Interim Guidance for Conserving and Extending Filtering Facepiece Respirator Supply in Non-Healthcare Sectors

Audience: This steering is meant to be used throughout the coronavirus illness 2019 (COVID-19) public well being emergency by federal, state, and native public well being officers, respiratory safety program managers, leaders in occupational well being providers and industrial hygiene packages, and different leaders who’re liable for creating and implementing insurance policies and procedures for stopping occupational exposures in non-healthcare worksites.

Purpose: This doc gives methods to preserve, lengthen, and reply to shortages within the provide of NIOSH-approved filtering facepiece respirators (FFRs) utilized in non-healthcare worksites corresponding to manufacturing and development. NIOSH-approved FFRs defend customers by filtering particles out of the air the consumer is respiration and embrace a number of lessons of filters, together with N95s.

The following methods apply the ideas of the hierarchy of controls and are supposed to help employers in deciding on methods to regulate office exposures throughout instances of identified provide shortages attributable to the COVID-19 pandemic. Strategies 1 and a couple of reinforce employer necessities for the continual analysis and implementation of conventional hazard management practices corresponding to elimination, substitution, engineering and administration controls. Other methods described herein embrace sure allowances corresponding to use of FFRs past the manufacturer-designated shelf life to be included into apply solely throughout instances of provide shortages throughout the COVID-19 public well being emergency.

A secondary goal is to cut back the demand for FFRs normally trade settings throughout the COVID-19 response in order that (1) FFR producers and distributors can maximize provides to healthcare settings and (2) normal trade worksites can consider if any extra inventories they might maintain are appropriate for redistributing (e.g., promoting, donating) to healthcare settings. Employers ought to contemplate redistribution of extra inventories provided that ample publicity controls for his or her staff are carried out. For steering to forestall office exposures to acute respiratory sicknesses, together with COVID-19, please see CDC’s Interim Guidance for Businesses and Employers.

Background

The increasing outbreak of COVID-19 within the United States has created an awesome demand for private protecting tools (PPE), together with NIOSH-approved FFRs, in healthcare services throughout the nation. Additionally, the provision chains of PPE from manufacturing nations have been considerably disrupted attributable to native COVID-19 unfold and demand. Because of this enhance in demand and reduce in provide, CDC has offered guidance to healthcare settings for strategies to optimize their supply of N95 respirators. This steering describes surge capability for healthcare services offering care in typical, contingency, and disaster conditions. The choices to implement measures for healthcare services in contingency and disaster conditions are primarily based, partially, on the provision of N95 respirators, particularly, and different kinds of respirators, normally.

In recognition of the demand for FFRs within the healthcare setting and the precedence to guard healthcare staff who’re the employees at highest threat for COVID-19, the U.S. Food and Drug Administration has issued two emergency use authorizationsexternal icon to permit FFRs not sometimes worn in healthcare settings to be worn. This could cut back the provision of those FFRs for different worksites.

Infographic: Hierarchy if Controls. Chart displays Most effective at top, and Least effective at the bottom: Elimination-Physically remove the hazard, Substitution-Replace the hazard, Engineering Controls-Isolate people from the hazard, Administrative Controls-Change the way people work, PPE-Protect the worker with Personal Protective Equipment.

Users of NIOSH-approved FFRs in non-healthcare settings ought to develop and implement methods to preserve and lengthen their present inventory of respirator provides whereas defending their staff throughout the COVID-19 pandemic. Employers ought to implement various controls to cut back, as a lot as potential, their reliance on PPE, notably FFRs. Conventionally, a hierarchy of controls has been used to supply possible and efficient controls to guard staff. Multiple management methods might be carried out concurrently and/or sequentially. This hierarchy might be described as follows:

  • Elimination
  • Substitution
  • Engineering controls
  • Administrative controls
  • Personal protecting tools (PPE)

Elimination and Substitution

Employers ought to consider work duties and processes to establish these actions or processes the place the elimination or substitution of hazards could also be carried out. While the best at controlling hazards, these could be the most tough to implement in current processes, notably throughout instances of nationwide or native emergencies.

Engineering Controls

Engineering controls cut back staff’ exposures by inserting a barrier between the hazard and the employee or eradicating the hazard on the supply. While the preliminary value of engineering controls might be larger than the price of administrative controls or PPE, engineering controls usually present a price financial savings over the long term and may remove the necessity for respirators if correctly designed, carried out, and maintained. Examples for consideration consists of:

  • Local exhaust air flow
  • Wet strategies (when water is sprayed on a dusty floor or when a cloth is blended with water to forestall aerosolization)
  • Glove bins, cupboards, or different enclosures for isolation of the hazard

Administrative Controls

Administrative controls are used with current processes to restrict or forestall a hazard by altering the way in which folks work. Examples embrace:

  • Job rotation during which staff change job duties or areas to cut back their exposures and the should be in respiratory safety
  • Establishing insurance policies and implementing procedures limiting the period of time that a person employee can work on a selected job job or in areas with excessive exposures
  • Training staff on the hazards and controls accessible to cut back exposures
  • Installing warning labels and indicators to remind staff to steer clear of hazardous job duties or areas

