MEDICAL SUPPLY CHAIN & COVID-19 APRIL 6, 2020N95 Masks: Important Questions Answered
As Covid-19 ravages the globe, PPE (Protective Medical Equipment) is in high demand and short supply. The news has focused issues around access to the N95 masks which are necessary for medical professionals on the front lines. Aric Gray, CEO of Gray Ghost Solutions, and an expert in medical risk management, did some investigation and here is what you need to know.
What is the meaning of the “95” in N95?
The “95” means they block non-oil-based particulate down to 0.3um at an efficiency rate of 95%. With that, the N95 is approved by the National Institute for Occupational Safety and Health (NIOSH). There are specific guidelines from NIOSH on how these masks must be manufactured in order to be considered and to meet compliance standards.
Who produces N95 and KN95 Masks?
There are 10 factories in China that are producing N95 and KN95 masks. What is difference between the N95 and the KN95 Mask? The KN95 series is the Chinese comparable that still blocks non-oil-based particulate down to 0.3um at 95% efficiency. However, they have not been certified by NIOSH (there is a cost). On April 3, 2020 the FDA issued the following guidance and clarification that approved the use of KN95 masks as a viable alternative to N95 masks during the shortage. Under a new emergency use authorization, the FDA said that the KN95 devices could be imported into the country and are “eligible for authorization.” It stopped short of giving blanket approval for all of the KN95 respirators which are certified under Chinese rather than US health standards — noting that it would only approve use of those that meet certain criteria, “including evidence demonstrating that the respirator is authentic.” As of Friday, April 3rd, the FDA said that it had so far authorized one specific model of KN95 mask, manufactured by BYD Precision Manufacture Co., a Shenzen-based company.
I’m treating Covid-19 patients, how can I be sure the mask I buy isn’t a counterfeit?
Each factory that is approved to sell N95 and KN95 materials is selling via approved distributors. Goods from non-approved distributors may arrive with blank spaces or whited out sections on certificates of authenticity or conformity letters. These are being produced by a factory that is NOT being held to the standards necessary to guarantee the established protection standard.
In addition, with approved, legitimate products, due to the very high demand, payment is required in full prior to delivery. Any vendors/distributors offering alternate payment terms should be considered highly suspect. Whenever possible, you should work with known distributors and vendors.
Finally, Gray Ghost Solutions checked in with Mark Waddleton, Innovative supply chain leader, to share his thoughts on the disruption of medical supply chain.
Companies need to consider the implications of concentrating the US medical supply chain, both equipment and active drug ingredients, outside of the United States. Outsourcing this supply chain introduces concerns regarding oversight and quality. What mechanisms are in place to protect us from bad actors who may alter our products? It’s not just China. When Puerto Rico was hit with hurricane Maria, we were all out of IV bags. This is due to poor risk management. You can’t have all your supply in one location. The drive for lower costs has limits. The supply and demand issues are creating price wars, with products going to the highest bidder, cash up front. This correction will continue to bite the taxpayer in the pocket.