Update on KN95 Masks: Because of the better price point for non-NIOSH approved, KN95 masks, there is still strong interest in these respirators. The challenge is to make sure you avoid low quality mask products. If you don’t want to research the testing results for each mask company yourself, the next easiest way is to purchase from companies listed on Appendix A Respirator Assessment Results of the FDA’s Emergency Use Authorization updated on June 6, 2020. Make sure you work with your supplier to ensure that the masks you are purchasing are on this list or they can share the testing results with you directly.
From May 5, 2020. At this point, most everyone understands that Personal Protective Equipment (PPE) is critical to containing the spread of the COVID-19 pandemic. This reality has created an exploding world-wide demand for these supplies, straining existing supply chains over the last two months to produce and deliver PPE.
To address these demands, existing medical suppliers attempted to expand sales to counties, states, and private companies for non-medical uses, i.e. civilian staff and personal. At the same time, new suppliers worked to fill the gap in needed supplies to all customers, medical and non-medical alike. In March, we were stunned to see millions of PPE masks in American storage facilities being sold in the span of hours for exorbitantly high prices.
Amidst this chaos, inappropriate PPE began flowing into hospitals, endangering the lives of our dedicated medical staff. County, state, and business personnel didn't know what PPE they are getting and frequently had shipments lost in transit (even after putting down significant deposits). Many suppliers raised concerned about what they perceive as an ever-changing Export-Import process and the seizure of their shipments.
In early April 2020, our buyer in China reported that the Chinese government was cracking down on manufacturers who are producing sub-quality PPE. The Chinese government reduced the number of mask manufacturers from around 35,000 to 1,900 on the Chinese National Medical Products export list. Then in mid-April, that number was again reduced by an additional 35% while each factory waited for their required physical inspection, ensuring compliance with Chinese export regulations. The challenge for buyers was to place orders only with the few approved manufacturers or quickly change to another manufacturer as the names on the Chinese export list changed. All of this drove, not only the costs, but also the minimum order quantities (MOQ), through the roof in March-April 2020.
In the US, the Federal Drug Administration, Customs and Border Protection, and other federal agencies had the difficult task of balancing safety in both medical and non-medical environments with the need to get the right PPE to the right people at the right time. FDA held weekly update meetings for transportation specialists. They created a number of new product categories to help import appropriate PPE into the US. To date, they still remain hard at work, rapidly updating the FDA registration status of Chinese manufacturers and providing emergency status to products that are not yet registered in the US.
The result of these actions has been an improvement in the quality and quantity of PPE coming into the US. On the downside, many shipments, paid for by American companies and governmental entities, still remain stranded in China. However, what most of us hear (secondhand) is the US Federal personnel seizing PPE supplies. From our conversations with numerous Customs Officers, it has become clear, these seizures are due to lack of appropriate documentation and use, and/or even counterfeit representation. We should note that these US seizures appear to be focused on compliance with product registration as a means to support the safety of the American public, not on reallocation of purchased supplies.
While in the long run, these actions by both the Chinese and US governments will help ensure the overall quality of Chinese PPE imports, they have significantly impacted the existing supply as overall demand continues to increase. It goes without saying that we are in a highly disruptive time, and obtaining the very things that we need to protect us from COVID-19 is still a murky process.
For almost 10 years, NVA250 has specialized in a consulting practice that links complex information with critically needed solutions. As a bit of a fluke, NVA250 was tasked with bringing PPE into Washoe Co Nevada in March-April of 2020; some of the most disruptive times in the import of Chinese PPE. As an importer and supplier, everyone at NVA250 had to scramble; continuously working with our stakeholders to make sure that the orders could be filled and supplies received. While processing shipments in March and April were hard on all of us, we were able to successfully import and deliver PPE from China into Nevada and Oregon, learning a great deal about what previously worked, what currently works, and what most likely will work in the future.
From our experiences with a number of international supply chain entities, we have continued to define and implement an effective process for import of Chinese PPE. Here are some of the critical elements we found to ensuring successful importation of PPE from China.
As Chinese and US regulations on PPE begin to stabilize, NVA250 will continue to publish best import practices for Chinese PPE into the US.
We would like to thank Washoe County Commissioner Bob Lucey and his wisdom in understanding the need to get these products to Washoe County as well as County Manager Eric Brown and Comptroller Kathy Hill for their patience as we developed our import process. We especially like to thank Robert Arroyo, Port Director for US Customs and Border Protection, Reno-Tahoe International Airport, and the Federal Drug Administration, Las Vegas Office for their expertise and help in creating order and structure to a chaotic PPE import process. We would also like to thank Max Myers, Talos Holdings and Will Dalton, Bender International for their support, insight, and donated time through the last months. We could not have done this without the many local, national, and international folks who helped us better understand and define our import process. There is a lot of good will out there. Now is the time to tap into it and help make a difference!