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Cardiac Implants For Children: Top hospitals using unauthorised devices | Unauthorised cardiac devices in Bangladesh | The Daily Star

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class="panel-separator"></div><div class="panel-pane pane-node-content no-title block" class="panel-pane pane-node-content no-title block"> <div class="pane-content"> <script type="application/ld+json">{"@context":"https:\/\/schema.org","@type":"BreadcrumbList","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/thedailystart.net"},{"@type":"ListItem","position":2,"name":"Health","item":"https:\/\/www.thedailystar.net\/health"},{"@type":"ListItem","position":3,"name":"Healthcare","item":"https:\/\/www.thedailystar.net\/health\/healthcare"},{"@type":"ListItem","position":4,"name":"Hospitals","item":"https:\/\/www.thedailystar.net\/health\/healthcare\/hospitals"}]}</script><article id="node-3430706" class="article-section pb-30 clearfix node node-news odd view-mode-full" > <!-- <div class="line line-4"><div class="line-inner"></div></div> --> <div class="row align-bottom e-mb-12 e-mt-12 hide-for-medium"> <div class="columns text-14 lh-20 flex-container medium-5 small-12 mb-10"> <div class="color-pacific-blue category fw-700 mb-5"><a href="/health/healthcare/hospitals">Hospitals</a></div> </div> <div class="columns a-share medium-7 small-12 text-right"> <div class="addthis_inline_share_toolbox" data-title="Cardiac Implants For Children: Top hospitals using unauthorised devices" data-url="https://www.thedailystar.net/health/healthcare/hospitals/news/cardiac-implants-children-top-hospitals-using-unauthorised-devices-3430706"></div> </div> </div> <div class="columns medium-12 small-12 pl-0 ml-0"> </div> <div class="row show-for-print"> <div class="columns medium-12 text-left"> <h6 class="widget-title news-details-cat author-name" style="text-decoration:none"> <a href="/health/healthcare/hospitals">Hospitals</a> </h6> </div> </div> <h1 class="fw-700 e-mb-16 article-title">Cardiac Implants For Children: Top hospitals using unauthorised devices</h1> <!-- Only show for print Start --> <div class="byline-wrapper row collapse align-middle e-mb-32 show-for-print"> <div class="image columns shrink medium-12 small-12"> </div> <div class="content columns medium-12 small-12"> <div class="byline fw-600 text-16 e-mb-4"></div> <div class="date text-14 lh-20 color-iron"> Sat Sep 30, 2023 12:00 AM <br> Last update on: Sat Sep 30, 2023 10:58 AM </div> </div> </div> <!-- Only show for print End --> <div class="bg-cyan br-4 e-p-12 e-mb-16 text-16"> Experts raise alarm over patient safety </div> <div class="byline-wrapper row collapse align-middle e-mb-32 hide-for-medium"> <div class="image columns shrink e-mr-12"> <div class="rounded overflow-hidden img"> <picture class="ratio ratio__1x1"> <!--[if IE 9]><video style="display: none;"><![endif]--> <source data-srcset="https://tds-images.thedailystar.net/sites/default/files/styles/small_201/public/images/author/4.jpg 1x" data-aspectratio="/" media="(min-width: 1024px)" /> <!--[if IE 9]></video><![endif]--> <!--[if lt IE 9]> <img class="ratio ratio__1x1 lazyload" data-aspectratio="" data-src="https://tds-images.thedailystar.net/sites/default/files/styles/small_201/public/images/author/4.jpg" alt="" title="" /> <![endif]--> <!--[if !lt IE 9]><!--> <img class="ratio ratio__1x1 lazyload" data-aspectratio="" data-srcset="https://tds-images.thedailystar.net/sites/default/files/styles/small_201/public/images/author/4.jpg" alt="" title="" /> <!-- <![endif]--> </picture> </div> </div> <div class="content columns"> <div class="byline fw-600 text-16 e-mb-4"><a href="/author/moudud">Moudud Ahmmed Sujan</a></div> <div class="date text-14 lh-20 color-iron">Sat Sep 30, 2023 12:00 AM Last update on: Sat Sep 30, 2023 10:58 AM </div> </div> </div> <div class="row mt-20 align-middle e-mb-32 hide-for-medium"> <div class="columns medium-12 small-12"> <div class="a-share"> <div class="sharethis-inline-share-buttons" data-title="Cardiac Implants For Children: Top hospitals using unauthorised devices" data-url="https://www.thedailystar.net/health/healthcare/hospitals/news/cardiac-implants-children-top-hospitals-using-unauthorised-devices-3430706"></div> </div> </div> </div> <div class="section-media sm-float-none position-relative small-full-extended mb-30 no-margin-lr"> <div class="media-youtube-video media-youtube-1 responsive-embed widescreen margin-bottom-0"> <iframe class="media-youtube-player" width="640" height="390" title="অবৈধ ডিভাইস ব্যবহৃত হচ্ছে শিশুদের জন্মগত হৃদরোগ চিকিৎসায়" src="https://www.youtube.com/embed/6AX9LNKzKQI?wmode=opaque&controls=1" name="অবৈধ ডিভাইস ব্যবহৃত হচ্ছে শিশুদের জন্মগত হৃদরোগ চিকিৎসায়" frameborder="0" allowfullscreen>Video of অবৈধ ডিভাইস ব্যবহৃত হচ্ছে শিশুদের জন্মগত হৃদরোগ চিকিৎসায়</iframe> </div> </div> <div class="pb-20 clearfix"> <p class="rtejustify"><strong>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.</strong></p><div class="mb-20 mr-20 hide-for-print dfp-tag-wrapper text-center "><div id="dfp-ad-en_photo_banner-wrapper" class="dfp-tag-wrapper"> <!-- slot name : en_photo_banner --> <div id="dfp-ad-en_photo_banner" class="dfp-tag-wrapper"> <script type="text/javascript"> function advagg_mod_5() { // Count how many times this function is called. advagg_mod_5.count = ++advagg_mod_5.count || 1; try { if (advagg_mod_5.count <= 40) { googletag.cmd.push(function () { googletag.display("dfp-ad-en_photo_banner"); }); // Set this to 100 so that this function only runs once. advagg_mod_5.count = 100; } } catch(e) { if (advagg_mod_5.count >= 40) { // Throw the exception if this still fails after running 40 times. throw e; } else { // Try again in 250 ms. window.setTimeout(advagg_mod_5, 250); } } } function advagg_mod_5_check() { if (window.jQuery && window.Drupal && window.Drupal.settings) { advagg_mod_5(); } else { window.setTimeout(advagg_mod_5_check, 250); } } advagg_mod_5_check();</script> </div> </div></div> <p class="rtejustify">Over the last one and a half years, these unauthorised devices were used to treat <a href="https://www.thedailystar.net/news/bangladesh/news/4-children-get-new-lease-life-3369946">children with congenital heart defects</a> 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.