One Piece Ostomy bag (Adult) – Clamp type (Drainable)

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The One Piece Ostomy bag (Adult) – Clamp type (Drainable) is a disposable, single-unit medical appliance used to collect liquid to semi-formed fecal waste following ileostomy or colostomy surgery . This integrated system combines a skin-friendly hydrocolloid adhesive barrier and a collection pouch into a seamless design, featuring a durable curved plastic clamp closure at the drainage end for a secure, leak-proof seal .
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 stoma health . The clamp-type drainable design allows the user to empty the pouch multiple times before changing the entire appliance—typically every 1-4 days—making it the preferred system for ileostomy patients with high-output, liquid stool .
For clinicians, the clamp-type one-piece drainable system provides a highly secure closure mechanism that many patients find more reliable than other methods. For the patient, this appliance offers enhanced security and confidence, particularly during physical activities, swimming, and travel , while protecting peristomal skin integrity and facilitating an active, unrestricted lifestyle.
Description

One Piece Ostomy bag (Adult) – Clamp type (Drainable)

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Post-Operative Fecal Diversion Following Ileostomy or Colostomy Surgery
  • Primary Use: Provides a sterile, single-use, one-piece drainable ostomy appliance that combines a skin barrier (adhesive flange) and a collection pouch into one unit, featuring a plastic clamp closure at the drainage end for secure, repeated sealing and emptying .
  • How it helps: For the surgeon and stoma care nurse, the one-piece drainable system with clamp closure simplifies post-operative management of patients with ileostomies or colostomies where output is liquid to semi-formed . The integrated design reduces the risk of leakage around the skin barrier, while the curved plastic clamp provides a highly secure, leak-proof seal that many users find more reliable than other closure methods . For the patient recovering from bowel surgery, the clamp-type drainable bag offers a hygienic, easy-to-use solution that enables discreet emptying throughout the day without removing the entire appliance.
2. Long-Term Management of High-Output Ileostomies
  • Primary Use: Specifically designed to manage the continuous, corrosive, liquid output typical of ileostomies, featuring a durable, odor-proof pouch with a secure clamp outlet that can be emptied 4-6 times daily .
  • How it helps: For the gastroenterologist and ostomy nurse, this appliance is engineered to handle high-output stomas (up to 700-800 mL daily) with large capacity pouches (up to 24 oz.)  and materials that resist degradation from digestive enzymes. The clamp-type drainable design is essential for ileostomy patients who cannot use closed pouches due to the frequency and liquid nature of their output . For the patient with an ileostomy, the clamp-type bag allows for regular emptying (rather than changing the entire appliance multiple times daily), significantly reducing skin irritation, lowering supply costs, and enabling a more normal daily routine.
3. Protection of Peristomal Skin Integrity
  • Primary Use: Utilizes a medical-grade hydrocolloid skin barrier that adheres securely to the peristomal area, protecting skin from enzymatic damage caused by direct contact with stoma effluent, with many models featuring an additional medical tape border for enhanced security .
  • How it helps: For the wound ostomy and continence nurse (WOCN), the integrated hydrocolloid wafer is critical for preventing Medical Adhesive-Related Skin Injury (MARSI) and contact dermatitis—common complications that can lead to leakage, discomfort, and hospital readmissions. The clamp drainable design is particularly beneficial because it allows frequent emptying without breaking the skin seal, preserving the integrity of the peristomal skin . For the patient, robust skin protection prevents painful irritation, bleeding, and itching around the stoma, directly improving quality of life and reducing the risk of skin breakdown.
4. Secure Leak-Proof Closure for Active Lifestyles
  • Primary Use: Features a durable plastic clamp that provides a tight, leak-proof seal at the drainage end, offering enhanced security for physically active patients and those concerned about accidental opening .
  • How it helps: For the ostomate, the clamp-type closure provides an additional level of security and confidence during physical activities, swimming, and travel . Unlike some other closure methods, the clamp creates a mechanical seal that many users find more reassuring for high-output situations or during exercise. For the patient, this enhanced security allows for full participation in work, sports, and social activities without fear of accidental pouch opening or leakage.

