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Regulating facemasks and hand sanitisers | Ensuring safety

30 May 2020

Facemasks and hand sanitiser gel, while recommended by the health authorities as a preventive measure to reduce the chance of contracting Covid-19, are also becoming items with the highest demand at present. When the country went into a prolonged curfew mode in March, any and every available facemask ran out of stock in a matter of days. Personal use hand sanitiser gel bottles too were not spared and shelves were been emptied. Two months later, there is a surplus of stocks available with known and unknown suppliers, with social media feeds flooding with single-use and reusable facemasks being promoted. Hand sanitiser liquids are readily available with some suppliers, some of whom are even selling them on the roadside off lorries. But in the long run, will these products made with the least amount of consideration to quality standards save us from catching a virus? In this regard, we spoke to the National Medicines Regulatory Authority (NMRA) to inquire whether the institute is looking into the quality of the hand sanitisers as well as reusable facemasks that are available in the market. Regulating work in place
"Regulating the formulation of hand sanitisers is already in place to ensure the quality of products that are locally made. The World Health Organisation (WHO) had given two formulations for hand sanitisers by using ethanol and the other by using isopropyl alcohol as active ingredients. We are now deploying a team to obtain samples of the products that are available in the market for testing,” NMRA Chairman Prof. Asitha de Silva explained.
If the products are found to be substandard, the NMRA will recall the whole consignment in the market and legal action will be taken. However, regulating the various types of facemasks that are available in the market is a complex process, Prof. De Silva noted. The NMRA is only able to quality-check the disposable surgical masks and the N95 respirators. Gazette No. 2160/28 of the National Medicines Regulatory Authority Act No.5 of 2015 issued on 29 January 2020 said that a surgical facemask will not be sold for more than Rs. 15 and a N95-type facemask for Rs. 150. However, this gazette was amended on 16 March 2020, stating that the control price of facemasks will be Rs. 50 and the N95 masks must be sold for no more than Rs. 325. Considering the prevailing situation, the NMRA decided to facilitate the submission of requests for Waivers of Registration (WoR) for urgent requirements of medicines, medical devices, and cosmetics (hand sanitisers) through email. Therefore, the request with the scanned copies of the relevant documents was to be emailed to the NMRA. The NMRA was to grant temporary WoR to numerous organisations to supply medicinal products urgently required to counter the challenge posed by Covid-19 in order to facilitate emergency supplies by providing abbreviated regulatory oversight. Hand sanitiser recommended formulas Final recommended concentrations of active ingredients of hand sanitiser are ethanol 80%v/v and isopropyl alcohol 75%v/v. In line with this, the National Medicines Regulatory Authority (NMRA) requires finished products to contain alcohol in the following concentrations:
  • Ethanol 75-85% (v/v)
  • Isopropyl alcohol 74-76% (v/v)
Manufacturers are required to strictly adhere to this recommendation. Comparing surgical masks and surgical N95 respirators A surgical mask is a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. These are often referred to as facemasks, although not all facemasks are regulated as surgical masks. Note that the edges of the mask are not designed to form a seal around the nose and mouth. A N95 respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles. Note that the edges of the respirator are designed to form a seal around the nose and mouth. Surgical N95 respirators are commonly used in healthcare settings and are a subset of N95 filtering facepiece respirators (FFRs), often referred to as N95s. The surgical masks and surgical N95s do share some similarities as they are tested for fluid resistance, filtration efficiency (particulate filtration efficiency and bacterial filtration efficiency),  flammability, and biocompatibility. Most importantly, they should not be shared or reused. Cloth face coverings With the affordability and reduction of environmental pollution in mind, many seem to have opted for the cloth face covers. Since surgical masks and N95 respirators must be reserved for healthcare workers and other medical first responders, cloth face covers are a popular option for the general public. Follow the below steps when wearing a cloth face cover: Wear your face covering correctly
  • Wash your hands before putting on your face covering
  • Put it over your nose and mouth and secure it under your chin
  • Try to fit it snugly against the sides of your face
  • Make sure you can breathe easily
Use the face covering to protect others
  • Wear a face covering to help protect others in case you’re infected but don’t have symptoms
  • Keep the covering on your face the entire time you’re in public
  • Don’t put the covering around your neck or up on your forehead
  • Don’t touch the face covering; if you do, wash your hands
Follow everyday health habits
  • Stay at least six feet away from others
  • Avoid contact with people who are sick
  • Wash your hands often with soap and water for at least 20 seconds each time
  • Use hand sanitiser if soap and water are not available
Take off your cloth face covering carefully when you’re home
  • Untie the strings behind your head or stretch the ear loops
  • Handle only by the ear loops or ties
  • Fold outside corners together
  • Place covering in the washing machine or wash it right away and leave it to dry
  • Be careful not to touch your eyes, nose, and mouth when removing and wash hands immediately after removing
PHOTOS SAMAN ABESIRIWARDENA

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