One Piece Ostomy bag (Adult) – Urostomy bag (Drainable)

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The One Piece Ostomy bag (Adult) – Urostomy bag (Drainable) is a disposable, single-unit medical appliance specifically designed for the collection and management of urine following urinary diversion surgery (urostomy or ileal conduit) . Unlike ostomy bags for fecal output, the urostomy bag is optimized for continuous liquid drainage with features including an integrated anti-backflow valve to prevent urine reflux and reduce urinary tract infection risk .
This integrated one-piece system combines a skin-friendly hydrocolloid adhesive barrier and a collection pouch into a seamless design, featuring a drainable outlet with secure closure (soft plug or clamp) for easy, hygienic emptying throughout the day . Constructed with multi-layer, 100% odor-proof film and covered with soft, breathable non-woven fabric, the pouch includes an integrated activated charcoal filter for discreet gas release and a viewing window for monitoring output .
The drainable design allows the user to empty the pouch 4-6 times daily without changing the entire appliance—making it the standard of care for urostomy management. For overnight use, the drainable outlet can be connected to a larger bedside drainage bag for gravity drainage, allowing uninterrupted sleep .
For the urologist and stoma care nurse, the one-piece urostomy system simplifies post-operative management following cystectomy for bladder cancer. For the patient, this appliance provides security, confidence, and skin protection while facilitating an active, unrestricted lifestyle with minimal disruption.
Description

One Piece Ostomy bag (Adult) – Urostomy bag (Drainable)

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Post-Operative Urinary Diversion Following Cystectomy or Urostomy Surgery
  • Primary Use: Provides a sterile, single-use, one-piece urostomy appliance that combines a skin barrier (adhesive flange) and a collection pouch into one unit, specifically designed for the collection of urine following surgical creation of a urinary diversion (urostomy or ileal conduit) .
  • How it helps: For the urologist and stoma care nurse, the one-piece urostomy system simplifies post-operative management of patients who have undergone bladder removal (cystectomy) due to bladder cancer or other conditions. The integrated design provides a secure, leak-resistant seal around the stoma, protecting the surrounding skin from constant urine exposure . For the patient recovering from major urinary diversion surgery, the one-piece design offers a simple, easy-to-apply solution that provides confidence, protects skin integrity, and allows patients to focus on healing without the complexity of managing separate components.
2. Protection of Peristomal Skin from Corrosive Urine
  • Primary Use: Utilizes a medical-grade hydrocolloid skin barrier specifically formulated to withstand constant exposure to urine, which is highly corrosive to skin due to its pH and enzyme content. The barrier adheres securely to the peristomal area, preventing maceration and chemical burns .
  • How it helps: For the wound ostomy and continence nurse (WOCN), the specialized hydrocolloid barrier is critical for preventing urinary-induced skin breakdown—a common complication following urostomy surgery. Unlike fecal output, urine is continuously flowing and highly irritating, making barrier integrity essential . For the patient, robust skin protection prevents painful irritation, bleeding, and fungal infections around the stoma, dramatically improving quality of life and reducing the risk of hospital readmission for skin complications.
3. Anti-Backflow Design for Infection Prevention
  • Primary Use: Features a unique anti-backflow valve or design that prevents urine from flowing back from the bottom of the pouch toward the stoma, even when the pouch is full or the patient is lying down .
  • How it helps: For the urologist and infectious disease specialist, the anti-backflow mechanism is essential for reducing the risk of urinary tract infections (UTIs) and pyelonephritis (kidney infection)—common complications in urostomy patients. When a patient lies flat during sleep, gravity can cause pooled urine to flow back toward the stoma, potentially introducing bacteria into the upper urinary tract . For the patient, the anti-backflow design allows for uninterrupted sleep without sacrificing safety, significantly reducing the risk of serious urinary infections that can lead to hospitalization and kidney damage.
4. Secure Drainable Outlet for Hygienic Emptying
  • Primary Use: Equipped with a drainable outlet with a secure closure mechanism (soft plug, clamp, or valve) that allows the patient to empty the pouch multiple times daily without removing the entire appliance .
  • How it helps: For the ostomate, the drainable design is essential for managing the continuous flow of urine (approximately 400-800 mL every 24 hours) without needing to change the entire appliance multiple times daily. This reduces skin trauma, lowers supply costs, and enables a more normal daily routine . For the patient, the drainable feature allows for discreet, hygienic emptying in a standard toilet throughout the day, providing independence and confidence in managing their urostomy without disrupting work, social activities, or travel.