</p><div class="mb-20 mr-20 hide-for-print dfp-tag-wrapper text-center "><h4><a style="font-weight:400; color:#4285F3; border-bottom: 1px dotted #4285F3; font-size: 18px;" href="https://news.google.com/publications/CAAiECW73usLivqPCSeQRsSUvRQqFAgKIhAlu97rC4r6jwknkEbElL0U"> <img src="https://tds-images.thedailystar.net/sites/all/themes/tds/images/google_news.svg" alt="Google News Link" style="display: inline-block; margin-right: 15px; margin-bottom: -3px; height: 30px;"/>For all latest news, follow The Daily Star's Google News channel. </a></h4></div> <p class="rtejustify">Hospital sources and business insiders say a significant number of <a href="https://www.thedailystar.net/news/bangladesh/news/cardiac-treatment-patients-hit-hard-costly-stents-3312006">cardiac medical devices</a> for children is in fact supplied illegally at different hospitals across the country.</p><div class="mb-20 mr-20 hide-for-print dfp-tag-wrapper text-center d-hide m-show"><div id="dfp-ad-en_three_special-wrapper" class="dfp-tag-wrapper"> <!-- slot name : en_three_special --> <div id="dfp-ad-en_three_special" class="dfp-tag-wrapper"> <script type="text/javascript"> function advagg_mod_6() { // Count how many times this function is called. advagg_mod_6.count = ++advagg_mod_6.count || 1; try { if (advagg_mod_6.count <= 40) { googletag.cmd.push(function () { googletag.display("dfp-ad-en_three_special"); }); // Set this to 100 so that this function only runs once. advagg_mod_6.count = 100; } } catch(e) { if (advagg_mod_6.count >= 40) { // Throw the exception if this still fails after running 40 times. throw e; } else { // Try again in 250 ms. window.setTimeout(advagg_mod_6, 250); } } } function advagg_mod_6_check() { if (window.jQuery && window.Drupal && window.Drupal.settings) { advagg_mod_6(); } else { window.setTimeout(advagg_mod_6_check, 250); } } advagg_mod_6_check();</script> </div> </div></div> <p class="rtejustify">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 <a href="https://www.thedailystar.net/news/bangladesh/news/more-transparency-needed-medical-device-import-3388246">medical device business</a>.</p><div class="mb-20 mr-20 hide-for-print dfp-tag-wrapper text-center "><div id="dfp-ad-en_four_banner-wrapper" class="dfp-tag-wrapper"> <!-- slot name : en_four_banner --> <div id="dfp-ad-en_four_banner" class="dfp-tag-wrapper"> <script type="text/javascript"> function advagg_mod_7() { // Count how many times this function is called. advagg_mod_7.count = ++advagg_mod_7.count || 1; try { if (advagg_mod_7.count <= 40) { googletag.cmd.push(function () { googletag.display("dfp-ad-en_four_banner"); }); // Set this to 100 so that this function only runs once. advagg_mod_7.count = 100; } } catch(e) { if (advagg_mod_7.count >= 40) { // Throw the exception if this still fails after running 40 times. throw e; } else { // Try again in 250 ms. window.setTimeout(advagg_mod_7, 250); } } } function advagg_mod_7_check() { if (window.jQuery && window.Drupal && window.Drupal.settings) { advagg_mod_7(); } else { window.setTimeout(advagg_mod_7_check, 250); } } advagg_mod_7_check();</script> </div> </div></div> <p class="rtejustify">Experts say unregulated medical devices may jeopardise patient safety and raise concerns about the efficacy and safety of cardiac treatments.</p> <p class="rtejustify">"It is highly likely that unauthorised cardiac products will be of poor quality. They may cause serious harm to patients," said Dr Chowdhury Meskat, a professor of cardiology at Bangabandhu Sheikh Mujib Medical University.</p> <h3 class="rtejustify"><strong>A RAID ON HEARTON</strong></h3> <p class="rtejustify">On March 31, the Directorate General of Drug Administration raided the office of Hearton Bangladesh, a medical equipment supplier, in Mirpur and seized devices that are used to treat congenital heart defects among children. The seized cardiac devices were worth Tk 27 lakh.</p><div class="mb-20 mr-20 hide-for-print dfp-tag-wrapper text-center "><div id="dfp-ad-en_five_banner-wrapper" class="dfp-tag-wrapper"> <!-- slot name : en_five_banner --> <div id="dfp-ad-en_five_banner" class="dfp-tag-wrapper"> <script type="text/javascript"> function advagg_mod_8() { // Count how many times this function is called. advagg_mod_8.count = ++advagg_mod_8.count || 1; try { if (advagg_mod_8.count <= 40) { googletag.cmd.push(function () { googletag.display("dfp-ad-en_five_banner"); }); // Set this to 100 so that this function only runs once. advagg_mod_8.count = 100; } } catch(e) { if (advagg_mod_8.count >= 40) { // Throw the exception if this still fails after running 40 times. throw e; } else { // Try again in 250 ms. window.setTimeout(advagg_mod_8, 250); } } } function advagg_mod_8_check() { if (window.jQuery && window.Drupal && window.Drupal.settings) { advagg_mod_8(); } else { window.setTimeout(advagg_mod_8_check, 250); } } advagg_mod_8_check();</script> </div> </div></div> <p class="rtejustify">According to the Registration Guidelines for Medical Device, marketing these devices requires a Maximum Retail Price (MRP) certificate from the DGDA. Hearton Bangladesh did not have the certificate.</p> <p class="rtejustify">The company claimed the products they were selling were produced by Lifetech Scientific, a China-based company, and imported by another local company.</p> <p class="rtejustify">That local company, Rahman Medical Services, has no authorisation for distribution of Lifetech products since 2020, multiple sources have confirmed. </p> <p class="rtejustify"><blockquote class="quote-section bg-cyan br-12 sm-float-none full-width paragraph-margin"><div class="flex-container"><svg width="34" height="27" viewBox="0 0 34 27" fill="none" xmlns="http://www.w3.org/2000/svg" class="flex-child-grow mr-20"> <path d="M0 27V19.2336C0 16.9749 0.43257 14.6467 1.29771 12.249C2.16285 9.85135 3.30483 7.59266 4.72366 5.47297C6.14249 3.31853 7.69975 1.49421 9.39542 0L16.3511 4.06564C15.1053 6.15058 14.0326 8.39189 13.1328 10.7896C12.2331 13.1873 11.7832 16.0019 11.7832 19.2336V27H0ZM17.6489 27V19.2336C17.6489 16.9749 18.0814 14.6467 18.9466 12.249C19.8117 9.85135 20.9537 7.59266 22.3725 5.47297C23.7913 3.31853 25.3486 1.49421 27.0443 0L34 4.06564C32.7542 6.15058 31.6814 8.39189 30.7817 10.7896C29.8819 13.1873 29.4321 16.0019 29.4321 19.2336V27H17.6489Z" fill="#0086C9"/> </svg><div><p class="fw-600 e-mb-24">"Anyone involved in illegally importing or marketing these devices should be brought to book. And that's where the drug administration has a role to play." </p><div class="author-title text-14 lh-20 color-iron"><span>— Prof Dr Rashid-E-Mahbub, chairman of Bangladesh Health Rights Movement</span></div></div></div></blockquote> <p class="rtejustify">Following the DGDA raid, The Daily Star has learnt that a number of local companies, marketing professionals and doctors are involved in selling these devices to several city hospitals.