Faulty implants

An ongoing international investigation into the use of faulty medical implants paints a rather scary picture – medical corporations bribing doctors in Europe to sell unapproved implants, lax regulations, and decisions by regulators to turn a blind eye to medical malpractice. The global story becomes an even more scandalous one in Pakistan, where there appears to be no basic data available on the use of faulty medical implants. This cannot mean that Pakistan imports the best medical devices in the world. In fact, there is no one who wants to collect the appropriate data – let alone go a step further and take action to prevent low-quality medical devices being distributed at astronomical prices to needy patients.

Medical implants are often a matter of life and death. Ensuring their quality is as important as ensuring the quality of medicines. However, in Pakistan, a nexus between doctors and distributors is central to faulty devices being planted inside patients. The issue came to light in the case of heart stents, where, after a case in the Supreme Court of Pakistan, it turned out that none of the devices being used was registered. Quality monitoring would be two steps forward. No one was even verifying if the stents being used in Pakistan were being provided by real medical companies. It is also worrying that the situation has barely changed since the SC orders eight months ago. While the pricing of stents has been fixed, most labs remain unregistered while the cardiac registry remains non-functional. Unregistered stents also continue to be procured in bulk over and above the actual requirement. One in three cardiologists performing heart procedures is also not qualified to do so.

In terms of its official policy, DRAP claims to defer judgment to foreign regulators, such as the EU and FDA. However, international reporting has confirmed that EU regulators have allowed many untested devices to be used. A number of US manufacturers are producing ‘export only’ devices that fall outside the scope of US medical regulations. In the UK, more than 62,000 incidents were reported in three years. The US FDA has received 5.4 million such reports in 10 years. The numbers in Pakistan are likely to be higher. Only two hospitals in Pakistan have adopted the global clinical governance system but even these hospitals don’t report adverse events to pharmacovigilance sections. It is clear that the world has a long way to go to regulate medical devices, but Pakistan has not even taken the first steps on the ladder. The issue must be the highest priority of the sitting government and health officials.