Personal Protective Equipment

While engineering and administrative controls needs to be thought of first when implementing controls, PPE might be a part of a set of methods used to guard staff. PPE consists of respirators, protecting gloves, protecting eyewear and face shields, and a wide range of different protecting gear. PPE is regularly used with current processes the place hazards aren’t notably well-controlled. This technique for shielding staff is usually much less efficient than different measures because of the reliance on the consumer to placed on, use, and take off the PPE accurately and the potential for PPE breaches. Additionally, correct use of respiratory safety requires a complete program (together with medical clearance, coaching, and match testing) that complies with OSHA’s Respiratory Protection Standardexternal icon.

In instances of excessive demand and low provide of PPE because of the COVID-19 pandemic, non-healthcare sector employers ought to consider present work practices and management methods to create a strategic publicity prevention and management plan to proceed to guard staff. As a part of such a plan, methods for employers to think about are prioritized beneath. These measures are really useful to preserve and lengthen their FFR provide and to answer shortages of manufacturer-supplied FFRs throughout the COVID-19 pandemic. The Occupational Safety and Health Administration (OSHA) has additionally offered guidanceexternal icon on many of those measures associated to their enforcement of the Respiratory Protection Standard, 29 CFR 1910.134external icon, and sure different well being requirements, with regard to produce shortages of disposable N95 FFRs.

The following measures emphasize engineering and administrative controls to implement for publicity prevention and management plans and to cut back reliance on FFRs

  1. Evaluate and execute long-term methods for the elimination and substitution of hazards and the implementation of engineering controls for processes during which FFRs are at present required.
    1. NIOSH engineering management methods are outlined for a wide range of industries and hazards on-line at: https://www.cdc.gov/niosh/engcontrols/default.html
    2. Industry- and process-specific management methods are detailed by the British Health and Safety Executive as part of the Control of Substances Hazardous to Health (COSHH) Essentials and can be found on-line at: https://www.hse.gov.uk/pubns/guidance/index.htmexternal icon
  2. Implement instantly possible engineering and administrative controls to remove or reduce exposures for which employers are at present requiring using FFRs. These controls needs to be routinely evaluated to make sure they proceed to regulate exposures to acceptable ranges and embrace:
    1. Moving work to inside ventilated enclosures corresponding to fume hoods and organic security cupboards.
    2. Modifying the processes to cut back exposures, corresponding to placing dry supplies right into a moist slurry to cut back the potential for publicity.
    3. Postponing non-essential work requiring using FFRs.
    4. Limiting the variety of staff needing respirators to the minimal required to soundly full the duty.
    5. Arranging work/manufacturing schedules to cut back the variety of respirators wanted.

The following measures could require adjustments in every day customary respiratory safety practices however could not have important impression and could also be used briefly during times of anticipated FFR shortages

  1. Use qualitative methods to fit test workers for FFRsexternal icon. Quantitative match check strategies require consuming FFRs throughout the match check, whereas qualitative don’t. As such, qualitative match testing strategies would preserve FFRs for use for controlling office exposures.
  2. Transition respiratory safety packages to make use of NIOSH-approved alternate options to FFRs, the place possible. NIOSH maintains a searchable, on-line model of the certified equipment list figuring out all NIOSH-approved respirators. Alternatives to FFRs, so as of desire to implement at non-healthcare worksites with a view to protect as many N95s as potential for healthcare settings, embrace:
    1. Elastomeric half facepiece air-purifying respirators: tight-fitting respirators which might be product of artificial or rubber materials allowing them to be repeatedly disinfected, cleaned, and reused. They are outfitted with exchangeable filter cartridges.
    2. Elastomeric full facepiece air-purifying respirators: Like the elastomeric half facepiece respirator, the elastomeric full facepiece respirator is a reusable system that makes use of exchangeable filter cartridges however has a transparent plastic lens that covers the face and offers eye safety.
    3. Powered air-purifying respirators (PAPRs): reusable respirators that sometimes have loose-fitting hoods or helmets. These respirators are battery-powered with a blower that pulls air by means of hooked up filters or cartridges. The filter is usually a excessive effectivity (HE) filter. Loose-fitting PAPRs don’t require match testing and might be worn by folks with facial hair.
  3. When non-PPE controls can’t feasibly be carried out and when no various respirators to FFRs might be obtained, preserve present FFR provides on-hand by extending the employer’s schedule for when they’re disposed and changed.
    1. For corporations with insurance policies permitting the common disposal and substitute of N95s and different FFRs, prolonged use of those FFRs past regular change-out schedules, when acceptable, may also be thought of. The determination to implement insurance policies that allow prolonged use of FFRs needs to be made by the professionals who handle the establishment’s respiratory safety program. Criteria for disposing and changing FFRs embrace when respiration by means of the filter materials turns into too restricted fairly than merely disposing of them on a usually scheduled foundation corresponding to after a single shift. In such circumstances, correct coaching on storage of used respirators is required.
  4. Use FFRs past the manufacturer-designated shelf life for coaching and match testing.
    1. In instances of scarcity, you might be able to use FFRs past the manufacturer-designated shelf life for coaching and match testing functions. However, expired respirators won’t carry out to the necessities for which they had been licensed. Over time, parts such because the strap and filter materials could degrade, which may have an effect on the standard of the match and seal. Using such respirators for coaching and match testing would permit non-expired N95 FFRs for use for regular work operations.
  5. Use respirators authorized below requirements utilized in different nations which might be much like NIOSH-approved FFRs. (See Table 1.)
    1. Within Table 1, the nation, conformity evaluation requirements, requirements and steering paperwork, acceptable product classification, and NIOSH classification are offered in alphabetical order. All of those respirators have safety components of a minimum of 10 within the nations listed within the desk, as outlined within the requirements and steering paperwork specified. NIOSH has confidence that units provided by present NIOSH-approval holders producing respirators below the varied requirements licensed in different nations are anticipated to supply the safety indicated, given {that a} correct match is achieved. Non-NIOSH-approved merchandise developed by producers who aren’t NIOSH approval holders, together with these authorized by and acquired from China, ought to solely be utilized in disaster conditions when no different NIOSH-approved N95 respirator or a listed system from one of many different acknowledged nations is on the market. To guarantee this stage of confidence, NIOSH has developed an evaluation to guage the filter effectivity of respirators from different nations. NIOSH is comfortable to conduct the testing for you and supply you the outcomes of the testing. The webpages to request respirator assessments can be found right here:  https://www.cdc.gov/niosh/npptl/respirators/testing/default.html.