</p> <p class="rtejustify">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.</p> <p class="rtejustify">Ursi did not return our requests for comments.</p> <p class="rtejustify">The Daily Star has documents showing both the NICVD and the Heart Foundation purchased devices without necessary authorisation on a number of occasions.</p> <p class="rtejustify">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.</p> <p class="rtejustify">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. </p> <p class="rtejustify"><div class="img-is-potrait"><div class="img-potrait-full section-media text-center mb-20"><span class="lg-gallery " data-exthumbimage="https://tds-images.thedailystar.net/sites/default/files/styles/small_1/public/images/2023/09/30/text20.jpg" data-src="https://tds-images.thedailystar.net/sites/default/files/styles/very_big_1/public/images/2023/09/30/text20.jpg" data-sub-html=""> <span class="open-popup"><i class="expand"></i></span><picture > <!--[if IE 9]><video style="display: none;"><![endif]--> <source data-srcset="https://tds-images.thedailystar.net/sites/default/files/styles/big_5/public/images/2023/09/30/text20.jpg 1x" data-aspectratio="/" media="(min-width: 1024px)" /> <!--[if IE 9]></video><![endif]--> <!--[if lt IE 9]> <img class="lazyload" data-aspectratio="" data-src="https://tds-images.thedailystar.net/sites/default/files/styles/big_5/public/images/2023/09/30/text20.jpg" alt="Cardiac Implants For Children: Top hospitals using unauthorised cardiac medical devices" title="" /> <![endif]--> <!--[if !lt IE 9]><!--> <img class="lazyload" data-aspectratio="" data-srcset="https://tds-images.thedailystar.net/sites/default/files/styles/big_5/public/images/2023/09/30/text20.jpg" alt="Cardiac Implants For Children: Top hospitals using unauthorised cardiac medical devices" title="" /> <!-- <![endif]--> </picture></span></div></div> <p class="rtejustify">Between September 23 and 27 alone, NICVD used 50 Lifetech cardiac devices to treat as many children. </p> <p class="rtejustify">Earlier on July 7, Lifetech products were used to treat heart defects of 13 children at the Cath Lab of the Labaid Hospital in the capital, documents show.  </p> <p class="rtejustify">Brig Gen (retd) Prof Nurun Nahar Fatema, who performed the procedures, shared details about the products on her LinkedIn profile recently.</p> <p class="rtejustify">Contacted, she said she got the devices from her previous supplier, Rahman Medical Services.</p> <p class="rtejustify">"They provide me implants when I need them. But I do not have any idea about the legal issues," said Prof Nurun Nahar.</p> <p class="rtejustify">Mizanur Rahman, owner of Rahman Medical Services, said his company no longer supplies Lifetech products. </p> <h3 class="rtejustify"><strong>THE WORKSHOP THAT NEVER HAPPENED</strong></h3> <p class="rtejustify">Hospital sources say after Usri Ghosh had flown in with unauthorised Lifetech Scientific devices on January 16, customs officials at Hazrat Shahjalal International Airport (HSIA) held those for not having the required paperwork and asked her to pay duties to collect those.</p> <p class="rtejustify">The same day, NICVD's Head of Paediatric Cardiology Department Prof Abdullah Shahriar wrote to the HSIA customs commissioner, requesting duty-free release of the products, "meant for a technology transfer workshop" to be held the next day.</p> <p class="rtejustify">Subsequently, the items were released and used to carry out minimally invasive cardiac intervention procedures on 10 children on January 17.</p> <p class="rtejustify"><blockquote class="quote-section bg-cyan br-12 sm-float-none full-width paragraph-margin"><div class="flex-container"><svg width="34" height="27" viewBox="0 0 34 27" fill="none" xmlns="http://www.w3.org/2000/svg" class="flex-child-grow mr-20"> <path d="M0 27V19.2336C0 16.9749 0.43257 14.6467 1.29771 12.249C2.16285 9.85135 3.30483 7.59266 4.72366 5.47297C6.14249 3.31853 7.69975 1.49421 9.39542 0L16.3511 4.06564C15.1053 6.15058 14.0326 8.39189 13.1328 10.7896C12.2331 13.1873 11.7832 16.0019 11.7832 19.2336V27H0ZM17.6489 27V19.2336C17.6489 16.9749 18.0814 14.6467 18.9466 12.249C19.8117 9.85135 20.9537 7.59266 22.3725 5.47297C23.7913 3.31853 25.3486 1.49421 27.0443 0L34 4.06564C32.7542 6.15058 31.6814 8.39189 30.7817 10.7896C29.8819 13.1873 29.4321 16.0019 29.4321 19.2336V27H17.6489Z" fill="#0086C9"/> </svg><div><p class="fw-600 e-mb-24">"It is highly likely that unauthorised cardiac products will be of poor quality. Those may cause serious harm to the patients." </p><div class="author-title text-14 lh-20 color-iron"><span>— Dr Chowdhury Meskat, professor of cardiology at Bangabandhu Sheikh Mujib Medical University</span></div></div></div></blockquote> <p class="rtejustify">Sources said no international workshop was held that day, but Usri Ghosh was present when cardiac intervention procedures were carried out on the children using those devices.</p> <p class="rtejustify">Prof Shahriar wrote the letter on the letterhead of Labaid Diagnostics, a private hospital where he is a consultant. The Daily Star has a copy of the letter. </p> <p class="rtejustify">The letter also mentioned that an Indian paediatric cardiologist named Dr Neeraj Awasthy would conduct the workshop.</p> <p class="rtejustify">Dr Awasthy declined to comment and asked this correspondent to speak to the authorities.</p> <p class="rtejustify">Prof Shahriar said he had no idea that Hearton had no authorisation from the DGDA.</p> <p class="rtejustify">"We had been using Lifetech products for the past one and a half years. We stopped using their products as soon as we learnt about this," he told The Daily Star.</p> <p class="rtejustify">Asked why he wrote the letter, he said, "Hearton officials approached me, saying the NICVD director referred them to me as he [NICVD director] was unavailable at the time."</p> <p class="rtejustify">NICVD Director Prof Mir Jamal Uddin denied having any knowledge about the letter.</p> <p class="rtejustify">He also said he was not aware of any "international workshop" taking place on January 17.</p> <p class="rtejustify">As for scrutinising suppliers' documents, he said the director's office does not have any role in purchasing devices that are used commercially on patients.