Mumbai MRI death: India has no regulatory body for MRI scanners

Updated: Feb 02, 2018, 16:40 IST | Vinod Kumar Menon | Mumbai

While X-Ray and CT machines come under Atomic Energy Regulatory Board, there is no such regulatory body for MRI scanners

Representation pic/Thinkstock
Representation pic/Thinkstock

Over the past week, the shocking death of Rajesh Maru has brought the lack of safety at MRI centres under scanner. Turns out, India has no regulatory body to monitor any safety parameters at these centres. "It is shocking, but it is a fact that in India we have no such body or directorate to monitor safety parameters, if any, at MRI centres," said Dr A U Sonawane, director of regulatory affairs and communication, Atomic Energy Regulatory Board (AERB).

Doctors want more trained staffers manning MRI centres in hospitalsDoctors want more trained staffers manning MRI centres in hospitals

Dr Sonawane explained, "We already have in place the Directorate of Radiation Safety (DRS) to decentralize the diagnostic medical imaging test centres, which conduct X-Rays, Computed Tomography (CT), Interventional Radiology (IR) and dental X-rays, as all these machines emit ionising radiation, which is highly penetrating. Hence, they come under the regulatory powers of AERB, which is not the case with MRI, that has a powerful magnetic flux, and laser machines.

"The need of the hour after the Nair episode is for the health ministry to have an independent directorate or regulatory body to check the safety parameters in place at these MRI centres that rarely have any safety officers present. Officers are mandatory in CT scan centers," said Dr Sonawane.

Interestingly, a question was raised in the Parliament to AERB two years ago on having a regulatory authority for MRI and X-ray-based medical devices. AERB's reply stated MRI machines do not fall under their regulatory purview of AERB, because they don't emit ionising or highly penetrating radiation, unlike CT and X-ray, Dr Sonawane added.

Unfortunate
Dr Wiqar Shaikh, professor of medicine and head of medicine unit, Grant Medical College agrees with Sonawane, "It should be mandatory for the medical and non-medical staff at the hospitals and diagnostic centres to have a yearly training program [for operating these machines and ensuring safety]."

Dr Sandeep Nyayanirgune, a Sion-based consulting radiologist said, "We must understand that these are centres which require experienced hands trained in handling not only the equipment, but also ensuring patient safety. They cannot be replaced with regular, untrained staffers. The Nair incident should be treated as an eye-opener. It is high time a regulatory body or directorate is appointed to monitor these centres."

Not possible to have it
However, senior radiologist Dr Suleman Merchant doesn't feel the need for the same, "It is not possible to have a directorate or safety officials monitor some blunder that has been committed at an individual level. We must understand that a majority of patients and their relatives who visit civic run or government hospital are illiterate and don't even bother looking at the posters pasted outside the MRI and CT scan centres."

He added the hospitals need to be more proactive and have multi-level checks to ensure that no untoward objectionable metal piece gets carried inside the scan room. Head of the hospital's radiology department, medical superintendent and dean should ensure safety parameters are strictly followed.

Dr KK Agarwal, national president, Indian Medical Association said, "We must understand there is a fault on the part of the system and we don't need to appoint a regulator or directorate for everything. This [Maru's death] is a clear accident, which occurred due to human error. It is a known fact that if a person stands in the middle of a railway line, he is bound to get run over by a train. The past incidents that were reported were also due to human negligence and lack of trained staff at these centres."

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