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EXHIBIT 2
Case 1:20-cv-02949-LAP Document 16-2 Filed 04/24/20 Page 1 of 6
Coronavirus Disease 2019 (COVID-19)
Strategies for Optimizing the Supply of N95
Respirators
Related Pages
N95 Respirator Summary
Stockpiled N95 Respirators
Updated April 2, 2020
Summary of Updates as of April 2, 2020:
• Conventional capacity strategies
◦Edited the section on use of airborne infection isolation rooms (AIIRs) for aerosol-generating procedures
performed on patients with conÒrmed or suspected COVID-19 patients.
◦Added language on FDA’s Emergency Use Authorization (EUA) authorizing the use of certain NIOSH-approved
respirator models in healthcare settings to the section on N95 alternatives.
• Contingency capacity strategies
◦Added a section on temporarily suspending annual Òt testing following updated guidance from OSHA
◦Added more details in the extended use section.
• Crisis capacity strategies
◦Added language on the use of respirators approved under international standards and updated the tables.
◦Combined sections on limited re-use of N95 respirators for tuberculosis and then COVID-19 patients. Added
more details surrounding limited re-use.
Audience: These considerations are intended for use by federal, state, and local public health oÕcials, respiratory
protection program managers, leaders in occupational health services and infection prevention and control programs, and
other leaders in healthcare settings who are responsible for developing and implementing policies and procedures for
preventing pathogen transmission in healthcare settings.
Purpose: This document o×ers a series of strategies or options to optimize supplies of disposable N95 Òltering facepiece
respirators (commonly called “N95 respirators”) in healthcare settings when there is limited supply. It does not address
other aspects of pandemic planning; for those, healthcare facilities can refer to COVID-19 preparedness plans. The
strategies are also listed in order of priority and preference in the Checklist for Healthcare Facilities: Strategies for
Optimizing the Supply of N95 Respirators during the COVID-19 Response in an easy-to-use format for healthcare facilities.
Controlling exposures to
occupational hazards is a
fundamental way to protect
Case 1:20-cv-02949-LAP Document 16-2 Filed 04/24/20 Page 2 of 6
personnel. Conventionally, a
hierarchy has been used to
achieve feasible and e×ective
controls. Multiple control
strategies can be implemented
concurrently and or sequentially.
This hierarchy can be
represented as follows:
• Elimination
• Substitution
• Engineering controls
• Administrative controls
• Personal protective
equipment (PPE)
To prevent infectious disease
transmission, elimination
(physically removing the hazard) and substitution (replacing the hazard) are not typically options for healthcare settings.
However, exposures to transmissible respiratory pathogens in healthcare facilities can often be reduced or possibly
avoided through engineering and administrative controls and PPE. Prompt detection and e×ective triage and isolation of
potentially infectious patients are essential to prevent unnecessary exposures among patients, healthcare personnel
(HCP), and visitors at the facility.
N95 respirators are the PPE most often used to control exposures to infections transmitted via the airborne route, though
their e×ectiveness is highly dependent upon proper Òt and use. The optimal way to prevent airborne transmission is to
use a combination of interventions from across the hierarchy of controls, not just PPE alone. Applying a combination of
controls can provide an additional degree of protection, even if one intervention fails or is not available.
Respirators, when required to protect HCP from airborne contaminants such as some infectious agents, must be used in
the context of a comprehensive, written respiratory protection program that meets the requirements of OSHA’s
Respiratory Protection standard
. The program should include medical evaluations, training, and Òt testing.
Surge capacity refers to the ability to manage a sudden, unexpected increase in patient volume that would otherwise
severely challenge or exceed the present capacity of a facility. While there are no commonly accepted measurements or
triggers to distinguish surge capacity from daily patient care capacity, surge capacity is a useful framework to approach a
decreased supply of N95 respirators during the COVID-19 response. Three general strata have been used to describe
surge capacity and can be used to prioritize measures to conserve N95 respirator supplies along the continuum of care.
• Conventional capacity: measures consist of providing patient care without any change in daily contemporary
practices. This set of measures, consisting of engineering, administrative, and PPE controls should already be
implemented in general infection prevention and control plans in healthcare settings.
• Contingency capacity: measures may change daily standard practices but may not have any signiÒcant impact on the
care delivered to the patient or the safety of HCP. These practices may be used temporarily during periods of
expected N95 respirator shortages.
• Crisis capacity: strategies that are not commensurate with U.S. standards of care. These measures, or a combination
of these measures, may need to be considered during periods of known N95 respirator shortages.
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Conventional Capacity Strategies (should be incorporated into everyday practices)
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Engineering Controls
Engineering controls reduce exposures for HCP by placing a barrier between the hazard and the HCP. Engineering
controls can be very e×ective as part of a suite of strategies to protect HCP without placing primary responsibility of
implementation on them (i.e., they function without HCP having to take an action).
Selective use of airborne infection isolation rooms
Use of physical barriers
Properly maintained ventilation systems
Administrative Controls
Administrative controls are employer-dictated work practices and policies that reduce or prevent hazardous
exposures. Their e×ectiveness depends on employer commitment and HCP acceptance and consistent use of the
strategies.
