How do we know if our stockpiled respirators remain protective?

What do we do with respirators stored beyond their manufacturer designated shelf life?

Are shelf-life extension programs available for respirators?

 

If these questions sound familiar, we hope this follow-up blog to last year’s “Tips for Managing Personal Protective Equipment in your Stockpile” will provide clarity to your stockpiling efforts. As a refresher before we dive in (we know it’s been a while since the first blog on this topic), stockpiling essential personal protective equipment (PPE) is an important part of preparing for emergencies. However, stockpiled respirators may remain in storage for several years, resulting in the high cost of replacing products that exceed their shelf life. This is why this second blog focuses on respirator shelf life and storage conditions.

The tips found in this blog and previous blogs are based on NIOSH’s extensive research on stockpile practices. This research includes the evaluation of nearly 4,000 filtering facepiece respirators (FFRs) from 10 stockpile facilities across the nation along with consensus studies and workshops conducted by the National Academies of Sciences, Engineering, and Medicine performed in collaboration with universities and hospitals.

Shelf Life 101

Respirator or filter shelf life refers to how long a product can be stored before degradation and reduced performance may begin to occur. NIOSH does not require an expiration or “use-by-date” indicator. When a respirator manufacturer[i] designates a shelf-life date for their product, they are indicating that the respirator may not be protective beyond the designated use-by-date. This date is typically based on data collected during the design and development of the product. Some manufacturers may choose to identify an FFR or filter shelf life; others may identify an expiration or use-by-date.

The manufacturer is responsible for understanding how storage conditions may impact their products’ performance over time based on the products’ design, materials, and construction.

Fast fact #1: For respirators made of multiple components, the components may have differing shelf-life dates.

Disposable FFRs, such as an N95® respirator, have a single shelf-life date (many are five years). However, reusable respirators, such as elastomeric half mask respirators (EHMRs) and powered air-purifying respirators (PAPRs), are made of multiple sub-components that may each have a different shelf life. For example, an EHMR facepiece or PAPR hood may have a shelf life of ten years, whereas the particulate filter may have a shelf life of only 5 years.

Fast fact #2: The respirator’s packaging or User Instructions may include shelf-life information.

Shelf life is typically on the respirator’s packaging, shipping container, user instructions, or on the manufacturer’s website. Shelf life may be associated with an hourglass icon and may also be calculated based on the date of manufacture (e.g., YYYY-MM-DD). Additional information regarding how to verify a NIOSH Approved® respirator’s shelf life, including what to do if you cannot find this information, can be found in this PPE CASE Notes.

Fast fact #3: Documenting shelf life (and other key) information and considering optimal rotation strategies can go a long way to avoid respirators exceeding their shelf life while in storage.

It is important for Respiratory Protection Program managers or stockpile managers to document shelf-life information in their inventory management database. Consider documenting the following key inventory information:

Examples of Information to Document

Manufacturer/NIOSH approval holder name

Model and/or part number for all components as applicable

NIOSH Approval Number (84A-XXXX)

Manufacturing date (may be included through the Lot Number)

Lot and shelf life designated by the manufacturer (e.g., number of years and/or year exceeded)

Lot and shelf-life date for the replacement filtering elements (filters, cartridges, canisters)

Lot and shelf-life date for facepiece, if designated

Shelf-life date and other applicable long-term storage considerations for batteries, if designated

Number of cases per model

Units per case

Total quantity

Year purchased and/or years in storage

Storage condition recommendations

 

Rotating inventory can help ensure respirator availability and product usage within optimized shelf lives, ensuring a “first in, first out” approach. In a previous blog, we highlighted the importance of working with local medical centers to survey what models they use within their respiratory protection program and potentially coordinate rotation strategies with them. When monitoring shelf life, consider rotating products to these entities before shelf life is reached.

When it comes to shelf life, these “101 basics” are important considerations for every PPE stockpile. However, we understand that the basics only get you so far. A lot of questions arise when establishing and maintaining a PPE stockpile to ensure it is both cost-effective and meets the needs of your organization. So, we’re going to use the rest of this blog to provide tips that address some of the top questions we’ve received specific to stockpiled respirator shelf life.

Beyond the Basics

What are the proper storage conditions for the respirators I am stockpiling?

In general, the Occupational Safety and Health Administration (OSHA) requires respirators be stored in the original packaging and away from contamination, dust, sunlight, extreme temperatures, excessive moisture, and damaging chemicals (29 CFR 1910.134).

Tip #1: Identify any manufacturer-designated storage conditions for each type of respirator you are stockpiling.