</p> <p class="rtejustify">"We just procure devices for the hospital stock, which is supplied free of cost for poor patients, and the funds for those come from the government or donors. The unit chiefs are responsible for allowing any company to sell their products to the patients inside the hospitals."</p> <p class="rtejustify"><div class="img-is-potrait"><div class="img-potrait-full section-media text-center mb-20"><span class="lg-gallery " data-exthumbimage="https://tds-images.thedailystar.net/sites/default/files/styles/small_1/public/images/2023/09/30/text20.jpg" data-src="https://tds-images.thedailystar.net/sites/default/files/styles/very_big_1/public/images/2023/09/30/text20.jpg" data-sub-html=""> <span class="open-popup"><i class="expand"></i></span><picture > <!--[if IE 9]><video style="display: none;"><![endif]--> <source data-srcset="https://tds-images.thedailystar.net/sites/default/files/styles/big_5/public/images/2023/09/30/text20.jpg 1x" data-aspectratio="/" media="(min-width: 1024px)" /> <!--[if IE 9]></video><![endif]--> <!--[if lt IE 9]> <img class="lazyload" data-aspectratio="" data-src="https://tds-images.thedailystar.net/sites/default/files/styles/big_5/public/images/2023/09/30/text20.jpg" alt="Cardiac Implants For Children: Top hospitals using unauthorised cardiac medical devices" title="" /> <![endif]--> <!--[if !lt IE 9]><!--> <img class="lazyload" data-aspectratio="" data-srcset="https://tds-images.thedailystar.net/sites/default/files/styles/big_5/public/images/2023/09/30/text20.jpg" alt="Cardiac Implants For Children: Top hospitals using unauthorised cardiac medical devices" title="" /> <!-- <![endif]--> </picture></span></div></div> <h3 class="rtejustify"><strong>A MERRY-GO-ROUND</strong></h3> <p class="rtejustify">In early March, Lifetech products supplied by Hearton were used at the NICVD to treat at least 47 children with heart conditions during a weeklong charity campaign funded by Qatar Red Crescent Society.</p> <p class="rtejustify">The Daily Star has copies of all the invoices approved by the NICVD for the campaign.</p> <p class="rtejustify">In May, Hearton Bangladesh received around Tk 50 lakh against 47 invoices signed by Prof Abdullah Shahriar.</p> <p class="rtejustify">This newspaper has also obtained a screenshot of a WhatsApp group conversation among prominent cardiac surgeons where Lifetech products were discussed. Dr Muhammad Ataul Haqq, associate professor at NICVD's paediatric cardiology department, favoured these products in the conversation.</p> <p class="rtejustify">"In Bangladesh, we comfortably use Amplatzer devices and Lifetech devices as per the registration with the drug administration. Lifetech products are a little bit cheaper … We can't judge the quality as we don't have any testing facility. But we are comfortable with both the brands," he told the group.</p> <p class="rtejustify">Contacted, Dr Ataul Haqq, who leads the paediatric cardiology department's "green unit," said there was another Dr Ataul who had taken part in the WhatsApp conversation.</p> <p class="rtejustify">His namesake, who has the same position at the same department, said he was not a member of the Qatar Red Crescent campaign committee, and so there was no question of his involvement in this.</p> <p class="rtejustify">He also said he leads the department's "blue unit," not the "green unit".</p> <p class="rtejustify">These units – green and blue – are two groups created by the hospital authorities to facilitate job distribution among physicians and other medical staff.</p> <p class="rtejustify">NICVD sources said the Ataul who leads the "green unit" was the one in the WhatsApp conversation.</p> <p class="rtejustify">Asked about the use of unauthorised Lifetech devices on multiple occasions at the NICVD, Prof Mir Jamal Uddin said, "The issue has been brought to our notice. I have already issued directives to the doctors concerned not to allow the products that lack proper authorisation from the drug administration."</p> <h3 class="rtejustify"><strong>CUT FROM THE SAME CLOTH</strong></h3> <p class="rtejustify">The National Heart Foundation Hospital received devices from Hearton for the whole of 2022.</p> <p class="rtejustify">"Hearton submitted relevant documents including the product registration certificate, but they could not provide the MRP certificate from the DGDA. So, we stopped using their products from January this year," said Shahajadee Sultana Doly, additional director of public relations at the Heart Foundation.</p> <p class="rtejustify">Asked why they permitted Hearton for a year, she said Usri Ghosh, manager of Lifetech Scientific in India, introduced Hearton Bangladesh to them.</p> <p class="rtejustify">"Usri Ghosh has been representing different foreign cardiac device makers at Heart Foundation for the last 15 years. In recent years, she started campaigning for Lifetech products. She also sponsored several scientific seminars and supplied many devices for free here," Doly said.</p> <p class="rtejustify">But Heart Foundation Director Brigadier General (retd) Younusur Rahman denied using unauthorised products at the hospital.</p> <p class="rtejustify"><strong>ANOTHER COG IN THE WHEEL</strong> <p class="rtejustify">Anamul Haque Prince, owner of Hearton Bangladesh, said all of the products they supplied were legally imported by Rahman Medical Services Ltd, former distributor of Lifetech Scientific in Bangladesh.</p> <p class="rtejustify">In 2020, Hearton received 93 devices from Rahman Medical Services, according to an agreement, seen by this paper, between the two parties.</p> <p class="rtejustify">The Daily Star is also in possession of documents that show Hearton supplied many devices to its clients that were collected from sources other than Rahman Medical Services.</p> <p class="rtejustify">Mizanur Rahman, owner of Rahman Medical Services, said, "Lifetech terminated its contract with us in 2020. We have had no business with them since."</p> <p class="rtejustify">He also denied selling or distributing any other devices to Hearton.</p> <p class="rtejustify">A certificate of registration, issued by the DGDA, also confirms termination of the contract between Rahman and Lifetech. It also shows that another company, Bangladesh Healthcare and Pharma Solution, has obtained registration for distribution of Lifetech products.</p> <p class="rtejustify">However, sources at the DGDA said Bangladesh Healthcare and Pharma has not yet started marketing any Lifetech products.