One piece Ostomy bag (Pediatrics) – Integrated type for infant (Drainable)
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The One piece Ostomy bag (Pediatrics) – Integrated type for infant (Drainable) is a sterile, single-unit medical appliance specifically designed for the collection and management of liquid to semi-formed intestinal effluent (stool) following ileostomy or colostomy surgery in infants under 12 months . This integrated one-piece system combines a soft, gentle hydrocolloid skin barrier and a collection pouch into a seamless, integrated unit, featuring a drainable outlet with integrated closure for easy, hygienic emptying by parents or NICU caregivers .
The infant integrated drainable pouch is significantly shorter than adult models (approximately 16 cm/6-7 inches in length, 190 mL capacity) and features a cut-to-fit skin barrier (typically covering stomas from 0-22mm up to 40mm) that accommodates the tiny stomas of newborns and infants . The soft hydrocolloid adhesive is specially formulated for fragile, sensitive neonatal/infant 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, many infant pouches feature child-friendly designs—teddy bear prints on the fabric backing—along with a “split back” fabric design that allows caregivers to inspect the stoma without removing the pouch .
The integrated drainable design allows caregivers to empty the pouch multiple times daily without changing the entire appliance . This reduces skin trauma from frequent full changes, lowers supply costs, and enables more normal care routines for the infant and family. The integrated closure is easy for parents to learn, supporting successful hospital-to-home transition after infant ostomy surgery. The appliance is EOS sterilized, making it suitable for use in immunocompromised neonatal populations .
For the pediatric surgeon and NICU nurse, the infant one-piece integrated drainable system simplifies post-operative management for neonates with congenital anomalies (imperforate anus, Hirschsprung’s disease), necrotizing enterocolitis (NEC), or traumatic bowel injury requiring temporary or permanent fecal diversion . For the infant and family, this appliance provides security, skin protection, dignity, and the opportunity for normal growth, feeding, and bonding—with minimal disruption to daily care routines .
Categories: CONSUMABLES AND DISPOSABLES, Incontinence Products, Wound Care
Tags: baby ostomy supplies, infant integrated drainable pouch, infant stoma care, integrated ostomy infant, NEC infant ostomy, neonatal colostomy bag, neonate ostomy bag, NICU ostomy bag, One piece infant ostomy bag, pediatric one-piece ostomy appliance
Description
One piece Ostomy bag (Pediatrics) – Integrated type for infant (Drainable)
PRIMARY CLINICAL & DIAGNOSTIC USES
1. Post-Operative Fecal Diversion Following Neonatal and Infant Intestinal Surgery
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Primary Use: Provides a sterile, single-use, one-piece integrated drainable ostomy appliance specifically sized for neonates and infants, combining a soft hydrocolloid skin barrier and a collection pouch as a single integrated unit, featuring a drainable outlet with integrated closure mechanism for secure, repeated sealing and emptying following surgical creation of a colostomy or ileostomy .
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How it helps: For the pediatric surgeon and neonatal intensive care nurse, the infant-sized one-piece integrated drainable system is essential for managing neonates and infants who have undergone emergency bowel surgery for conditions such as necrotizing enterocolitis (NEC), intestinal atresia, meconium ileus, or gastroschisis. The integrated design provides a secure, leak-resistant seal around the stoma through a thin, flexible hydrocolloid adhesive that conforms to an infant’s small, curved abdominal contours. For the critically ill infant in the NICU, the one-piece system provides reliable protection, significantly reducing the risk of skin breakdown and allowing the infant to focus on healing, growth, and development.
2. Management of Liquid Stool Output in Neonatal and Infant Ileostomies
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Primary Use: Specifically designed to manage the continuous, corrosive, liquid output typical of neonatal and infant ileostomies, featuring a small-capacity integrated pouch with a drainable outlet that allows caregivers to empty the pouch multiple times daily without removing the entire appliance .
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How it helps: For the neonatologist and NICU nurse, the drainable integrated pediatric pouch is extremely practical for managing high-output stomas. The ability to empty the pouch without removing the entire appliance preserves the integrity of the infant’s fragile peristomal skin and reduces the frequency of full appliance changes. The small capacity is appropriate for the low output volumes of newborns, while allowing for accurate output measurement—critical for monitoring hydration status, electrolyte balance (sodium, potassium loss), and nutritional absorption in premature and low-birth-weight infants at high risk for dehydration and failure to thrive.
