Objectives

The primary objective of this tender is to procure a catheterization set with multi-lumen central venous features, specifically a 7FR x 20cm device, to meet the clinical needs of Harry Gwala Regional Hospital. The procurement aims to ensure the availability of high-quality, compliant medical devices that facilitate safe and effective central venous access for fluid and drug administration.

Scope

The scope encompasses the supply of adult triple (multi) lumen central venous catheter sets, including all specified components such as polyurethane catheters, guidewires, introducer needles, and accessories, conforming to detailed specifications. The procurement covers the delivery of these medical devices to Harry Gwala Regional Hospital, with requirements for compliance with technical standards, quality, and safety specifications as outlined in the detailed product description and annexure.

Technical Requirements

• Indwelling polyurethane (PUR-3) central venous catheters that are flexible, radio-opaque, softening in situ, with clear cm markings and atraumatic, tapered, non-kinking tips.
• Catheter clamps and fasteners that secure without kinking, with precisely aligned holes and smooth edges.
• Integral suture wing hubs with low profile, marked with product name, size, and length, featuring flexible wings with suture holes.
• Transparent extension lines with color-coded lumen lock connections, secure clamps, and markings at 10cm, 20cm, and 30cm.
• Guidewire: Nitinol spring guidewire OD: 0.81mm (0.032"), with rounded atraumatic ends, marked at 10cm, 20cm, 30cm, and featuring an advancer/wire dispenser with see-through barrel and bulb.
• Accessories: Extra thin-walled 18G x 6.35cm introducer needle, 5 ml spring-wire syringe or valved Y system, tissue dilator, optional pressure transduction probe, and relevant information leaflets.
• All components to be sterile, latex-free, single-use, and manufactured from medical-grade plastics, complying with ISO 11070 and ISO 10555-3 standards.

Skills Requirements

Suppliers must demonstrate the ability to provide:

• Compliance with detailed technical specifications and quality standards.
• Provision of samples for evaluation and testing, if required.
• Proper documentation including certificates of conformity, SAHPRA licensing, and CSD compliance.
• Experience in supplying medical devices of similar nature and standards.
• Capacity to deliver within the specified timeframe and ensure product integrity during transit.
• Understanding of procurement policies, including preference points and regulatory compliance.