</p> <p class="rtejustify">Since 2020, sales and distribution of Lifetech products through any company other than Bangladesh Healthcare and Pharma Solution are illegal.</p> <p class="rtejustify">This means, Hearton lacks not only the MRP certificates to sell medical devices but also a legal contract with a registered distributor.</p> <p class="rtejustify">"No company can supply products without getting an MRP ceiling from us. We have been investigating the issue," said DGDA Director General Mohammad Yousuf.</p> </div> <div class="mb-20 mr-20 hide-for-print dfp-tag-wrapper text-center"> <div id="dfp-ad-en_six_banner-wrapper" class="dfp-tag-wrapper"> <!-- slot name : en_six_banner --> <div id="dfp-ad-en_six_banner" class="dfp-tag-wrapper"> <script type="text/javascript"> function advagg_mod_9() { // Count how many times this function is called. advagg_mod_9.count = ++advagg_mod_9.count || 1; try { if (advagg_mod_9.count <= 40) { googletag.cmd.push(function () { googletag.display("dfp-ad-en_six_banner"); }); // Set this to 100 so that this function only runs once. advagg_mod_9.count = 100; } } catch(e) { if (advagg_mod_9.count >= 40) { // Throw the exception if this still fails after running 40 times. throw e; } else { // Try again in 250 ms. window.setTimeout(advagg_mod_9, 250); } } } function advagg_mod_9_check() { if (window.jQuery && window.Drupal && window.Drupal.settings) { advagg_mod_9(); } else { 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node node-news odd view-mode-full" > <!-- <div class="line line-4"><div class="line-inner"></div></div> --> <div class="row align-bottom e-mb-12 e-mt-12 hide-for-medium"> <div class="columns text-14 lh-20 flex-container medium-5 small-12 mb-10"> <div class="color-pacific-blue category fw-700 mb-5"><a href="/health/healthcare/hospitals">Hospitals</a></div> </div> <div class="columns a-share medium-7 small-12 text-right"> <div class="addthis_inline_share_toolbox" data-title="Cardiac Implants For Children: Top hospitals using unauthorised devices" data-url="https://www.thedailystar.net/health/healthcare/hospitals/news/cardiac-implants-children-top-hospitals-using-unauthorised-devices-3430706"></div> </div> </div> <div class="columns medium-12 small-12 pl-0 ml-0"> </div> <div class="row show-for-print"> <div class="columns medium-12 text-left"> <h6 class="widget-title news-details-cat author-name" style="text-decoration:none"> <a href="/health/healthcare/hospitals">Hospitals</a> </h6> </div> </div> <h1 class="fw-700 e-mb-16 article-title">Cardiac Implants For Children: Top hospitals using unauthorised devices</h1> <!-- Only show for print Start --> <div class="byline-wrapper row collapse align-middle e-mb-32 show-for-print"> <div class="image columns shrink medium-12 small-12"> </div> <div class="content columns medium-12 small-12"> <div class="byline fw-600 text-16 e-mb-4"></div> <div class="date text-14 lh-20 color-iron"> Sat Sep 30, 2023 12:00 AM <br> Last update on: Sat Sep 30, 2023 10:58 AM </div> </div> </div> <!-- Only show for print End --> <div class="bg-cyan br-4 e-p-12 e-mb-16 text-16"> Experts raise alarm over patient safety </div> <div class="byline-wrapper row collapse align-middle e-mb-32 hide-for-medium"> <div class="image columns shrink e-mr-12"> <div class="rounded overflow-hidden img"> <picture class="ratio ratio__1x1"> <!--[if IE 9]><video style="display: none;"><![endif]--> <source 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hide-for-medium"> <div class="columns medium-12 small-12"> <div class="a-share"> <div class="sharethis-inline-share-buttons" data-title="Cardiac Implants For Children: Top hospitals using unauthorised devices" data-url="https://www.thedailystar.net/health/healthcare/hospitals/news/cardiac-implants-children-top-hospitals-using-unauthorised-devices-3430706"></div> </div> </div> </div> <div class="section-media sm-float-none position-relative small-full-extended mb-30 no-margin-lr"> <div class="media-youtube-video media-youtube-1 responsive-embed widescreen margin-bottom-0"> <iframe class="media-youtube-player" width="640" height="390" title="অবৈধ ডিভাইস ব্যবহৃত হচ্ছে শিশুদের জন্মগত হৃদরোগ চিকিৎসায়" src="https://www.youtube.com/embed/6AX9LNKzKQI?wmode=opaque&controls=1" name="অবৈধ ডিভাইস ব্যবহৃত হচ্ছে শিশুদের জন্মগত হৃদরোগ চিকিৎসায়" frameborder="0" allowfullscreen>Video of অবৈধ ডিভাইস ব্যবহৃত হচ্ছে শিশুদের জন্মগত হৃদরোগ চিকিৎসায়</iframe> </div> </div> <div class="pb-20 clearfix"> <p class="rtejustify"><strong>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.</strong></p><div class="mb-20 mr-20 hide-for-print dfp-tag-wrapper text-center "><div id="dfp-ad-en_photo_banner-wrapper" class="dfp-tag-wrapper"> <!-- slot name : en_photo_banner --> <div id="dfp-ad-en_photo_banner" class="dfp-tag-wrapper"> <script type="text/javascript"> function advagg_mod_11() { // Count how many times this function is called. advagg_mod_11.count = ++advagg_mod_11.count || 1; try { if (advagg_mod_11.count <= 40) { googletag.cmd.push(function () { googletag.display("dfp-ad-en_photo_banner"); }); // Set this to 100 so that this function only runs once. advagg_mod_11.count = 100; } } catch(e) { if (advagg_mod_11.count >= 40) { // Throw the exception if this still fails after running 40 times. throw e; } else { // Try again in 250 ms. window.setTimeout(advagg_mod_11, 250); } } } function advagg_mod_11_check() { if (window.jQuery && window.Drupal && window.Drupal.settings) { advagg_mod_11(); } else { window.setTimeout(advagg_mod_11_check, 250); } } advagg_mod_11_check();</script> </div> </div></div> <p class="rtejustify">Over the last one and a half years, these unauthorised devices were used to treat <a href="https://www.thedailystar.net/news/bangladesh/news/4-children-get-new-lease-life-3369946">children with congenital heart defects</a> 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.</p><div class="mb-20 mr-20 hide-for-print dfp-tag-wrapper text-center "><h4><a style="font-weight:400; color:#4285F3; border-bottom: 1px dotted #4285F3; font-size: 18px;" href="https://news.google.com/publications/CAAiECW73usLivqPCSeQRsSUvRQqFAgKIhAlu97rC4r6jwknkEbElL0U"> <img src="https://tds-images.thedailystar.net/sites/all/themes/tds/images/google_news.svg" alt="Google News Link" style="display: inline-block; margin-right: 15px; margin-bottom: -3px; height: 30px;"/>For all latest news, follow The Daily Star's Google News channel. </a></h4></div> <p class="rtejustify">Hospital sources and business insiders say a significant number of <a href="https://www.thedailystar.net/news/bangladesh/news/cardiac-treatment-patients-hit-hard-costly-stents-3312006">cardiac medical devices</a> for children is in fact supplied illegally at different hospitals across the country.