ISLAMABAD: After receiving complaints that non-registered medical devices were implanted on government officials getting treatment in different hospitals, the Ministry of Capital Administration and Development Division (CADD) has decided not to reimburse the bills for such devices.

Moreover, because of the complaints that in some cases bills were submitted even though the devices were not implanted, it has been decided that the original sticker of the device would have to be pasted on the cash memo or the medical report.

In January this year, not only a huge amount of unregistered stents worth over Rs250 million were recovered from Mayo Hospital Lahore but it was also revealed that in some cases patients were falsely told that stents had been fixed in their arteries. The Supreme Court of Pakistan took a suo motu notice of the matter and has been pushing the Drug Regulatory Authority of Pakistan (Drap) and other stakeholders to ensure the quality of stents at affordable rates.

Moreover, it also emerged that there was no mechanism for the sale of stents due to which instead of selling through medical stores representatives of the companies remained present in the cardiac centres of hospitals and sold the stents directly to the patients without giving them any authentic receipt. As a result, the patients never knew what kind of stent was fixed in their arteries.

Stents are small, expandable tubes that treat narrowed arteries in the body. In people with coronary heart diseases caused by the built-up of plaque, stents can open narrowed arteries, reduce symptoms such as chest pain and help avoid a heart attack.

A letter sent by the Ministry of CADD to all the ministries and divisions stated that according to Medical Devices Rules 2015, medical devices can only be manufactured or imported under Drap licences and sold after registration with the authority.

“It is, therefore, imperative for federal government departments that no case for reimbursement of any medical device, especially cardiac stents, may be processed unless the supplier produces a valid registration certificate issued by Drap and the manufacturer’s sticker is affixed on the angiography report/cash memo of such implant/stent,” the letter stated.

Deputy Director General (Health) Ministry of CADD Dr Minhajus Siraj told Dawn that the aim of the letter was to discourage the use of unregistered medical devices as no one knew about the quality of such devices.

“We care about the health of government officials. Moreover, the Supreme Court has taken notice of the use of unregistered stents. As a large number of government officials get medical treatment on their own expense and then submit bills for a reimbursement it has been decided that from March 15, 2017, a certificate stating that a registered stent was implanted in the arteries of the patient will be required,” he said.

“As there are complaints that sometimes doctors do not implant medical devices, it has been decided that the sticker of the device will have to be affixed on the angiography report or the cash memo,” he said.

In reply to a question, Dr Siraj said it would be the responsibility of the doctor or hospital to provide the certificate that the device was registered with Drap otherwise the bill would not be reimbursed.

“Registration certificates will be required for the reimbursement cases of stents, knee joints and hip joints as they are costly and their bills go up to around Rs400,000,” he said.

Published in Dawn, March 17th, 2017