Limit number of patients going to hospital or outpatient settings
Telemedicine
Exclude all HCP not directly involved in patient care
Limit face-to-face HCP encounters with patient
Exclude visitors to patients with known or suspected COVID-19
Source control
Cohorting patients
Cohorting HCP
Training on indications for use of N95 respirators
Training on use of N95 respirators
Just-in-time Òt testing
Limiting respirators during training
Qualitative Òt testing
Personal Protective Equipment: Respiratory Protection
While engineering and administrative controls should be considered Òrst when selecting controls, the use of personal
protective equipment (PPE) should also be part of a suite of strategies used to protect personnel. Proper use of
respiratory protection by HCP requires a comprehensive program (including medical clearance, training, and Òt
testing) that complies with OSHA’s Respiratory Protection Standard
and a high level of HCP involvement and
commitment. The program should also include provisions for the cleaning, disinfecting, inspection, repair, and storage
of respirators used by HCP on the job according to manufacturer’s instructions. Proper storage conditions can
Case 1:20-cv-02949-LAP Document 16-2 Filed 04/24/20 Page 4 of 6
maximize shelf life of respirators. The following strategies in this section are traditionally used by some healthcare
systems. If not already implemented, these strategies can be considered by healthcare settings in the face of a
potential N95 respirator shortage before implementing the contingency strategies that are listed further below.
N95 respirators
Use of alternatives to N95 respirators
Contingency Capacity Strategies (during expected shortages)
Decisions to implement contingency are based upon these assumptions:
1. Facilities understand their current N95 respirator inventory and supply chain
2. Facilities understand their N95 respirator utilization rate
3. Facilities are in communication with local healthcare coalitions, federal, state, and local public health partners (e.g.,
public health emergency preparedness and response sta×) regarding identiÒcation of additional supplies
4. Facilities have already implemented conventional capacity measures
5. Facilities have provided HCP with required education and training, including having them demonstrate competency
with donning and doÕng, with any PPE ensemble that is used to perform job responsibilities, such as provision of
patient care
Administrative Controls
Decrease length of hospital stay for medically stable patients with COVID-19
Temporarily suspend annual Òt testing
Personal Protective Equipment: Respiratory Protection
Use of N95 respirators beyond the manufacturer-designated shelf life for training and Òt testing
Extended use of N95 respirators
Crisis Capacity Strategies (during known shortages)
Decisions to implement crisis strategies are based upon these assumptions:
1. Facilities understand their current N95 respirator inventory and supply chain
2. Facilities understand their N95 respirator utilization rate
3. Facilities are in communication with local healthcare coalitions, federal, state, and local public health partners (e.g.,
public health emergency preparedness and response sta×) regarding identiÒcation of additional supplies
4. Facilities have already implemented contingency capacity measures
5. Facilities have provided HCP with required education and training, including having them demonstrate competency
with donning and doÕng, with any PPE ensemble that is used to perform job responsibilities, such as provision of
patient care
Case 1:20-cv-02949-LAP Document 16-2 Filed 04/24/20 Page 5 of 6
When N95 Supplies are Running Low
Personal Protective Equipment: Respiratory Protection and Facemasks
Use of respirators beyond the manufacturer-designated shelf life for healthcare delivery
Use of respirators approved under standards used in other countries that are similar to NIOSH-approved
respirators
Limited re-use of N95 respirators
Use of additional respirators beyond the manufacturer-designated shelf life for healthcare delivery that have
not been evaluated by NIOSH
Prioritize the use of N95 respirators and facemasks by activity type
When No Respirators are Left
Administrative Controls
Exclude HCP at higher risk for severe illness from COVID-19 from contact with known or suspected COVID-19
patients
Designate convalescent HCP for provision of care to known or suspected COVID-19 patients
Engineering Controls
Expedient patient isolation rooms for risk-reduction
Ventilated Headboards
References
•
Hick JL, Barbera JA, Kelen GD. ReÒning surge capacity: conventional, contingency, and crisis capacity. Disaster Med
Public Health Prep. 2009;3(2 Suppl): S59-67.
•
Bergman, MS, Viscusi DJ, Zhuang Z, Palmiero AJ, Powell JB, Sha×er RE. Impact of multiple consecutive donnings on
Òltering facepiece respirator Òt. Am J Infect Control. 2012;40(4): 375-380.
•
van Doremalen N, Bushmaker T, Morris DH. Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-
CoV-1. N Engl J Med. 2020 Mar 17.
•
Dato, VM, Hostler, D, and Hahn, ME. Simple Respiratory Mask, Emerg Infect Dis. 2006; 12(6): 1033–1034
•
Rengasamy S, Eimer B, and Sha×er R. Simple respiratory protection-evaluation of the Òltration performance of cloth
masks and common fabric materials against 20-1000 nm size particles, Ann Occup Hyg.
2010;54(7):789-98.
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Page last reviewed: April 16, 2020
Content source: National Center for Immunization and Respiratory Diseases (NCIRD), Division of Viral Diseases
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