</p><div class="mb-20 mr-20 hide-for-print dfp-tag-wrapper text-center d-hide m-show"><div id="dfp-ad-en_three_special-wrapper" class="dfp-tag-wrapper"> <!-- slot name : en_three_special --> <div id="dfp-ad-en_three_special" class="dfp-tag-wrapper"> <script type="text/javascript"> function advagg_mod_12() { // Count how many times this function is called. advagg_mod_12.count = ++advagg_mod_12.count || 1; try { if (advagg_mod_12.count <= 40) { googletag.cmd.push(function () { googletag.display("dfp-ad-en_three_special"); }); // Set this to 100 so that this function only runs once. advagg_mod_12.count = 100; } } catch(e) { if (advagg_mod_12.count >= 40) { // Throw the exception if this still fails after running 40 times. throw e; } else { // Try again in 250 ms. window.setTimeout(advagg_mod_12, 250); } } } function advagg_mod_12_check() { if (window.jQuery && window.Drupal && window.Drupal.settings) { advagg_mod_12(); } else { window.setTimeout(advagg_mod_12_check, 250); } } advagg_mod_12_check();</script> </div> </div></div> <p class="rtejustify">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 <a href="https://www.thedailystar.net/news/bangladesh/news/more-transparency-needed-medical-device-import-3388246">medical device business</a>.</p><div class="mb-20 mr-20 hide-for-print dfp-tag-wrapper text-center "><div id="dfp-ad-en_four_banner-wrapper" class="dfp-tag-wrapper"> <!-- slot name : en_four_banner --> <div id="dfp-ad-en_four_banner" class="dfp-tag-wrapper"> <script type="text/javascript"> function advagg_mod_13() { // Count how many times this function is called. advagg_mod_13.count = ++advagg_mod_13.count || 1; try { if (advagg_mod_13.count <= 40) { googletag.cmd.push(function () { googletag.display("dfp-ad-en_four_banner"); }); // Set this to 100 so that this function only runs once. advagg_mod_13.count = 100; } } catch(e) { if (advagg_mod_13.count >= 40) { // Throw the exception if this still fails after running 40 times. throw e; } else { // Try again in 250 ms. window.setTimeout(advagg_mod_13, 250); } } } function advagg_mod_13_check() { if (window.jQuery && window.Drupal && window.Drupal.settings) { advagg_mod_13(); } else { window.setTimeout(advagg_mod_13_check, 250); } } advagg_mod_13_check();</script> </div> </div></div> <p class="rtejustify">Experts say unregulated medical devices may jeopardise patient safety and raise concerns about the efficacy and safety of cardiac treatments.</p> <p class="rtejustify">"It is highly likely that unauthorised cardiac products will be of poor quality. They may cause serious harm to patients," said Dr Chowdhury Meskat, a professor of cardiology at Bangabandhu Sheikh Mujib Medical University.</p> <h3 class="rtejustify"><strong>A RAID ON HEARTON</strong></h3> <p class="rtejustify">On March 31, the Directorate General of Drug Administration raided the office of Hearton Bangladesh, a medical equipment supplier, in Mirpur and seized devices that are used to treat congenital heart defects among children. The seized cardiac devices were worth Tk 27 lakh.</p><div class="mb-20 mr-20 hide-for-print dfp-tag-wrapper text-center "><div id="dfp-ad-en_five_banner-wrapper" class="dfp-tag-wrapper"> <!-- slot name : en_five_banner --> <div id="dfp-ad-en_five_banner" class="dfp-tag-wrapper"> <script type="text/javascript"> function advagg_mod_14() { // Count how many times this function is called. advagg_mod_14.count = ++advagg_mod_14.count || 1; try { if (advagg_mod_14.count <= 40) { googletag.cmd.push(function () { googletag.display("dfp-ad-en_five_banner"); }); // Set this to 100 so that this function only runs once. advagg_mod_14.count = 100; } } catch(e) { if (advagg_mod_14.count >= 40) { // Throw the exception if this still fails after running 40 times. throw e; } else { // Try again in 250 ms. window.setTimeout(advagg_mod_14, 250); } } } function advagg_mod_14_check() { if (window.jQuery && window.Drupal && window.Drupal.settings) { advagg_mod_14(); } else { window.setTimeout(advagg_mod_14_check, 250); } } advagg_mod_14_check();</script> </div> </div></div> <p class="rtejustify">According to the Registration Guidelines for Medical Device, marketing these devices requires a Maximum Retail Price (MRP) certificate from the DGDA. Hearton Bangladesh did not have the certificate.</p> <p class="rtejustify">The company claimed the products they were selling were produced by Lifetech Scientific, a China-based company, and imported by another local company.</p> <p class="rtejustify">That local company, Rahman Medical Services, has no authorisation for distribution of Lifetech products since 2020, multiple sources have confirmed. </p> <p class="rtejustify"><blockquote class="quote-section bg-cyan br-12 sm-float-none full-width paragraph-margin"><div class="flex-container"><svg width="34" height="27" viewBox="0 0 34 27" fill="none" xmlns="http://www.w3.org/2000/svg" class="flex-child-grow mr-20"> <path d="M0 27V19.2336C0 16.9749 0.43257 14.6467 1.29771 12.249C2.16285 9.85135 3.30483 7.59266 4.72366 5.47297C6.14249 3.31853 7.69975 1.49421 9.39542 0L16.3511 4.06564C15.1053 6.15058 14.0326 8.39189 13.1328 10.7896C12.2331 13.1873 11.7832 16.0019 11.7832 19.2336V27H0ZM17.6489 27V19.2336C17.6489 16.9749 18.0814 14.6467 18.9466 12.249C19.8117 9.85135 20.9537 7.59266 22.3725 5.47297C23.7913 3.31853 25.3486 1.49421 27.0443 0L34 4.06564C32.7542 6.15058 31.6814 8.39189 30.7817 10.7896C29.8819 13.1873 29.4321 16.0019 29.4321 19.2336V27H17.6489Z" fill="#0086C9"/> </svg><div><p class="fw-600 e-mb-24">"Anyone involved in illegally importing or marketing these devices should be brought to book. And that's where the drug administration has a role to play." </p><div class="author-title text-14 lh-20 color-iron"><span>— Prof Dr Rashid-E-Mahbub, chairman of Bangladesh Health Rights Movement</span></div></div></div></blockquote> <p class="rtejustify">Following the DGDA raid, The Daily Star has learnt that a number of local companies, marketing professionals and doctors are involved in selling these devices to several city hospitals.</p> <p class="rtejustify">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.</p> <p class="rtejustify">Ursi did not return our requests for comments.</p> <p class="rtejustify">The Daily Star has documents showing both the NICVD and the Heart Foundation purchased devices without necessary authorisation on a number of occasions.