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Ghana FDA trains stakeholders in regulation of medical devices

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The Food and Drugs Authority (FDA) has trained various stakeholders in the health sector on regulation of medical devices used in medical facilities.

The participants include pharmacists, nurses, bio-medical engineers, procurement officers at heath facilities and importers of medical devices.

According to the FDA medical devices such as X-ray machines, BP apparatus, MRI machines, the openers, Bio-chemistry analyzers, Incubators, Concometres and even syringes and needles have to be licensed and regulated by the FDA to ensure that they were safe and up to expected standards.

Mr Joseph Bernie, Head of Medical Devices Department of FDA, said the law requires that every medical device whether for public or private use is registered and regulated by the FDA, however, this has not been followed keenly to the latter, hence the training to remind them as well as create the awareness.

He said the FDA regulations involve certifying such devices through how they are installed, handled and serviced by visiting the facilities as well as testing the devices to ensure that, the devices were working according to expected standards.

He said the FDA has embarked on a nationwide training to create the awareness and urged health facilities to verify or check with the FDA certified devices when purchasing or receiving donations from well-wishers.

Mr Samuel Kwakye, Eastern Regional Director, FDA, said medical devices are critical components in health care delivery and it is important that whiles FDA check the efficacy of drugs, it did same to the devices.

He advised individuals who have purchased BP apparatus or any related equipment for use in their homes or selling or distributing them for sale to visit any of the FDA offices to check its efficacy.

The Regional Director said usually devices manufactured locally had seal of the FDA, however, this was not the case with the imported ones for known reasons and urged the public to make the effort to check with them.

Source: GNA

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