To date there seems to be a lot of confusion in the market as to what mask is suitable or sufficient, does it have the right documentation, does it meet the right standards, who is legally responsible should someone get infected? Even with N95 or P2 masks when worn correctly, the filtering ability is better than the ordinary mask and medical mask. However, even if worn in full compliance, a 100% risk of infection or death cannot be eliminated. Clinical studies have demonstrated that fit-tested and non-fit-tested N95 masks demonstrated little difference in results. https://www.ncbi.nlm.nih.gov/pubmed/21477136
It has been stated that health departments and frontline persons are looking for “A P2 mask is one certified to Australian Standard AS/NZS 1716:2012 as a P2 mask.” or “We are seeking masks certified by the United States National Institute for Occupational Safety and Health (NIOSH) as N95 or greater.” Others have included the FFP2 under CE certification yet most have missed some important points in their attempts to qualify a legitimate manufacturer or understand how the manufacturing process works. China is not intentionally sending “fake” or low-quality products into the market, in fact, the government is trying to stop “sellers” from exporting random or low-quality products. China has some of the best if not world-leading manufacturing plants in the world.
In Australia, the health department has labelled the P2 and N95 masks as the same or similar, and in respect, it is, however, not all N95 or P2 masks are suitable or have been tested for use in health care settings. These are usually N95 surgical or FFP2 surgical where the resistance to penetration by blood has been tested according to ASTM protocols to be 120mm/hg or higher. It is interesting to note that there are several points of consideration that should be evaluated when reviewing a mask or respirator for use.
The testing facility needs to be accredited. This provides confidence in the laboratory approach to the testing protocols and processes while providing for easier accreditation in other governing countries. These facilities are usually recognized by the TGA and NATA. In China, the approved testing facilities are CNAS approved and or certified. CNAS is a partner of NATA and is recognized by the TGA.
Another point of consideration is the levels of protocols that the standards are typically testing. P2, FFP2 are commonly dust filtration masks and as such should not be used in healthcare situations without first testing for the resistance to blood penetration level. This is why a lot of P2 and N95 masks are not permitted for use in hospitals, general practice, and other allied health situations.
Is P2 compliant testing a requirement? Government legislation does not require that an imported mask be certified to the Australian standard if the mask is already approved to a recognized international standard. It has been a common question regarding TGA approval which is an incorrect approach to the role of the TGA. The TGA is a regulatory body that audit sponsors regarding the claims associated with their product and that there is sufficient evidence that is deemed acceptable. They do not approve if a product is suitable (a role for the health department or other such body), nor do they approve a mask or respirator prior to issuing a listing number. The question should be asked, “Are the claims associated with this product sufficiently evidenced for a TGA audit?”
Similarities in standards. Many are stating that FFP2 or P2 and N95 are the same than equally, KN95, and other such international standards should also be justifiably accepted. As yet, I have not had anyone demonstrate a reason why the GB2626-2006 should be rejected for being an acceptable standard as it is largely the same as the NIOSH standard and slightly higher than the Australian P2. So why the rejection?
With well-known brands suffering from supply shortages, there has become a need for countries and organizations to accept other standards that have typically not been reviewed in the past, leaving them in unfamiliar territory.
What is an N95, P2, or FFP2 respirator? It is a piece of protection equipment, designed to fit the face more tightly than the ordinary surgical mask, which has been tested to filter aerosol particles and other industrial pollutants effectively. The character “N” indicates that it can be used to protect non-oil suspended particles; 95 means that the filtration efficiency is greater than or equal to 95%, indicating that the respirator can block at least 95% of very small (0.3 micron level) test particles. FFP has a simpler acronym, “Filtering Face Piece” level 1, 2, or 3. At this point it is worth noting that N95 is a level one mask and does not compare filtration rate to that of a surgical mask 2 or 3, likewise, the filtration rate of dust masks (P or FFP) have lower filtration test requirements than surgical masks level 2 and 3. Does this mean that a surgical mask level 3 offers more protection than an N95? Unfortunately, out of the few studies comparing N95 masks to surgical masks, there is yet to be definitive conclusion however, N95 has demonstrated slightly better conclusions largely due to its design being more conforming to the face. https://www.ncbi.nlm.nih.gov/pubmed/20095070
What respirator or mask is suitable? Is the KN95 respirator a suitable replacement for the P2 or N95 mask? For industrial applications, the KN95 has demonstrated testing standards comparable to that of the P2, FFP2, or N95 however, for health applications, without blood penetration testing or testing against ASTM protocols, the mask is either unsuitable or classified as a level 1. Does this mean that all KN95 masks are suitable? The answer is no. There are differences in manufacturing quality and consistency, with manufacturers using lower grade materials or using whatever material is available due to ongoing supply shortages. In the past, companies have used local staff to conduct post-manufacturing audits to ensure consistency in product specifications or original test report samples. With a number of “new” or short term suppliers in the market, post-production audits are unlikely to occur resulting in questions associated with manufacturing consistency from sample to batch or from batch to batch. Who becomes responsible? Life Biotech, have reviewed some 700 manufacturers in China to ensure the highest quality for an affordable price while still offering the capacity of bulk supply. All manufacturers were audited and documentation reviewed and adjusted to suit the requirements of Australia. The KN95 masks have been tested to GB2626-2006 standards in CNAS approved centers with additional testing to CE and FDA standards. Further testing to ASTM protocols has been commissioned by Life Biotech to ensure that the KN95 masks are suitable for use in the healthcare network. It should be noted that certification processes and timelines can be lengthy including CE and FDA approvals, and given the circumstances often not permissible or achievable for many of the new manufacturers or previous manufacturers who have not previously had the need or requirement for international recognition.