‘Regulate Medical Devices’ - The New Indian Express

‘Regulate Medical Devices’

Published: 14th March 2014 08:07 AM

Last Updated: 14th March 2014 08:07 AM

Asking for more transparency in the pricing of medical devices, members of a trust have approached the government demanding that the procurement, sale and monitoring of these equipment be regulated to ensure patients’ safety.

The Surakshit Vatavaran Charitable Trust has launched a nationwide e-petition to garner support for this cause. It is also pushing for the enactment of the Drugs and Cosmetics Amendment Bill, 2013 which is still pending in Parliament.

Mahalingam Balaji, technology advisor to the trust, said the e-petition seemed necessary after an incident at the District Civil Hospital in Sriganganagar in Rajasthan where 10 out of 15 infant incubators caught fire, critically injuring babies. He said the reason for the mishap had to be improper use of the devices and lax inspections. “Hospitals might buy a high quality incubator, but if training is not imparted, it is of no use,” he said.

In a petition to be given to the Union Minister for Health and Family Welfare in June, members of the Bangalore-based trust have asked for the constitution of a regulatory body to examine medical devices.

They want to ensure that critical care devices like ventilators, anaesthesia monitoring equipment and infant incubators are included as part of the existing list of notified devices by the Central Drugs Standard Control Organisation (CDSCO). The members say patients now lack complete access to information on pricing of these devices.

The online petition, available through the trust website, says, “The body should regulate and monitor testing, evaluation, manufacture, import, sale, usage, maintenance and disposal of medical devices and ensure the availability of safe medical devices in India.”

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