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

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A One Piece Ostomy bag (Adult) – Integrated type (Drainable) is a disposable, single-unit medical appliance used to collect intestinal waste (effluent) following ostomy surgery. It combines a skin-friendly hydrocolloid adhesive barrier and a collection pouch into a seamless design . The drainable feature allows the user to empty the pouch multiple times before changing the entire appliance, offering convenience and cost-effectiveness. Constructed with multi-layer, odor-proof film and soft, breathable non-woven fabric, it features an integrated activated carbon filter for discreet gas release and a viewing window for monitoring output . For clinicians, this system simplifies post-operative stoma management and supports patient discharge. For the patient, it provides security, protects peristomal skin integrity, and enables an active lifestyle by preventing leaks and controlling odors .

Categories: CONSUMABLES AND DISPOSABLES, Incontinence Products, Wound Care Tags: Adult Ostomy Care, Colostomy Bag, Drainable Ostomy Pouch, Ileostomy Bag, Integrated Ostomy Appliance, One Piece Ostomy bag, Ostomy Drainable Pouch, Stoma Bag

Description

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

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Post-Operative Fecal Diversion Following Colostomy or Ileostomy Surgery

Primary Use: Provides a sterile, single-use, integrated ostomy appliance that combines a skin barrier (adhesive flange) and a drainable collection pouch into one unit, designed for the management of fecal output following surgical creation of a colostomy or ileostomy .
How it helps: For the surgeon and stoma care nurse, this one-piece system simplifies the immediate post-operative management of bowel diversion by providing a secure, leak-resistant seal around the stoma, protecting the surgical site and peristomal skin from corrosive effluent. For the patient recovering from colorectal surgery, the integrated design offers a simple, easy-to-apply solution that boosts confidence, protects skin integrity, and allows the patient and caregivers to focus on healing without the complexity of managing separate components.

2. Management of Liquid to Semi-Formed Stool Output for Ileostomies

Primary Use: Specifically designed to manage the continuous, corrosive, liquid to semi-liquid output typical of an ileostomy, featuring a durable, odor-proof pouch and a drainable outlet for frequent emptying .
How it helps: For the gastroenterologist and ostomy nurse, this bag is engineered to handle high-output stomas (up to 800 mL per day) with materials that resist degradation and neutralize odors, preventing leakage and skin breakdown . For the patient with a high, continuous output, the drainable feature allows for hygienic, discreet emptying without needing to change the entire appliance multiple times a day—reducing skin irritation, saving money on supplies, and enabling a more normal daily routine.

3. Long-Term Daily Management for Community-Dwelling Ostomates

Primary Use: Provides the primary waste collection system for individuals living with a permanent or temporary stoma, allowing users to maintain hygiene, comfort, and social confidence during work, travel, and leisure activities .
How it helps: For the primary care physician and community nurse, the one-piece drainable system supports independent living by offering a reliable, low-profile appliance with features like quiet materials and effective odor filters . For the long-term ostomate, the ease of application and removal of an integrated system provides independence, security, and peace of mind. Features like soft, breathable non-woven fabric, a view window, and an activated carbon filter allow for discreet, comfortable, and odor-free wear throughout daily life .

4. Protection of Peristomal Skin Integrity

Primary Use: Utilizes a medical-grade hydrocolloid skin barrier that adheres to the peristomal area to protect the skin from enzymatic damage caused by direct contact with stoma effluent .
How it helps: For the wound ostomy and continence nurse (WOCN), the integrated skin barrier (hydrocolloid wafer) is critical for preventing medical adhesive-related skin injury (MARSI) and contact dermatitis by maintaining a tight seal and absorbing moisture. For the patient, robust skin protection prevents painful irritation, bleeding, and itching around the stoma, which is one of the most common complications and a primary driver of reduced quality of life.

SECONDARY & SUPPORTIVE USES

1. Management of Fecal Output Following Colostomy for Diverticulitis or Cancer: Used as the primary collection device for formed stool output after sigmoid colostomy for benign or malignant disease, providing security and odor control .

2. Protection and Drainage Following Trauma or Emergency Fecal Diversion: Used in emergency surgery or trauma settings (e.g., gunshot wounds, pelvic fractures) requiring temporary fecal diversion to protect distal anastomoses and allow healing.

3. Pediatric and Neonatal Ostomy Care: Smaller-sized one-piece drainable pouches are used in pediatric surgery for infants and children with congenital anomalies (e.g., imperforate anus, Hirschsprung’s disease, necrotizing enterocolitis), offering gentle adhesion for delicate skin.

4. Use in Conjunction with Irrigation for Colostomy Management: For select colostomates who perform colostomy irrigation, the drainable pouch can be used as a collection device between irrigations or during the irrigation process.