SECONDARY & SUPPORTIVE USES

1. Overnight Drainage Connection for Uninterrupted Sleep: The drainable outlet can be connected to a larger overnight urine collection bag (bedside drainage bag), allowing gravity drainage throughout the night so the patient can sleep without waking to empty the pouch .
2. Post-Cystectomy Bladder Cancer Management: Provides essential post-operative urinary management for patients who have undergone radical cystectomy for muscle-invasive bladder cancer, the most common indication for urostomy surgery.
3. Management of Neurogenic Bladder with Incontinence: Used as a urinary diversion option for patients with severe neurogenic bladder (spinal cord injury, spina bifida, multiple sclerosis) who cannot manage intermittent catheterization or who have failed other incontinence treatments.
4. Protection Following Trauma or Pelvic Surgery: Used in patients requiring temporary or permanent urinary diversion following pelvic trauma, radiation injury, or complications from pelvic surgery that compromise normal bladder function.
5. Pediatric Urostomy Care: Smaller-sized one-piece urostomy pouches are used in pediatric urology for children with congenital anomalies (e.g., bladder exstrophy, posterior urethral valves) requiring urinary diversion, offering gentle adhesion for delicate skin .
6. Chemotherapy and Radiation Oncology Support: Allows patients undergoing pelvic radiation or chemotherapy for bladder cancer to manage treatment-related urinary frequency and changes while protecting skin from irritation.
7. Long-Term Care and Assisted Living Facilities: Used in nursing homes where ease of application and management by caregivers is a priority, with the drainable design allowing for scheduled emptying during care routines.
8. Travel and Active Lifestyle Management: For long-term urostomates, the one-piece drainable system is preferred for travel, camping, and outdoor activities where access to a toilet for emptying is available, but carrying multiple closed pouches would be impractical.
9. Discharge Planning and Home Care Management: Facilitates early hospital discharge by providing patients and home health aides with a simple, easy-to-apply appliance that can be emptied multiple times, reducing the need for frequent bag changes.
10. Palliative Care for Advanced Pelvic Malignancies: Used in patients with advanced, inoperable pelvic malignancies (cervical, prostate, bladder cancer) causing urinary obstruction, where a diverting urostomy is created for palliation to relieve symptoms and improve end-of-life quality of life.
11. Post-Operative Monitoring of Urine Output: Used in the immediate post-operative period to measure and record urine output volume, providing clinicians with valuable data on kidney function, hydration status, and recovery.
KEY PRODUCT FEATURES

1. BASIC IDENTIFICATION ATTRIBUTES

  • Device Type: A single-use, one-piece drainable urostomy bag designed for adult patients with a urinary diversion (urostomy), consisting of an integrated adhesive skin barrier and collection pouch with a drainable outlet .
  • Designation: One-piece urostomy bag, urostomy pouch, urinary stoma bag, ileal conduit bag, one-piece drainable urostomy appliance .
  • Key Components:
  • Pouch Body: A leak-proof, 100% odor-proof collection chamber made of multi-layer film (including EVOH - Ethylene-Vinyl Alcohol Copolymer) .
  • Skin Barrier (Flange/Wafer): An integrated medical-grade hydrocolloid adhesive disc with a cut-to-fit or pre-sized opening; typically measures 1-1.2mm thickness .
  • Drainable Outlet: An open-ended tail located at the bottom of the pouch for emptying urine .
  • Closure Mechanism: Secure closure system (soft silicone plug, clamp, or valve) to seal the outlet after emptying .
  • Anti-Backflow Valve: Internal mechanism that prevents urine from flowing back toward the stoma, reducing infection risk .
  • Filter: An integrated activated charcoal filter to allow gas release while containing odor .
  • Comfort Layer: A soft, breathable non-woven fabric covering the body-facing side to reduce friction and noise .
  • Viewing Window: A transparent film section allowing for output and stoma monitoring without removal .

