Objectives

The primary objective is to secure a qualified supplier for the one-off provision of specialised cardiovascular surgical equipment to support open-heart procedures at a public healthcare facility. The procurement aims to ensure uninterrupted access to critical intraoperative devices while adhering to national preferential procurement policies and regulatory standards.

Scope

The contract covers the supply and delivery of sterile, single-use left heart vent cannulas across four specified diameters. The required quantities are:

• 40 units of 10 French (F)
• 20 units of 13 F
• 20 units of 16 F
• 40 units of 20 F

Delivery must be completed directly to the hospital’s designated receiving area. The agreement is structured as a single transaction with a quotation validity period of 90 days. All logistics, insurance, and delivery costs must be factored into the quoted price.

Technical Requirements

Bidders must supply cannulas that strictly conform to the following clinical, material, and performance specifications:

• Clinical Purpose: Devices are designed for percutaneous or direct insertion into the left ventricle or left atrium. They function to decompress the left side of the heart by draining blood and entrained air during cardiopulmonary bypass, preventing ventricular distention and systemic embolism.
• Material Construction: Must be manufactured from medical-grade, biocompatible, non-pyrogenic, and thrombus-resistant polyvinyl chloride (PVC) or polyurethane. The proximal section must contain an embedded stainless steel or plastic wire coil to maintain structural integrity and prevent kinking under suction.
• Performance Metrics: Must achieve a minimum flow rate of 500 ml/min at a -100 mmHg pressure differential. The device must withstand negative pressures up to -300 mmHg without collapse. Side holes must be smooth and free of sharp edges to minimise myocardial trauma.
• Packaging & Shelf Life: Supplied in cartons of 10 units. Manufacturer shelf life must be between 3 and 5 years. Upon delivery, products must retain a minimum of six months of remaining shelf life. Used, refurbished, or second-hand items are strictly prohibited.
• Regulatory Compliance: Suppliers must hold a current licence issued by the South African Health Products Regulatory Authority (SAHPRA) permitting the wholesale or distribution of Class II/III medical devices.

Skills & Supplier Capabilities

As this is a goods-supply tender, individual staff qualifications are not mandated. Instead, bidders must demonstrate organisational competence and regulatory readiness:

• Active registration and verified compliance status on the Central Suppliers Database (CSD).
• Valid tax clearance documentation and adherence to National Treasury supply chain management directives.
• Established supply chain infrastructure capable of sourcing, storing, and delivering temperature-stable medical devices within agreed timeframes.
• Proven commercial history with no records of unexcused delivery defaults or contract breaches.
• Operational capacity to produce and ship physical product samples for clinical validation when requested.

Key Procurement & Evaluation Terms

80/20 Preference Point System: Evaluation allocates 80 points to price competitiveness and 20 points to socio-economic transformation. Full points for the specific goal are reserved exclusively for enterprises owned by youth, substantiated via B-BBEE certificates, sworn affidavits, or CSD reports.

Sample Validation Requirement: The three highest-scoring bidders will be formally requested to submit physical samples. Contract award is contingent upon successful technical and clinical verification of these samples against the published specifications.

Contractual Framework: Standard General and Special Conditions of Contract govern the agreement. Key terms include a 12-month warranty covering defects in design, materials, or workmanship, performance security obligations, liquidated damages for delayed delivery (calculated at the prevailing prime interest rate), and strict enforcement against collusive bidding or fraudulent declarations.