Cardiologists of Kerala are seeking a review of the ordinance banning the reuse of single-use medical devices

Cardiologists have called for a review of the recent directive issued by the Director General of Health Services (DGHS) that strictly prohibits sterilization and reuse of single-use devices and disposable surgical items used in critical specialties such as cardiology and cardiothoracic and vascular surgery, citing patient safety concerns.

Addressing the annual conference of the Cardiology Society of India (CSI), Kerala Chapter, here on Sunday, CSI Kerala Chapter President Asokan PK said the association would seek a review of the order by the DGHS as the exorbitant cost of medical devices and accessories would make essential procedures such as angioplasty unaffordable and unaffordable for many.

Prathap Kumar N., organizing chairman of the conference, said the rising cost of complex angioplasty, especially procedures requiring more specialized equipment, had become a major concern. Reimbursement package rates under government-sponsored health insurance programs were often insufficient to cover the true costs of advanced cardiac interventions.

With an increasing proportion of the population requiring advanced cardiac interventions, it has been a major challenge to make complex procedures accessible to ordinary patients. Allowing the regulated reuse of selected interventional devices whenever they are scientifically proven to be safe could help reduce treatment costs and extend the benefits of modern cardiology care to a wider portion of the population, Dr. Prathap Kumar

He said cardiologists have requested a review to determine whether selected catheters, guidewires and other equipment can be safely reprocessed according to scientifically proven protocols and reused for patients.

“Patient safety must remain paramount. Any proposal for reuse must be supported by scientific evidence, validated sterilization, functional testing and rigorous regulatory oversight,” said Dr. Prathap Kumar.

He called for broader consultation between medical specialists, infection control experts and regulators to develop evidence-based policies on sterilization and reuse of medical devices that balance affordability and patient safety.

The DGHS order stated that the practice of reusing single-use devices and disposable surgical items is a serious concern in terms of patient safety, infection prevention and control, regulatory compliance and healthcare expenditure. He said such reuse can also expose patients to significant risks, including cross-infection, device failure, loss of performance and other procedure-related complications.

However, the fact is that sterilization and reuse of medical devices to ensure device integrity and patient safety are common practice in both private and public sector hospitals across the country.

The Cardiology Society of India issued a consensus document in 2017, “Guidelines for Reuse of Cardiovascular Catheters and Devices in India”, which clearly supported reuse but laid down certain requirements that must be met for reuse to be safe and effective.

Devices that can be reused should be clearly defined, a careful process of disinfection and sterilization should be followed, and their functionality should be verified before use. The document also states that “appropriate consent should be obtained where necessary” and the associated cost savings should be passed directly on to the patient.

The CSI(K) conference also discussed the evolving roles of drug-eluting balloons and drug-eluting stents in coronary angioplasty, leadless pacemakers, laser-assisted coronary interventions, invasive coronary function tests, newer cholesterol-lowering therapies, complex valvular procedures, and advances in the treatment of heart failure.

Published – 9 Nov 2026 20:18 IST