Objectives

The primary objective of this tender is to procure and deliver 1,000 units of universal sterile disposable surgical light handle covers to Victoria Mxenge Hospital under the KwaZulu-Natal Department of Health. The initiative aims to enhance infection control protocols by providing healthcare professionals with safe, single-use barriers that maintain sterile fields while adjusting operating theatre lighting during surgical procedures.

Scope

The contract encompasses a one-off supply and delivery of 1,000 units to the designated hospital facility. Quotations must remain valid for 90 days, and all delivery costs must be included in the submitted price. The procurement operates under an 80/20 preferential scoring framework, allocating 20 points specifically to promote South African-owned enterprises. Bidders must adhere to standard public sector contracting regulations, including Central Supplier Database (CSD) registration, tax compliance verification, and mandatory disclosure of interest declarations. Late submissions, expired products, or second-hand items will be disqualified.

Technical Requirements

• Product Type: Universal sterile disposable surgical light handle covers.
• Sterility & Usage: Must be supplied sterile for single-patient, single-use applications to minimize cross-contamination risks.
• Material Composition: Manufactured from medical-grade, latex-free polymer or an equivalent approved material.
• Design & Functionality: Ergonomic grip for secure manipulation; universal sizing compatible with most operating theatre light handle systems; features a secure locking or friction-fit mechanism to prevent accidental dislodgement during use.
• Packaging & Labeling: Individually wrapped in tamper-evident sterile packaging. Each package must clearly display the product description, batch number, expiry date, and manufacturer details.
• Quality & Compliance: Free from manufacturing defects, burrs, or sharp edges. Must meet applicable South African Health Products Regulatory Authority (SAHPRA) requirements and be manufactured under ISO 13485 quality management standards where applicable.
• Shelf Life: Minimum of 24 months remaining upon delivery.
• Documentation: Must include manufacturer instructions for use.

Skills Requirements

This tender pertains exclusively to the supply of goods rather than specialized services. Consequently, no advanced technical or professional skills are mandated. Suppliers are expected to demonstrate standard commercial and logistical competencies, including inventory management, cold-chain or sterile supply coordination, regulatory compliance, and adherence to public procurement frameworks. Successful bidders must possess the operational capacity to source, manufacture, or distribute certified medical consumables, manage quality assurance processes, and fulfill delivery obligations within agreed timeframes. Familiarity with South African health product regulations and ISO quality standards is essential for compliance.

Explanation of Unusual or Complicated Terms

• Universal Disposable Light Handles: These are single-use, sterile protective sleeves designed to fit over existing surgical light handles. They allow medical staff to adjust lighting during operations while maintaining a sterile barrier, thereby reducing infection risks associated with reusable equipment.
• 80/20 Preference Point System: A public procurement scoring model where 80% of evaluation points are awarded based on price competitiveness, and 20% are allocated for specific socio-economic goals, in this case, prioritizing South African-owned enterprises.
• SAHPRA & ISO 13485 Compliance: SAHPRA regulates health products in South Africa, ensuring safety and efficacy. ISO 13485 specifies quality management requirements for medical device manufacturers, guaranteeing consistent production standards and traceability throughout the supply chain.