Two-piece ostomy bag – Only drainable bag (Clip type)

1. BASIC IDENTIFICATION ATTRIBUTES

• Device Type: A single-use, drainable ostomy pouch with a plastic clip (clamp) closure mechanism, designed to be attached to a two-piece ostomy baseplate for the collection and management of liquid or semi-formed stool in patients with an ileostomy or colostomy. It is part of a two-piece system where the pouch is exchanged without removing the baseplate .

• Designation: Two-piece drainable ostomy bag, clip closure drainable pouch, two-piece drainable pouch with plastic clamp, ileostomy pouch drainable clip, open-ended ostomy bag, two-piece clip drainable bag, ostomy pouch with clamp .

• Key Components:

• Pouch Body: A leak-proof, 100% odor-proof collection chamber made of multi-layer film (including EVOH - Ethylene-Vinyl Alcohol Copolymer) designed for liquid to pasty stool .

• Mechanical Coupling (Flange Ring): A plastic ring (flex coupling or guided coupling) that snaps onto the matching ring on the baseplate, providing a secure, audible lock .

• Floating Ring/Floating Flange: Allows the pouch to be attached and removed without applying pressure to the abdomen near the stoma; fingers can be placed under the flange to minimise abdominal pressure .

• Drainable Outlet: An open-ended tail at the bottom of the pouch for emptying liquid or pasty stool .

• Plastic Clip (Clamp) Closure: A durable plastic clip (typically reusable) that seals the folded or rolled end of the drainable pouch tail; provides a very secure, leak-proof seal .

• Filter: An integrated activated charcoal filter (standard or full-circle) 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, noise, and moisture against the skin (ComfortWear™ panels) .

• Belt Tabs: Integrated tabs on the coupling ring for attaching an ostomy belt for additional security .

• Clip Features: Durable, reusable, provides tactile/audible closure confirmation, may include clip storage feature .

2. TECHNICAL & PERFORMANCE PROPERTIES

• GMDN Term & Definition: Two-piece ostomy bag. A device designed to be attached to a base plate as a receptacle for intestinal output following a colostomy or ileostomy (effluent is typically of a pasty consistency). The device consists of a pouch designed to be attached, via a flange, to a base plate. The proximal end of the device is open to the stoma and the distal end is openable for drainage (drainable). Typically, it is intended to be replaced one to three times per day .

• FDA Product Code: EZS - Ostomy Pouch .

• Capacity: Standard drainable pouch capacity ranges from 500 mL to 980 mL depending on size and manufacturer. High-output models available up to 980 mL .

• Coupling Type: Mechanical (flex coupling or guided coupling) with audible click confirmation; floating flange for pressure-free attachment; available with different coupling sizes (typically 50mm, 55mm, 60mm, 70mm) .

• Drainable Outlet Type: Open-ended / drainable with plastic clip (clamp) closure .

• Clip Closure Mechanism: Durable plastic clip (clamp) that is applied to the rolled or folded end of the drainable pouch tail .

• Operation: Fold or roll the pouch tail, then apply the clip over the folded end .

• Advantages: Very secure seal, reusable, provides tactile/audible closure confirmation, trusted for overnight use .

• Disadvantages: Small part that can be lost, may be difficult for patients with arthritis or reduced dexterity .

• Filter Type: Activated charcoal filter; available as standard filter or full-circle filter that reduces ballooning by up to 61% .

• Body-side Covering: Soft double-sided non-woven fabric that is quiet, breathable, non-rustling; available in opaque (beige, white) for discretion .

• Belt Fixation: Belt tabs integrated into coupling ring; available in two or three different positions .

• Wear Time (Pouch): The clip-type drainable pouch is emptied multiple times daily and typically changed every 1-3 days. The baseplate remains in place for 2-7 days while pouches are exchanged .

• Wear Time (Baseplate): 2-7 days depending on product line and patient anatomy .

• Clip Reusability: The plastic clip is designed to be reused across multiple pouch changes; one clip typically lasts for several boxes of pouches .

• Sterility: Non-sterile; intended for use on clean, intact peristomal skin with a properly adhered baseplate .

• Single-Use: The pouch itself is single-use (discarded after wear). The clip is reusable .

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

• Product Characteristics: Drainable, odour-proof, non-sterile, single-use pouch with reusable plastic clip closure .

• Packaging: Individually wrapped; sold in boxes (e.g., 10, 20, 30 pieces); clips may be included in the box or sold separately .

3. PHYSICAL & OPERATIONAL PROPERTIES

• Configuration: Part of a two-piece system where the clip-type drainable pouch and baseplate are separate components attached via a mechanical coupling; the drainable pouch is emptied multiple times and exchanged while the baseplate remains on the skin .

• Appearance: Available in opaque (fabric-covered) for discretion (beige, white), or transparent/translucent with measuring scale for clinical assessment .

• Flexibility: Flexible pouch design that conforms to body movement; soft coupling material for adaptability to body contours .

• Coupling Orientation: Systems may offer multiple coupling positions for optimal pouch orientation .

