In January, the Central Drugs Standard Control Organisation banned the import of pre-owned and refurbished medical devices into India.
Even though governments are unable to provide the bare minimum of medical products and devices to their populations, formal and informal efforts on
the part of individuals and organisations to send expired, recycled and reconditioned devices as donations have been entirely stopped. The putative reason for the CDSCO’s recent ban was the fear of infections from recycled devices in response to an anecdotal mishap that was widely reported and blown out of proportion.
Data, however, tell a different story. In 2024, an international randomised trial of 298 patients — ‘My Heart Your Heart’ — conducted by researchers from the University of Michigan found that reconditioned pacemakers “provide a noninferior, more affordable alternative to new implants with respect to infection risk.” Unfortunately, the World Health Organization and human rights organisations have issued statements pointing to the moral and the ethical grounds against recycling.
However, they do not give sufficient weight to the consequences of this approach. With no hope whatsoever of any government-funded costly devices, like pacemakers, such a policy direction robs the socio-economically disadvantaged communities of the hope of recovery and care. Until and unless we can assure universal access to unused products and devices at affordable prices, a ban on recycling can unwittingly become a death sentence.
In the developed world, reticence to recycling is understandable given the wide availability of devices and the prohibitive cost of human labour necessary for recycling that pushes up prices. Fear of medico-legal litigations and resultant punitive compensations have further deterred the practice in those countries. However, in India, the cost of labour and, thus, recycling is relatively low. If the safety concern, especially the infection potential of these devices, is addressed through proper guidelines and specifications issued by regulatory bodies and professional associations, the medico-legal risks can also be carefully managed. The environmental imperatives weigh in favour of recycling commonly used medical hardware as well.
It would be naïve, however, to ignore the factors at play. Globally, recycling is at cross purposes with the powerful medical device industry that thrives on the ‘use and throw’ paradigm. Endemic corruption in regulatory bodies also means that corporate lobbies find political accomplices at the cost of unsuspecting patients. In the European context, the infamous Implant Files report by the International Consortium of Investigative Journalists found that top European Union politicians and officials across 36 countries were won over by misleading claims from implant industry lobby groups. In India, the CDSCO ban was unsurprisingly supported by medical manufacturers. We must also be wary of the argument that a regulated import regime would turn India into a dumping ground of ‘unsafe’ medical equipment. In a market as large and underserved as India, regulated imports will be unsafe not for patients but for corporate bottom lines.
A scientifically driven policy that regulates recycling is the need of the hour. We would be well-advised to devise innovative ways of recycling to clearly enunciate what kind of products can be recycled and reused and to issue recommendations and guidelines for
protocolised recycling of medical devices and so-called ‘disposables’, with penal provisions for unscrupulous actors and regulatory oversight to ensure that financial benefits accrue to patients as much as to hospitals. This would also require us to revisit the Medical Devices Rules, 2017 and a reversal of the CDSCO ban. Alongside, we need to raise awareness amongst patients to counter social taboos against the usage of reconditioned devices.
O.P. Yadava is CEO, National Heart Institute, New Delhi, and Director, All India Heart Foundation