In the realm of global health crises, respiratory personal protective equipment (PPE) has always been at the forefront of defense. Over the past two decades, the world has encountered several significant outbreaks, each posing unique challenges to the availability, accessibility, and effectiveness of respirator PPE.
From the 2003 SARS epidemic to the 2019 COVID-19 pandemic, the journey has been fraught with obstacles and lessons learned.Let's delve into the challenges and key analyses and responses to these pivotal moments in public health history from the perspective of developing a true standard for respiratory protection.
2003 SARS:
The Severe Acute Respiratory Syndrome (SARS) outbreak in 2003 was a wake-up call for the inadequacies in respiratory PPE preparedness. The sudden emergence of a highly contagious respiratory virus caught many off guard, leading to major issues with availability, distribution, standardized guidelines for respirator use, and fit testing, leaving frontline workers vulnerable to infection.
2006 IOM Report
In 2006, the National Personal Protective Technology Laboratory (NPPTL) at the National Institute for Occupational Safety and Health (NIOSH) asked the Institute of Medicine (IOM) to examine issues regarding PPE for healthcare workers. The study request was strongly influenced by the SARS outbreak of a few years earlier. Included in the charge to the IOM Committee on Personal Protective Equipment was to examine the establishment of standards and the risk assessment issues specific to PPE for healthcare workers in the event of a pandemic influenza in the future.
2008 Project B.R.E.A.T.H.E
In 2008 Project BREATHE (Better Respiratory Equipment using Advanced Technologies for Health Care Employees) was initiated by the U.S. Dapartment of Veterans Affairs (VA) and was co-chaired by the VA and CDC with representatives from multiple federal departments. Its initial focus was on developing a detailed set of performance characteristics for health care respirators. Its 2009 report listed 28 consensus recommendations for detailed performance characteristics of an ideal health care respirator and prioritized those objectives. The call for a new standard of care for respiratory protection was officially unveiled.
Initially designed for industrial workers, N95 respirators gained prominence during the outbreak of severe acute respiratory syndrome (SARS) in 2003. The shortage of personal protective equipment (PPE), combined with their high filtration efficiency highlighted the importance of N95 respirators in preventing infectious disease transmission.
2009 H1N1
The H1N1 influenza pandemic of 2009, also known as swine flu, further emphasized the vulnerabilities in respiratory PPE readiness clearly identified previously in response to SARS. While the virus spread rapidly, the response from manufacturers and regulatory bodies was often sluggish. The results were similar to the SARS outbreak, only magnified. Supply chain bottlenecks resulted in prolonged shortages of N95 respirators. Additionally, issues with counterfeit and substandard respirators surfaced, raising concerns about their efficacy and safety. The crisis underscored the critical need for improved surveillance, regulation, and collaboration across sectors to ensure the availability of reliable respiratory PPE during emergencies.
2010 IOM Report, Update
In 2009 in respose to H1N1, similar to 2006 following SARS (H5N1), the National Personal Protective Technology Laboratory (NPPTL) at the National Institute for Occupational Safety and Health (NIOSH) asked the IOM to conduct a study. The charge of this study was to provide an update on the progress of research regarding PPE for healthcare personnel relative to pandemic influenza, and identify future directions. This action further emphasized the shortcomings and inadequacies of the N95 as a desirable standard for respiratory protection.
2014 Ebola Outbreak
The Ebola outbreak in West Africa in 2014 posed unique challenges to respiratory PPE due to the nature of the virus transmission. While Ebola primarily spreads through direct contact with bodily fluids, aerosol-generating procedures in healthcare settings necessitated the use of respiratory protection. However, the specialized PPE required for Ebola, such as full-body suits and powered air-purifying respirators (PAPRs), faced significant supply constraints. The limited availability of such equipment, coupled with the complexities of most of their donning and doffing protocols, put healthcare workers at risk of exposure. Furthermore, inadequate training and infrastructure in resource-limited settings compounded the challenges, emphasizing the need for tailored solutions and capacity building in at-risk regions.
2014 IOM Workshop and Report, PAPRS in Healthcare
In mid-2014, the National Personal Protective Technology Laboratory (NPPTL) requested the IOM to conduct a workshop to explore the use and effectiveness of Powered Air Purifying Respirators for Health Care situations. Charges to the committee included delving into the present landscape of practices and research concerning PAPRs, potential updates to enhance PAPR performance, scrutinize the merits and demerits of existing standards, and the potential introduction of a new standard.The need to look beyond the mask respirator, the N95, was further emphasized.
2019 COVID-19 Pandemic
The emergence of COVID-19, following the series of global health crises including SARS, H1N1, and Ebola, underscored the urgent need for improved respiratory protection measures. COVID-19 has highlighted the enormity of the threat posed by respiratory viruses and the devastating impact they can have on public health, economies, and societies worldwide. The rapid spread of COVID-19 exposed significant vulnerabilities in existing respiratory protection strategies.
Covid-19 was perhaps a final wakeup call for those still doubting the level of priroity needed for respiratory protection to prevent and mitigate the transmission of respiratory viruses through a more safe, comfortable, convenient, and affordable respiratory PPE. Much larger scale implementation of a more advanced respiratory protection technology was clearly needed to better safeguard public health and mitigate the impact of ongoing respiratory virus threats.
2020 NIOSH New PAPR Class, PAPR100
As a direct reaction to the monumental pressures brought about by the impact of Covid-19 on our healthcare system, in April 2020, the Department of Health and Human Services (HHS) announced that a new class of respirators, PAPR100, was being established that “may be better suited to the needs of workers in the healthcare and public safety sectors…”. This new class for Powered Air Purifying Respirators paved the way for manufacturers to take better advantage of more state-of-the-art technologies and designs to better meet the requirements for a new standard in respiratory protection.
The trials posed to respiratory PPE by the 2003 SARS epidemic, 2007 H1N1 pandemic, 2014 Ebola outbreak, and 2019 COVID-19 pandemic have been extensive and consequential. Each crisis has laid bare deficiencies in our readiness and reactive measures, underscoring the urgent call for updated PPE standards and a redefined standard of care in respiratory protection.
In our forthcoming edition, we will delve deeper into how these pivotal events have laid the foundation for the development of a new standard for the most suitable respirator, prioritizing factors such as safety, comfort, and affordability to better safeguard individuals in times of crisis.