Locally-made face masks equivalent to N-95 face masks – FDA
The Food and Drugs Authority (FDA) Ghana has said that the locally-made face masks are of equal standard as that of the N-95 and therefore fit to be used in health facilities.
It said the thickness of registered imported N-95 ranged between 0.85mm – 1.4mm, and that of locally-made, between 1.0mm – 1.34mm, which complied with the standard of not less than 0.85mm.
The Authority through the FDA Medical Device ISO 17025 – 2017 Accredited Laboratory, said the tests of the locally-made medical face masks were compared head-to-head with the N-95 using the American Society for Testing of Materials (ASTM) methods.
A statement from the FDA said the locally-made face masks had been approved based on the Public Available Specifications (GS PAS 4:2020) and FDA requirements for registration of locally made face masks.
It described the locally-made face masks as a three-layered face mask, which has a two-layer fabric with a hard stiff in between.
It said the prescribed materials that are being used are plain fabric, which is bleached to ensure the removal of starch to avoid coagulation for easy breathability.
For the dimensions, FDA Medical Device ISO 17025 -2017 Accredited Laboratory said it must a length of 200mm – 250mm (cheek to cheek) and width 90mm – 150mm thus above the nose to bottom of the chin.
For the thickness test, it said when measured with the digital thickness gauge, the thickness should not be less than 0.85mm.
For porosity test, the ability of the mask to create a barrier to viruses, bacteria, and germs, but also enables easy breathability as air easily passes through and that with breathability test, the person wearing the masks should be able to breathe without difficulty.
With the aerosol splash test, the Lab said the masks must have the ability to protect the wearer from oropharyngeal secretions and vice versa, thus preventing the spread of viruses adding that the aerosol used for the Aerosol Splash Test has less viscosity than blood and oropharyngeal secretions.
A news story carried by Graphic Online on May 30 noted that the Ashanti Regional branch of the Ghana Medical Association (GMA) and the Ghana Registered Nurses and Midwifery Association rejected directives given by the management of the Komfo Anokye Teaching Hospital (KATH) to doctors and midwives at the hospital to use locally made nose masks.
The story said the management of the hospital, in a letter dated May 22, directed doctors and nurses who were not deployed at the critical area to consider wearing home-made nose masks to help the hospital deal with a shortage of basic personal protective equipment.
The health personnel however rejected the suggestion, insisting there could not be segregation between those working directly in the frontline of managing the coronavirus situation and others managing other patients at the other units.
Source: GNA