Body surface conduit fixing device – Type B

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The Body Surface Conduit Fixing Device – Type B is a sterile, adhesive catheter stabilization device specifically engineered for the securement of epidural catheters, central venous catheters (CVCs), and large-bore drainage tubes . Unlike standard tape or suture methods, the Type B device features a rigid locking cradle or mechanical clamp integrated into a breathable, transparent adhesive dressing .
For the clinician (anesthesiologist, intensivist, or nurse), Type B devices offer a “hands-free” solution to catheter fixation. The specialized clamp holds the catheter wings or hub firmly in place, preventing pistoning (back-and-forth movement) that introduces bacteria into the bloodstream, thereby reducing Catheter-Related Bloodstream Infections (CRBSI) . The transparent film backing allows for continuous visual inspection of the insertion site without disturbing the dressing, facilitating early detection of phlebitis or drainage .
For the patient, the primary benefit is safety and comfort. Elimination of silk sutures removes the “pinching” and “pulling” sensation at the insertion site, which is often a major source of pain for patients with long-term central lines (e.g., oncology or dialysis patients). The hypoallergenic, waterproof adhesive allows patients to shower without fear of the dressing falling off, significantly improving quality of life. Type B devices are anatomically versatile, used on the chest for PICCs, the back for epidurals, and the abdomen for drainage tubes, offering a universal, standardized solution for device stabilization across the hospital .
Description

Body Surface Conduit Fixing Device – Type B

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Securement of Epidural and Central Venous Catheters
  • Primary Use: Provides a sterile, single-use adhesive device with a specialized mechanical fixation clamp (or locking cradle) designed to securely anchor epidural catheters, central venous catheters (CVCs), and peripherally inserted central catheters (PICCs) to the patient’s skin without sutures .
  • How it helps: For the anesthesiologist, interventional radiologist, and critical care nurse, the Type B device features a rigid or semi-rigid locking mechanism that securely grips the catheter hub or wings, preventing pistoning (back-and-forth movement) and accidental dislodgement . Unlike standard tape, the fixation clamp holds the catheter without compressing the lumen, maintaining flow integrity. For the patient receiving epidural analgesia, chemotherapy, or long-term antibiotics, this secure fixation eliminates the pain of suture removal and reduces the risk of catheter-related bloodstream infections (CRBSI) by preventing skin flora migration along the catheter tract.
2. Universal Compatibility with Multiple Conduit Types
  • Primary Use: Engineered with an adjustable fixation cradle that accommodates a wide range of catheter diameters and connector sizes, including central lines, drainage catheters, arterial lines, and feeding tubes .
  • How it helps: For the hospital supply chain manager and intensive care unit (ICU) clinician, the Type B device reduces inventory complexity by using a single fixation device across multiple catheter types. The adjustable cradle (often utilizing a “snap-on” or “click-lock” design) fits various manufacturers’ catheter wings without modification. For the patient, this means the nursing staff always has the correct securement device readily available, reducing delays in catheter dressing changes and minimizing the risk of accidental line pulls during patient turning or transport.
3. Skin-Friendly Adhesive Base with Hydrocolloid Protection
  • Primary Use: Incorporates a soft, hypoallergenic adhesive pad (typically polyurethane film or non-woven fabric) that adheres to the percutaneously, providing a stable base for the fixation clamp while protecting the fragile skin of critically ill or irradiated patients .
  • How it helps: For the wound care nurse and dermatology liaison, the Type B device features a gentle acrylic or silicone adhesive that minimizes the risk of Medical Adhesive-Related Skin Injury (MARSI). The integrated hydrocolloid or foam layer wicks moisture away from the insertion site, reducing maceration associated with sweat or serous drainage. For the patient with sensitive skin, history of radiation therapy, or long-term central access (e.g., oncology patients), this gentle but secure adhesion prevents painful skin tears and contact dermatitis, allowing for extended wear times (up to 7 days) without the need for painful re-taping.
4. Integrated Strain Relief for High-Flow and Large-Bore Catheters
  • Primary Use: Features a reinforced strain relief channel that redirects tubing stress vectors away from the catheter insertion site, preventing kinking and pullout of large-bore hemodialysis or apheresis catheters .
  • How it helps: For the dialysis nurse and apheresis specialist, the Type B device includes a built-in “J-loop” or “stress-relief” channel that absorbs the torque generated by heavy IV tubing. This prevents the catheter from being pulled out of the vessel during patient position changes. For the patient undergoing renal replacement therapy or stem cell collection, this strain relief prevents the sudden, painful sensation of the catheter tugging at the insertion site, allowing them to sleep or sit comfortably during long procedures (often 4-6 hours).
5. Visual Site Inspection Window for Infection Surveillance
  • Primary Use: Manufactured with a transparent film or fenestrated window that allows clinicians to directly visualize the catheter insertion site for early signs of infection (erythema, drainage, swelling) without removing the securement device .
  • How it helps: For the infection control practitioner and bedside nurse, the transparent backing provides continuous visibility of the “VAD” site. This facilitates compliance with the “Daily Review of Necessity” protocols and allows for instant assessment of site integrity during hourly rounding. For the patient, this transparency means the device does not need to be changed unnecessarily just to check the skin, reducing the frequency of dressing changes, which can be both painful and costly.

