Ministery of Food and Drug Safety said on the 29th that it designated a biopsy tool needed to diagnose neonatal congenital megacolon (Hirschsprung's disease) as an urgently introduced medical device. Congenital megacolon is a disease in which some parts of the intestine lack nerve cells from birth, preventing credit entry from passing normally. About 100 patients occur annually in Korea.
Using this tool, a newborn can have a rectal mucosal tissue sample collected without anesthesia and be diagnosed with congenital megacolon. However, domestic supply was halted, and newborns experienced the inconvenience of undergoing general anesthesia for diagnosis.
The Ministery of Food and Drug Safety explained that, through the designation of an urgently introduced medical device, newborns can be diagnosed more safely. This is when the government directly imports and supplies medical devices that are necessary for diagnosing and treating rare or intractable diseases but are not approved or distributed domestically.
Lee Ju-yeon, a professor of pediatric surgery at Chonnam National University Children's Hospital, said, "It has become possible for children to be tested in clinical settings without the risks of general anesthesia." An official at the Ministery of Food and Drug Safety said, "We will closely monitor opinions related to the supply and demand of medical devices."