Objectives

The primary objective is to procure and deliver high-quality, sterile combined spinal epidural pack systems to support clinical anaesthesia and analgesia procedures at the designated hospital facility. The contract aims to ensure a reliable supply of compliant medical devices while adhering to public procurement regulations, including preferential scoring for youth-owned enterprises.

Scope

The tender covers the one-off supply and delivery of 160 units of combined spinal epidural pack systems. Deliveries must be made directly to the specified hospital location. The quotation validity period is 90 days, and all prices must be firm and inclusive of VAT where applicable. The contract focuses exclusively on the provision of ready-to-use sterile medical kits and does not include installation, maintenance, or clinical training services.

Technical Requirements

Bidders must supply packs meeting strict clinical, material, and packaging specifications:

• Tuohy Needle: 18G, 80–90mm length, 1cm graduations, precision fit stylet, smooth inner bevel, clear ridged hub, and ergonomic grip flange.
• Spinal Needle: 26G pencil-point design with a locking mechanism, compatible needle-through-needle configuration (protrusion ≤15mm), and a clear hub for rapid cerebrospinal fluid visualization.
• Epidural Catheter: 20G, radio-opaque or reinforced, kink-resistant, closed-ended with an atraumatic multi-orifice tip, precise centimeter markings, and a secure snap-type connection device.
• Accessories: Includes a 10ml low-friction, pre-lubricated loss-of-resistance syringe and a 20-micron inline filter with a luer-lock connector.
• Materials & Safety: All components must be latex-free, pyrogen-free, and constructed from stainless steel and medical-grade plastics.
• Packaging: Sterile, single-use, individually sealed in peel pouches. Labels must display size, specification, trade name, CE marking, sterilization method, manufacturing site, lot number, and manufacture/expiry dates.
• Compliance Documentation: Valid SAHPRA licensing for medical device distribution/importation, Central Supplier Database (CSD) registration, tax clearance, and Broad-Based Black Economic Empowerment (B-BBEE) proof are mandatory.

Skills Requirements

As this is a pure goods supply contract, no specialized technical, installation, or clinical skills are required from the supplier. The evaluation focuses strictly on logistical capability, inventory management, regulatory compliance, financial stability, and the ability to execute timely deliveries according to the specified schedule.

Key Terms & Unusual Requirements

Combined Spinal Epidural Pack: A pre-assembled, sterile surgical kit containing precisely calibrated needles and catheters designed for simultaneous or sequential spinal and epidural anaesthesia administration. The integrated design reduces setup time and minimizes contamination risks in operating theatres.

Needle-through-Needle Configuration: A procedural safety feature requiring the spinal needle to remain within a strict 15mm limit relative to the epidural needle to prevent accidental tissue trauma during insertion.

Preference Procurement Framework: Evaluation follows an 80/20 scoring model (80% price, 20% specific goals), with full points allocated to youth-owned enterprises per national procurement regulations. Proof of ownership must be submitted via official certification or sworn affidavits.

Sample Submission: Top-scoring bidders will be required to submit physical samples for clinical and technical verification before final contract award. Failure to provide compliant samples results in disqualification.

Regulatory Compliance: Suppliers must hold active SAHPRA authorization to wholesale or distribute medical devices, alongside standard municipal tax and central supplier database validations. Expired or second-hand products are strictly prohibited.