Staggered eye punching process in replacing eye burning process for production of Urethral Foley Catheter

Abstract

A catheter is a medical device used to drain fluids from the human body. There are variety types of catheter such as cardiovascular, urology, gastrointestinal, neurovascular and ophthalmic catheters. It is commonly made from natural rubber, synthetic rubber, Teflon and other materials. For urology catheters, it used to drain urine out from the bladder in the human body in the urine bag. The urine will drain out of a hole at the catheter which call eyelet. A study was conducted in a catheter manufacturer located in the north of Peninsular Malaysia which aims to improve the quality of the process of making eyelet. In a catheter manufacturing process, operators are required to make eyelet to the catheter by manual burning process. There is a problem where the eyelet can easily form black stain and torn or dented eye because of poor skills during the eyelet making process. This catheter manufacturer also identified to have high losses because more than 1,000 units of catheter are rejected due to this issue. The proposed new process for making this eyelet is staggered eye punching process, had been identified to solve this issue. This process has been done with an extensive research and numerous tests to comply with industry requirements and also adapted to their product. The quality and safety issue have been seriously taken into consideration in order to make the process.