Objectives

The primary objective of this tender is to secure a reliable, compliant, and timely supply of specialised paediatric cardiopulmonary bypass equipment for clinical use at Inkosi Albert Luthuli Central Hospital. The procurement aims to ensure uninterrupted surgical capabilities by providing high-quality, sterile, and clinically validated oxygenation devices that meet strict provincial health department standards.

Scope

The tender covers a one-off supply and delivery of twenty-five (25) units of Paediatric Oxygenator Combo Packs to the designated hospital facility in KwaZulu-Natal. The contract is strictly limited to the provision of goods, with no additional installation, commissioning, training, or long-term maintenance services required. All quoted prices must be firm, inclusive of freight and delivery to the specified destination, and remain valid for ninety (90) days from the closing date.

Technical Requirements

• Product Specification: Paediatric Oxygenator Combo Pack designed for cardiopulmonary bypass procedures, sized for fluid capacities between 0 and 5000mls.
• Materials & Construction: Clear plastic composition with an integrated heat exchanger, minimal priming volume, and tubing engineered for optimal hardness during thermal regulation in bypass circuits.
• Performance Criteria: Must deliver efficient oxygenation, support a flow range of 0–5000mls, allow straightforward setup and priming, facilitate rapid de-airing, and maintain optimal transmembrane pressure throughout operation.
• Packaging & Validity: Supplied as single-unit combo packs. All items must be brand new, unused, and carry a minimum remaining shelf life of six months upon delivery. Expired, refurbished, or second-hand products are strictly prohibited.
• Compliance Standards: Goods must conform to applicable SANS/SABS specifications and fully satisfy the clinical performance benchmarks detailed in the official specification annexure.

Skills and Qualification Requirements

• Regulatory Licensing: Bidders must hold a current licence issued by the South African Health Products Regulatory Authority (SAHPRA) authorising the import, export, manufacturing, or wholesale distribution of medical devices.
• Administrative & Financial Compliance: Active verification on the Central Suppliers Database (CSD) with confirmed tax clearance status. Submission of updated CIPC registration documents or a sworn B-BBEE affidavit is mandatory.
• Preference Documentation: To claim the twenty (20) preference points allocated for youth empowerment, bidders must provide verifiable evidence of majority ownership and operational control by individuals under the age of thirty-five.
• Operational Capacity: Demonstrated ability to execute one-off medical device deliveries without prior records of non-performance, default, or contractual breaches.
• Sample Submission Capability: Top-scoring bidders may be required to submit physical samples for clinical validation. Suppliers must maintain ready stock and logistical readiness to promptly deliver unopened, compliant units when formally requested.

Explanation of Unusual or Complicated Terms

• Paediatric Oxygenator Combo Pack: A specialised medical device used during open-heart surgeries to temporarily assume heart and lung functions. The "combo pack" integrates the oxygenator membrane, heat exchanger, and pre-connected tubing into a single unit, minimising blood exposure and priming volume for smaller patients.
• SAHPRA Licence: Mandatory regulatory approval from South Africa’s health product authority, ensuring all distributed medical devices meet national safety, efficacy, and quality control standards before clinical use.
• 80/20 Preference Point System: A government procurement scoring framework where eighty percent of evaluation points are awarded based on competitive pricing, and twenty percent are reserved for socio-economic transformation goals (specifically, promoting youth-owned enterprises).
• Transmembrane Pressure: A critical clinical measurement indicating the pressure differential across the oxygenator's semi-permeable membrane. Maintaining optimal levels ensures efficient oxygen-carbon dioxide exchange while preventing haemolysis (red blood cell damage) or circuit failure.