 ml.

Flange diameters (coupling size): Common sizes are 25 mm (1″), 35 mm (1 3⁄8″), 45 mm (1 3⁄4″), 55 mm (2 3⁄16″), 65 mm (2 9⁄16″), 70 mm (2 3⁄4″) and 80 mm (3 1⁄8″). The selected barrier and pouch must have matching diameters.

Stoma opening (cut‑to‑fit): For most two‑piece systems the skin barrier is cut‑to‑fit by the user; the recommended opening is 1–1.5 mm larger than the stoma diameter to avoid pressure necrosis.

Outlet width: Wide‑mouth opening (e.g. 7 cm) to facilitate easy cleaning and to accommodate semi‑solid output.

Regulatory status: Class I medical device. CE marked under the Medical Device Regulation (EU) 2017/745. Registered with the FDA as a 510(k) exempt device (Product Code EXB for colostomy/ileostomy pouches and EXG for urostomy pouches). Manufactured under ISO 13485 quality management systems.

Odour control: The multi‑layer film is certified to be 100 % odour‑proof. The integrated activated‑carbon filter de‑odorises intestinal gases and prevents pouch ballooning.

Storage: Keep in a clean, dry place at room temperature (15–30 °C). Protect from dust, direct sunlight and sources of high heat. The pouch should be used before the expiry date printed on the box.

Cutting the barrier: Measure the stoma size with the measuring guide supplied. Cut the opening in the skin barrier 1–1.5 mm larger than the stoma diameter to ensure a comfortable fit without pressure or trauma. Scissors with curved blades are recommended.

Application: Remove the protective liner from the skin barrier. Apply the barrier directly onto the dry peristomal skin, centring the cut opening on the stoma. Press firmly for 30 seconds to ensure proper adhesion. Snap the pouch onto the barrier until an audible “click” is heard.

Proper fit is critical for skin protection: The skin barrier opening must be cut to the correct size – no larger than 1–1.5 mm of the stoma. An opening that is too large will expose the peristomal skin to corrosive stool or urine, leading to maceration, excoriation and fungal infection.