Objectives

The primary objective of this tender is to procure percutaneous dilation sets suitable for bedside insertion, specifically for medical procedures such as tracheostomy. The aim is to acquire high-quality, compliant, and standardized equipment that meets safety, durability, and performance standards to support long-term patient care and procedural efficiency at Grey's Hospital.

Scope

The scope of the tender includes the supply of:

• Percutaneous dilation sets with sizes specified (7mm, 8mm, 9mm, 10mm);
• Complete tracheostomy kits containing tubes, inner cannulas, obturators, holders, brushes, and accessories;
• Additional components such as guidewires, dilators, guiding catheters, scalpel, syringes, introducer cannulas, and needles;
• Sterile, individually packed, single-use devices compliant with ISO 5366 or equivalent standards;
• Equipment manufactured from biocompatible, hypoallergenic, latex-free, non-DEHP PVC/silicone materials suitable for long-term use.

The procurement also covers the packaging, labeling, and documentation requirements, including sterilization details, expiry dates, and manufacturing information.

Technical Requirements

• Set suitable for bedside insertion using Seldinger guidewire dilation technique;
• Includes a stainless-steel safety scalpel, syringe, introducer cannula, needle assembly, short dilator, J Tip guidewire with stainless-steel core and PTFE coating, curved dilator with hydrophilic coating, and a stabilizer;
• Guidewire with markings for alignment and a safety ridge/stop on the guiding catheter;
• Curved dilator with skin-level dilation diameter guide, conforming to the guiding catheter’s safety ridge;
• Tracheostomy tube with cuff, obturator, and low-pressure cuff system that conforms when deflated;
• Inner cannulas with a safe locking system, and a perforated obturator/stylet introducer;
• Neck flange that is soft, anatomically shaped, movable on two axes, with size, ID, OD, and brand indicated;
• Manufactured from biocompatible, hypoallergenic, latex-free, non-DEHP PVC/silicone materials;
• Sterile, individually packed, with clear labeling including trade name, size, sterilization method, CE number, lot number, and expiry date;
• Design series to standardize sizes and components across different purchase sizes.

Skills Requirements

• Knowledge of medical device specifications, standards (ISO 5366 or equivalent), and sterilization processes;
• Understanding of Seldinger guidewire dilation technique and bedside tracheostomy procedures;
• Ability to evaluate product compliance with technical and safety standards;
• Experience in handling, inspecting, and verifying medical devices and accessories;
• Competence in documentation and labeling standards for medical equipment;
• Capacity to provide technical support and documentation for product use and safety;
• Familiarity with procurement procedures, quality assurance, and regulatory compliance in the healthcare sector.