Objectives

The primary objective is to secure a one-off supply of a paediatric intraosseous (IO) drill system and compatible sterile needles to enable immediate, life-saving vascular access in emergency and critical care environments where traditional intravenous routes are inaccessible.

Scope

The procurement encompasses the delivery of the following items to King Dinuzulu Hospital Complex:

• One (1) unit of an E-Z-10 powered intraosseous drill driver.
• Five (5) packs of paediatric IO power drive needles (15 mm per pack).

The contract is classified as a single-delivery transaction. Successful bidders must provide complete, ready-to-use clinical kits and comply with standard public sector warranty and after-sales support obligations.

Technical Requirements

Bidders must supply equipment that adheres to precise clinical and engineering specifications:

• Needle Design: 15-gauge surgical-grade 304 stainless steel cannulas with a fixed 15 mm effective length. Optimised for infants and children weighing 3 kg to 39 kg. Features a multi-faceted cutting bevel for rapid cortical penetration and permanent black depth-markings at 5 mm intervals.
• Driver Interface: Needles must utilise a magnetic or rigid mechanical push-to-lock hub to securely attach to the rotating shaft of the supplied battery-powered driver.
• Material & Safety: Latex-free, non-pyrogenic, DEHP-free, and biocompatible. Terminally sterilised via gamma irradiation or ethylene oxide gas, with a minimum four-year sterile shelf life from manufacture.
• Packaging & Contents: Each carton contains five individually sealed, sterile peel-pouch kits. Every pouch must include the 15G needle and a matching removable solid stylet to maintain sterility until point-of-use.

Skills Requirements

As this is a goods-based procurement, specific personnel certifications are not mandated. Instead, bidders must demonstrate organisational capability in:

• Supply chain management for regulated, sterile medical devices.
• Regulatory compliance navigation, including SAHPRA licensing and international device approvals.
• Post-market surveillance execution, including adverse event tracking, lot recall management, and clinical feedback integration.
• Logistical proficiency to guarantee timely delivery of sensitive clinical equipment without compromising sterility or integrity.

Regulatory & Compliance Requirements

Bidders must submit verifiable documentation proving legal and quality adherence:

• Valid SAHPRA Medical Device Importer/Distributor Licence (Section 22C(1)(b)).
• Current ISO 13485:2016 Quality Management System certificate.
• International regulatory clearance (EU MDR/MDD CE Mark, US FDA 510(k), or Australian TGA approval).
• Documented post-market vigilance policy compliant with SAHPRA guidelines.
• Standard procurement compliance: Central Suppliers Database (CSD) registration, SARS tax clearance, B-BBEE status proof, and completed SBD preference forms.

Explanation of Unusual/Complex Terms

• Intraosseous (IO) Access: An emergency medical procedure used when peripheral veins collapse or cannot be located. Medications and fluids are injected directly into the bone marrow cavity, which functions as a highly absorbent, non-collapsible venous reservoir. This technique is critical for paediatric resuscitation and trauma care.
• SAHPRA Reliance Framework: A regulatory mechanism that allows South Africa to accept medical device safety and efficacy approvals from established international authorities (e.g., EU, US, Australia) to accelerate local market entry without requiring redundant clinical testing.
• 80/20 Preference Point System: A government procurement scoring methodology where 80 points are awarded for competitive pricing and 20 points for socio-economic transformation goals. In this tender, the 20 points are exclusively allocated to verifying South African ownership to promote economic inclusion.