Is It Necessary To Supplement The Risk Reminder For The Use Of Lubricants In The Instructions For Use Of Urinary Catheter Products?


Yes. A urinary catheter is a medical device used for urine drainage and bladder irrigation, etc. Its material includes natural latex, rubber, silicone, or polyvinyl chloride (PVC). Petroleum­based lubricants such as liquid paraffin, petroleum jelly, etc., have a swelling effect on natural latex materials. After the balloon of the urinary catheter swelled, a thin-walled structure is formed. Under the effect of petroleum-based lubricants, the risk of rupture increases. Therefore, it is recommended to use water-soluble lubricants for balloon urinary catheters made of natural latex. Petroleum-based lubricants such as liquid paraffin and petroleum jelly should be avoided. Silicone urinary catheters should avoid the use of silicones as lubricants. Administrative counterpart should list relevant risk information in product IFU and labels.