by Moudud Ahmmed Sujan in The Daily Star, Sept 30, 2023
Unauthorised companies are smuggling a number of cardiac medical devices into the country and selling those to some of Dhaka’s top public and private hospitals without proper vetting, raising questions about health regulations and patient safety.
Over the last one and a half years, these unauthorised devices were used to treat children with congenital heart defects at the government-run National Institute of Cardiovascular Disease and Hospital (NICVD) and National Heart Foundation Hospital as well as private hospital Labaid in the capital, documents show.
Hospital sources and business insiders say a significant number of cardiac medical devices for children is in fact supplied illegally at different hospitals across the country.
Some of these devices are marketed without the permission of the drug regulatory body, the Directorate General of Drug Administration, the documents show, exposing regulatory flaws in medical device business.
Experts say unregulated medical devices may jeopardise patient safety and raise concerns about the efficacy and safety of cardiac treatments….
Usri Ghosh, an Indian national, brought these devices into the country and marketed them through Hearton Bangladesh, said sources at the NICVD and Heart Foundation.
Ursi did not return our requests for comments.
The Daily Star has documents showing both the NICVD and the Heart Foundation purchased devices without necessary authorisation on a number of occasions.
Every year, an estimated 1,200 children require cardiac implants in Bangladesh. This year alone, around 30 percent of the devices worth around Tk 3 crore have been supplied by Hearton, sources with direct knowledge of the market said.
From January to September this year, 127 Lifetech devices illegally imported by Hearton were implanted at three top hospitals – 102 at NICVD, 12 at Heart Foundation and 13 at Labaid, the sources have confirmed.
Between September 23 and 27 alone, NICVD used 50 Lifetech cardiac devices to treat as many children. ……..
https://www.thedailystar.net/health/healthcare/hospitals/news/cardiac-implants-children-top-hospitals-using-unauthorised-devices-3430706