</p> <p class="rtejustify">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.</p> <p class="rtejustify">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. </p> <p class="rtejustify"><div class="img-is-potrait"><div class="img-potrait-full section-media text-center mb-20"><span class="lg-gallery " data-exthumbimage="https://tds-images.thedailystar.net/sites/default/files/styles/small_1/public/images/2023/09/30/text20.jpg" data-src="https://tds-images.thedailystar.net/sites/default/files/styles/very_big_1/public/images/2023/09/30/text20.jpg" data-sub-html=""> <span class="open-popup"><i class="expand"></i></span><picture > <!--[if IE 9]><video style="display: none;"><![endif]--> <source data-srcset="https://tds-images.thedailystar.net/sites/default/files/styles/big_5/public/images/2023/09/30/text20.jpg 1x" data-aspectratio="/" media="(min-width: 1024px)" /> <!--[if IE 9]></video><![endif]--> <!--[if lt IE 9]> <img class="lazyload" data-aspectratio="" data-src="https://tds-images.thedailystar.net/sites/default/files/styles/big_5/public/images/2023/09/30/text20.jpg" alt="Cardiac Implants For Children: Top hospitals using unauthorised cardiac medical devices" title="" /> <![endif]--> <!--[if !lt IE 9]><!--> <img class="lazyload" data-aspectratio="" data-srcset="https://tds-images.thedailystar.net/sites/default/files/styles/big_5/public/images/2023/09/30/text20.jpg" alt="Cardiac Implants For Children: Top hospitals using unauthorised cardiac medical devices" title="" /> <!-- <![endif]--> </picture></span></div></div> <p class="rtejustify">Between September 23 and 27 alone, NICVD used 50 Lifetech cardiac devices to treat as many children. </p> <p class="rtejustify">Earlier on July 7, Lifetech products were used to treat heart defects of 13 children at the Cath Lab of the Labaid Hospital in the capital, documents show.  </p> <p class="rtejustify">Brig Gen (retd) Prof Nurun Nahar Fatema, who performed the procedures, shared details about the products on her LinkedIn profile recently.</p> <p class="rtejustify">Contacted, she said she got the devices from her previous supplier, Rahman Medical Services.</p> <p class="rtejustify">"They provide me implants when I need them. But I do not have any idea about the legal issues," said Prof Nurun Nahar.</p> <p class="rtejustify">Mizanur Rahman, owner of Rahman Medical Services, said his company no longer supplies Lifetech products. </p> <h3 class="rtejustify"><strong>THE WORKSHOP THAT NEVER HAPPENED</strong></h3> <p class="rtejustify">Hospital sources say after Usri Ghosh had flown in with unauthorised Lifetech Scientific devices on January 16, customs officials at Hazrat Shahjalal International Airport (HSIA) held those for not having the required paperwork and asked her to pay duties to collect those.</p> <p class="rtejustify">The same day, NICVD's Head of Paediatric Cardiology Department Prof Abdullah Shahriar wrote to the HSIA customs commissioner, requesting duty-free release of the products, "meant for a technology transfer workshop" to be held the next day.</p> <p class="rtejustify">Subsequently, the items were released and used to carry out minimally invasive cardiac intervention procedures on 10 children on January 17.</p> <p class="rtejustify"><blockquote class="quote-section bg-cyan br-12 sm-float-none full-width paragraph-margin"><div class="flex-container"><svg width="34" height="27" viewBox="0 0 34 27" fill="none" xmlns="http://www.w3.org/2000/svg" class="flex-child-grow mr-20"> <path d="M0 27V19.2336C0 16.9749 0.43257 14.6467 1.29771 12.249C2.16285 9.85135 3.30483 7.59266 4.72366 5.47297C6.14249 3.31853 7.69975 1.49421 9.39542 0L16.3511 4.06564C15.1053 6.15058 14.0326 8.39189 13.1328 10.7896C12.2331 13.1873 11.7832 16.0019 11.7832 19.2336V27H0ZM17.6489 27V19.2336C17.6489 16.9749 18.0814 14.6467 18.9466 12.249C19.8117 9.85135 20.9537 7.59266 22.3725 5.47297C23.7913 3.31853 25.3486 1.49421 27.0443 0L34 4.06564C32.7542 6.15058 31.6814 8.39189 30.7817 10.7896C29.8819 13.1873 29.4321 16.0019 29.4321 19.2336V27H17.6489Z" fill="#0086C9"/> </svg><div><p class="fw-600 e-mb-24">"It is highly likely that unauthorised cardiac products will be of poor quality. Those may cause serious harm to the patients." </p><div class="author-title text-14 lh-20 color-iron"><span>— Dr Chowdhury Meskat, professor of cardiology at Bangabandhu Sheikh Mujib Medical University</span></div></div></div></blockquote> <p class="rtejustify">Sources said no international workshop was held that day, but Usri Ghosh was present when cardiac intervention procedures were carried out on the children using those devices.</p> <p class="rtejustify">Prof Shahriar wrote the letter on the letterhead of Labaid Diagnostics, a private hospital where he is a consultant. The Daily Star has a copy of the letter. </p> <p class="rtejustify">The letter also mentioned that an Indian paediatric cardiologist named Dr Neeraj Awasthy would conduct the workshop.</p> <p class="rtejustify">Dr Awasthy declined to comment and asked this correspondent to speak to the authorities.</p> <p class="rtejustify">Prof Shahriar said he had no idea that Hearton had no authorisation from the DGDA.</p> <p class="rtejustify">"We had been using Lifetech products for the past one and a half years. We stopped using their products as soon as we learnt about this," he told The Daily Star.</p> <p class="rtejustify">Asked why he wrote the letter, he said, "Hearton officials approached me, saying the NICVD director referred them to me as he [NICVD director] was unavailable at the time."</p> <p class="rtejustify">NICVD Director Prof Mir Jamal Uddin denied having any knowledge about the letter.</p> <p class="rtejustify">He also said he was not aware of any "international workshop" taking place on January 17.</p> <p class="rtejustify">As for scrutinising suppliers' documents, he said the director's office does not have any role in purchasing devices that are used commercially on patients.</p> <p class="rtejustify">"We just procure devices for the hospital stock, which is supplied free of cost for poor patients, and the funds for those come from the government or donors. The unit chiefs are responsible for allowing any company to sell their products to the patients inside the hospitals."