• Clip Closure Characteristics:

• Security: Very strong, secure seal; highly resistant to accidental opening

• Closure Feedback: Tactile and audible "snap" or "click" when properly closed

• Reusability: Clip can be rinsed and reused across multiple pouch changes

• Durability: Made of durable plastic that withstands repeated use

• Maintenance: Rinse with warm water after each use; allow to dry

• Wear Time (Pouch): The drainable pouch is emptied multiple times daily and typically changed every 1-3 days. The baseplate remains in place for 2-7 days while pouches are exchanged .

• Output Assessment: Transparent measuring scale allows estimation of output amount; viewing window allows stoma inspection without pouch removal .

• Noise Reduction: Quiet material that does not rustle during movement, with sound-absorbing fabric for discretion .

• Odor Control: Multi-layer film provides 100% odor-proof barrier; activated charcoal filter deodorizes escaping gas; some pouches feature integrated deodorizing technology .

• Application (Pouch Attachment): Attach to the coupling ring of the baseplate, press until audible click confirms secure locking. The floating ring allows attachment without abdominal pressure .

• Emptying Procedure:

• Remove the plastic clip by pulling it off the folded pouch tail .

• Unfold/unroll the pouch tail .

• Empty contents into the toilet .

• Wipe the outlet clean .

• Fold or roll the pouch tail (typically 2-3 rolls) .

• Apply the plastic clip over the folded end, ensuring a secure closure .

• Wash hands thoroughly .

• Clip Storage: Store the clip in a clean, dry place when not in use. Some patients keep the clip attached to the pouch tail (folded) for convenience .

• Pouch Removal (Discarding): Press the release tabs on the coupling ring to detach the pouch. Remove the clip (to reuse) and discard the used pouch. Rinse the clip with warm water and allow to dry before reuse .

4. SAFETY & COMPLIANCE ATTRIBUTES

• Regulatory Status: Class I medical device (FDA Product Code EZS - Ostomy Pouch) .

• Quality Standards: Complies with international ostomy standards; manufactured under quality management systems (ISO 13485). CE marked for European market .

• Biocompatibility: Manufactured with skin-friendly, hypoallergenic, non-irritating materials; hydrocolloid-free (the pouch itself does not contact the skin; the baseplate provides skin adhesion) .

• Odor Control: Certified to meet odor-barrier efficacy standards using multilayer high-barrier co-extrusion membrane .

• Latex-Free: Manufactured without natural rubber latex .

• Clip Safety: The plastic clip is a small part; ensure it is kept away from small children (choking hazard). Some clips are designed with curved edges for safety and comfort .

• Storage: Store in a cool, dry place away from direct heat and sunlight, which can degrade the materials .

• Expiration: Shelf life typically 3 years; check packaging for expiration date .

5. STORAGE & HANDLING ATTRIBUTES

• Storage: Store in a cool, dry place at room temperature below 30°C (86°F). Avoid exposure to direct sunlight, extreme heat, or humidity, which can degrade the pouch film, filter, and clip material. Keep out of reach of children (clip is a small part) .

• Shelf Life: Typically 3 years from the date of manufacture when stored properly; check individual packaging for expiration date .

• Pre-use Preparation: No special preparation required before attaching to the baseplate .

• Coupling Check: Ensure the coupling ring is clean and dry before attaching to the baseplate; if stool contacts the coupling ring, it should be cleaned before attaching a new pouch .

• Pouch Attachment: Align the coupling ring with the baseplate flange and press together firmly until an audible "click" confirms secure locking. The floating ring allows attachment without abdominal pressure .

• Clip Care: Rinse the plastic clip with warm water after each use. Inspect for cracks or damage. Replace the clip if it becomes cracked, warped, or fails to close securely .

• Emptying Procedure:

• Remove the clip .

• Unfold the pouch tail .

• Empty contents into the toilet .

• Wipe the outlet clean .

• Fold or roll the pouch tail (typically 2-3 rolls) .

• Apply the clip over the folded end .

• Ensure the clip is fully closed (listen for the "snap" or "click") .

• Pouch Removal (Discarding): Press the release tabs on the coupling ring to detach the used pouch. Remove the clip (to reuse) and discard the used pouch in general waste per local regulations. Do not flush .

• Output Monitoring: Use the transparent measuring scale (if available) or viewing window to assess stool volume and consistency without removing the pouch .

• Filter Care: When showering or swimming, use the provided filter cover sticker (if available) to prevent water from entering the filter and saturating the pouch .

6. LABORATORY & CLINICAL APPLICATIONS

• Primary Application: Collection and management of liquid or semi-formed stool following ileostomy or colostomy surgery in patients with high-output, pasty, or liquid stools. The clip-type drainable pouch is part of a two-piece system where pouches are emptied multiple times daily and exchanged without removing the baseplate .

• Clinical Role: Essential post-operative and long-term care device in colorectal surgery, gastroenterology, and home healthcare for the management of patients with an ileostomy or colostomy who have high-output or liquid stool requiring frequent emptying. Particularly suitable for patients who prefer a very secure, durable closure mechanism and do not have significant arthritis or dexterity limitations .