Cardiologists seek review of DGHS order banning re-use of single-use medical devices to reduce angioplasty costs

Cardiologists have called for a review of a recent order issued by the Director General of Health Services (DGHS), strictly prohibiting the sterilisation and re-use of single-use devices and disposable surgical items used in critical specialties like cardiology and cardiothoracic and vascular surgery, citing issues of patient safety

At the annual conference of the Cardiological Society of India (CSI), Kerala chapter, here on Sunday, the CSI Kerala Chapter president Asokan P.K. said the association would seek a review of the order by DGHS as the exorbitant cost of medical devices and accessories would make crucial procedures such as angioplasty unaffordable and inaccessible to many.

Prathap Kumar N., organising chairman of the conference, said the rising cost of complex angioplasty, particularly procedures requiring multiple specialised devices, had become a major concern. Reimbursement package rates under government-funded health insurance schemes were often inadequate to cover the actual cost of advanced cardiac interventions.

With an increasing proportion of the population requiring advanced cardiac interventions, making complex procedures affordable to ordinary patients was a major challenge. Permitting the regulated re-use of select interventional devices, wherever scientifically proven safe, could help reduce treatment costs and extend the benefits of modern cardiac care to a wider section of the population, Dr. Prathap Kumar pointed out

He said cardiologists had sought a review to determine whether selected catheters, guidewires and other equipment could be safely re-processed under scientifically validated protocols and re-used for patients.

“Patient safety must remain paramount. Any proposal for re-use must be supported by scientific evidence, validated sterilisation, functional testing and strict regulatory oversight,” Dr. Prathap Kumar said.

He called for wider consultation among medical specialists, infection-control experts and regulatory authorities to develop an evidence-based policy regarding the sterilisation and re-use of medical devices, balancing affordability with patient safety.

The order by the DGHS said the practice of re-using single-use devices and disposable surgical items was a serious concern from the perspective of patient safety, infection prevention and control, regulatory compliance and healthcare expenditure. It said such re-use may also expose patients to significant risks, including cross-infection, device malfunction, loss of performance and other procedure-related complications

However, it is a fact that sterilisation and re-use of medical devices, ensuring the integrity of the devices and patient safety, is a common practice in both private and public sector hospitals across the country.

The Cardiological Society of India had in 2017 brought out a consensus document, “Guidance on reuse of cardio-vascular catheters and devices in India”, which clearly endorsed re-use, but set out certain requirements which had to be met for re-use to be safe and effective.

The devices, which can be reused, should be clearly defined, a meticulous process for disinfection and sterilisation followed and its functionality ascertained before use. Also, “an appropriate consent should be obtained where necessary” and the cost saving entailed should be directly passed on to the patient, the document said.

The CSI(K) conference also featured discussions on the evolving roles of drug-coated balloons and drug-eluting stents in coronary angioplasty, leadless pacemakers, laser-assisted coronary interventions, invasive coronary function testing, newer cholesterol-lowering therapies, complex valve procedures and advances in heart failure management.