Objectives

The primary objective of this tender is to procure adult peritoneal dialysis catheters to be used for dialysis of renal impaired patients at Port Shepstone Hospital. The procurement aims to ensure the supply of high-quality, certified medical devices that meet specified standards and specifications, supporting effective patient treatment and care.

Scope

The scope of the tender includes:

• Supply and delivery of 500 units of adult peritoneal dialysis catheters.
• Provision of associated kit components such as scalpel, trocar, stylet, guidewire, dilators, introducer, syringe, and injection caps.
• Delivery to Port Shepstone Hospital’s SCM Department at No. 7 Bazley Street, during office hours (07:30 - 15:00).
• Compliance with technical specifications, quality standards, and certification requirements.

Technical Requirements

The technical specifications for the peritoneal dialysis catheter include:

• Multi-hole, open-end catheter with one cuff for insertion in the peritoneal position.
• Compatible with a trocar for trauma-free and painless insertion.
• Latex-free injection port for medication administration.
• Stainless-steel trocar with triple-angle sharpness for smooth insertion.
• Disposable scalpel size No. 11 with handle.
• Catheter length: 62cm including a 20cm coil.
• Accessories: Stylet (18g x 7cm), guidewire (0.035" x 70cm J-tip), vessel dilators, introducer, syringe, injection caps.
• Kit contents as specified, including the catheter, scalpel, trocar, stylet, guidewire, dilators, and syringe.
• Certification: SAB/SANS or equivalent proof of certification for the product.

Skills and Qualification Requirements

Bidder qualifications and skills requirements include:

• Provision of valid certification demonstrating compliance with SAB/SANS standards or equivalent.
• Proof of licensing from the South African Health Products Regulatory Authority (SAHPRA) to manufacture, wholesale, or distribute medical devices.
• Experience in supplying medical devices of similar nature and volume.
• Capability to deliver within the specified timeframe and to the designated location.
• Completion of all mandatory documentation, including bid forms, disclosure forms, and preference claim forms.
• Ability to provide samples for evaluation if requested, and to meet quality and technical standards.