A Current Affair – Pippa Bradshaw “Fake Masks”
The report was not researched but a plagiarized presentation of the original work by Liam Mannix and Kate Aubusson – an original substandard, poorly researched article. As A Current Affair, The Age, and The Financial Review are all Nine News outlets, it is not a surprise that the same level of reporting and the same level of limited understanding is employed universally across a network or collective company or A Current Affair is being used to give credibility to a previous report. Liam, after being corrected in his original research by Life Biotech’s expert team, is quoted in an email to Life Biotech stating “Thanks for all your help with this. I now know a lot more about masks than I ever imagined I would!”
Pippa Bradshaw’s position:
NIOSH or the USA standard is the only acceptable standard in Australia or that Australia should consider;
Australian standard P2 masks are not acceptable for use unless certified to USA standard;
Face Masks are determined suitable by their thickness rather than clinical evidence;
Spunbound material and Meltblown material thickness and texture are irrelevant elements of consideration;
Pulling against the welding (against manufacturing recommendations) is the best way to determine the quality of masks;
TGA is guilty of approving products for use in hospitals.
While these points demonstrated a low level of research, it culminated in the misrepresentation of the TGA and the limited allowance to permit the Federal government to purchase only products temporarily to bypass the full listing process. The TGA is not an approval body to evaluate the suitability of a product but rather a regulatory body which audits product claims against suitable and sufficient evidence. No surgical mask or respirator is “approved” by the TGA, they are only listed (hence the listing number) to assist the TGA in post-market auditing.
Points not considered yet important:
CDC makes the standing a positioning of >95% in conjunction with NIOSH or USA standards;
Australia takes the position of >95%, however, their own standard dictates >94%
CDC has lowered its positioning due to shortages of supply;
The European standard is acknowledged and supported by the CDC even while testing standards for the FFP2 mask are lower such as the BFE of >94%;
Only NIOSH has the standard requirement for head-mounted straps, not required under Australian and European standards;
The Australian Federal Health department has claimed it only accepts N95 and P2 masks as the KN95 masks are allegedly tested to an inferior standard – as per phone conversation with the head of the department;
Certified and tested to, are both applicable standards provided manufacturing under both options are consistent;
Meltblown filters are higher quality, more consistent in quality, fewer layers required to ensure effectiveness, limited raw material options available maintaining manufacturing quality and consistency, and thinner than the optional spunbound filters;
Spunbound filters are cheaper, a higher risk with quality concerns, multiple raw material options, and design flaw reduces efficacy requiring multiple layers to be effective, and are thick providing the misconception of effectiveness;
Welded straps are designed to be pulled with the welding not against. Tests have demonstrated tensile effectiveness when pulled with the welding but ineffective when pulled against;
Onsite Safety Australia are fit test experts who specialize in reusable masks with expertise in non-medical avenues;
Previous independent evaluations referenced by Pippa Bradshaw were retracted (post legal requests) by Liam Mannix as the testing facility was not independent and therefore Pippa shifted the focus to Onsite Safety Australia who orchestrated the testing through the “independent” facility;
GB2626:2006 standard is equal in caliber to that of the NIOSH standard with standards higher than the Australian AS/NZ1716:2012 which is based largely off the European EN 149:2009 standard.
Fake or counterfeit masks are one of two options:
Claim to be certified while using wrong certification documents, wrong batch numbers, or wrong notations in accordance with standard recommendations – need to be reported to the local authorities;
Claim to be tested or manufactured to a standard yet clinically proven to not meet the standard – should be reported to the local authorities.
Both options conclude in an element of deception or misleading the public which falls under the ACCC who would work with the TGA to investigate such claims.
Life Biotech maintains the following position:
All products are listed with the TGA;
All products are tested and manufactured under internal audited QA protocols;
Life Biotech KN95 masks maintain multiple test reports to GB2626:2006, EN 149:2009, NIOSH N95, and ASTM standards yet claim only KN95 standard with the addition of level 3 surgical under ASTM.
Life Biotech is working with leading Australian and European certifying bodies to finalise additional certification.
Life Biotech KN95 masks have been independently tested and proven to have >95% BFE.
Life Biotech’s research and development team of medical professionals, stand behind all their products that have been carefully procured under their extensive experience, to ensure suitability not only to the individual but to the medical profession as a whole.