One piece Ostomy bag (Pediatrics) – Velcro type for infant (Drainable)

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The One piece Ostomy bag (Pediatrics) – Velcro type for infant (Drainable) is a disposable, single-unit medical appliance specifically designed for the collection and management of intestinal effluent (stool) following ileostomy or colostomy surgery in infants and young children . This pediatric-specific ostomy system combines a soft, gentle hydrocolloid skin barrier and a collection pouch into a seamless, one-piece design, featuring a Velcro (hook-and-loop) closure at the drainage end for easy, hygienic emptying by parents or caregivers .
The pediatric drainable pouch is significantly smaller than adult models (neonatal capacity approximately 190 mL) and features a cut-to-fit skin barrier (typically 10-40mm diameter) that accommodates the tiny stomas of infants and growing children . The soft hydrocolloid adhesive is specially formulated for fragile, sensitive pediatric skin, providing secure fixation while allowing atraumatic removal without causing skin tears or irritation .
Constructed with multi-layer, 100% odor-proof film and covered with soft, breathable, non-rustling non-woven fabric, the pouch includes an integrated low-profile activated charcoal filter that allows flatus to escape while containing odor, preventing visible “ballooning” and “pancaking” that can be distressing for older children . Many pediatric pouches feature child-friendly designs—teddy bear prints, animal themes, or cartoon patterns—along with a “split back” fabric design that allows caregivers to inspect the stoma without removing the pouch .
The Velcro-type drainable design allows caregivers to empty the pouch 4-6 times daily without changing the entire appliance . This reduces skin trauma from frequent full changes, lowers supply costs, and enables more normal daily routines for the child and family. The simple Velcro closure is easy for parents to learn and manage, supporting successful hospital-to-home transition after pediatric ostomy surgery .
For the pediatric surgeon and stoma care nurse, the pediatric one-piece drainable system simplifies post-operative management for infants with congenital anomalies (imperforate anus, Hirschsprung’s disease), necrotizing enterocolitis (NEC), or traumatic bowel injury requiring temporary or permanent fecal diversion . For the child and family, this appliance provides security, skin protection, dignity, and the opportunity for full participation in age-appropriate activities—including play, school, swimming, and sports—with minimal disruption to daily life .
Description

One piece Ostomy bag (Pediatrics) – Velcro type for infant (Drainable)

