Objectives

The primary objective of this tender is to procure the 1st Generation Laryngeal Mask Airway Device with a preformed curved design, intended for single-use application in airway management. The device aims to provide a reliable supraglottic airway solution suitable for spontaneously breathing or ventilated patients, ensuring stability and ease of insertion.

Scope

The scope encompasses the supply of the specified laryngeal mask airway devices in various sizes (2 to 5) tailored to patient weight ranges (10kg to 100kg). The procurement is for use at Harry Gwala Regional Hospital, KwaZulu-Natal, and includes the delivery of sterile, individually packed devices compliant with relevant standards. The contract is a once-off purchase with a validity period of 90 days from the date of advertisement.

Technical Requirements

• The device must be a single-use, anatomically curved PVC airway tube with a soft elliptical silicone pharyngeal cuff, incorporating a one-way valve and inflation bulb.
• The airway tube should allow easy one-hand insertion, feature a 15mm connector proximally, and have a smooth transition to the posterior aspect of the boot.
• The cuff must create a high-pressure seal suitable for positive pressure ventilation of at least 20cm H2O, with aperture bars and a cuff inflation indicator.
• The device must be manufactured from latex-free medical-grade PVC and silicone, sterile, and individually packed in peel pouches for single use.
• Clear, durable markings indicating trade name, size, patient weight, and orientation guidelines must be present on the device.
• The device must conform to CE 0086 or equivalent quality standards.
• Sizes to be supplied include Size 2 (10-20kg), 2.5 (20-30kg), 3 (30-50kg), 4 (50-70kg), and 5 (70-100kg).

Skills and Skills Requirements

• Proven manufacturing capability to produce medical-grade, sterile airway devices compliant with international standards.
• Knowledge of medical device sterilization, packaging, and quality assurance processes.
• Experience in supplying medical devices to healthcare institutions, with demonstrated compliance to CE or equivalent standards.
• Ability to provide technical documentation, including CE certification, manufacturing site details, expiry dates, lot numbers, and CE number.
• Capacity to deliver within the specified timeframe and in accordance with the technical specifications outlined.
• Compliance with regulatory requirements, including licensing and distribution authorizations from the South African Health Product Regulatory Authority (SAHPRA).