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OpinionOur view

A catheter meant for one heart should not be used on the next. The health directorate's warning needs teeth

The DGHS says some private and corporate hospitals are sterilising and reusing devices made for a single procedure. A letter to the states is a start. Patients need inspections, penalties and the right to know what was used on them.

From the editorial deskPublished
A cardiac catheterisation laboratory in a hospital (file photo)
A cardiac catheterisation laboratory in a hospital (file photo)Photo: Navy Medicine / Wikimedia Commons, Public domain

A guide wire threaded into a patient’s heart during an angioplasty is made to be used once and thrown away. So is a dialyser filter, a biopsy needle or a stapler used in surgery. The manufacturer has not designed it to be taken apart, cleaned and sterilised, and cannot promise that it will work, or be germ-free, the second time.

Yet the Directorate General of Health Services has now had to write to every state and union territory to say that some private and corporate hospitals are doing exactly that. It found single-use devices and surgical items being reprocessed and reused in cardiology, nephrology, oncology and neurosurgery, the specialties where patients are most fragile and procedures most expensive. It named four concerns: patient safety, infection control, compliance with the law on medical devices, and the cost of care.

Not a new problem

None of this should surprise the regulators. In 2017 Maharashtra’s Food and Drug Administration found that a large private hospital in Mumbai had reused 66 angioplasty catheters in three months, billing patients ₹26,000 a piece for devices whose maximum retail price was ₹6,000. Complaints followed against 37 hospitals in the state, and the government promised a portal to track each device from purchase to use.

That is the uncomfortable part of the problem. Reuse is not usually about scarcity. In a well-equipped private hospital it is often about margin: the patient pays for a new device and receives one that has already been used on someone else.

The fair objection

There is a serious argument on the other side. Some countries allow certain single-use devices to be reprocessed under strict, licensed conditions, and doing so can cut costs and medical waste. For a public hospital with a thin budget, a blanket ban can feel like a luxury.

That argument is for a regulated system, not for what the directorate describes. Reprocessing done properly needs validated cleaning, testing, a limit on how many times an item can be used, and, above all, the patient’s knowledge and a lower bill. A hospital quietly sterilising a catheter in its own supply department and charging full price meets none of those tests.

What the states should do

First, inspect. A letter asking states to enforce the rules strictly means little unless drug controllers and health departments actually visit catheterisation labs, dialysis units and operating theatres and check stock against billing. The results of those inspections should be published.

Second, make hospitals show their working. Every bill for a procedure should list the devices used with their batch or serial numbers, so that a patient or an insurer can check that what was charged was new. Insurers, including those running government schemes, should refuse claims that cannot be matched to a device.

Third, penalise in a way hospitals feel. Refunds to patients, fines tied to the number of devices reused and, for repeat offenders, suspension of the specialty’s licence would change behaviour faster than a circular.

Finally, if the Centre believes some devices can safely be reprocessed, it should say which, under what standards and with what consent, rather than leaving a grey zone that the worst operators fill.

A patient on an operating table cannot check what is going into their body. The rules exist so that they do not have to. The directorate has named the problem; the states now have to show that its warning will be enforced.