ප්‍රශ්නගත ඇන්ජියෝග්‍රැෆික් කැතීටර් හා කොලොස්ටොමි බෑග් තොග රජයේ රෝහල් වලින් ඉවතට

Due to the reporting of several functional defects that could directly impact patient safety and the treatment process, the Medical Supplies Division (MSD) has taken steps to immediately withdraw several special categories belonging to two types of medical devices used in government hospitals. This decision has been made based on recommendations provided by the National Medicines Regulatory Authority (NMRA) and the Medical Device Evaluation Committee (MDEC).

Accordingly, instructions have already been issued through special circulars to all hospitals, provincial and regional health service directors, and other authorities, informing them to immediately cease the use of the relevant devices and remove them from circulation.

One of the devices ordered to be withdrawn from use is a special type of colostomy bag called 'Colostomy Appliance Set Complete', manufactured by BAO Health Medical Instruments of China. It has been found that devices under batch numbers DD202508-1301, DD202311-19, and DD202405-01 have weaknesses in their adhesive properties. This defect poses a risk of skin surface infections for patients, and the effective usage period of the bags has significantly decreased, as stated in the issued professional guidelines.

Concurrently, a special type of 'Angiodyn' brand angiographic catheter, widely used for cardiac-related examinations, has also been removed from the hospital system. Manufactured by PendraCare International of the Netherlands, the relevant batch number for these catheters is 2307-0076, and their expiration date is recorded as June 30, 2026. Doctors have reported issues such as difficulties in handling this device, inability to properly insert it into the right coronary artery, and a tendency for it to advance unnecessarily deep. Considering this serious threat to patient safety, the Medical Supplies Division has taken this step.