2. TECHNICAL & PERFORMANCE PROPERTIES

  • GMDN Term & Definition: One-piece urostomy bag, open-ended. A one-piece plastic pouch designed to be attached with adhesive to a patient's skin around a stoma for use as a urine collection device in the management of urinary diversions; it includes a drainage tap to permit the emptying of fluids (open-ended). The entire device is removed when changed. This is a single-use device .
  • GMDN Term Code: 64583 .
  • FDA Product Code: EXG (Bag, Urine Collecting, Ureterostomy) .
  • Capacity: Typically ranges from 300 mL to 700 mL; larger capacity models up to 24 oz (700 mL) available for overnight use .
  • Skin Barrier Material: Medical-grade hydrocolloid adhesive; full hydrocolloid thickness 1-1.2mm; features high viscosity and leak-proof characteristics; 24-72 hour wear time .
  • Pouch Film: High-barrier, multi-layer film (often including Ethylene-Vinyl Alcohol copolymer or EVOH) to ensure 100% odor-proof containment; high resistance film thickness 0.06-0.08mm .
  • Closure Type: Silicone soft plug, plastic clamp, or valve closure; secure, leak-proof; may be reused across multiple bag changes .
  • Cut-to-Fit Range: Skin barrier opening is adjustable, typically ranging from 15mm to 60mm (0.6-2.4 inches), to accommodate various stoma sizes .
  • Anti-Backflow Feature: Internal anti-backflow valve or design prevents urine reflux toward stoma, reducing infection risk .
  • Filter Type: High-efficiency activated charcoal filter; available in round, square, or crescent shapes .
  • Body-side Covering: Soft double-sided non-woven fabric (approximately 30g/m²) that is quiet, breathable, and reduces skin friction .
  • Sterility: Non-sterile (except in certain markets); intended for use on clean, intact peristomal skin .
  • Single-Use: Intended for single patient use only; the bag is typically changed every 1-4 days, depending on output volume and skin condition. The drainable pouch can be emptied 4-6 times daily before changing .
  • Latex-Free: Manufactured without natural rubber latex to accommodate patients with latex allergies .
  • Overnight Drainage Compatibility: Drainable outlet can be connected to bedside drainage bag for gravity drainage during sleep .

3. PHYSICAL & OPERATIONAL PROPERTIES

  • Configuration: One-piece system where the skin barrier and collection pouch are permanently attached as a single unit .
  • Standard Dimensions: Approximately 11" length x 5-3/4" width (28 cm x 14.5 cm) to 27.5 cm x 15 cm .
  • Appearance: Available in transparent, translucent, or opaque (fabric-covered), white, or skin color options for discretion or clinical utility .
  • Flexibility: The pouch and integrated barrier are designed to flex with body movement. Available in flat or convex configurations to manage flush or retracted stomas .
  • Wear Time: Standard wear time is 1 to 4 days; some extended-wear models offer up to 72-hour wear time .
  • Packaging: Individually wrapped and sold in boxes (typically 10, 20, or 30 pieces) .
  • Accessories: Typically supplied with measuring card for custom-cutting the opening, disposal bags, night drainage connection adapters, and illustrated instructions .
  • Quality Certifications: CE marked, ISO 13485 compliant, FDA registered; SGS or BV certified .

4. SAFETY & COMPLIANCE ATTRIBUTES

  • Regulatory Status: Class I medical device (GMDN Code 64583; FDA Product Code EXG) .
  • Quality Standards: Complies with international ostomy standards; manufactured under quality management systems (ISO 13485) .
  • Biocompatibility: Manufactured with skin-friendly, hypoallergenic materials; the hydrocolloid barrier is free from common sensitizers .
  • Odor Control: Certified to meet odor-barrier efficacy standards using multilayer high-barrier co-extrusion membrane and activated carbon filter .
  • Latex-Free: Manufactured without natural rubber latex to accommodate patients with latex allergies .
  • Infection Prevention: Anti-backflow design reduces risk of urinary tract infection by preventing retrograde urine flow .

