Cardiac institutes purchase unregistered stents in bulk

ISLAMABAD: The Punjab government cardiac hospitals purchased unregistered stents in bulk, with the Rawalpindi Institute of Cardiology (RIC) in the lead closely followed by the Punjab Institute of Cardiology, Lahore, says an inquiry report available with The News.

The RIC alone procured 4,265 stents (both registered and unregistered) during 2014 and 2017 and could use only 37 percent (1,572) of them.

“Due to poor procurement forecasting, stents were procured over and above the actual requirement of the hospital and a large number of stents remained unutilized in the stock resulting in blockage of public funds as well as decreasing the available shelf life of stents during all the three years under scrutiny,” the report reads.

This reporting is part of the Implant Files, an ICIJ-led investigation into the medical device industry and regulations. Readers can share their stories here.

The Punjab Health Department ordered an inquiry in 2017 to determine the use of unregistered stents at the cardiac institutes after the FIA unearthed their rampant supply at the Mayo Hospital, Lahore.

The record of Punjab Institute of Cardiology (PIC), Rawalpindi Institute of Cardiology (RIC), Faisalabad Institute of Cardiology (FIC) and Multan Institute of Cardiology (MIC) as well as cardiac departments of Mayo Hospital, Sheikh Zaid Hospital and Jinnah Hospital was examined and all of them were found using unregistered stents but their purchase in bulk was done by the RIC and PIC only.

Majority of stents (registered and unregistered both) purchased by the cardiac facilities carried the price tag of more than Rs1 lakh for each article up to Rs3,15,000 which was drastically cut after the Supreme Court’s intervention.

Now, the maximum price of a stent is Rs100,000. Incidentally, the committee of cardiologists who fixed the price [on the SC orders] are the ones heading the institutions. The stents were purchased in bulk at exorbitant rates. The inquiry committee pointed out flaws in the procurement process and discussed the explanations offered in defense of purchasing unregistered stents.

Majority of them said it was done on the basis of “technical assessment” of consultants. However, the committee found out procurement in bulk by RIC and PIC highly questionable and recommended a special audit of both the institutes.

Officials privy to the exercise are tightlipped about the findings of audit. As for the RIC procurement, the committee noted that during the fiscal year 2014-15, the hospital “procured 11 brands of stents which were not registered at the time of procurement.”

Included among them were 50 bioresorbable stents procured at the rate of Rs3,15,000 each and “were neither included in the annual demand nor in the bidding document.” Again, four brands of unregistered stents were purchased the following year (2015-16), the report said.

Responding to the above-stated observations of the committee, he said that the procurement of surgical disposable and stents was always made on bulk purchase basis through tender process as per PPRA rules.

Eleven brands, which have been mentioned, include registered and unregistered stents; however, all unregistered stents were given relaxation from the DRAP till September 2017, he continued.

Fifty BVS absorbable stents were procured from M/S Digital Imaging System (sole distributor of ABBOT VASCULAR USA) as monopoly item as per PAPRA rule 59 C clause 2 by direct contracting, he further explained.

The committee calling into question the procurement process in 2016-17 has noted that “although tenders for procurement of stents were advertised in accordance with the PPRA guidelines, in technical evaluation only one bidder was selected in each category thus eliminating competition in the financial bid.”

Responding to this objection, Kayani said 13 types of stents were demanded in annual tender of surgical and disposable items in 2016-17 in which three types of stents were not selected. The remaining 10 types of stents were received as single bidder and other three types of stents were rejected on technical grounds, he said.

In his explanation before the inquiry committee about the usage of unregistered stents, he said the choice was “dependent on the technical assessment of consultant and should not be restricted to registered products.”

Registered products means the devices were approved by the Drug Regulatory Authority of Pakistan (DRAP) for the purchase. Dr. Nadeem Hayat Malik, the CEO of PIC, acknowledged the purchase of unregistered stents and told the committee that one such stent ‘Xience Expedition’ was purchased because of its length.

The committee, in its findings, has answered such explanation. It said if a certain stent was required for its special length/width dimensions, the same may be recommended through notified SOPs and special permission taken from the appropriate forum.

The committee noted that the cardiology units had neither exercised due diligence to comply with the DRAP regulations for procurement of registered stents nor taken up the matter with the DRAP for seeking relaxation to procure unregistered stents. It has held “successive management/administration and consultants/staff of the cardiology institutes and hospitals” responsible for use of unregistered stents.