3. Protection of Fragile Neonatal and Infant Peristomal Skin
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Primary Use: Utilizes an ultra-thin, medical-grade hydrocolloid skin barrier integrated into the one-piece system, specifically formulated for fragile, sensitive neonatal and infant skin, featuring a gentle adhesive that provides secure fixation while allowing atraumatic removal without causing skin tears or irritation. The barrier features a cut-to-fit opening precisely matched to the stoma size .
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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 in newborns and infants—complications that are particularly common due to their fragile, thin skin (up to 40% thinner than adult skin). The one-piece integrated design means the barrier and pouch are removed as a single unit, minimizing skin manipulation . For the infant, proper skin protection prevents painful irritation, bleeding (excoriated skin), and fungal infections (candidiasis)—directly improving comfort and preventing hospital readmission for skin breakdown.
4. Small and Discreet Integrated Design for Infants
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Primary Use: Engineered specifically for the anatomy of infants (under 12 months), with an integrated one-piece design that is exceptionally low-profile, flat, and discreet under clothing or hospital linens. The integrated pouch is constructed with a short length (approximately 16 cm / 6-7 inches) and low capacity (approximately 190 mL) to prevent dragging and discomfort .
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How it helps: For the infant, the integrated design sits flatter against the body compared to bulky two-piece systems, which is essential for very small patients where every millimeter matters. The short length ensures the pouch does not extend down to the knees, preventing tangling and allowing the infant to be swaddled, held by parents (kangaroo care), and positioned safely without discomfort. The integrated closure is soft and easy for parents to operate, supporting the transition from hospital to home care . For parents, the one-piece integrated appliance is simpler and less intimidating to apply and remove than a two-piece system, which requires assembling separate parts, boosting their confidence during the critical transition from hospital to home care.
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) or spontaneous intestinal perforation (SIP), with the integrated drainable pouch allowing NICU nurses to empty the pouch without removing the entire appliance, preserving fragile skin integrity .
2. Management of Congenital Anomalies (Imperforate Anus, Hirschsprung’s Disease): Provides essential post-operative ostomy management for newborns born with congenital malformations requiring immediate or staged surgical correction, including imperforate anus, Hirschsprung’s disease, and cloacal exstrophy .
3. Biliary Atresia Post-Kasai Procedure Drainage: Used as a modified drainage system to collect bile and ascites from abdominal drains post-Kasai procedure in infants with biliary atresia, reducing the frequency of dressing changes and the incidence of skin dermatitis .
4. Post-Operative Monitoring of Stoma Output in Infants: Used in the immediate post-operative period to measure and record stoma output volume, providing clinicians with critical data on bowel function recovery, nutritional absorption, and fluid/electrolyte balance—particularly important in neonates who are at high risk for dehydration .
5. Transition from Hospital to Home Care for Infant Ostomates: Facilitates early hospital discharge by providing parents with a simple, easy-to-apply integrated appliance that allows for confident continuation of care in the home environment, with the simple integrated closure reducing anxiety for parents learning to manage their infant’s stoma .
6. Soft Fabric Backing for Comfort: Features a soft, breathable non-woven fabric covering on the body-facing side to reduce friction, noise (rustling), and moisture against delicate infant skin. Many infant pouches feature child-friendly designs (teddy bear prints) on the fabric backing to reduce anxiety for the child and parents .
7. Split Back Design for Stoma Monitoring: The fabric covering may have a split or window allowing parents and healthcare providers to inspect the stoma without removing the pouch, reducing unnecessary appliance changes and skin trauma .
8. Pediatric Oncology and Post-Tumor Resection Care: Supports infants who have undergone tumor resection surgery where bowel resection and temporary ostomy creation is required for conditions such as neuroblastoma or sacrococcygeal teratoma .
9. Caregiver Training and Parent Education: Essential teaching device for training parents in pediatric ostomy management before hospital discharge, with the simple integrated design allowing hands-on learning without complex assembly requirements .
10. Use with Clamp or Wire Tie for Additional Security: While the pouch features an integrated drainable outlet with closure, some systems allow the bottom to be secured with a soft pediatric wire clamp (tie) for immobilization and to prevent accidental leakage in active infants .
11. Clostridium Difficile Colitis in Infants: Used in severe cases of refractory C. difficile colitis requiring surgical intervention with fecal diversion in pediatric patients.
12. Use as a Shorter Pouch for Small-Statured Adults: Infant/small pediatric integrated pouches (shorter length, smaller capacity) are sometimes used by small-statured adults who struggle with the length of standard adult pouches.
KEY PRODUCT FEATURES
1. BASIC IDENTIFICATION ATTRIBUTES
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Device Type: A sterile, single-use, one-piece integrated drainable ostomy bag specifically sized and designed for infants (typically under 12 months), consisting of a soft hydrocolloid skin barrier and collection pouch manufactured as a single integrated unit .
