FDA And GSA Collaborate To Speed Access To Effective Face Masks

The Medical Devices Unit of the Food and Drugs Authority (FDA) and the Textiles Department of the Ghana Standards Authority (GSA)are collaborating to ensure that all face masks that are locally produced in Ghana are fit for use and comparable to the highest international requirements.

To this end, the two agencies have come up with Public Available Specifications (PAS) for what constitutes effective face masks and are also making available all international standards for personal protective equipment free of charge online.

The Food and Drugs Authority (FDA) has the responsibility and mandate to ensure that all Personal Protective Equipment (PPEs) and medicines for preventing the spread of the Coronavirus meet the required standards.

In order to avoid the shortage of face masks on the market, and in direct response to the call by the Government for the local production of face masks, the Medical Devices Unit (MDU) of the Laboratory Services Department (LSD) of the FDA and the Textiles Department of the GSA worked with the Ministry of Health and the Ministry of Trade and Industry to come up with attainable standards for use by local manufacturers to facilitate production, and eventually, the approval of locally-manufactured face marks.

In response to shortage of face masks globally, several countries, including; the US, have encouraged citizens to use home-made face masks. However, no stringent requirements were stated making it difficult to regulate.

The FDA therefore undertook assessment of the available local materials to determine the optimum products that will offer effective protection in Ghana.

Through this, it was noted that the Paper-Paper-Paper (three layers) combination is not suitable and, therefore, not recommended for use in the manufacture of nose masks for the fight against the COVID-19 pandemic.

However, a Calico-Paper-Calico (three layers); a Calico-Stiff (Hard/Medium)-Calico (three layers) combination; and the Calico-Calico-Calico (three layers)combination are suitable for the production of local face masks that can be used to assist in slowing down the spread of the Coronavirus in Ghana.

The FDA is therefore calling on all local commercial manufacturers of face masks to contact the FDA and/or the GSA for guidance and assistance.

This is because the FDA has a mandate to ensure that all medical devices, including; face masks, sold to the public provided the expected benefits to be derived from the use of these nose masks including; safety, quality, and good performance.

As part of its routine regulatory mandate, the FDA, through its market surveillance activities, would monitor the performance of the face masks to ensure that users derived the maximum benefits.

Any substandard ones found on the market would be removed and the manufacturers and other culprits would be appropriately dealt with under the provisions of the law.

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