DCGI calls for strict reporting of side-effects related to medical devices

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Mint. “As the MvPI is an important programme for reporting of adverse events, coordinated analysis etc., related to the medical devices including in-vitro diagnostic devices, therefore, all licence holders should also use the MvPI platform for reporting of any adverse or serious events associated with the devices to enhance the procedure for identifying risk associated with such equipment," he said. The DCGI said that post market surveillance (PMS) of medical devices is important to ensure safety and performance of medical devices and allows regulatory authorities to take appropriate measures to mitigate risks and safeguard public health.

The drug regulator also instructed licence holders and manufactures to seek training for understanding and proficiency in reporting and understanding adverse events. “Adverse events in medical devices depend upon the classification of the product.

High risk medical devices are more prone to show adverse events. Every manufacturer follows a Standard operating Procedure (SoP) laid down as per QMS.

If the medical device is not complying with the defined product standards or while using the same shows reactions to the patient, then it needs to be investigated. After thorough analysis necessary corrective and preventive actions are takenas per guidelines by the manufacturer and the same needs to be informed the competent authority for further action," said Jatin Mahajan, Secretary, Association of Diagnostic Manufacturers of India.