Why an Association of US Manufacturers?

In 2007, Federal health officials were concerned about the potential for a pandemic (global) outbreak of the H5N1 virus (Bird Flu). Risk managers from large and small commercial enterprises were creating pandemic preparedness plans that included infection control practices, supply acquisition and stockpiling (masks, respirators, hand sanitizers, thermometers, etc.) and -- in the face of a 60% mortality rate associated with the H5N1 virus -- succession planning.

In November of 2007, the office of the Assistant Secretary of Preparedness and Emergency Response (ASPR), an agency under the Department of Health and Human Services (HHS), visited the very few U.S. mask and respirator manufacturers that remain, to discuss their concerns of severe shortages of masks and respirators in the event of a pandemic event. This “Discussion with Respiratory Protection Device Manufacturers on Preparedness and Surge Capacity” is what they presented.

Key concerns included:

90% of surgical masks are manufactured outside of the U.S., leaving U.S. access to these countermeasures at risk during a global infectious disease threat.
The Strategic National Stockpile only contained 2% and .2% of the required number of N95 respirators and surgical masks, respectively.
Global commercial surge capacity is insufficient to meet U.S. demands.

Prestige Ameritech (Dallas, TX), Crosstex International (Hauppauge, NY), Louis M. Gerson Co., Inc (Middleboro, MA) - which, combined, comprise an overwhelming majority of U.S. mask manufacturing capacity - were included in those discussions. Each company, individually, responded to government concerns by offering their commercial insights and resources to help address the issue by participating in meetings, responding to official solicitations for research and development, and sharing detailed manufacturing capacity and surge capabilities. During the 2009 H1N1 Influenza outbreak each of these companies participated in meetings held by the office of the Strategic National Stockpile (SNS) with anticipation that the woefully inadequate stockpile of masks and respirators would be augmented -- it wasn’t. Instead, each manufacturer supplied weekly manufacturing production and distribution data to provide a dashboard by which health officials could prioritize and potentially ration mask supplies. As the H1N1 virus threat faded with far less impact as feared, government efforts were lauded as “a success” with no resolution to the inadequate U.S. mask and respirator manufacturing base required to respond to infectious disease threats.

Today, eleven years and several viral threats after being approached by HHS with their concern, Prestige Ameritech, Crosstex, Gerson, and Medicom have come together to raise awareness of this critical gap in U.S. preparedness to defend against infectious disease threats.