Minimally invasive medical devices such as catheters, stents, balloon catheters, guidewires, biopsy needles are designed to perform procedures with minimal disruption to the patient’s body. Their manufacture and quality control requires meticulous attention to detail.
Taking a catheter device as an example, visual inspection requirements can vary based on factors such as the type of catheter, its intended use, the materials used, and applicable regulatory requirements. The below list however details some typical visual inspection criteria that manufacturers must assess their catheter device against:
- Surface defects such as scratches, dents, cracks, and discoloration that could affect the device’s integrity or cause harm to the patient’s tissue.
- Tip shape and integrity must be properly formed, smooth, and free from defects that could cause injury or discomfort during insertion.
- Lumen must be free of any obstructions, blockages, or irregularities that could impede the flow of fluids or lead to complications during use.
- Adhesive and bonding quality to prevent detachment during use.
- Hub and connector for proper alignment, secure attachment, and absence of defects that could hinder proper connection to other devices.
- Radiopaque markers correctly positioned and visible to aid in accurate placement.
- Balloon integrity must be ensured and have an absence of defects that could affect its functionality.
- Dimensional accuracy must be checked for any deviations from specified dimensions, including length, diameter, and curvature, to ensure proper fit and function.
- Tapered transitions between different sections must be checked to ensure they are smooth and without irregularities that could cause tissue damage.
The impact of missing any of these defects can be significant, affecting patient safety, healthcare provider reputation, regulatory compliance, and financial stability. Therefore, medical device manufacturers must prioritise rigorous quality control measures, and employ advanced inspection technologies to avoid risk.