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Post-Operative Fecal Diversion Following Neonatal or Pediatric Intestinal Surgery
  • Primary Use: Provides a sterile, single-use, one-piece drainable ostomy appliance specifically sized for infants and young children, combining a soft hydrocolloid skin barrier and a collection pouch into one unit, featuring a Velcro (hook-and-loop) closure for secure, repeated sealing and emptying .
  • How it helps: For the pediatric surgeon and stoma care nurse, the pediatric one-piece drainable system is essential for the management of infants and children who have undergone bowel surgery for congenital anomalies such as necrotizing enterocolitis (NEC), imperforate anus, Hirschsprung’s disease, or intestinal atresia. The integrated design provides a secure, leak-resistant seal around the stoma while protecting the infant’s fragile, sensitive skin from corrosive effluent . For the infant or child recovering from intestinal surgery, the small-sized pouch (neonatal capacity approximately 190 mL) and soft hydrocolloid barrier are specifically designed for tiny bodies, providing comfort, skin protection, and the dignity of hygienic waste management without requiring complete appliance changes multiple times daily .
2. Long-Term Management of Ileostomies and Colostomies in Growing Children
  • Primary Use: Specifically designed to manage the continuous output of liquid to semi-formed stool typical of pediatric ileostomies and colostomies, featuring a durable, 100% odor-proof pouch with a resealable Velcro outlet that allows caregivers to empty the pouch 4-6 times daily without removing the entire appliance .
  • How it helps: For the pediatric gastroenterologist and home care nurse, the Velcro-type drainable pouch is essential for managing the ongoing needs of children with permanent ostomies. The drainable design allows caregivers to empty the pouch multiple times throughout the day—without breaking the skin seal—preserving the integrity of the child’s delicate peristomal skin and reducing the frequency of full appliance changes . For the child and caregivers, the Velcro closure provides a hygienic, easy-to-use solution that enables discreet emptying and cleaning, reducing daily care time and minimizing disruption to the child’s play, school, and family activities.
3. Protection of Fragile Pediatric Peristomal Skin
  • Primary Use: Utilizes a soft, medical-grade hydrocolloid skin barrier specifically formulated for delicate infant and pediatric skin, featuring a gentle adhesive that provides secure fixation while allowing atraumatically removal without causing skin tears or irritation .
  • How it helps: For the wound ostomy and continence nurse (WOCN) and pediatric dermatologist, the gentle hydrocolloid barrier is critical for preventing Medical Adhesive-Related Skin Injury (MARSI) and contact dermatitis—complications that are particularly common in infants due to their thin, sensitive skin and frequent diaper-area moisture. Unlike adult barriers, pediatric barriers are designed with lower adhesion strength and softer materials to protect fragile skin . For the infant or child, proper skin protection prevents painful irritation, bleeding, weeping, and itching around the stoma—directly improving quality of life and reducing the risk of hospital readmission for skin breakdown, which can lead to pouch failure and leakage.
4. Soft Fabric and Child-Friendly Design for Comfort and Compliance
  • Primary Use: Features a soft, breathable non-woven fabric covering on the body-facing side to reduce friction, noise (rustling), and moisture against the skin, with many products featuring child-friendly designs such as teddy bear prints or animal-themed chassis to reduce anxiety and increase acceptance .
  • How it helps: For the pediatric ostomate and their family, the soft fabric backing is essential for comfort during daily activities, including crawling, walking, running, and sleeping. The non-rustle material prevents embarrassing noises during quiet activities or in school settings, while the absorbent fabric wicks moisture away from the skin, reducing the risk of diaper rash and fungal infections around the stoma . For the child, the cute animal prints and teddy bear designs transform a medical device into something playful and less threatening, reducing anxiety, improving cooperation during changes, and supporting positive body image development. Some designs include a split back feature that allows caregivers to peek at the stoma without removing the pouch .
5. Odor Control and Gas Management with Filter Technology
  • Primary Use: Features an integrated low-profile activated charcoal filter that allows flatus (gas) to escape from the pouch while trapping odor molecules, preventing “ballooning” (pouch bloating) and “pancaking” (pouch flattening/vacuum effect), with filter covers often decorated in coordinating child-friendly prints .
  • How it helps: For the child and caregivers, the carbon filter is essential for odor control, eliminating the worry of embarrassing smells at school, during sleepovers, or at family gatherings. The anti-ballooning feature prevents the pouch from bulging visibly under clothing, which can be distressing for older children and teens, while anti-pancaking technology ensures the pouch maintains proper shape for effective drainage . For the infant, the filter helps manage gas buildup that can cause discomfort and crying. Some filters have protective flaps or honeycomb designs to prevent liquid bypass, ensuring reliable performance even with liquid stool typical of pediatric ileostomies.

SECONDARY & SUPPORTIVE USES

1. Neonatal Intensive Care Unit (NICU) Post-Surgical Management: Used in neonatal ICUs for infants who have undergone emergency bowel surgery for conditions such as necrotizing enterocolitis (NEC), providing a secure, small-sized pouching system that accommodates the unique needs of premature and full-term newborns with stomas as small as 15mm .
2. Pediatric Oncology and Post-Tumor Resection Care: Supports children who have undergone tumor resection surgery for conditions such as neuroblastoma, Wilms’ tumor, or rhabdomyosarcoma where bowel resection and temporary or permanent ostomy creation is required.
3. Management of Congenital Anomalies (Imperforate Anus, Hirschsprung’s Disease): Provides essential post-operative ostomy management for newborns and infants born with congenital malformations requiring immediate or staged surgical correction, including imperforate anus and Hirschsprung’s disease.
4. Pediatric Inflammatory Bowel Disease (IBD) Surgery: Used for children with severe Crohn’s disease or ulcerative colitis who require colectomy with ileostomy formation, providing long-term ostomy management during childhood and adolescence.
5. Clostridium Difficile Colitis in Pediatric Patients: Used in severe cases of refractory C. difficile colitis requiring surgical intervention with fecal diversion in pediatric patients.
6. Trauma and Emergency Pediatric Surgery: Used in emergency surgical settings for children with traumatic bowel injuries (e.g., from motor vehicle accidents, penetrating trauma) requiring temporary fecal diversion.
7. Post-Operative Monitoring of Stoma Output in Infants and Children: Used in the immediate post-operative period to measure and record stoma output volume and consistency, providing clinicians with critical data on bowel function recovery, nutritional absorption, and fluid/electrolyte balance—particularly important in neonates and infants who are at high risk for dehydration.
8. Transition from Hospital to Home Care for Pediatric Ostomates: Facilitates early hospital discharge by providing parents and home health nurses with a simple, easy-to-apply, easy-to-empty appliance that allows for confident continuation of care in the home environment, with child-friendly designs that reduce anxiety for both child and parent.
9. School and Daycare Management for Children with Ostomies: Supports older children and teens in school settings by providing a low-profile, discreet, odor-proof pouching system that allows independent emptying in school bathrooms, enabling full participation in classroom and social activities without embarrassment.
10. Travel and Active Lifestyle Management for Pediatric Ostomates: For children and families, the Velcro-type drainable system is preferred for travel, camping, vacations, and extracurricular activities (swimming, sports, dance) where access to a toilet for emptying is available, but carrying multiple closed pouches would be impractical.
11. Palliative Care for Pediatric Patients with Advanced Malignancy: Used in pediatric palliative care for children with advanced, inoperable abdominal or pelvic malignancies causing bowel obstruction, where a diverting ostomy is created for palliation to relieve symptoms and improve end-of-life quality of life.
12. Caregiver Training and Parent Education: Essential teaching device for training parents and caregivers in pediatric ostomy management before hospital discharge, with the simple Velcro closure and cut-to-fit skin barrier allowing hands-on learning without complex assembly requirements.
13. Sizing Flexibility for Growing Children: The cut-to-fit skin barrier (typically 15-40mm diameter) allows the same product to accommodate the child’s growth over time, reducing the need for frequent product changes as the stoma changes size during the first weeks and months post-operatively .
14. Split Back Design for Stoma Monitoring: Many pediatric pouches feature a split back design in the fabric covering, allowing parents and healthcare providers to inspect the stoma and peristomal skin without removing the pouch, reducing unnecessary appliance changes and skin trauma .
15. Specialized Neonatal Pouch for Premature Infants: Ultra-small pouches (approximately 190 mL capacity) with cut-to-fit barriers accommodating stomas from 0-22mm are available for premature and very low birth weight infants, with drain taps compatible with Luer-Lock syringes for precise output measurement .
KEY PRODUCT FEATURES