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Designation: One-piece infant ostomy bag, neonate ostomy bag, infant integrated drainable pouch, pediatric one-piece ostomy appliance, neonatal integrated colostomy bag, baby stoma pouch .
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Key Components:
o Pouch Body: A leak-proof, 100% odor-proof collection chamber made of multi-layer film (including EVOH) with pediatric-appropriate capacity (approximately 190 mL, 6-7 inches/16 cm in length) .
o Skin Barrier (Flange/Baseplate): An ultra-thin, integrated medical-grade hydrocolloid adhesive disc with a cut-to-fit opening (up to 40mm diameter, neonatal down to 0-22mm) that adheres to the peristomal skin; features a gentle formula for fragile infant skin .
o Integrated Drainable Outlet: An open-ended tail at the bottom of the pouch with an integrated closure mechanism (fold-over with tabs, clamp, or soft plug) for emptying .
o Closure Mechanism: Integrated closure (fold-over with integrated tabs, soft plastic clamp, or Velcro) for secure sealing after emptying .
o Fabric Backing: Soft, breathable non-woven fabric (e.g., PE, comfort netting) covering the body-facing side to reduce friction, moisture, and noise (rustle-free). May include a "split back" design for visual inspection .
o Adhesive Technology: Soft hydrocolloid barrier; standard wear, gentle to the skin, designed to conform to small body contours .
o Filter: Some models include a low-profile activated charcoal filter to allow flatus to escape while containing odor; many neonatal/infant pouches are filterless for liquid output .
o Sterility: Ethylene Oxide (EOS) sterilized, guaranteeing sterility for use in neonatal and infant populations .
2. TECHNICAL & PERFORMANCE PROPERTIES
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GMDN Term & Definition: 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 (effluent is typically of a fluid consistency). The distal end of the pouch can be opened for drainage of the waste and emptied, e.g., several times per day. This is a single-use device .
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FDA Product Code: EZS (Ostomy Pouch)
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Pediatric Capacity: Neonatal/infant capacity approximately 190 mL. Significantly smaller than adult pouches (500-780 mL) to match the smaller output volume of infants .
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Cut-to-Fit Range: Skin barrier opening is adjustable (cut-to-fit) and extremely small to match neonatal stomas, typically accommodating diameters from 0-22mm up to 40mm .
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Skin Barrier Material: Ultra-thin medical-grade hydrocolloid adhesive; standard wear (1-3 days); gentle adhesion specifically formulated for sensitive infant skin .
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Pouch Film: High-barrier, multi-layer film (often including Ethylene-Vinyl Alcohol copolymer - EVOH) to ensure 100% odor-proof containment; rustle-free material .
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Pouch Length: Approximately 16 cm (6-7 inches). Significantly shorter than adult pouches (11-12 inches) to fit an infant's body size .
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Closure Type: Integrated closure (fold-over, clamp, or Velcro) .
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Filter Type: Some models include a low-profile activated charcoal filter; many neonatal/infant pouches are filterless for liquid output .
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Body-side Covering: Soft double-sided non-woven fabric that is quiet, breathable, non-rustling; may feature teddy bear prints for child-friendly design .
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Sterility: Ethylene Oxide (EOS) sterilized. Neonatal/infant integrated pouches are often supplied sterile due to the immunocompromised and vulnerable nature of NICU patients .
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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 .
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Latex-Free: Manufactured without natural rubber latex to accommodate patients with latex allergies .
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Drainable Outlet: Open-ended tail at the bottom of the pouch with integrated closure for emptying.
3. PHYSICAL & OPERATIONAL PROPERTIES
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Configuration: Integrated one-piece system where the skin barrier and collection pouch are permanently attached as a single unit; no assembly required by the user .
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Appearance: Pouch body is often transparent or translucent to allow clinicians and parents to inspect the stoma and assess the color of the output; fabric backing may feature teddy bear prints .
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Standard Dimensions: Pouch length approximately 16 cm (6-7 inches); significantly shorter than adult pouches to fit an infant's body size .
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Flexibility: The integrated system is highly flexible, designed to conform to the curved abdominal wall of a small infant without causing pressure points or leaks .
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Wear Time: Standard wear time is 1 to 3 days, depending on stoma type, output volume, and skin condition .
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Packaging: Individually wrapped sterile packaging; often sold in bulk boxes (e.g., 30 baseplates and 30 bags) for hospital central supply .
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Accessories: May be supplied with a stoma measuring card for custom-cutting the opening, pediatric wire clamps (ties), and illustrated instructions for caregivers .
