Imported medical devices found to be substandard

A NUMBER of medical devices imported into the country have been found to be substandard and would thus affect the diagnoses and treatment of ailment of people who patronise them.

Consequently, the Food and Drug Authority (FDA) has asked hospitals and importers of such medical devices to liaise with the Authority to ensure that the devices were registered and are of the required standard before purchasing them.

The devices include syringes, bandages, disposable gloves, cervical collars, sanitary pads, dippers, reagents for laboratory test and any other apparatus used to treat, prevent or diagnose diseases.

The Head of Medical Devices of FDA, Joseph Bannie, said this in Cape Coast yesterday at a training programme on the regulation of medical devices in Ghana.

The two-day programme being supported with funds from the Department for International Development (DFID) is to sensitise importers and users of medical devices to the need to avoid the use of substandard medical devices due to their effect on the health of users.

Mr Bannie said there was a report of a leaking syringe at one of the hospitals in the country which was detected by a nurse on duty which, he said, could have affected the dose of medicine being given to a patient at that point.

Additionally, he said, the FDA was alerted about a defective infusion process which could have resulted in overdose or under-dose of medicines for patients.

He indicated that the main challenge confronting the country was porous borders that allowed people to smuggle items, including medical devices into the country.

He explained that despite the influx of such sub-standard devices into the system, FDA’s post-market surveillance always made it easier for the Authority to track the source and pick such items for destruction.

Mr Bannie asked people with unwholesome products to contact the FDA to ensure safe disposal of such products, stressing that the law forbids disposal of unwholesome products without the supervision of the Authority.

The Authority, he said would close down premises unsafe for production and storage of medical devices if there was the risk of contamination of the devices which could affect its use and efficacy.

In an address, Mrs Akua Amartey, acting Deputy Chief Executive responsible for Medical Devices, Cosmetics and Household Division of the FDA, noted that unwholesome and substandard medical devices were harmful to the one using it.

She, therefore, urged importers and users of medical devices to ensure that the devices they procured conformed to the required standards.

The Central Regional Director of the FDA, Kingsley Nsiah-Poku, appealed to Ghanaians to demonstrate collective responsibility by insuring that food, medical devices and consumable items were of the required standards.

He expressed concern about the way a section of the country’s population patronised products without paying critical attention to their health needs.

From David O. Yarboi-Tetteh, Cape Coast

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