Objectives

The primary objective of this tender is to procure cuff reinforced endotracheal tubes, specifically designed for paediatric use, that meet specified standards for safety, quality, and functionality. The procurement aims to ensure the availability of sterile, latex-free, single-use endotracheal tubes suitable for oral and nasal intubation, with features that facilitate proper placement, minimize trauma, and withstand clinical conditions such as Nitrous Oxide exposure.

Scope

The scope encompasses the supply of cuff reinforced oral/nasal endotracheal tubes for paediatric patients, with specified sizes (e.g., 4mm and 4.5mm ID), adhering to ISO 5361:2016 or equivalent standards. The tubes must be sterile, latex-free, individually packed, kink-resistant, and marked with clear, durable depth and size markings. The procurement includes the provision of samples for evaluation, compliance with technical specifications, and delivery to Grey's Hospital in Pietermaritzburg, KwaZulu-Natal, South Africa.

Technical Requirements

• Components must be latex-free, sterile, and individually packed in peel pouches.
• Tube specifications:
  • Size: 4mm and 4.5mm ID (full specifications attached)
  • Material: Soft flexible PVC with spiral-wound medical-grade reinforcing wire
  • Length: approximately 321mm
  • Outer diameter: 7.3mm
• Must comply with ISO 5361:2016 or equivalent standards.
• Features:
  • Radio-opaque line and clear, durable markings in 1cm intervals
  • Numbered depth markings, tube size, length, ID, OD, trade name
  • Precision band mark for depth guidance, with optional second circumferential band
  • Proximal end: secure 15mm OD circuit connector
  • Distal end: atraumatic bevelled tip with Murphy eye
  • Cuff inflation/deflation: easy, conforms closely to tube when deflated, resistant to Nitrous Oxide effects
  • Cuff thickness: approximately 50 microns
• Minimum shelf life of 2 years.
• Samples must be provided for evaluation.

Skills Requirements

• Manufacturers or suppliers must demonstrate compliance with international standards (ISO 5361:2016 or equivalent).
• Ability to produce sterile, latex-free, single-use paediatric endotracheal tubes with specified features.
• Provision of technical documentation, including detailed specifications, quality standards, and compliance certificates.
• Capability to supply samples for testing and evaluation prior to full procurement.
• Experience in manufacturing or supplying medical devices, particularly paediatric airway management equipment.
• Adherence to procurement procedures, including submission of accurate documentation, samples, and compliance declarations.