Objectives

The primary objective of this tender is to procure adult filter ventilators for use on ventilator breathing circuits at Port Shepstone Hospital. The goal is to acquire high-quality, microbiologically efficient heat moisture exchange filters that ensure patient safety, effective humidification, and contamination protection, in compliance with specified technical standards.

Scope

The scope encompasses the supply and delivery of 8,000 units of adult filter ventilators to Port Shepstone Hospital's Supply Chain Management Department. The procurement includes providing filters that meet detailed specifications, ensuring compliance with relevant standards, and delivering within the contractual timeframe. The tender also covers associated documentation, quality certifications, and adherence to specified packaging and labeling requirements.

Technical Requirements

• Must be Heat Moisture Exchange Filters (HMEF) suitable for adult ventilator circuits.
• Effective bi-directional microbiological filtration with ≥99.99% efficiency against bacteria and viruses.
• Liquid and airborne bacterial and viral filtration capabilities.
• Single-use, individually packed in peel pouches with view paper.
• Constructed from transparent, medical-grade plastic, latex-free, non-pyrogenic, hypoallergenic, and DEHP-free.
• Connections compatible with standard breathing circuits: 15F/22M ISO connections and circuit end.
• Includes a luer monitoring port with cap for end-tidal CO2 monitoring.
• Minimum tidal volume: 75ml; maximum: 250ml; maximum filter volume: 30mg H2O/litre.
• Effective for up to 48 hours of clinical use.
• Includes batch/lot number, manufacturing and expiry dates, and manufacturer contact details on the container.
• Must comply with SABS/SANS standards and be certified accordingly.
• Shelf life to be specified by bidder; failure to do so disqualifies the quotation.

Skills Requirements

• Understanding of medical device specifications, particularly ventilator circuit filters.
• Knowledge of microbiological filtration standards and validation processes.
• Ability to ensure compliance with South African and international standards (SABS/SANS).
• Experience in packaging, labeling, and quality assurance of medical devices.
• Capability to provide technical documentation, certificates, and product datasheets.
• Proficiency in supply chain management, logistics, and timely delivery of large quantities.
• Ability to provide after-sales support, including product training and technical assistance if required.