SECONDARY & SUPPORTIVE USES

1. Peripheral Nerve Catheter Stabilization: Used in regional anesthesia to secure catheters for continuous peripheral nerve blocks (femoral, sciatic, brachial plexus), preventing dislodgement that would interrupt post-operative pain control .
2. Chest Tube and Surgical Drain Management: Secures thoracostomy tubes and Jackson-Pratt (JP) drains to the chest or abdomen, preventing pullout that could lead to pneumothorax or surgical site infection .
3. Endotracheal Tube Fixation (Oral/Nasal): Modified Type B devices are used in anesthesia and critical care to anchor endotracheal tubes to the face, replacing traditional tape and reducing facial skin breakdown .
4. Nasogastric and Orogastric Tube Securement: Used to affix feeding tubes to the nose or cheek, preventing accidental removal which requires radiographic confirmation for re-placement .
5. Tracheostomy Tube Holder: Functions as a securement device for tracheostomy flanges, preventing tube dislodgement and reducing the risk of tracheal injury .
6. Hemodialysis Catheter Anchor: Specifically designed for large-bore dialysis catheters to withstand the high flow rates and patient movement during treatment, preventing venous stenosis caused by mechanical irritation .
7. Cardiovascular Monitoring Line Fixation: Used to hold arterial lines (A-lines) and pulmonary artery catheters in place in the ICU to ensure continuous hemodynamic monitoring accuracy .
8. Urinary Catheter Stabilization: Secures Foley catheters to the patient’s leg, preventing urethral traction and reducing the risk of catheter-associated urinary tract infections (CAUTI) .
9. Wound Drainage Tube Management: Attaches to surgical drains (e.g., Hemovac, Blakes) exiting the wound to prevent tugging and tension on the fresh incision line .
10. Interventional Radiology Access Site Care: Used to fix sheaths and dilators during interventional procedures to maintain vascular access without manual holding .
11. Pediatric Catheter Securement: Provides a secure, low-profile anchor for pediatric patients with small vasculature and highly mobile skin, reducing the risk of extravasation from dislodged IVs .
12. Patient-Controlled Analgesia (PCA) Line Protection: Holds PCA tubing securely in place so that the patient does not dislodge the line during sleep or ambulation .
13. Cerebral Spinal Fluid (CSF) Drainage System Securement: For patients with external ventricular drains (EVDs) or lumbar drains, the Type B device ensures the critical zero-level reference point remains stable to prevent over-drainage .
14. No-Sting Removal Protocols: Designed to be used in conjunction with silicone-based adhesive removers to facilitate pain-free device changes for burn or graft patients .
15. Home Healthcare Long-Term Line Management: Used by visiting nurses for patients with Port-a-Caths or PICC lines receiving home infusions, ensuring secure access without requiring professional suture removal .
16. Pre-hospital and Emergency Room Securement: Quickly applied in trauma bays to stabilize emergency lines (chest tubes, central lines) before the patient is transported to radiology or the ICU .
17. Magnetic Resonance Imaging (MRI) Compatibility: Type B devices are typically manufactured without metal components, making them safe to wear during MRI scans .
KEY PRODUCT FEATURES

1. BASIC IDENTIFICATION ATTRIBUTES

  • Device Type: A sterile, single-use adhesive securing device consisting of a skin-friendly base patch integrated with a mechanical locking clamp or gel pad designed to fixate medical conduit to the body .
  • Designation: Body Surface Conduit Fixing Device - Type B, Catheter Fixation Device, Central Line Holder, Epidural Catheter Anchor, Tube Securement Device, Catheter Stabilization Device, Dressing with Fixation .
  • Key Components:
o Adhesive Base (Skin Patch): Polyurethane film or breathable non-woven fabric; may include a hydrocolloid moisture-wicking layer .
o Fixation Mechanism: Locking clamp, "Christmas tree" adapter, or hook-and-eye closure; often designed with a low profile to prevent snagging .
o Catheter Channel: Pre-formed groove or cradle (sizes range from 5 Fr to 18 Fr) to seat the conduit.
o Strain Relief Tab: Extended portion of the device to tape down the tubing loop, preventing direct pull on the clamp.
o Absorbent Pad: Some versions include an iodine or silver-infused pad directly at the exit site to provide light antimicrobial protection.
o Reinforced Hub Gripper: Specific molded features designed to grip the wings of central venous catheters (CVCs).

