Objectives

The primary objective of this tender is to procure South facing cuffed endotracheal tubes for use at Grey’s Hospital, KwaZulu-Natal, ensuring compliance with specified standards and specifications. The procurement aims to meet the hospital’s clinical needs for airway management, particularly for intubation of pediatric patients, with quality assurance and adherence to regulatory requirements.

Scope

The scope includes the supply of:

• South facing cuffed endotracheal tubes (oral RAE), size 3.5mm, sterile, individually packed, with expiry date and safety features.
• Quantity: 3 boxes of 10 units each.
• Delivery to Grey’s Hospital, Pietermaritzburg, KwaZulu-Natal, within the specified contract period.
• Compliance with detailed specifications including size, material, packaging, and quality standards.

The procurement process involves evaluation based on administrative compliance, technical specification adherence, sample submission, price, and preference points for specific goals such as ownership criteria.

Technical Requirements

The technical specifications for the endotracheal tubes include:

• Item: Paediatric oral RAE / South facing cuffed endotracheal tube
• Size: ID 3.5mm, OD 4.9mm, length 213mm, cuff 7mm
• Material: Microcuff or similar, sterile, individually packed
• Features:
  • Advanced micro-thin polyurethane cuff membrane (10 microns)
  • Short cylindrical cuff with effective seal at 11cmH2O cuff pressure
  • Clear markings starting at 1cm, continuing in 1cm intervals
  • Inner diameter 3.5mm
  • Packaging indicating CE number, size, manufacturing and expiry dates, manufacturer
• Standards: Conformance to relevant medical device standards and specifications attached.

Skills and Competency Requirements

Suppliers must demonstrate:

• Compliance with all technical specifications and quality standards.
• Ability to supply sterile, medical-grade endotracheal tubes as per detailed specifications.
• Provision of samples for evaluation prior to award, if required.
• Proper documentation including certificates of conformity, CE marking, expiry dates, and manufacturing details.
• Experience in supplying medical devices to healthcare institutions, with proven track record.
• Understanding of regulatory and safety standards applicable to medical devices in South Africa.
• Capacity to deliver within the specified timeframe and to meet the hospital’s logistical requirements.