PETALING JAYA, Aug 18 — Think of face masks as the latest trending accessory that can save your life and the lives of those you love.
But instead of going for masks with fancy patterns, logos or slogans, settle for one that provides good protection against the deadly Covid-19 virus no matter what environment you are in.
As more contagious Covid-19 variants circulate in the air, including the latest Delta variant which can infect a person in just 15 seconds, doctors say it is important to ensure the effectiveness of the mask one chooses to wear.
Associate Prof Dr Mogana Sundari Rajagopal, dean of the Faculty of Pharmaceutical Sciences at USCI University, said various types of face masks are available in the market and these include fabric masks that are reusable, and surgical or medical masks.
“Each country has its own certification standard for each mask type. For example, Europe uses the EN 14683 or ASTM F2100 standard for medical or surgical masks, whereas China uses the YY 0469 standard.
“Although the standards vary a little in each country, they are, however, broadly similar. For respirator masks, China uses the KN standard (for example, KN95) and the US uses the N standard (for example, N95),” she told Bernama.
To avoid purchasing counterfeit masks, there are certain ways to identify the quality of a medical or surgical face mask, said Dr Mogana, adding that masks carrying the ASTM (American Society for Testing and Materials) or EN (European Standard) rating meet international standards and requirements.
The ASTM rating is a standard to review the quality of medical masks. There are three classifications for its standard: a lower level 1 which is the minimum level required to meet the ASTM standard and a higher level 3 for manufacturers that want to produce face masks.
“While surgical masks, N95 masks and other medical-grade personal protective equipment have long had established standards in place, this new standard for everyday masks is a first and is meant to provide a benchmark for both manufacturers and the general public.
“Manufacturers will be encouraged to comply with the standard and consumers will be able to have confidence in compliant products, knowing that they are certified.
“However, certain mask manufacturers follow the European Standard which is EN14683 and categorise their masks as Type I, II and Type IIR,” she said.
She said consumers can simply look for ASTM Level 1, 2 or 3 rating on the face mask package before they purchase it. However, not all face masks are ASTM-rated.
“It is worth the effort to find face masks that do carry the ASTM rating and to be sure you’re getting the proper level of protection,” she said.
She said the public is often confused about N95 and medical-grade face masks such as surgical face masks. The N95 or KN95 masks are categorised as respirators.
She said according to the United States Centers for Disease Control and Prevention (CDC), at least 60 per cent of the KN95 masks evaluated by the National Institute for Occupational Safety and Health (an agency under CDC) did not meet the requirements that they claimed to meet.
“A majority of the KN95 or N95 masks, which are prioritised for healthcare workers, in the market are fake,” she said
She added that for adequate protection against the Covid-19 virus, which is about 0.1 micron in size, a medical or surgical face mask in compliance with EN TYPE IIR or ASTM LEVEL 3 with good filtration is highly recommended.
Identify counterfeit masks
Dr Mogana said the US Niosh-approved respirators should have an approval marking beginning with TC – XXX- XXXX which can be checked via its website http://www.cdc.gov/Niosh/nppt/topics/respirators/disp_part/default.html.
“The public can also notice the signs of a counterfeit mask – there will be no Niosh logo for the respirator, sketchy (information on the) retailer and the price is too good to be true.
“In fact, Niosh doesn’t approve any mask for children, hence any statement claiming that the respirator is approved for children is fake,” she said.
She said all medical or surgical face mask manufacturers in Malaysia are required to hold an ISO 13485 certification and be registered under the Medical Device Authority (MDA).
“The MDA helps to monitor the role of the medical device manufacturer and all these manufacturers have to register their establishments along with their products.
“The public must ensure the face masks are regulated under the international standard such as EN or ASTM by authorised bodies such as Sirim Bhd, SGS Malaysia and many others.
“Unfortunately, many manufacturers and distributors are not registered and are selling face masks that are not properly regulated,” she added.
Dr Mogana said while certain mask manufacturers produce masks in a variety of colours and patterns, there is, however, no colour coding for surgical masks.
“Colours or writing or printing on masks should be avoided as per studies done. Dyes should be selected according to internationally accepted industry standards to protect our health and the environment.
“Thus, an international consensus concerning face mask colours based on their impact on health should be investigated and determined. Certain dyes are toxic and persistent and have both short- and long-term negative impact on human health, fauna and flora,” she added.
To choose the right face mask providing adequate protection against Covid-19, Dr Mogana recommended using masks manufactured by companies that hold a Medical Device Quality Management System ISO 13485:2016 certificate.
One such company is Careline Manufacturing Sdn Bhd which specialises in manufacturing surgical face masks and medical face masks for both adults and children. All their products are lab-tested by Sirim and are also registered under Sirim Product Certification.
“One of the favourable properties of Careline Face Mask is that its inner layer material does not cause skin allergies. The material also has anti-fogging properties.
“Such face masks are friendly to consumers who have to deal with skin allergies due to wearing a mask for many hours and those wearing spectacles, respectively,” Dr Mogana said, adding that all Careline products, including the Careline Kids Face Surgical Face Mask, comply with ASTM Level 3 and EN Type IIR ratings.
‘Double masking’ prevents infections
Lately, health experts have been recommending double masking, that is wearing two masks at once, to protect the public against the more aggressive and highly transmissible Covid-19 variants.
Double masking means wearing a fabric mask on top of a medical-grade mask which, according to experts, can help to filter more particles than a single mask.
Associate Prof Dr Kyu Kyu Win, a microbiology lecturer at the Faculty of Medicine and Health Sciences at USCI University, said the combination of a fabric mask and surgical mask can improve fit and filtration of the particles.
“Wear one disposable medical or surgical face mask underneath and a cloth mask on top to have a better fit and extra protection. The cloth mask can also be combined with a fitter or brace.
“Knot and tuck ear loops of a three-ply face mask where they join the edge of the mask, fold and tuck the unneeded material under the edges.
“However, the surgical or medical mask should not be layered with the same type of mask as this combination doesn’t improve fit, while the N95 mask is meant to be used alone,” she said.
She said the World Health Organisation has recommended a four-hour lifespan for surgical masks, which means that a face mask should be replaced after it is worn for about four hours.
Dr Hean Ooi, who is vice director of the International Centre at China Medical University Hospital, said wearing a face shield alone is not only against the existing standard operating procedure, it also does not provide good fitting for sufficient protection.
Surgical, medical masks for daily use
Dr Ooi said the performance of masks is tested by assessing their bacterial filtration efficiency (for bacteria more than three microns in size), particle filtration efficiency (for less than 0.1-micron particles) and so on.
“Covid-19 is commonly spread by droplets and the size of the SARS-CoV-2 virus (which causes Covid-19) is about 0.1 micron,” he said.
He said surgical mask standards have higher requirements for capturing virus-sized (0.1 microns) particles at more than 98 per cent.
“For respirators such as the N95 and KN95, use multiple layers of synthetic material to protect yourself from outside particles.
“As their names suggest, both must filter out 95 per cent of particles that are 0.3 microns in size or larger,” he said.
Dr Ooi advised the public to look for a medical or surgical face mask that complies with the EN or ASTM standard required for a face mask.
“Plus, a good face mask should be constructed with three layers unlike those cheap face masks which have only one layer,” he said.
He said a respirator such as the N95 and KN95 or KF 94 is not encouraged for daily use as it can cause breathing difficulties if worn for up to eight hours a day.
“For the public, the CDC and WHO recommend that they wear a medical or surgical face mask in order to protect themselves and other people.
“Thus, for daily use purpose, wearing a surgical or medical face mask is sufficient and it can protect people from the current pandemic,” he added.