Explore our specialized range of interventional cardiology drapes, reinforced surgical gowns, and procedure packs manufactured for optimal fluid control and microbial barrier protection.
AAMI Level 4
Femoral Access
Radial Access
Cath Lab Universal
EN 13795 High Performance
OEM Custom Kit
Heavy-Duty SMS
Cleanroom Certified
Surgeine Healthcare combines vertical integration, advanced nonwoven chemistry, and rigorous compliance to serve over 25 healthcare markets globally.
Full regulatory compliance across all product families. Maintained continuous CE marking since 2008 and updated under stringent EU MDR requirements in 2024 with complete technical documentation for global tenders.
Every lot undergoes internal testing for hydrostatic head, microbial barrier resistance, bursting strength, tensile durability, and lint generation in accordance with AAMI PB70 and EN 13795 standards.
Commissioned in 2023, our specialized procedure pack manufacturing unit produces micro-customized angiography trays with exact component folding, sequence alignment, and hospital-specific labeling.
In-house medical grade barrier film lamination and automated pouch sealing ensure consistent microbial sterility assurance, zero delamination during surgery, and extended shelf-life integrity.
Recognized for enterprise-grade international fulfillment, supporting private label (OEM) programs, multi-lingual Instructions for Use (IFU), and seamless customs clearing documentation in 25+ countries.
Right-sized pack design engineered to minimize surgical waste in cardiac cath labs, reducing post-operative bio-waste burden while maintaining uncompromised sterile field integrity.
In contemporary interventional cardiology and radiology, the Cath Lab environment presents unique infection prevention challenges. Diagnostic angiography and percutaneous coronary interventions (PCI) demand rapid room turnaround, extensive fluoroscopic equipment coverage, precise fluid absorption, and flawless microbial barriers. Hospital procurement teams and medical device distributors are increasingly shifting from fragmented component sourcing to integrated, high-performance sterile angiography procedure packs.
Historically, transfemoral angiography dominated interventional procedures, requiring large dual-groin fenestrations and heavy-duty liquid collection pouches capable of absorbing large volumes of blood and contrast media. However, global clinical guidelines now strongly favor Transradial Access (TRA) due to reduced bleeding complications and faster patient mobilization.
As a leading angiography pack manufacturer, Surgeine Healthcare has engineered hybrid and dedicated radial angiography drapes featuring dual-access fenestrations (wrist and femoral backup), transparent lateral side panels for unobstructed C-arm fluoroscopy imaging, and specialized cable holders that stabilize guide wires and catheter sheaths during complex angioplasty procedures.
Modern interventional packs depend heavily on the material integrity of nonwoven fabrics. The baseline standard of spunbond polypropylene has evolved into sophisticated multi-layer substrates:
When evaluating angiography packs for hospital tenders, procurement officers must align drape and gown specifications with international standards. Below is the technical compliance matrix implemented across our manufacturing facilities:
| Barrier Rating / Standard | Hydrostatic Head Resistance | Impact Penetration | Microbial / Viral Barrier | Primary Cath Lab Application |
|---|---|---|---|---|
| AAMI Level 2 | ≥ 20 cm H2O | ≤ 1.0 g | Liquid Resistance Only | Low-fluid diagnostic angiography, minor vascular line placements |
| AAMI Level 3 | ≥ 50 cm H2O | ≤ 1.0 g | High Fluid Resistance | Standard transradial cardiac catheterization, pacemaker implantation |
| AAMI Level 4 / EN 13795 High | ≥ 100 cm H2O (ASTM F1670/F1671) | 0.0 g (Impervious) | Bacteriophage & Bloodborne Viral Barrier | High-irrigation PCI, structural heart procedures (TAVI/TAVR), complex trauma |
Hospitals are moving away from stock standard packs toward custom-configured trays tailored to specific physician preference cards. A custom angiography pack integrates every single consumable required for a procedure into a single sterile pouch, including:
• Transradial/Transfemoral Angiography Drape with Incise Film
• AAMI Level 3 or 4 Reinforced Surgical Gowns & Hand Towels
• Equipment Covers (C-Arm, Control Console, Fluoroscopy Shield)
• CHG Skin Prep Applicators & Swab Sticks
• Manifold Sets, Syringes, Scalpel Blades, Waste Bowls & Gauze Swabs
By sourcing customized procedure packs from an ISO 13485 certified direct manufacturer, hospital supply chain directors achieve volume procurement savings, single-source lot traceability, and guaranteed EU MDR regulatory compliance.
According to the Society for Healthcare Epidemiology of America (SHEA) and the CDC, surgical site infections and central line-associated bloodstream infections (CLABSI) carry significant patient morbidity and financial cost. Implementing full-body sterile angiography drapes with integrated incise films establishes an absolute sterile barrier. The incise film immobilizes resident skin flora at the puncture site, preventing micro-organisms from migrating into arterial sheaths during catheter manipulation.
Detailed technical, regulatory, and commercial responses for hospital purchasing committees, OEM clients, and international medical distributors.
Optimize your catheterization laboratory supply chain with ISO 13485 & EU MDR certified surgical packs. Contact our technical engineering team today for custom sample kits, regulatory technical files, and competitive direct-factory pricing.