The following measures could should be thought of during times of identified respirator shortages

  1. Use FFRs past the manufacturer-designated shelf life for work operations.
    1. Consideration might be made to make use of FFRs past the manufacturer-designated shelf life for work operations when no different controls or respiratory safety can be found. Respirators past the manufacturer-designated shelf life could not carry out to the necessities for which they had been licensed. Over time, parts such because the straps and nostril bridge materials could degrade, which may have an effect on the standard of the match and seal. Many fashions present in U.S. stockpiles have been discovered to proceed to carry out in accordance with NIOSH efficiency requirements. Users ought to take the next precautionary measures previous to utilizing the respirator within the office.
      1. Visually examine the FFR to find out if its integrity has been compromised.
      2. Check that parts such because the straps, nostril bridge, and nostril foam materials didn’t degrade, which may have an effect on the standard of the match and seal and subsequently the effectiveness of the respirator.
      3. If the integrity of any a part of the respirator is compromised, discard the respirator and check out one other respirator.
      4. Users ought to carry out a consumer seal test instantly after they don every respirator and mustn’t use a respirator on which they can not carry out a profitable consumer seal test.
  1. When the above management steps aren’t possible, FFR and better ranges of respiratory safety are unavailable, and various respiratory safety methods aren’t potential, it is suggested that work actions requiring such safety be suspended.

Employers who efficiently implement methods for conserving and increasing their FFR provides throughout the COVID-19 pandemic could discover that they possess extra inventories. It is really useful that employers contemplate redistributing (e.g., promoting, donating) accessible extra inventories to healthcare settings throughout the COVID-19 pandemic to assist cut back identified shortages of respirators. Worksites which might be now not lively attributable to emergency work stoppages and restrictions are inspired to think about redistributing their extra PPE and match check kits to their state medical countermeasure contacts, the Federal Emergency Management Agency (FEMA)external icon, or by means of different applicable channels. Non-healthcare employers who purchased massive portions of respirators within the months previous the disaster ought to contemplate if they’re keen to redistribute (e.g., promote, donate) these respirators for healthcare use.

Table 1. Respirators Approved Under Standards Used in Other Countries That Are Similar to NIOSH-Approved N95 Filtering Facepiece Respirators

Respirators Approved Under Standards Used in Other Countries That Are Similar to NIOSH-Approved N95 Filtering Facepiece Respirators
Country Performance Standard Acceptable Product Classification May Be Used in Lieu of NIOSH-Certified Products Classified as
Australia AS/NZS 1716:2012 P2 N95
P3 N99 or decrease
Brazil ABNT/NBR 13698:2011 PFF2 N95
PFF3 N99 or decrease
People’s Republic of China GB 2626-2006

GB 2626-2019

GB19083-2010

KN/KP95 N95
KN/KP100 N95
Europe EN 149-2001 P2 N95
P3 N99 or decrease
Japan JMHLW-2000 DS/DL2 N95
DS/DL3 N99 or decrease
Korea KMOEL-2017-64 Special 1st N95
Mexico NOM-116-2009 N95 N95
R95 R95 or decrease
P95 P95 or decrease
N99 N99 or decrease
R99 R99 or decrease
P99 P99 or decrease
N100 N100 or decrease
R100 R100 or decrease
P100 P100 or decrease

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