FDA trains stakeholders in regulation of medical devices


Bertha Badu-Agyei, GNA

Koforidua, Oct. 23,
GNA – 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.



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