2. TECHNICAL & PERFORMANCE PROPERTIES

  • Material Composition: Backing: Polyurethane (PU) or Polyethylene (PE); Adhesive: Acrylic or Silicone; Clamp: Medical-grade ABS plastic or Nylon; Latex-Free.
  • Adhesion Strength: Stronger than standard medical tape, often designed to withstand high pull forces (e.g., > 2 lbs or antimicrobial dressings) .
  • Clamp Versatility: Type B models typically cover a range of 5 Fr to 12 Fr catheters; some are universal, while others are size-specific.
  • Fluid Resistance: Waterproof backing protects the insertion site from external moisture during showering.
  • Wear Time: Up to 7 days per application, provided the site remains clean, dry, and intact.
  • Moisture Vapor Transmission Rate (MVTR): High (breathable) to prevent maceration of the skin under the patch.
  • Sterility: Sterile; Ethylene Oxide (EtO) or Gamma sterilized.
  • HCPCS Code: A4450 or A4452 (Tape, non-waterproof / waterproof, per 18 inches), depending on local coverage specifics.

3. PHYSICAL & OPERATIONAL PROPERTIES

  • Construction: Multi-layer design: PET release liner / Acrylic adhesive / PU backing / Foam block / Plastic clamp .
  • Application: "Peel and stick" base plate application followed by "snap-down" clamp closure.
  • Visibility: Fully transparent base to allow for continuous site assessment (ISO 10993 tested) .
  • Portability: Individually packed in a peel-pouch maintaining sterility; available in bulk boxes of 50 or 100.
  • Texture: The backing is often slightly textured to prevent slipping and to provide a surface for writing the date of insertion.
  • Disposal: Discard as medical waste; do not recycle due to potential biohazard contamination.

4. SAFETY & COMPLIANCE ATTRIBUTES

  • Regulatory Status: Class I Medical Device (21 CFR 880.5090 - Catheter Securement Device) or Class II with specific infection prevention claims .
  • Latex-Free: Standard for modern securement devices .
  • Biocompatibility: ISO 10993 tested for cytotoxicity, sensitization, and irritation.
  • MRI Compatibility: Non-ferromagnetic components; labeled as "MR Safe" or "MR Conditional."
  • Phthalate-Free: Free of DEHP (Di(2-ethylhexyl)phthalate).
  • Adhesion Type: Pressure-sensitive adhesive (PSA) that requires activation by firm finger pressure.

5. STORAGE & HANDLING ATTRIBUTES

  • Storage: Store in a cool, dry place (15-30°C / 59-86°F). Keep away from direct sunlight and extreme heat, which may melt the adhesive.
  • Shelf Life: Typically 2 to 3 years from date of manufacture.
  • Skin Prep: Requires clean, dry, alcohol-free skin (if using silicone adhesive) or thoroughly dried Chlorhexidine prep (if using acrylic adhesive).
  • Inspection: Do not use if the package is torn, opened, or if the adhesive appears yellowed or dry.
  • Removal: Requires an adhesive remover wipe to prevent skin stripping; remove by gently pulling the film parallel to the skin surface (low-and-slow technique).

6. LABORATORY & CLINICAL APPLICATIONS

  • Primary Application: To non-invasively secure and immobilize invasive medical lines (central lines, epidurals, chest tubes) to the skin surface to prevent dislodgement and infection .
  • Clinical Role: An essential infection control and patient safety supply used in Intensive Care Units (ICUs), Operating Rooms (ORs), Emergency Departments (EDs), Oncology Clinics, and Home Healthcare settings.
SAFETY HANDLING PRECAUTIONS

1. SAFETY PRECAUTIONS

  • Avoid Tension: Ensure the tubing has a "service loop" (slack) between the fixation clamp and the patient's clothing to prevent accidental pull-outs .
  • Do Not Cover the Clamp: Ensure the mechanical clamp itself is not covered by secondary tape that could put tension on the release mechanism.
  • Site Assessment: Remove and replace immediately if signs of phlebitis (redness, heat, swelling) or purulent drainage are visible through the viewing window .
  • Do Not Reuse: The mechanical clamp is designed for single patient use only; reuse risks cross-contamination and clamp fatigue.
  • Pressure Injury Prevention: For patients with edema or thin skin, do not overtighten the clamp; ensure the foam block provides cushioning without blanching the skin.

2. FIRST AID MEASURES

  • Contact Dermatitis: If the skin under the patch becomes red, weepy, or itchy, remove the device, cleanse the skin, and consult the wound care team about switching to silicone-based adhesive devices.
  • Adhesive Residue: Use a silicone-based medical adhesive remover (wipes or spray) to remove sticky residue from the skin; do not use alcohol on fragile skin as it causes drying and cracking.
  • Bleeding at Insertion Site: If the catheter site bleeds when the device is removed, apply sterile gauze with direct pressure for 5 minutes and assess for coagulopathy.

3. FIRE FIGHTING MEASURES

  • Flammability: The plastic components (backing and clamp) are slow to ignite but will melt if exposed to open flame.
  • Extinguishing Media: Use Water, Foam, Dry Chemical, or CO₂ for fires involving the packaging.