Health care professionals, including emergency response personnel, face unique occupational health and safety challenges, one of which is exposure to uncontrolled airborne infectious particles. To protect themselves, these professionals rely heavily on N95 filtering facepiece respirators (FFRs) which, when used appropriately, provide a known level of respiratory protection.
The National Institute for Occupational Safety and Health (NIOSH) is mandated to certify respirators used in the United States through a set of tests that includes filtration performance assessment (42 CFR Part 84). The Food and Drug Administration (FDA) designates a subset of NIOSH-certified respirators as “surgical N95 respirators” through a clearance process that requires manufacturers to demonstrate that the respirators meet certain standards for fluid resistance, flammability, and biocompatibility (FDA, 2004). Currently, efforts are underway by the two agencies to streamline the regulatory oversight and approval processes, and this commentary offers support for those efforts. A recent National Academies workshop examined the scientific issues critical to these efforts (NASEM, 2017).
While health care organizations are not required to use surgical N95s, there is a common misperception that surgical N95s provide health care workers with an increased level of protection over standard N95s. This misperception places workers, patients, the health care system, and national security at substantial risk. First, surgical N95s do not provide protection from fluids and thermal exposures; therefore, these additional tests for fluid resistance and flammability add cost without benefit and provide a false sense of security. Second, the overregulation involved with N95s has caused supply chain systems to become unnecessarily expensive, overly complicated, and vulnerable to shortages during pandemics. This impairs budgets, ordering processes, education, and national defense.