5. Post-Operative Fluid and Electrolyte Monitoring: Used in the immediate post-operative period to measure and monitor stoma output volume, aiding in fluid and electrolyte balance management, which is critical for ileostomy patients at risk of dehydration .

6. Temporary Diversion to Protect Distal Bowel Anastomosis: Used as a temporary measure to divert the fecal stream after low anterior resection for rectal cancer, protecting the newly formed anastomosis to allow it to heal without exposure to stool.

7. 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.

8. Radiological and Chemotherapy Treatment Support: Allows patients undergoing radiation therapy or chemotherapy for colorectal or bladder cancer to maintain hygiene and dignity while managing treatment-related bowel changes.

9. Discharge Planning and Home Care Management: Facilitates early hospital discharge by providing patients and home health aides with a simple, easy-to-manage appliance for continuation of care at home.

KEY PRODUCT FEATURES

1. BASIC IDENTIFICATION ATTRIBUTES

Device Type: A single-use, one-piece drainable ostomy bag designed for adult patients with an ileostomy or colostomy, consisting of an integrated adhesive skin barrier and collection pouch with a resealable open end .
Designation: One-piece drainable ostomy bag, colostomy bag, ileostomy bag, stoma pouch, integrated drainable pouch .
Key Components:
- Pouch Body: A leak-proof, 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 .
- Drainable Outlet: An open-ended tail located at the bottom of the pouch, designed for easy emptying.
- Closure Mechanism: A secure, re-sealable closure system (e.g., Velcro, hook-and-loop, fold-over, or clamp) to seal the outlet after emptying .
- Filter: An integrated activated carbon filter to allow flatus to escape while containing odor, preventing "ballooning" .
- Comfort Layer: A soft, breathable 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 output monitoring without removal .

2. TECHNICAL & PERFORMANCE PROPERTIES

GMDN Term & Definition: One-piece intestinal ostomy bag, open-ended. A plastic pouch designed to be attached around a stoma for use as a receptacle for intestinal output following a colostomy or ileostomy .
Capacity: Typically ranges from 630 mL to 780 mL, depending on brand and specific application .
Skin Barrier Material: Medical-grade hydrocolloid adhesive, often featuring a non-woven fabric border for flexibility and extended wear time .
Pouch Film: High-barrier, multi-layer film (often including Ethylene-Vinyl Alcohol copolymer or EVOH) to ensure 100% odor-proof containment .
Closure Type: Available in several secure options including integrated hook-and-loop (Velcro), fold-over with integrated tabs, or plastic clamp .
Stoma Opening Compatibility: Pre-sized cut-to-fit openings (typically ranges like 10-76 mm or 20-65 mm) allow for customization to individual stoma size .
Filter Type: High-efficiency activated charcoal filter with features to prevent liquid bypass (e.g., honeycomb design or protective flaps), available with or without a user-applied sticker .
Body-side Covering: Soft, double-sided non-woven fabric that is quiet, breathable, and reduces skin friction .
Inspection Window: Integrated transparent film layer allowing visual assessment of stoma and output without removing or opening the bag .
Sterility: Non-sterile; intended for use on clean, intact peristomal skin (not for use in an open surgical field) .
Single-Use: Intended for single patient use only; the bag is changed every 1-7 days depending on output and skin condition .

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 opaque (fabric), translucent, or transparent options to suit user preference for discretion or clinical utility .
Flexibility: The pouch and integrated barrier are designed to flex with body movement, making them suitable for use on convex or flat abdominal surfaces.
Wear Time: Standard wear time is 24 to 72 hours depending on stoma type (ileostomy vs. colostomy), volume, and skin condition.
Packaging: Individually wrapped and sold in boxes (e.g., 10, 20, 30 pieces) .
Accessories: Often supplied with a measuring card for custom-cutting the opening, disposal bags, and illustrated instructions .

4. SAFETY & COMPLIANCE ATTRIBUTES

Regulatory Status: Class I medical device (GMDN Code 31075; FDA Product Code EZS) .
Quality Standards: Complies with international ostomy standards including ISO 8670-2 (Ostomy collection bags - Part 2: Requirements and test methods) .
Biocompatibility: Manufactured with skin-friendly, hypoallergenic materials; the hydrocolloid barrier is free from natural rubber latex and common sensitizers.
Odor Control: Certified to meet odor-barrier efficacy standards, ensuring odor is contained within the pouch .
Latex-Free: Manufactured without natural rubber latex to accommodate patients with latex allergies.

