STEVE FOLEY CATHETER FOR HUMAN URINARY HEALTH
Foley Catheter Finished Product Production: The Core Link of Technological Transformation and Standardization .The production process of urinary catheters integrates materials science, clinical medicine and industrial manufacturing, and its value is reflected in three directions: standardization, refinement and innovation.
Medical Value
The production process must comply with the ISO 13485 Medical Device Quality Management System. Through processes such as injection molding, balloon assembly and sterile packaging, the dimensional accuracy (e.g., tube diameter, length) and sterile state of urinary catheters are ensured to meet the clinical needs of different populations (adults, children, patients with urethral stricture). For example, the small-diameter design of pediatric urinary catheters and the coating process of antibacterial urinary catheters are precise responses to clinical needs in the production link.
Industrial Value
The application of automated production lines improves production efficiency and reduces costs, making urinary catheters affordable devices for primary hospitals and home care. Meanwhile, the quality control data during the production process (such as sterile test reports and performance test reports) serve as the core basis for certifications such as CE, FDA and NMPA, supporting the international circulation of products.
Innovation Value
Technological iteration in the production link drives the upgrading of urinary catheters. For instance, the evolution from ordinary rubber urinary catheters to hydrophilic-coated urinary catheters (reducing urethral damage during insertion and removal) and temperature-controlled urinary catheters (adapting to minimally invasive urological surgeries) has improved the safety and comfort of clinical use.