1. BASIC IDENTIFICATION ATTRIBUTES

  • Device Type: A single-use, one-piece drainable ostomy bag with Velcro (hook-and-loop) closure, specifically sized and designed for pediatric and infant patients, consisting of an integrated soft hydrocolloid skin barrier and collection pouch .
  • Designation: One-piece pediatric ostomy bag, infant colostomy bag, pediatric drainable pouch, child stoma bag, neonatal ostomy pouch, one-piece drainable pediatric ostomy appliance .
  • Key Components:
    • Pouch Body: A leak-proof, 100% odor-proof collection chamber made of multi-layer film (including EVOH) with pediatric-appropriate capacity (typically 190-400 mL) .
    • Skin Barrier (Flange/Wafer): An integrated soft hydrocolloid adhesive disc with a cut-to-fit opening (typically 15-40mm diameter) specifically formulated for sensitive pediatric skin, featuring gentle adhesion and atraumatic removal .
    • Velcro Closure: A resealable hook-and-loop fastening system at the bottom of the pouch for easy, hygienic emptying and cleaning by caregivers .
    • Split Back Design: A fabric split or window in the body-side covering that allows caregivers to inspect the stoma without removing the pouch .
    • Filter: An integrated low-profile activated charcoal filter to allow flatus to escape while containing odor, with filter covers in child-friendly designs; prevents ballooning and pancaking .
    • Comfort Layer: A soft, breathable non-woven fabric covering the body-facing side to reduce friction, noise (rustling), and moisture against delicate skin .
    • Child-Friendly Design: Fabric with teddy bear prints, animal themes, or cartoon patterns to reduce anxiety and increase acceptance in pediatric patients .