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Split Back Design: The fabric covering may have a split or window allowing parents and healthcare providers to inspect the stoma without removing the pouch .
4. SAFETY & COMPLIANCE ATTRIBUTES
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Regulatory Status: Class I medical device (FDA Product Code EZS; GMDN Code 64583). CE and ISO13485 certified .
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Quality Standards: Complies with international ostomy standards; manufactured under quality management systems (ISO 13485) .
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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 neonatal/infant skin .
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Sterility: Ethylene Oxide (EOS) sterilized making it safe for use in sterile neonatal intensive care environments .
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Odor Control: Certified to meet odor-barrier efficacy standards using multilayer high-barrier co-extrusion membrane .
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Latex-Free: Manufactured without natural rubber latex to accommodate patients with latex allergies .
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Expiration: 3 years from date of manufacture when stored properly .
5. STORAGE & HANDLING ATTRIBUTES
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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 .
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Shelf Life: 3 years from the date of manufacture when stored properly .
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Disposal: Empty contents into the toilet. Dispose of used bag in general waste as per local regulations. Do not flush the bag itself .
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Pre-use Preparation: For best adhesion in the NICU, warm the skin barrier with body heat before applying; ensure peristomal skin is clean, dry, and free of lotions or adhesive residue .
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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 .
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Closure Care: After emptying, wipe the drainable outlet clean before securing the integrated closure to ensure a leak-proof seal .
6. LABORATORY & CLINICAL APPLICATIONS
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Primary Application: Collection and management of liquid to semi-formed intestinal effluent from a diverted bowel following ileostomy or colostomy in infant patients (typically under 12 months), including neonates, following surgery for NEC, congenital anomalies, or other pathologies .
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Clinical Role: Essential post-operative care device in Neonatal Intensive Care Units (NICUs), pediatric surgery wards, and home healthcare for the management of infants with a stoma .
SAFETY HANDLING PRECAUTIONS
1. SAFETY PRECAUTIONS
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Sterilization: Always verify that the product packaging is sterile before use in a NICU setting. Never use if the package is open or damaged .
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Skin Preparation: The peristomal skin must be meticulously cleaned, dried, and free of lotions or barrier creams (often avoided in NICU settings to ensure adhesion) before application .
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Customization: The opening must be cut to the exact size of the stoma (usually using a guide). An opening that is too large will expose the fragile neonatal skin to corrosive liquid stool, leading to maceration and breakdown .
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Monitor for Leaks: Inspect the pouch frequently, as NICU patients are often lying supine. Change the appliance immediately if any effluent is observed leaking under the barrier .
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Closure Security: Ensure the integrated closure is fully engaged before resuming activity; failure to secure properly may result in leakage .
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Signs of Skin Breakdown: Discontinue use and consult a WOCN or neonatologist if the peristomal skin becomes red, weepy, raw, or develops a rash (candidiasis is common in the diaper area) .
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Filter Management: When showering or bathing the infant, cover the filter with the provided sticker (if available) to prevent water from entering the pouch .
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Dehydration/Hydration Monitoring: Neonates with high-output ileostomies are at extreme risk for dehydration and sodium depletion. Monitor strict input/output (I/O) and electrolytes daily.
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Body Image and Family Support: For parents, the teddy bear prints on the fabric backing help transform a medical device into something less threatening, reducing anxiety and supporting bonding during infant care .
2. FIRST AID MEASURES
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Adhesive Allergy: If signs of an allergic reaction (rash, severe itching, blistering) occur at the adhesive site, remove the appliance immediately, gently cleanse the skin with warm water, discontinue use of that brand, and consult a neonatologist .
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Bleeding Stoma: If the stoma bleeds when cleaning (common due to high vascularity), apply gentle pressure with a sterile gauze pad. Contact the surgeon if bleeding is profuse .
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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 .
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Closure Failure: If the integrated closure fails to seal securely, replace the entire pouch immediately to prevent leakage .
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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 .
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Pancaking (Pouch Flattening): Gently pull the pouch away from the body to introduce a small amount of air; ensure the filter is not blocked .
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Signs of Dehydration in Infants with High-Output Ostomies: Monitor for dry mucous membranes, sunken fontanelle, 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
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Flammability: The plastic pouch and non-woven fabric are combustible. Keep away from open flames and direct heat sources .
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Extinguishing Media: Use water, foam, CO₂, or dry chemical for fires involving combustible material .
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Storage Warning: Do not store ostomy supplies near radiators, heating vents, or in vehicles during hot weather .
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