5. STORAGE & HANDLING ATTRIBUTES

Storage: Store in a cool, dry place at room temperature. Avoid exposure to direct sunlight, extreme heat, or humidity, which can degrade the adhesive and film.
Disposal: Used bags should be emptied into the toilet and then disposed of in a general waste bag. Do not flush the bag itself, as it is not designed to be flushable.
Shelf Life: Typically 2-3 years from the date of manufacture when stored properly.

6. LABORATORY & CLINICAL APPLICATIONS

Primary Application: Collection and management of intestinal effluent (feces, gas) from a diverted bowel following colostomy, ileostomy, or urostomy procedures .
Clinical Role: Essential post-operative and long-term care device in colorectal surgery, gastrointestinal oncology, trauma surgery, neonatal surgery, and general nursing for the management of patients with a stoma.

SAFETY HANDLING PRECAUTIONS

1. SAFETY PRECAUTIONS

Skin Preparation: The peristomal skin must be clean, dry, and free of lotions or oils before application to ensure proper adhesion of the hydrocolloid barrier .
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 .
Application Temperature: For best adhesion, warm the skin barrier with body heat (by holding the palm against it for 30-60 seconds) before applying.
Monitor for Leaks: Change the appliance immediately if any effluent is observed leaking under the barrier to prevent skin damage.
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.
Pre-filter Sticker: When showering or swimming, use the protective sticker (if provided) over the filter to prevent water from entering the pouch .

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. If irritation persists, a barrier powder or wipe may be required.

3. FIRE FIGHTING MEASURES

Flammability: The plastic pouch and 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.

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

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

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Post-Operative Fecal Diversion Following Colostomy or Ileostomy Surgery

Primary Use: Provides a sterile, single-use, integrated ostomy appliance that combines a skin barrier (adhesive flange) and a drainable collection pouch into one unit, designed for the management of fecal output following surgical creation of a colostomy or ileostomy .

2. Management of Liquid to Semi-Formed Stool Output for Ileostomies

Primary Use: Specifically designed to manage the continuous, corrosive, liquid to semi-liquid output typical of an ileostomy, featuring a durable, odor-proof pouch and a drainable outlet for frequent emptying .

3. Long-Term Daily Management for Community-Dwelling Ostomates

Primary Use: Provides the primary waste collection system for individuals living with a permanent or temporary stoma, allowing users to maintain hygiene, comfort, and social confidence during work, travel, and leisure activities .

4. Protection of Peristomal Skin Integrity

Primary Use: Utilizes a medical-grade hydrocolloid skin barrier that adheres to the peristomal area to protect the skin from enzymatic damage caused by direct contact with stoma effluent .

SECONDARY & SUPPORTIVE USES

1. Management of Fecal Output Following Colostomy for Diverticulitis or Cancer: Used as the primary collection device for formed stool output after sigmoid colostomy for benign or malignant disease, providing security and odor control .

2. Protection and Drainage Following Trauma or Emergency Fecal Diversion: Used in emergency surgery or trauma settings (e.g., gunshot wounds, pelvic fractures) requiring temporary fecal diversion to protect distal anastomoses and allow healing.

3. Pediatric and Neonatal Ostomy Care: Smaller-sized one-piece drainable pouches are used in pediatric surgery for infants and children with congenital anomalies (e.g., imperforate anus, Hirschsprung’s disease, necrotizing enterocolitis), offering gentle adhesion for delicate skin.

4. Use in Conjunction with Irrigation for Colostomy Management: For select colostomates who perform colostomy irrigation, the drainable pouch can be used as a collection device between irrigations or during the irrigation process.

5. Post-Operative Fluid and Electrolyte Monitoring: Used in the immediate post-operative period to measure and monitor stoma output volume, aiding in fluid and electrolyte balance management, which is critical for ileostomy patients at risk of dehydration .

6. Temporary Diversion to Protect Distal Bowel Anastomosis: Used as a temporary measure to divert the fecal stream after low anterior resection for rectal cancer, protecting the newly formed anastomosis to allow it to heal without exposure to stool.

7. 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.

8. Radiological and Chemotherapy Treatment Support: Allows patients undergoing radiation therapy or chemotherapy for colorectal or bladder cancer to maintain hygiene and dignity while managing treatment-related bowel changes.

9. Discharge Planning and Home Care Management: Facilitates early hospital discharge by providing patients and home health aides with a simple, easy-to-manage appliance for continuation of care at home.

1. BASIC IDENTIFICATION ATTRIBUTES

Device Type: A single-use, one-piece drainable ostomy bag designed for adult patients with an ileostomy or colostomy, consisting of an integrated adhesive skin barrier and collection pouch with a resealable open end .

Designation: One-piece drainable ostomy bag, colostomy bag, ileostomy bag, stoma pouch, integrated drainable pouch .

Key Components:

Pouch Body: A leak-proof, 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 .