2. TECHNICAL & PERFORMANCE PROPERTIES

  • GMDN Term & Definition: Pediatric one-piece intestinal ostomy bag, open-ended (drainable). A plastic pouch designed to be attached around a stoma for use as a receptacle for intestinal output following a colostomy or ileostomy. The device can be emptied and resealed using an integrated closure mechanism. Intended for pediatric use .
  • GMDN Term Code: 64583 (same as adult urostomy bag; pediatric-specific variants exist)
  • FDA Product Code: EZS (Ostomy Pouch)
  • Pediatric Capacity: Neonatal capacity approximately 190 mL; standard pediatric capacity ranges from 300-400 mL; significantly smaller than adult pouches (typically 500-780 mL) .
  • Cut-to-Fit Range: Skin barrier opening is adjustable, typically ranging from 10mm to 50mm (0.4-2.0 inches), accommodating various pediatric stoma sizes from neonates to older children .
  • Skin Barrier Material: Soft medical-grade hydrocolloid adhesive; standard wear (1-3 days); gentle adhesion specifically formulated for sensitive pediatric skin; atraumatic removal .
  • Pouch Film: High-barrier, multi-layer film (often including Ethylene-Vinyl Alcohol copolymer or EVOH) to ensure 100% odor-proof containment; rustle-free material .
  • Closure Type: Hook-and-loop (Velcro) fastener; soft, easy to open and close; provides a secure seal when pressed firmly; reusable across multiple emptying episodes .
  • Filter Type: Low-profile activated charcoal filter; available in round, square, or crescent shapes; includes protective filter cover often decorated with child-friendly prints; may include honeycomb design or protective flaps to prevent liquid bypass .
  • Body-side Covering: Soft double-sided non-woven fabric (approximately 30g/m²) that is quiet, breathable, non-rustling, and absorbs moisture (sweat) to prevent diaper rash and skin maceration .
  • 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 1-3 days, depending on output volume and skin condition. The drainable pouch can be emptied 4-6 times daily before changing the full appliance .
  • Latex-Free: Manufactured without natural rubber latex to accommodate patients with latex allergies.
  • Pouch Length: Neonatal pouch approximately 16 cm length; standard pediatric pouches significantly shorter than adult models to accommodate smaller body size .
  • Special Neonatal Features: Some neonatal pouches feature a drain tap compatible with Luer-Lock syringes for precise output measurement and controlled emptying .

3. PHYSICAL & OPERATIONAL PROPERTIES

  • Configuration: One-piece integrated system where the skin barrier and collection pouch are permanently attached as a single unit; no assembly required .
  • Appearance: Available in transparent, translucent, or opaque (fabric-covered) options. Opaque fabric pouches feature child-friendly designs (teddy bear prints, animal prints, cartoon themes) .
  • Flexibility: The pouch and integrated barrier are designed to flex with the child's body movement. Available in flat or convex configurations to manage flush or retracted stomas; the Pelican pediatric line offers the world's only soft convex pediatric pouches for infants with challenging stoma anatomy .
  • Wear Time: Standard wear time is 1 to 3 days, depending on stoma type (ileostomy output is more corrosive and may require more frequent changes), output volume, and skin condition .
  • Packaging: Individually wrapped and sold in boxes (e.g., 10, 20, 30 pieces), often with measurement tools and illustrated instructions .
  • Accessories: Typically supplied with a stoma measuring card for custom-cutting the opening, child-friendly filter covers, disposal bags, and illustrated instructions with child-friendly illustrations where available .
  • Inspection Window: The split back design in the fabric covering allows caregivers to inspect the stoma and peristomal skin without removing the pouch .

4. SAFETY & COMPLIANCE ATTRIBUTES

  • Regulatory Status: Class I medical device (FDA Product Code EZS; GMDN Code 64583) .
  • Quality Standards: Complies with international ostomy standards; manufactured under quality management systems (ISO 13485) .
  • Biocompatibility: Manufactured with skin-friendly, hypoallergenic, non-irritating materials; the hydrocolloid barrier is free from natural rubber latex and common sensitizers; specifically tested for sensitive pediatric skin .
  • 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 .
  • Neonatal Compatibility: Some products specifically validated for use in premature and low birth weight infants (stoma size compatibility down to 0-22mm) .

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. Keep out of reach of children.
  • Shelf Life: Typically 2-3 years from the date of manufacture when stored properly.
  • Disposal: Empty contents into the toilet. Dispose of used bag in general waste as per local regulations. 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, dry, and free of lotions, oils, or adhesive residue .
  • Cutting Instructions: Use the provided stoma measuring guide to determine correct stoma size. Cut the opening no larger than 1-2 mm (1/16-1/8 inch) larger than the stoma to prevent skin exposure to corrosive effluent .
  • Velcro Closure Care: After emptying, wipe the drainable outlet clean before folding and pressing the Velcro closure firmly to ensure a secure, leak-proof seal.

