Radiation hazards in using medical devices, such as x-ray machine, are grossly neglected in the country and most hospitals and diagnostic centres do not comply with the stipulated safety norms, according to Mohammed Amir, a researcher.

He was presenting a paper at a session on regulation of medical devices on Saturday, the concluding day, at the three-day WHO Global Forum on Medical Devices at AP Medtech Zone.

He said a study conducted in five states had shown that there was very little awareness in the general public as well as professionals in the field about radiation hazards. "No attempt is being made to keep the x-ray machines and other such devices in safe rooms and to train the staff handling them to take precautions to protect themselves as well as the patients. Such devices are being handled casually, exposing people to radiation risks," he said.

However, he said, of late the Government has initiated some steps to sensitise the public as well as the professionals on safety norms. In 10 states, a programme on safety norms has been launched but still a lot remains to be done.

Dr V.G Somani, the Joint Drug Controller, India, spoke about the steps being taken to regulate the manufacture, import and marketing of medical devices in the country. On Jan 1, 2018, a notification had been issued under the Drugs and Cosmetics Act, 1940, covering 27 medical devices including BP monitoring equipment. Rules stipulated in the notification were harmonised with the Medical Devices Rules, 2017. Still, the process was going on and many more medical devices would be notified.

He said the standards laid down by the Bureau of Indian Standards (BIS) would have to be complied with by the manufacturers, importers and others in the field. If there are no standards by the BIS, then ISO standards would have to be followed. Some of the rules would be enforced by the Centre and some by the States. AMTZ at Visakhapatnam, the first cluster of MD units in the country, would lend support to the regulatory authorities in the country, he added.

Dulce Maria Martinez Pereira and Alexandra Lemgruber spoke about the regulatory regime for medical devices in America and Latin America.

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