📊 Evidence-Based Reference
Central Venous Access Catheter
Hemed
Summary: The central venous access catheter by Hemed is a device used for venous access in various clinical settings. Key evidence highlights surgical experience as a factor in pediatric outcomes and the role of imaging in placement accuracy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K820736 ↗
Decision Date ?
April 15, 1982
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The central venous access catheter by Hemed was cleared through the FDA 510(k) pathway on April 15, 1982. It is classified as a Class 2 device under product code DQY.
What It Is
The central venous access catheter is a medical device designed to provide venous access for the administration of medications, fluids, and for blood sampling. It is commonly used in patients requiring long-term intravenous therapy.
FDA-Cleared Indications
- Percutaneous catheterization of a vein to provide central venous access.
- Administration of medications, fluids, blood products, or parenteral nutrition when venous access is needed.
- Blood sampling or monitoring through central venous access when indicated by the catheter's labeling and clinical need.
Clinical Applications
- Central venous access for intravenous medications and fluids.
- Administration of parenteral nutrition.
- Blood sampling through an established central venous line.
- Central venous access in patients with limited or difficult peripheral venous access.
- Selected critical-care applications requiring central venous access or hemodynamic monitoring, when supported by the specific catheter labeling.
Reported off-label uses
- Use as an access conduit during selected endovascular venous procedures, such as catheter-based treatment of deep vein thrombosis or placement of venous stents, when the catheter design and size are appropriate.
- Use for repeated outpatient infusions outside the device's specific labeled indications, depending on the catheter configuration and institutional policy.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The literature includes 15 studies, encompassing retrospective and prospective designs, with publication dates ranging from 2004 to 2023. These studies explore various aspects of catheter use, including surgical techniques and imaging guidance.
Reported Outcomes
Published studies report that surgical experience significantly affects outcomes in pediatric catheter implantation. Imaging techniques, such as ultrasound and fluoroscopy, are crucial for accurate placement and reducing complications. The use of tissue plasminogen activator has been shown to reduce infection rates in some cases.
Safety Profile
Reported complications include catheter-related infections, particularly in pediatric populations, and guidewire-mediated complications during placement. The risk of complications can be influenced by the surgical technique and the use of imaging guidance.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to standardize techniques and improve safety outcomes across diverse patient populations.
Practical Considerations
- Catheters are available in different lengths, diameters, lumen configurations, and materials; selection should match the access vein, therapy, flow requirement, and expected dwell time.
- Placement is commonly performed using ultrasound and fluoroscopy or other imaging guidance, with the tip positioned in an appropriate central vein according to the catheter's labeling and clinical indication.
- Confirm compatibility with infused medications, contrast media, blood products, pressure injection, and any required flow rates before use.
- MRI safety is model-specific. Check the exact catheter labeling for MR Safe, MR Conditional, or MR Unsafe status and follow any conditions for scanning.
- Potential complications include infection, bleeding, arterial puncture, thrombosis, air embolism, catheter malposition, vessel injury, and pneumothorax depending on the access site. Contraindications and precautions include local infection, uncorrected bleeding risk, and unsuitable venous anatomy.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for central venous access catheter?
The device is indicated for patients requiring long-term intravenous therapy, such as chemotherapy, parenteral nutrition, and difficult venous access.
What outcomes have been reported in clinical studies?
Studies have reported that surgical experience and imaging guidance significantly impact the success and safety of catheter placement.
What complications have been reported?
Safety data indicate risks of catheter-related infections and guidewire-mediated complications, with imaging guidance helping to mitigate some risks.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.