SECONDARY & SUPPORTIVE USES

1. Management of Colostomy Output for Patients with Formed Stool: While primarily designed for ileostomies, drainable clamp pouches are also used by colostomates with semi-formed stool who prefer the security of a clamp closure .
2. Post-Operative Fluid and Electrolyte Monitoring: Used in the immediate post-operative period to measure and record the volume and consistency of stoma output, providing clinicians with valuable data on bowel function recovery and hydration status—critical for ileostomy patients at risk of dehydration.
3. Protection and Diversion Following Trauma or Emergency Surgery: Used in emergency surgical settings (e.g., gunshot wounds, severe pelvic fractures) requiring temporary fecal diversion to protect distal anastomoses and allow the bowel to heal.
4. Palliative Care for Malignant Bowel Obstruction: Used in patients with advanced, inoperable abdominal or pelvic malignancies causing obstruction, where a diverting ostomy is created for palliation to relieve symptoms and improve end-of-life quality of life.
5. Long-Term Care and Assisted Living Facilities: Used in nursing homes where ease of use for caregivers is important; the clamp closure allows for efficient, hygienic emptying without removing the appliance.
6. Chemotherapy and Radiation Oncology Support: Allows patients undergoing abdominal or pelvic radiation to manage treatment-related diarrhea and frequent bowel movements with a pouching system that can be emptied multiple times daily without skin trauma.
7. Pediatric Ostomy Care: Smaller-sized one-piece drainable pouches with clamp closure are used in pediatric surgery for children with congenital anomalies (e.g., imperforate anus, Hirschsprung’s disease, necrotizing enterocolitis), offering gentle adhesion for delicate skin.
8. Travel and Active Lifestyle Management: For long-term ostomates, the clamp-type drainable system is preferred for travel, camping, and outdoor activities where the enhanced security of a mechanical closure provides peace of mind .
9. Convex Configuration for Flush or Retracted Stomas: Available in convex designs to manage flush or slightly retracted stomas, providing gentle pressure to help the stoma protrude for better output collection .
10. 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 using a secure clamp mechanism.
11. Convalescent and Rehabilitation Care: Supports patients transitioning from hospital to home during the recovery period, allowing them to practice independent ostomy management skills.
KEY PRODUCT FEATURES

1. BASIC IDENTIFICATION ATTRIBUTES

  • Device Type: A single-use, one-piece drainable ostomy bag with plastic clamp closure, designed for adult patients with an ileostomy or colostomy, consisting of an integrated adhesive skin barrier and collection pouch with a resealable clamp-type drainable outlet .
  • Designation: One-piece drainable ostomy bag, colostomy bag with clamp closure, ileostomy pouch (drainable), stoma bag with clamp, one-piece ostomy appliance with locking clamp .
  • Key Components:
  • Pouch Body: A leak-proof, 100% odor-proof collection chamber made of multi-layer film (including EVOH) .
  • Skin Barrier (Flange/Wafer): An integrated medical-grade hydrocolloid adhesive disc with a cut-to-fit or pre-sized opening that adheres to the peristomal skin; features a full hydrocolloid adhesive (1-1.2mm thickness) .
  • Clamp Closure: A durable curved plastic clamp that securely seals the bottom opening of the drainable pouch; reusable across multiple bag changes .
  • Filter: An integrated activated charcoal filter to allow flatus to escape while containing odor, preventing "ballooning" .
  • Comfort Layer: A soft, breathable double-sided non-woven fabric covering the body-facing side to reduce friction and noise .
  • Viewing Window: A transparent film section integrated into the front of the pouch to allow for stoma and output monitoring without removal .
  • Medical Tape Border: Additional medical tape encircling the hydrocolloid chassis for enhanced adhesion and leak prevention .

