Objectives

The primary objective of this tender is to procure cuffed oral endotracheal tubes suitable for short-term nasal intubation, ensuring they meet specified quality and safety standards for use at Grey's Hospital under the KwaZulu-Natal Department of Health.

Scope

The scope includes the supply of 11 boxes of cuffed oral endotracheal tubes in various sizes (5mm, 5.5mm, 6mm, 6.5mm, 7mm, 7.5mm, 8mm) with specific technical specifications such as material, design features, and sterilization requirements. The tubes are intended for use in theatre anesthetics, specifically for short-term nasal intubation where the tube is removed from the surgical site.

The procurement process involves compliance with detailed specifications, submission of samples for evaluation, and adherence to the departmental evaluation and preference point systems.

Technical Requirements

• Material: Clear thermosensitive PVC, latex-free, sterile, individually packed in peel pouches.
• Design: North polar preformed curve, kink resistant, atraumatic, with a radio-opaque line and clear, durable depth markings in 1cm intervals.
• Features:
  • Rectangular mark at preformed curve for positioning.
  • Secure 15mm OD circuit connector made from medical-grade plastic.
  • Bevelled atraumatic tip with Murphy eye opposite the bevel.
  • High volume low pressure polyurethane cuff with pilot cuff, easy to inflate/deflate, resistant to Nitrous Oxide, with a one-way valve and accurate inflation indicator.
• Packaging: Each unit individually sterile, with trade name, size, sterilization method, manufacturing site, CE number, lot number, expiry date clearly marked.
• Compliance with quality standards and specifications attached in the tender documentation.
• Single-use only.

Skills and Skills Requirements

• Knowledge of medical device specifications, especially endotracheal tubes and related airway management equipment.
• Understanding of sterilization processes and packaging standards for sterile medical devices.
• Ability to interpret technical specifications and ensure compliance with national and international standards (e.g., CE marking).
• Experience in supply chain management, including procurement procedures, sample submission, and evaluation criteria.
• Familiarity with departmental evaluation and preference point systems, including documentation for BBBEE and other specific goal claims.
• Technical competence to provide samples, technical documentation, and ensure product conformity to specifications.
• Ability to comply with regulatory requirements, including licensing by SAHPRA for manufacturing, importing, or distributing medical devices.