Objectives

The primary objective is to procure high-quality, sterile, single-use Combined Spinal Epidural (CSE) packs to support regional anaesthesia procedures at Northdale Hospital. These supplies will enable rapid-onset spinal anaesthesia, continuous epidural anaesthesia, and effective post-operative pain management within theatre and obstetric environments.

Scope

This is a once-off supply contract for twenty (20) individually packed CSE packs to be delivered to Northdale Hospital, KwaZulu-Natal Province. The procurement process follows a five-stage evaluation model covering administrative compliance, capacity verification, specification adherence, pricing/preference scoring, and sample submission. Quotations are valid for ninety days, and all delivered products must retain a minimum shelf life of six months. The evaluation utilises an 80/20 preferential procurement framework, weighting eighty percent on price and twenty percent on socio-economic goals, specifically favouring South African-owned enterprises. Late submissions, expired products, and second-hand items are strictly excluded.

Technical Requirements

• Sterile, single-use, disposable medical device system designed for adult regional anaesthesia.
• Latex-free composition is preferred.
• Mandatory CE and/or ISO certification with compliance to applicable SANS/SABS standards.
• Epidural Needle: Tuohy-type, 16-gauge, 80–90 mm length, medical-grade stainless steel, featuring visible depth markings and a curved Tuohy tip.
• Epidural Catheter: 18-gauge, flexible, radiopaque, closed tip with multiple lateral eyes preferred, equipped with depth markings and compatibility with bacterial filters and locking adaptors.
• Locking Mechanism: Integrated system to prevent needle migration during insertion, ensure precise alignment with the Tuohy needle, and minimise accidental displacement.
• Individually wrapped and packaged.
• Bidders must formally confirm compliance with the published specification document. Physical samples may be requested post-evaluation for rigorous scrutiny against set standards.

Skills Requirements

As this tender pertains to the supply of goods rather than professional services, no specialised clinical or technical service skills are mandated. However, suppliers must demonstrate operational, logistical, and regulatory capacity, including:

• Valid licensing from the South African Health Products Regulatory Authority (SAHPRA) for the manufacture, wholesale, or distribution of medical devices.
• Active registration on the Central Suppliers Database (CSD) with verified tax compliance status.
• Submission of current CIPC company registration documents.
• Provision of BBBEE certificates or sworn affidavits to substantiate preference point claims.
• Demonstrated ability to meet delivery timelines, adhere to packaging standards, and furnish performance security upon contract award.

Explanation of Key Terms

• Combined Spinal Epidural (CSE) Pack: A specialised anaesthetic kit that integrates a spinal needle and an epidural delivery system, permitting clinicians to administer both anaesthetic techniques simultaneously or sequentially for improved surgical and obstetric outcomes.
• 80/20 Preference Point System: A South African government procurement evaluation method where bids score up to 80 points based on competitive pricing and up to 20 points for designated socio-economic objectives, here prioritising locally owned businesses.
• SAHPRA Licensing: Mandatory regulatory authorisation required in South Africa for any entity manufacturing, importing, or distributing medical devices, ensuring products meet national safety, efficacy, and quality standards.
• SBD 4 & SBD 6.1: Standardised bidding forms mandating full disclosure of conflicts of interest involving public officials and formal claims for preferential procurement points, respectively. Incomplete or falsified submissions result in automatic disqualification.