6. LABORATORY & CLINICAL APPLICATIONS

  • Primary Application: Collection and management of liquid to semi-formed intestinal effluent from a diverted bowel following ileostomy or colostomy in pediatric patients, including neonates, infants, toddlers, young children, and adolescents .
  • Clinical Role: Essential post-operative and long-term care device in pediatric surgery, pediatric gastroenterology, neonatal intensive care, pediatric oncology, and home healthcare for the management of children with a stoma .
SAFETY HANDLING PRECAUTIONS

1. SAFETY PRECAUTIONS

  • Skin Preparation: The peristomal skin must be clean, completely dry, and free of lotions, oils, powders, or adhesive residue before application to ensure proper adhesion and prevent skin breakdown. Avoid using baby oils or creams, as they impair adhesive bonding .
  • Customization: The opening must be cut to the correct size—no larger than 1-2 mm (1/16-1/8 inch) of the stoma. An opening that is too large will expose fragile pediatric skin to corrosive effluent and cause maceration, excoriation, and potential infection .
  • Monitor for Leaks: Change the appliance immediately if any effluent is observed leaking under the barrier to prevent skin damage. Leakage can occur more frequently in infants due to their constant movement.
  • Showering and Bathing: The pouch can be worn while bathing or showering. Some products include a filter cover sticker to prevent water from entering the filter. Use a swim belt or waterproof tape around the barrier edges for swimming.
  • Signs of Skin Breakdown: Discontinue use and consult a stoma care nurse or pediatrician if the peristomal skin becomes red, weepy, raw, itchy, or develops a rash, indicating possible fungal infection (candidiasis - common in diaper area), contact dermatitis, or adhesive allergy.
  • Infant-Specific Considerations: Infants are at higher risk for diaper rash and fungal infections due to constant moisture in the diaper area; extra attention to peristomal skin care, frequent pouch checks, and prompt changes are essential. The soft fabric backing helps wick moisture away from the skin .
  • Dehydration Monitoring: Pediatric ostomates (particularly those with ileostomies) are at high risk for dehydration and electrolyte imbalance. Monitor stoma output volume, urine output, oral intake, and weight; consult a clinician immediately for signs of dehydration (dry mucous membranes, sunken fontanelle in infants, decreased wet diapers).
  • Growth Considerations: As the child grows, the stoma size may change, and the skin barrier opening may need to be adjusted. Regularly measure the stoma (especially in the first weeks post-operatively and during growth spurts) to ensure continued proper fit.
  • Child Development Stages: Consider the child's developmental stage (crawling, walking, running, swimming) when selecting pouch features; soft fabric backing and low-profile filters are essential for active children.
  • School Considerations: For older children, ensure the pouch has a low-profile design, is odor-proof, and can be emptied independently by the child in school bathrooms with appropriate training.

2. FIRST AID MEASURES

  • Adhesive Allergy: If signs of an allergic reaction (rash, severe itching, blistering, redness spreading beyond the barrier area) occur at the adhesive site, remove the appliance immediately, gently cleanse the skin with warm water, discontinue use of that brand, and consult a clinician. Barrier wipes or powders may be required for ongoing skin protection.
  • Bleeding Stoma: If the stoma bleeds slightly when cleaning or measuring (common due to the high vascularity of stomal tissue), apply gentle pressure with a clean, dry gauze pad for a few minutes. Contact a clinician immediately if bleeding is profuse, does not stop, or if there is blood in the stool output.
  • Leakage or Skin Irritation: If a leak occurs, remove the appliance immediately, gently cleanse the skin with warm water (avoid soaps and wipes containing alcohol, oils, or fragrances), dry thoroughly, and apply a new bag. If irritation persists, a barrier powder or wipe may be required.
  • Velcro Closure Failure: If the Velcro closure loses its ability to seal securely (less common in pediatric use due to shorter wear time), replace the entire pouch immediately to prevent leakage. For older children, teach them to check the closure each time after emptying.
  • Pancaking (Pouch Flattening): If the pouch becomes flattened (pancaking), use the filter cover to control air exchange; teach older children to gently pull the pouch away from the body to introduce a small amount of air; ensure the filter is not blocked.
  • Ballooning (Pouch Bloating): If the pouch balloons with gas, ensure the filter is not blocked by stool or moisture; replace the filter cover if needed; if ballooning persists, change the pouch and consult a stoma care nurse.
  • Signs of Dehydration in Infants with High-Output Ostomies: Monitor for dry mucous membranes, sunken fontanelle (soft spot on infant's head), decreased wet diapers (less than 3-4 per day), lethargy, irritability, or poor feeding. Seek immediate medical attention if any of these signs are present.

3. FIRE FIGHTING MEASURES

  • Flammability: The plastic pouch and non-woven fabric are combustible. Keep away from open flames, direct heat sources, cigarettes, and lighters.
  • Extinguishing Media: Use water, foam, CO₂, or dry chemical for fires involving combustible material. The pouch presents no special fire hazard beyond typical plastics.
  • Storage Warning: Do not store ostomy supplies near radiators, heating vents, or in vehicles during hot weather, as extreme heat can degrade the adhesive and film.