BEWARE OF UNPROVEN MEDICAL DEVICES

The Food and Drugs Authority’s (FDA) attention has been drawn to a recent launch by LG of a smartphone, LGK7i at the India Mobile Congress.  There are indications that attempts would be made to promote and market the device in Africa as a means of fighting malaria.

In Ghana, malaria is endemic and considered as one of the deadly diseases for which prevention and treatment are given topmost priority.  Children under 5 years and pregnant women are very vulnerable.

Mosquito bites transmit the parasite that causes malaria. To this end, there are a number of tested and proven means of preventing mosquito bites.  The FDA has approved mosquito repellents like sprays, coils, insecticide treated nets, body creams and paints.

The FDA is aware of products that use other technologies supposedly for the repellent of mosquitoes.  Among these is the ultrasonic mosquito repellent.

Reviews of numerous studies conducted in several countries including the USA by reputable institutions like the American Mosquito Control Association and published in peer-reviewed journals like the Journal of Vector Ecology have concluded that the ultrasonic mosquito repellents do not work.  These studies and publications span several decades from the 1970s to date and the conclusion have always been the same i.e. ineffective for purposes of repelling mosquitoes.  Statements like the following were captured:

“The ultrasound device used was not effective against mosquitoes in this strictly controlled trial.”

“For all species there was no significant difference between the numbers trapped when the devices were switched on or off, when all devices were tested simultaneously.”

“Studies have demonstrated that electronic mosquito repellers are useless and that some of them may even increase the attraction of mosquitoes.”

The FDA wishes to draw attention to the fact that under the Public Health Act, 2012 (Act 851), this is a medical device which must be given the appropriate regulatory clearance prior to importation, sale and use in Ghana.  The essence of the registration is to verify and confirm that the device meets the appropriate standards, of the right quality and performs as indicated.

Currently, there is no such application before the FDA. Consequently, the FDA cannot vouch for the quality and performance of such a device.

In view of the implications for public health and safety, the FDA wishes to caution the general public against the reliance on unproven technologies which have the potential of being deceitful in the expected protection against diseases.

The general public is further encouraged to provide information on any activities that are likely to endanger public health and safety with respect to FDA’s mandate through any of the following numbers; HOTLINES – 0299802932, 0299802933, TOLL FREE NUMBER – 0800151000 (free only on Airtel and Vodafone) SMS SHORTCODE –  4015.

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