Objectives

The primary objective of this tender is to procure cuffed tracheostomy tubes with subglottic suction lines suitable for use in the GJGM Regional Hospital. The procurement aims to ensure the availability of medical devices that meet specified standards, support patient care, and comply with relevant legislation and quality standards.

Scope

The scope encompasses the supply of cuffed tracheostomy tubes with subglottic suction lines in sizes 4 and 5, conforming to the attached specifications and standards (SABS). The procurement is a once-off requirement for the hospital's Emergency Department, with delivery to the specified hospital address in KwaDukuza. The contract period is for a single delivery, and the items must meet the detailed technical and quality specifications outlined in the tender documents.

Technical Requirements

• Item: Cuffed tracheostomy tube with subglottic suction line
• Sizes: 4 and 5
• Standard: Must comply with SABS standards and ISO 11712
• Material: Latex-free medical grade thermoplastic elastomer
• Design: Anatomically curved, kink-resistant, with a non-inflatable elliptical cuff
• Features:
  • Integral bite block
  • Buccal cavity stabiliser
  • Clear markings indicating trade name, size, patient weight, manufacturing site, CE number, lot number, expiry date
• Sterile, individually packed in peel pouches, for single use only
• Must meet quality standards: SABS
• Samples: To be provided with the bid

Skills and Compliance Requirements

• Bidder must demonstrate compliance with technical specifications and standards (SABS, ISO 11712)
• Provision of samples for evaluation (objective criteria)
• Proof of manufacturing or distribution authorization from SAHPRA
• Submission of valid BBBEE certificate or sworn affidavit for B-BBEE status
• Compliance with procurement legislation, including disclosure of any conflicts of interest and relationships with Department of Health employees
• Completion of all mandatory forms and declarations, including preference points claim and bidder disclosure (SBD 4, SBD 6.1)
• Delivery within the specified timeframe and to the correct address
• Adherence to the evaluation criteria, including administrative compliance, capacity to deliver, technical compliance, sample submission, and price/ preference points