2. TECHNICAL & PERFORMANCE PROPERTIES

  • Standard Sizes: Available in various dimensions; standard adult pouch measures approximately 11" length x 5-3/4" width (27.5 x 15 cm) .
  • Capacity: Standard adult pouch capacity ranges from 600 mL to 700 mL (up to 24 oz.) .
  • Skin Barrier Material: Medical-grade hydrocolloid adhesive; full hydrocolloid thickness 1-1.2mm; features high viscosity and leak-proof characteristics .
  • 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 0.08mm .
  • Closure Type: Curved plastic clamp; reusable; provides secure mechanical seal; may be used across multiple bag changes .
  • Cut-to-Fit Range: Skin barrier opening is adjustable, typically ranging from 15mm to 60mm (0.6-2.6 inches), to accommodate various stoma sizes .
  • Pre-Cut Options: Available with pre-cut openings (e.g., 1/2" round, 1" round, or oval configurations) for immediate post-operative use .
  • Filter Type: High-efficiency activated charcoal filter; available in round, square, or crescent shapes .
  • Body-side Covering: Soft double-sided non-woven fabric (30g/m²) that is quiet, breathable, and reduces skin friction .
  • Medical Tape: Additional medical tape border around the hydrocolloid chassis for enhanced adhesion .
  • Sterility: Ethylene oxide sterilized or non-sterile depending on market; 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.
  • Latex-Free: Manufactured without natural rubber latex to accommodate patients with latex allergies .

3. PHYSICAL & OPERATIONAL PROPERTIES

  • Configuration: One-piece closed system where the skin barrier and collection pouch are permanently attached as a single unit .
  • Appearance: Available in transparent, translucent, opaque (fabric-covered), beige, or skin color options for discretion or clinical utility .
  • Clamp Storage: The clamp can be cleaned and reused; some designs feature a built-in clamp holder on the pouch for convenience.
  • 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, depending on stoma type (ileostomy vs. colostomy), output volume, and skin condition.
  • Packaging: Individually wrapped and sold in boxes (e.g., 10, 20, 30 pieces) with clamps included separately .
  • Accessories: Typically supplied with clamps (e.g., 4-5 clamps per box), measuring card for custom-cutting the opening, disposal bags, and illustrated instructions .

4. SAFETY & COMPLIANCE ATTRIBUTES

  • Regulatory Status: Class I medical device (HCPCS Code A4390 for drainable pouch with clamp; FDA Product Code EZS; GMDN Code 31075) .
  • Quality Standards: Manufactured under quality management systems; often SGS or BV certified .
  • 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 .
  • Sterilization: Ethylene oxide sterilization option available .

5. STORAGE & HANDLING ATTRIBUTES

  • Storage: Store in a cool, clean, dustless environment away from direct sunlight, extreme heat, or humidity, which can degrade the adhesive and film .
  • Disposal: Empty contents into the toilet; dispose of used bag in general waste. Do not flush the bag itself .
  • Shelf Life: 3 years from the date of manufacture when stored properly .
  • Pre-use Preparation: For best adhesion, warm the skin barrier with body heat before applying; ensure peristomal skin is clean and dry.
  • Clamp Care: The plastic clamp can be rinsed and dried for reuse with subsequent bags.

6. LABORATORY & CLINICAL APPLICATIONS

  • Primary Application: Collection and management of liquid to semi-formed intestinal effluent from a diverted bowel following ileostomy or colostomy, particularly for patients requiring a highly secure closure mechanism .
  • Clinical Role: Essential post-operative and long-term care device in colorectal surgery, gastrointestinal oncology, trauma surgery, and general nursing for the management of patients with a stoma who require a drainable pouching system with clamp closure.
SAFETY HANDLING PRECAUTIONS

1. SAFETY PRECAUTIONS

  • Skin Preparation: The peristomal skin must be clean, 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 effluent and cause breakdown .
  • Clamp Security: Ensure the plastic clamp is fully closed and locked before resuming activity; failure to secure properly may result in leakage .
  • Monitor for Leaks: Change the appliance immediately if any effluent is observed leaking under the barrier to prevent skin damage .
  • Showering and Swimming: Cover the filter with the provided sticker (if available) to prevent water from entering the pouch. The clamp provides a secure seal during water activities.
  • 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 or contact dermatitis .
  • Ileostomy Frequency Warning: For ileostomy patients, change drainable pouches more frequently as liquid stool can irritate skin; continuous use of a single bag beyond recommended wear time will affect adhesion.

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 or measuring, 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 .
  • Clamp Malfunction: If the plastic clamp becomes damaged or fails to secure properly, replace it with a new clamp from the supply kit.

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.