It has therefore entreated management of various public and private health facilities across the country to discard all defective medical devices to safeguard public health and safety.
According to the Public Health Law, Act 851 passed in 2012, medical devices refers to an instrument, apparatus, implement, medical equipment, machine, contrivance, implant, invitro re-agent or other similar related articles used for the diagnosis of disease or other conditions meant for cure, mitigation, treatment and prevention of disease in a man or animal.
Mr Joseph Bennie, the Head of Medical Devices at the FDA, gave the advice at a day’s workshop for health professionals in Takoradi, on guidelines regulating the registration and regulation of medical devices in Ghana.
The event, organised by the FDA and funded by the Department of International Development, under the auspices of the United Kingdom Government, attracted public and private health professionals from the Effia-Nkwanta Regional Hospital, Dixcove Government Hospital, Takoradi Hospital, Essikadu Hospital, among others.
The participants are heath workers, who mostly use medical devices in their daily activities including, laboratory technicians, biological scientists, technologists, nurses and medical doctors,
Mr Bennie advised management of health facilities to exercise extreme caution and vigilance whenever taking delivery of medical devices as donation from philanthropists and corporate entities because some of the items might be substandard and could pose health risk to their clients.
He observed that using substandard medical devices for diagnostic test could give wrong results and thus, cited an instance where a defective medical device was used in a private laboratory in Accra to test the HIV status of a client which proved positive, however, a further confirmatory test at Nuguchi Memorial Institute proved negative.
“So you see how scary a substandard medical device used for diagnostic test can be?” he queried, and noted that people who failed to exercise courage at the initial test could even commit suicide for proving positive for HIV.
He urged health professionals and the general public to promptly report clinical failure of any medical device to the Authority for the necessary action and assured the public that the FDA would intensify its post-market surveillance exercise to clamp down on substandard medical devices in the system.
Mr Bennie entreated manufacturers, wholesalers, retailers and vendors who want to dispose-off substandard devices and products, to inform the FDA to supervise the exercise.
He warned that those who failed to comply with the directive and are caught doing the wrong thing would pay not less than 5,000 penalty units which is equivalent to GH¢60, 000.00.
The participants charged the FDA to exercise extreme vigilance in stopping substandard medical devices from entering the country to safeguard public health and safety.