Objectives

The primary objective of this tender is to procure cuffed tracheostomy tubes that meet specified standards and specifications for use at GJGM Regional Hospital. The procurement aims to ensure the supply of high-quality, sterile, and individually packed tracheostomy tubes that conform to international standards (ISO 5366 or equivalent) and SAPHRA certification, supporting safe and effective patient care.

Scope

The scope of the tender includes the supply of:

• Cuffed tracheostomy tubes with radio-opaque outer cannulas, anatomically shaped neck flanges, and low-profile cuffs.
• Extended length cuffed tracheostomy tubes capable of adapting to unusual anatomies.
• Inner cannulas with connectors, occlusion caps, perforated obturators, and neck straps.
• Sterile, individually packed, single-use, latex-free tubes.
• Compliance with relevant standards and certifications, including ISO 5366 and SAPHRA.

The procurement covers various sizes, specifications, and related accessories, with an emphasis on safety, standardization, and compatibility for series procurement.

Technical Requirements

General Specifications

• Radio-opaque outer cannula with anatomical shaping that moves on two axes (vertical and horizontal).
• Thin-walled construction to maximize airflow.
• Inner cannula conforming to outer cannula shape, with a 15mm connector, occlusion cap, perforated obturator, and neck strap.
• Low-profile cuff that inflates and deflates easily, with high volume and low pressure, and an accurate pilot cuff indicator with a one-way valve.
• Tube must soften with body temperature for patient comfort.
• Packaging must include trade name, size, sterilization method, manufacturing site, CE number, lot number, and expiry date.

Extended Length Tubes

• Radio-opaque, anatomically shaped, flexible outer cannula adaptable to unusual anatomies.
• Flexible inner cannula conforming to outer shape, with similar connectors and features as standard tubes.
• Same cuff and packaging requirements as standard tubes.

Additional Technical Notes

• Single-use, latex-free, sterile, individually packed in peel pouches.
• Compliance with ISO 5366 or equivalent and SAPHRA certification is mandatory.
• All tubes must be suitable for series procurement and standardization.

Summary

The technical requirements emphasize safety, compatibility, quality standards, and ease of use, ensuring the supplied tracheostomy tubes are suitable for clinical use, meet international standards, and support the hospital’s procurement and patient safety objectives.