Objectives

The primary objective of this tender is to procure Endobronchial Tubes to meet the clinical and operational needs of Grey's Hospital under the Department of Health in KwaZulu-Natal. The procurement aims to ensure the supply of high-quality, sterile, and compliant endobronchial tubes suitable for single lung ventilation and thoracic surgeries, adhering to specified standards and specifications.

Scope

The scope encompasses the supply of various sizes of double lumen endobronchial tubes, including left-sided tubes with specific features such as radio-opaque markers, colour-coded cuffs, and compatibility with fibre-optic bronchoscopy. The supply includes necessary components like stylets, connectors, suction catheters, and cuffs resistant to nitrous oxide effects. The tubes must be sterile, latex-free, individually packed, and conform to ISO 16628:2008 standards. The procurement covers the complete delivery to Grey’s Hospital, with specifications detailed in the annexure, and includes submission of samples for evaluation.

Technical Requirements

• Supply of double lumen endobronchial tubes (left-sided) in sizes 26Fr, 32Fr, 35Fr, 37Fr, 39Fr, and 41Fr.
• Tube features:
  • Radio-opaque lines and markers at key features starting at 26cm from distal end.
  • Flexible enough for manipulation without luminal collapse.
  • Smooth inner lumen with no narrowing for fibre-optic bronchoscope passage.
  • Colour-coded tracheal (clear) and bronchial (blue) extensions.
  • Supplied with malleable stylet and proximal right-angled connectors with aspiration port.
  • Cuffs:
    • High-volume, low-pressure, colourless tracheal cuff with pilot balloon, resistant to nitrous oxide.
    • Blue polyurethane bronchial cuff with pilot balloon, cylindrical, short, and cylindrical.
  • Components:
    • Latex-free, sterile, individually packed, single-use.
    • Compatible with standard Y-connectors and breathing circuits.
    • Includes suction catheters with control, matching tube length.
• Compliance with ISO 16628:2008 standards.
• Minimum shelf life of 2 years.
• Samples must be provided for evaluation prior to award.

Skills Requirements

• Technical expertise in the manufacturing and quality assurance of medical airway devices, specifically double lumen endobronchial tubes.
• Knowledge of relevant standards such as ISO 16628:2008 and compliance with medical device regulations.
• Capability to produce sterile, latex-free, individually packed, and high-quality medical devices.
• Experience in providing detailed product specifications, technical documentation, and samples for evaluation.
• Ability to ensure product compatibility with fibre-optic bronchoscopy and standard anaesthetic equipment.
• Proficiency in quality control, sterile packaging, and adherence to international standards for medical devices.