17 medical devices that failed tests now safe for use

17 medical devices that failed tests now safe for use

The Medical Device Authority says thorough investigations and corrective actions were carried out by the establishments involved.

Muralitharan Paramasua
MDA chief executive Dr Muralitharan Paramasua advised the public to be cautious when purchasing medical devices online. (Bernama pic)
PUTRAJAYA:
The Medical Device Authority (MDA) has confirmed that 17 medical devices sold online, which previously failed safety tests, are now safe for public use.

The devices in question are the Dynmed brand oxygen concentrators; Angel Biss (SH01) and Carer; blood pressure monitors (BPLife, Novoplus, Yuwell and Ouson+); glucose meters (Roche, Sinocare and Yasee); thermometers (BioCare, Scaneo and Ouson+); as well as surgical and examination gloves (Gammex, Shirudo, Puritex and Infinity Latex).

MDA chief executive Dr Muralitharan Paramasua said that thorough investigations and corrective actions had been carried out by the establishments involved following the Feb 15 MDA report regarding the devices’ failure to comply with standards.

“All the establishments involved showed a high commitment to undergoing full investigations. This is in line with the post-market responsibilities outlined in the Medical Device Act 2012,” he said in a statement today.

Muralitharan said comprehensive actions such as improvements in quality control systems, compliance with regulation guidelines, as well as increased transparency in managing safety and efficacy issues had helped restore public confidence.

He also advised the public to be cautious when purchasing medical devices online.

“The public needs to ensure that the medical devices are registered with MDA and sold by licensed establishments,” he said.

Information and complaint channels can be accessed via the official MDA website at www.mda.gov.my or by contacting 03-82300300.

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