</p> <p class="rtejustify"><div class="img-is-potrait"><div class="img-potrait-full section-media text-center mb-20"><span class="lg-gallery " data-exthumbimage="https://tds-images.thedailystar.net/sites/default/files/styles/small_1/public/images/2023/09/30/text20.jpg" data-src="https://tds-images.thedailystar.net/sites/default/files/styles/very_big_1/public/images/2023/09/30/text20.jpg" data-sub-html=""> <span class="open-popup"><i class="expand"></i></span><picture > <!--[if IE 9]><video style="display: none;"><![endif]--> <source data-srcset="https://tds-images.thedailystar.net/sites/default/files/styles/big_5/public/images/2023/09/30/text20.jpg 1x" data-aspectratio="/" media="(min-width: 1024px)" /> <!--[if IE 9]></video><![endif]--> <!--[if lt IE 9]> <img class="lazyload" data-aspectratio="" data-src="https://tds-images.thedailystar.net/sites/default/files/styles/big_5/public/images/2023/09/30/text20.jpg" alt="Cardiac Implants For Children: Top hospitals using unauthorised cardiac medical devices" title="" /> <![endif]--> <!--[if !lt IE 9]><!--> <img class="lazyload" data-aspectratio="" data-srcset="https://tds-images.thedailystar.net/sites/default/files/styles/big_5/public/images/2023/09/30/text20.jpg" alt="Cardiac Implants For Children: Top hospitals using unauthorised cardiac medical devices" title="" /> <!-- <![endif]--> </picture></span></div></div> <h3 class="rtejustify"><strong>A MERRY-GO-ROUND</strong></h3> <p class="rtejustify">In early March, Lifetech products supplied by Hearton were used at the NICVD to treat at least 47 children with heart conditions during a weeklong charity campaign funded by Qatar Red Crescent Society.</p> <p class="rtejustify">The Daily Star has copies of all the invoices approved by the NICVD for the campaign.</p> <p class="rtejustify">In May, Hearton Bangladesh received around Tk 50 lakh against 47 invoices signed by Prof Abdullah Shahriar.</p> <p class="rtejustify">This newspaper has also obtained a screenshot of a WhatsApp group conversation among prominent cardiac surgeons where Lifetech products were discussed. Dr Muhammad Ataul Haqq, associate professor at NICVD's paediatric cardiology department, favoured these products in the conversation.</p> <p class="rtejustify">"In Bangladesh, we comfortably use Amplatzer devices and Lifetech devices as per the registration with the drug administration. Lifetech products are a little bit cheaper … We can't judge the quality as we don't have any testing facility. But we are comfortable with both the brands," he told the group.</p> <p class="rtejustify">Contacted, Dr Ataul Haqq, who leads the paediatric cardiology department's "green unit," said there was another Dr Ataul who had taken part in the WhatsApp conversation.</p> <p class="rtejustify">His namesake, who has the same position at the same department, said he was not a member of the Qatar Red Crescent campaign committee, and so there was no question of his involvement in this.</p> <p class="rtejustify">He also said he leads the department's "blue unit," not the "green unit".</p> <p class="rtejustify">These units – green and blue – are two groups created by the hospital authorities to facilitate job distribution among physicians and other medical staff.</p> <p class="rtejustify">NICVD sources said the Ataul who leads the "green unit" was the one in the WhatsApp conversation.</p> <p class="rtejustify">Asked about the use of unauthorised Lifetech devices on multiple occasions at the NICVD, Prof Mir Jamal Uddin said, "The issue has been brought to our notice. I have already issued directives to the doctors concerned not to allow the products that lack proper authorisation from the drug administration."</p> <h3 class="rtejustify"><strong>CUT FROM THE SAME CLOTH</strong></h3> <p class="rtejustify">The National Heart Foundation Hospital received devices from Hearton for the whole of 2022.</p> <p class="rtejustify">"Hearton submitted relevant documents including the product registration certificate, but they could not provide the MRP certificate from the DGDA. So, we stopped using their products from January this year," said Shahajadee Sultana Doly, additional director of public relations at the Heart Foundation.</p> <p class="rtejustify">Asked why they permitted Hearton for a year, she said Usri Ghosh, manager of Lifetech Scientific in India, introduced Hearton Bangladesh to them.</p> <p class="rtejustify">"Usri Ghosh has been representing different foreign cardiac device makers at Heart Foundation for the last 15 years. In recent years, she started campaigning for Lifetech products. She also sponsored several scientific seminars and supplied many devices for free here," Doly said.</p> <p class="rtejustify">But Heart Foundation Director Brigadier General (retd) Younusur Rahman denied using unauthorised products at the hospital.</p> <p class="rtejustify"><strong>ANOTHER COG IN THE WHEEL</strong> <p class="rtejustify">Anamul Haque Prince, owner of Hearton Bangladesh, said all of the products they supplied were legally imported by Rahman Medical Services Ltd, former distributor of Lifetech Scientific in Bangladesh.</p> <p class="rtejustify">In 2020, Hearton received 93 devices from Rahman Medical Services, according to an agreement, seen by this paper, between the two parties.</p> <p class="rtejustify">The Daily Star is also in possession of documents that show Hearton supplied many devices to its clients that were collected from sources other than Rahman Medical Services.</p> <p class="rtejustify">Mizanur Rahman, owner of Rahman Medical Services, said, "Lifetech terminated its contract with us in 2020. We have had no business with them since."</p> <p class="rtejustify">He also denied selling or distributing any other devices to Hearton.</p> <p class="rtejustify">A certificate of registration, issued by the DGDA, also confirms termination of the contract between Rahman and Lifetech. It also shows that another company, Bangladesh Healthcare and Pharma Solution, has obtained registration for distribution of Lifetech products.</p> <p class="rtejustify">However, sources at the DGDA said Bangladesh Healthcare and Pharma has not yet started marketing any Lifetech products.</p> <p class="rtejustify">Since 2020, sales and distribution of Lifetech products through any company other than Bangladesh Healthcare and Pharma Solution are illegal.</p> <p class="rtejustify">This means, Hearton lacks not only the MRP certificates to sell medical devices but also a legal contract with a registered distributor.</p> <p class="rtejustify">"No company can supply products without getting an MRP ceiling from us. 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