Drainable Outlet: An open-ended tail located at the bottom of the pouch, designed for easy emptying.

Closure Mechanism: A secure, re-sealable closure system (e.g., Velcro, hook-and-loop, fold-over, or clamp) to seal the outlet after emptying .

Filter: An integrated activated carbon filter to allow flatus to escape while containing odor, preventing "ballooning" .

Comfort Layer: A soft, breathable 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 output monitoring without removal .

2. TECHNICAL & PERFORMANCE PROPERTIES

GMDN Term & Definition: One-piece intestinal ostomy bag, open-ended. A plastic pouch designed to be attached around a stoma for use as a receptacle for intestinal output following a colostomy or ileostomy .

Capacity: Typically ranges from 630 mL to 780 mL, depending on brand and specific application .

Skin Barrier Material: Medical-grade hydrocolloid adhesive, often featuring a non-woven fabric border for flexibility and extended wear time .

Pouch Film: High-barrier, multi-layer film (often including Ethylene-Vinyl Alcohol copolymer or EVOH) to ensure 100% odor-proof containment .

Closure Type: Available in several secure options including integrated hook-and-loop (Velcro), fold-over with integrated tabs, or plastic clamp .

Stoma Opening Compatibility: Pre-sized cut-to-fit openings (typically ranges like 10-76 mm or 20-65 mm) allow for customization to individual stoma size .

Filter Type: High-efficiency activated charcoal filter with features to prevent liquid bypass (e.g., honeycomb design or protective flaps), available with or without a user-applied sticker .

Body-side Covering: Soft, double-sided non-woven fabric that is quiet, breathable, and reduces skin friction .

Inspection Window: Integrated transparent film layer allowing visual assessment of stoma and output without removing or opening the bag .

Sterility: Non-sterile; intended for use on clean, intact peristomal skin (not for use in an open surgical field) .

Single-Use: Intended for single patient use only; the bag is changed every 1-7 days depending on output and skin condition .

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 opaque (fabric), translucent, or transparent options to suit user preference for discretion or clinical utility .

Flexibility: The pouch and integrated barrier are designed to flex with body movement, making them suitable for use on convex or flat abdominal surfaces.

Wear Time: Standard wear time is 24 to 72 hours depending on stoma type (ileostomy vs. colostomy), volume, and skin condition.

Packaging: Individually wrapped and sold in boxes (e.g., 10, 20, 30 pieces) .

Accessories: Often supplied with a measuring card for custom-cutting the opening, disposal bags, and illustrated instructions .

4. SAFETY & COMPLIANCE ATTRIBUTES

Regulatory Status: Class I medical device (GMDN Code 31075; FDA Product Code EZS) .

Quality Standards: Complies with international ostomy standards including ISO 8670-2 (Ostomy collection bags - Part 2: Requirements and test methods) .

Biocompatibility: Manufactured with skin-friendly, hypoallergenic materials; the hydrocolloid barrier is free from natural rubber latex and common sensitizers.

Odor Control: Certified to meet odor-barrier efficacy standards, ensuring odor is contained within the pouch .

Latex-Free: Manufactured without natural rubber latex to accommodate patients with latex allergies.

5. STORAGE & HANDLING ATTRIBUTES

Storage: Store in a cool, dry place at room temperature. Avoid exposure to direct sunlight, extreme heat, or humidity, which can degrade the adhesive and film.

Disposal: Used bags should be emptied into the toilet and then disposed of in a general waste bag. Do not flush the bag itself, as it is not designed to be flushable.

Shelf Life: Typically 2-3 years from the date of manufacture when stored properly.

6. LABORATORY & CLINICAL APPLICATIONS

Primary Application: Collection and management of intestinal effluent (feces, gas) from a diverted bowel following colostomy, ileostomy, or urostomy procedures .

Clinical Role: Essential post-operative and long-term care device in colorectal surgery, gastrointestinal oncology, trauma surgery, neonatal surgery, and general nursing for the management of patients with a stoma.

1. SAFETY PRECAUTIONS

Skin Preparation: The peristomal skin must be clean, dry, and free of lotions or oils before application to ensure proper adhesion of the hydrocolloid barrier .

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 .

Application Temperature: For best adhesion, warm the skin barrier with body heat (by holding the palm against it for 30-60 seconds) before applying.

Monitor for Leaks: Change the appliance immediately if any effluent is observed leaking under the barrier to prevent skin damage.

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.

Pre-filter Sticker: When showering or swimming, use the protective sticker (if provided) over the filter to prevent water from entering the pouch .

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. If irritation persists, a barrier powder or wipe may be required.

3. FIRE FIGHTING MEASURES

Flammability: The plastic pouch and 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.

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