5. STORAGE & HANDLING ATTRIBUTES

  • Storage: Store in a cool, dry place at room temperature (below 25°C / 77°F recommended). Avoid exposure to direct sunlight, extreme heat, or humidity, which can degrade the adhesive and film .
  • Shelf Life: Typically 3 years from the date of manufacture when stored properly .
  • Disposal: Empty contents into the toilet. Dispose of used bag in general waste. Do not flush the bag itself .
  • Pre-use Preparation: For best adhesion, warm the skin barrier with body heat before applying; ensure peristomal skin is clean and completely dry .
  • Closure Care: The drainable outlet closure (soft plug or clamp) can be rinsed and dried for reuse with subsequent bags .
  • Night Drainage: For overnight use, connect the drainable outlet to a larger bedside drainage bag using the provided adapter .
LABORATORY & CLINICAL APPLICATIONS
  • Primary Application: Collection and management of urinary effluent following urinary diversion surgery (urostomy, ileal conduit) in patients who have undergone cystectomy for bladder cancer or other conditions requiring urinary diversion .
  • Clinical Role: Essential post-operative and long-term care device in urology, uro-oncology, and general nursing for the management of patients with a urinary stoma.
SAFETY HANDLING PRECAUTIONS

1.SAFETY PRECAUTIONS

  • Skin Preparation: The peristomal skin must be clean, completely dry, and free of lotions, oils, or adhesive residue before application to ensure proper adhesion .
  • Customization: The opening must be cut to the correct size—no larger than 2 mm (1/8 inch) of the stoma. An opening that is too large will expose skin to corrosive urine and cause breakdown (macerated, excoriated skin) .
  • Anti-Backflow Function: Do not obstruct the anti-backflow valve; proper function is essential for preventing urinary tract infections .
  • Monitor for Leaks: Change the appliance immediately if any urine is observed leaking under the barrier to prevent skin damage .
  • Showering and Swimming: The pouch can be worn while showering; when swimming, use a swim belt or waterproof tape to secure the edges. Cover the filter with the provided sticker to prevent water from entering .
  • Overnight Drainage: When using a bedside drainage bag, ensure the tubing is not kinked and that the drainage bag is positioned lower than the bladder to allow gravity drainage .
  • Signs of Skin Breakdown: Discontinue use and consult a stoma care nurse if the peristomal skin becomes red, weepy, raw, or itchy, indicating possible fungal infection (candidiasis) or contact dermatitis.
  • Hydration Monitoring: Urostomy patients are at risk for dehydration and electrolyte imbalance; monitor urine output volume and color, and maintain adequate fluid intake.
  • Clogging Prevention: For patients with mucus production (common in ileal conduits), the drainable valve design should allow mucus plugs to pass through; if clogging occurs, irrigate the pouch as directed .

2. FIRST AID MEASURES

  • Adhesive Allergy: If signs of an allergic reaction (rash, severe itching, blistering) occur at the adhesive site, remove the appliance immediately, clean the skin with warm water, discontinue use of that brand, and consult a clinician .
  • Bleeding Stoma: If the stoma bleeds when cleaning, apply gentle pressure with a clean, dry gauze pad for a few minutes. Contact a clinician if bleeding is profuse or does not stop.
  • Leakage or Skin Irritation: If a leak occurs, remove the appliance immediately, gently cleanse the skin with warm water, dry thoroughly, and apply a new bag .
  • Signs of Urinary Tract Infection: If the patient develops fever, chills, flank pain, cloudy or foul-smelling urine, or increased leakage, evaluate for UTI and consult a clinician promptly.
  • Clogged Overnight Drainage Tubing: If the bedside drainage bag tubing becomes clogged with mucus, gently irrigate with warm water or replace the bag as needed.

3. FIRE FIGHTING MEASURES

  • Flammability: The plastic pouch and non-woven fabric are combustible. Keep away from open flames and direct heat sources .
  • Extinguishing Media: Use water, foam, CO₂, or dry chemical for fires involving combustible material. The pouch presents no special fire hazard beyond typical plastics.