Abstract
In mid-March, healthcare workers on social media and elsewhere sounded the alarm: #GetMePPE. This public plea was in response to shortages of personal protective equipment (PPE) at many hospitals, coinciding with surges in hospital emergency department and intensive care unit capacity due to COVID-19. Within days, the Strategic National Stockpile of PPE was depleted; states, localities, and hospitals had to act urgently to procure PPE and reuse or extend the use of existing PPE. A true cottage industry emerged, consisting of a network of designers, makers, engineers, and healthcare workers focused on designing and producing high-quality PPE to address urgent needs. Devices such as face shields were designed to protect healthcare workers from mucous membrane exposure. As N95 respirator masks became scarce, techniques for sterilization were developed, as were methods for ensuring a qualitative fit after multiple rounds of sterilization. Alternatives to N95 masks, known as powered air purifying respirators (PAPRs), were developed from scratch. Finally, ventilators and ventilator parts were produced in an effort to maximize resources during peak waves of COVID-19. The FDA released a series of guidance documents, accompanied by permissive emergency use authorizations (EUAs), to address the manufacture and use of PPE in healthcare settings. This article reviews actions taken by the FDA in response to the PPE shortage, evaluates the impact of local manufacturing of PPE in one U.S. state (Massachusetts), and offers solutions for federal and state policymakers to ensure robust state and community-level responses to shortages in the future.This paper was prepared as part of Assessing Legal Responses to COVID-19, a comprehensive report published by Public Health Law Watch in partnership with the de Beaumont Foundation and the American Public Health Association.
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