Heart patients remain at risk as safety standards set by SC not adopted

ISLAMABAD: On March 20 this year, a Supreme Court bench headed by Chief Justice Saqib Nisar delivered a landmark verdict which directed streamlining of the cardiac procedures in order to ensure safe and standardised treatment of heart patients. The court set the deadline of 90 days for the implementation of the order which has not been enforced even after the passage of eight months. This is despite the fact the guidelines issued were based on the recommendations of a committee of cardiologists headed by Maj Gen (R) Dr Azhar Kayani, Executive Director of Rawalpindi Institute of Cardiology.

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.

Although price of stents has been fixed in light of the court order, cath labs where cardiacprocedures are performed have not been registered, let alone their accreditation which is required to ensure the quality of treatment and safety of patient. The court order had further said that unregistered cath labs wouldn’t be allowed to function.

Cardiac registry, which was to keep the record of procedures, the nature and specification of stents/pacemakers implanted and the status of patients after the surgery, is non-functional due to lack of cooperation from the hospitals. The National Institute of Cardiology Board (NICB), which was tasked with the assignment of approving standards and guidelines for accreditation and operation of cath labs, has though been set up, the government has not sanctioned funds for its functioning.

Starting from cath lab, it is a special room with diagnostic imaging equipment where cardiologists perform angiography to determine if any artery of the heart is blocked and carry out angioplasty to implant stent in case the blockade is prone to heart failure. Right now, there is no procedure adopted at the government level to check their standards thus the cath labs conditions vary from hospital to hospital and so is the skill set of the cardiologists and the lab staff.

The court had directed the formulation of standards as a criteria to register them and subsequent accreditation. The labs were to categorise from 1 to 3 level depending on the equipment and the related staff. List of accredited labs were to be displayed at the websites of Drug Regulatory Authority of Pakistan (DRAP), Pakistan Society of Interventional Cardiologists (PSIC) and provincial healthcare facilities. The purpose was to help patients in deciding which cardiac facility will be better for treatment. As no cath lab has been registered to-date, their list has not been displayed.

Who were to register and accredit the cath labs? As per the court’s directions, this is the domain of respective provincial healthcare commissions, Dr Kayani told The News. Unfortunately, only Punjab Healthcare Commission (PHC) is fully operational, Sindh and KP though notified healthcare commission, they are not fully functional, whereas no commission exists either in Baluchistan or in Islamabad Capital Territory, he said.

Why cath labs have not been registered by the PHC? Dr Kayani said a meeting was held in this regard on May 16 where the PHC pointed out few clauses of the order relating to cath lab registration as contradictory to PMDC Ordinance 1962 and PHC Act 2010. “It was therefore decided that this matter needed to be taken to concerned authorities and legal opinion may be sought before initiating cath lab registrations and accreditations,” he said.

A well-placed official of the PHC while talking to The News somewhat echoed the same views and explained that response from the NICB and DRAP is awaited in order to legally empower the PHC for doing the needful. In case of other provinces, there is no progress at all in absence of any regulatory body whereas no alternative strategy has been adopted for the registration and accreditation of cath labs there.

The setting up of the National Medical Device Registry was another direction of the court. It was aimed at keeping the record of cardiac stents and other lifesaving medical devices and the cath labs were required to enter the data of manufacturing/importation and utilisation of cardiac stents. This was intended to eradicate any chance of illegal import of medical devices including stents. It was a mandatory condition that all devices are duly entered from the time of entry into Pakistan and track them right up-till use in a procedure upon a patient in the cath lab.

While DRAP has set up this registry, no hospital provides the mandatory information prescribed in the order. “Only importers of devices enter information right now,” said a DRAP official. Asked why DRAP isn’t enforcing the order, the official said the regulator lacks capacity and resources.

The court was also informed about yet another registry, Cardiac Registry of Pakistan (CROP), set up by PSIC replicating the National Cardiovascular Data Registry operated by the American College of Cardiology. It was intended to keep the data of patients operated and the procedure carried out as well as the success and failure rate with an intended objective to improve the cardiology procedure and patient care.

Hardly 3-4 hospitals are providing the requisite details as majority of the cardiologists think sharing data means exposing their shortcomings. Eventually, when a patient dies due to the negligence of a doctor or due to the improper stent, there is no system of determining it and holding the responsible to account.

Likewise, the court had ordered uploading the information on the websites of DRAP, PSIC and healthcare commissions regarding the list of accredited interventional cardiologists, approved medical devices as well as their pricing and charges permissible for cath labs. This order has also been flouted and situation thus remains as usual.