At the beginning of the Covid-19 pandemic in 2020, there was a mad scramble to get hold of personal protective equipment (PPE), including face masks.
The sudden spike in demand both locally and globally, caused a serious shortage in supply.
The gap was so huge that the government loosened the quota on the import of such devices, according to K. Karunakaran, who has over 15 years of experience in PPE manufacturing.
Even healthcare frontliners, who were prioritised for PPE due to their high risk of exposure, had to resort to making their own in many instances.
Members of the public were also competing to get their hands on these non-reusable devices as it became compulsory to wear them in public.
Fortunately, both the global and local supply of PPE have now risen to adequately meet the current demand.
And with the compulsory practice of wearing face masks in public set to be continued even as Malaysia prepares to transition to the endemic phase of Covid-19, there is likely to be continued high demand for this protective gear in the near future.
Many manufacturers and distributors, local and international, have leapt into the breach over the last two years to increase the supply of PPE like face masks.
E-shopping platforms, whose popularity experienced a boom during the movement control order, now abound with multiple types and brands of face masks for sale.
Such platforms allow shoppers to buy directly from sellers.
As long as there is a logistics service to send the item(s) from the seller to the buyer, the seller can literally be located anywhere in the world.
As such, not all items for sale on such platforms can be guaranteed to conform to the quality control and standards of manufacturing we might expect.
This applies equally to face masks, where it can be hard to ascertain whether or not such products – be they made locally or abroad – truly exhibit the safety and effectiveness we want from them.
Certify for quality
Karunakaran notes that local face mask manufacturers and distributors have long called for the certification of such products.
The government recently answered by making it compulsory for all locally-made and imported non-medical (or non-surgical) face masks to undergo Sirim certification and labelling before they can be sold in the Malaysian market by Jan 1, 2023.
According to Karunakaran, Sirim has a good protocol in place where they come and audit the company once every six months.
“Of course, there is cost incurred, but there’s a third party coming in and checking your production, making sure that the consumer receives a good product.”
He adds that it is important to make it compulsory as some companies would choose not to participate due to the extra cost and work involved if it is voluntary as it currently is.
On the other hand, the production and distribution of medical (or surgical) and respirator face masks (see Providing protection infographic above) have always been required to obtain certain certifications by the Malaysian Device Authority (MDA), he explains.
This is as both those types of face masks are considered medical devices, and as such, must adhere to certain standards to ensure safety and quality (see Up to snuff infographic below).
MDA, which comes under the Health Ministry, requires manufacturers to be certified as meeting the standards of the ISO 13485 quality management system before they can register their products with MDA.
ISO 13485 was developed specifically for the medical devices industry by the non-governmental International Organization for Standardization (more popularly known as ISO).
In addition, face mask manufacturers can apply to be certified under certain international standards for medical face masks, such as the ASTM F2100-20 from the United States or the EN 14683 from the European Union.
Meanwhile, importers and distributors have to conform to the Good Distribution Practice for Medical Devices (GDPMD), which covers the supply chain of medical devices.
Certification for this standard is needed before MDA grants the license to import and/or distribute any medical device.
Karunakaran notes however, that overseas sellers who receive orders for medical and respiratory face masks directly from customers via online shopping platforms or websites do not necessarily have to have a license from MDA as they are sending the product directly to the buyer (versus importing or distributing it in bulk within Malaysia).
He says that at the end of the day, the compulsory Sirim certification for non-medical face masks will help ensure a level playing field within the country.
“Players like us want to be sure that we meet the requirements that are asked for by GDPMD and ISO.
“There are many of us who have applied for these, but there are also many others who don’t care about all this, because to go in and do all these processes, you obviously have to pay a lot of registration fees and licensing fees, and there’s a lot of work involved.
“We are happy to compete with people on the same level playing field, but we do not want others who are not in the same category, who do not meet all the necessary requirements, to come into the market and tarnish the name of face mask manufacturers in Malaysia,” he says.
Not necessary, but nice
Standards Department Occupational Safety and Health Industrial Standards committee member Dr Priya Ragunath shares that Sirim actually embarked on a project in 2020 to develop local standards for non-medical face masks.
This resulted in the Sirim 40:2020 standard.
“The purpose of this standard is to provide some amount of standardisation or reference for the manufacturers of non-medical face masks – it was not there as a requirement,” explains the occupational health physician and Health Ministry Occupational and Environmental Health Sector head.
The standards certification body also has the MS2323:2010 standard, which can be applied to respiratory protective devices used in non- medical industries (e.g. construction).
She believes that the issue of compulsory certification for non-medical face masks came up because people weren’t sure of the quality of face mask they were buying.
“It’s about giving people the power to make informed decisions for themselves, so that they know what they need to buy,” she says.
Dr Priya notes that while the Health Ministry does not see a need to recommend standards for non-medical masks, having such standards does allow members of the public a choice when it comes to purchasing such products.
The main function of non-medical masks, which includes both disposable face masks and reusable ones, is to act as a barrier between the wearer and other people.
“For the community per se, it was decided – not just in Malaysia, but also around the world – that a non-medical mask was sufficient.
“It could be a disposable mask that does not conform to standards or it could be a fabric mask; it was found that these provided sufficient protection to people at large.
“The only thing is that they must make sure the mask has the necessary three layers,” she explains.
The three layers are a water-resistant outer layer, a non-woven polymer fabric that can act as a filter in the middle, and an absorbent inner layer.
Dr Priya says that medical or surgical face masks, which are mostly used in a healthcare setting, have always had manufacturing standards to adhere to.
While it is not legally required for manufacturers to follow such standards, she shares that the Health Ministry will only buy medical masks that are certified as following internationally-recognised standards.
As for members of the public, medical masks are recommended only for those aged 60 and above, those who are immunocompromised (e.g. patients with non-communicable diseases like cancer, diabetes, heart disease, etc) or those working in high-risk environments, like nursing homes.
There are also standards for respirator masks like the N95, KN95 and KF94.
“Different countries came up with standards that slightly vary from each other, but they are more or less around the same,” she says.
However, she emphasises that respirator masks are not meant to be worn for casual use.
“It is important to know that respirators need to be used in certain circumstances,” she says, giving the example of healthcare staff working in an infectious diseases ward.
“But we must understand that no one can wear a respirator and walk around, because it is impossible to breathe properly in a respirator for long periods of time.”
Most importantly, Dr Priya says that wearing a face mask is just part of a package of preventive measures, along with maintaining adequate physical distancing and practising hand hygiene.
“It works as a package – it’s not just about the mask.”
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