Objectives

The primary objective is to procure specialized paediatric cardiopulmonary bypass equipment to support life-saving cardiac surgeries at Inkosi Albert Luthuli Central Hospital. The procurement seeks to ensure clinical safety, operational reliability, and strict adherence to national health and regulatory standards, while advancing socio-economic transformation through targeted preferential procurement policies.

Scope

The tender covers a once-off supply and delivery of twenty (20) units of Infant/Paediatric Oxygenator Combo Packs. Deliveries must be made directly to the hospital’s designated facility within the agreed timeframe. The contract encompasses standard warranty obligations, logistics, packaging, and compliance with the General and Special Conditions of Contract issued by the KwaZulu-Natal Department of Health.

Technical Requirements

• Product Specifications: Transparent, polyvinylchloride (PVC) combo packs specifically sized for infant and paediatric patients.
• Clinical Performance: Efficient oxygenation, minimal priming volume, integrated heat exchanger, and configurable arterial filtration (external filters may be omitted if an integrated arterial filter is present).
• Operational Parameters: Flow range of 0–3000 ml/min, easy setup and priming, optimal transmembrane pressure management, and straightforward de-airing capabilities.
• Material Standards: Tubing must maintain optimum Shore hardness during thermal cycling to prevent kinking or rupture.
• Quality & Compliance: Products must be brand new, unused, and possess a minimum shelf-life of six months upon delivery. Bidders must formally confirm compliance with every specification criterion by ticking and initialing the document.
• Regulatory Mandate: A valid licence issued by the South African Health Products Regulatory Authority (SAHPRA) authorizing the distribution of medical devices is compulsory.

Supplier Capabilities & Skills Requirements

As this is a goods-supply tender, requirements centre on organisational capacity and regulatory competence rather than individual personnel skills:

• Proven logistical and supply chain capability to deliver medical-grade equipment on schedule without prior default history.
• Financial and operational stability to execute a once-off contract in accordance with public sector contracting standards.
• Ability to maintain active Central Suppliers Database (CSD) registration and demonstrate tax compliance verification.
• Capacity to provide verifiable documentation proving youth ownership or other designated enterprise status to claim preference points.
• Readiness to produce and submit physical product samples for clinical evaluation if ranked among the highest-scoring bidders.

Explanation of Key Technical & Procurement Terms

• Oxygenator Combo Pack: A complete extracorporeal circuit used during cardiopulmonary bypass surgery. It integrates the oxygenator (which exchanges gases in the blood), connecting tubing, and typically an integrated heat exchanger and filter, all scaled for small-patient physiology.
• Priming Volume: The amount of fluid required to fill the circuit before patient connection. Smaller volumes are critical in paediatrics to minimise haemodilution, reduce transfusion requirements, and improve haemodynamic stability.
• Transmembrane Pressure: The pressure differential across the oxygenator’s semi-permeable membrane. Maintaining optimal levels ensures efficient gas exchange while preventing shear stress and red blood cell damage.
• Shore Hardness: A standardized measure of polymer stiffness/flexibility. Tubing must retain appropriate Shore hardness across temperature fluctuations encountered during bypass procedures to maintain patency and prevent mechanical failure.
• 80/20 Preference Point System: A South African public procurement framework allocating 80 points for competitive pricing and 20 points for socio-economic goals. This tender reserves the full 20 points for enterprises owned by youth.
• SAHPRA Licensing: Mandatory regulatory clearance from the South African Health Products Regulatory Authority, confirming legal authorization to import, manufacture, or distribute medical devices within South Africa.