Manufacturers may designate specific storage conditions for their products, such as temperature and humidity thresholds. For example, many FFR models have specified storage conditions of under 80% relative humidity. Maximum temperatures can range widely, so it’s important to find this information for your specific stockpiled models. Contact the manufacturer if your storage conditions deviate from their recommendations or you have questions about component storage conditions.

It is important for stockpile managers to consider controlling and monitoring their storage conditions in accordance with the specified storage conditions of their respirators. If possible, alarms could be put in place to alert facility staff when the storage conditions deviate from the specified conditions. In addition, be sure to store respirators away from direct sunlight, chemicals (e.g., pesticides, cleaning products), and water.

Note: Some manufacturers account for storage deviations, for example during transportation.

Can shelf life be extended? If not, what else can I do with my supply of respirators past their shelf life?

Manufacturer-designated shelf lives are an indication of when an approval holder/manufacturer believes their product begins to degrade or lose efficiency. NIOSH cannot extend the shelf life on the respirator on a manufacturer’s behalf. However, NIOSH research continues to inform the respirator community’s understanding of respirator degradation. In one research study, NIOSH found that 98% of sampled stockpiled respirators (5 – 12 years old) continued to meet NIOSH’s performance requirements. Informed by NIOSH data such as this, during a public health emergency, the FDA can issue an Emergency Use Authorization to allow select respirator models that are stored past their shelf life to be used in healthcare settings.  That being said, outside of a designated public health emergency, no such policy exists to authorize the use of respirators that are beyond their shelf life.

Tip #2: Respirators that are past their designated shelf life are no longer approved by NIOSH to be used as part of a respiratory protection program. But you may be able to find other uses!

When respiratory protection is required in the workplace, OSHA requires the use of NIOSH Approved respirators as part of a respiratory protection program, per 29 CFR 1910.134. If a manufacturer elects to designate a shelf life during the NIOSH approval process, that shelf life becomes a condition of use for the end user. Once a respirator exceeds its designated shelf life, it is no longer considered approved by NIOSH, and therefore not compliant with OSHA regulations for occupational use.

To avoid wasting your stockpiled respirators, consider using them in situations where a NIOSH Approved respirator is not required by an OSHA standard or regulation, such as for training, fit testing, or personal use for source control or protection during times of unhealthy ambient air quality levels. In these cases, users should still be made aware that their respirators have exceeded shelf life and may no longer meet the requirements for which they were approved.

Other options for products past their shelf life can include donation, disposal, or recycling. The manufacturer may have specific guidelines for its products.

What if the respirators do not have a shelf life?

If your respirator does not have a shelf-life date noted on its packaging or User Instructions, it is best to contact the manufacturer to inquire about the specific respirator’s shelf life. Have the approval number (TC-84A-XXXX), model/part number, and lot number ready. Contact information can also be found on the Certified Equipment List, including private label information.

If no guidance from the manufacturer is available, refer to OSHA’s 1910.134 respiratory protection standard and replace the respirator filter or the FFR when it is damaged, soiled, wet, or becomes difficult to breathe through.

Tip #3: Regularly inspect respirators without specific shelf-life dates.

Respirators without specific shelf-life dates should be regularly inspected for any observed damage. An example of a visual inspection checklist is given below.

FFR Visual Inspection Items	Evaluation
1. Does the packaging have any signs of damage?	Damaged packaging may cause some of the additional challenges listed below, which can result in the need for product disposal. Large quantities of damaged packages suggest a need for review of product handling practices.
2. Does the respirator have an odor?	The presence of an odor indicates that storage practices are not optimal, and product packaging may have been compromised. Consider discarding these products.
3. Does the respirator have a presence of dust?	Large quantities of dust may increase user discomfort when inhaling. Refer to manufacturer guidance and consider discarding these products.
4. Does the respirator appear moldy?	Mold is a respiratory hazard. To avoid users inhaling this hazard, these products should be discarded.
5. Is the respirator deformed in any way? 6. Is the nose foam flaking, or does it appear damaged?	These issues indicate that the product may no longer meet NIOSH approval requirements and, thus, would not be considered a NIOSH Approved® respirator.
7. Is the nose clip cracked, corroded, or detached? 8. If applicable, are the staples attaching the straps cracked, corroded, or rusty? 9. Are the straps detached from the respirator? 10. Are the straps damaged in any way?	These issues indicate that the product does not meet NIOSH approval requirements and, thus, is no longer considered a NIOSH Approved® respirator.

What if the respirator’s approval status changes (e.g., the approval is rescinded [1] or revoked [2])?

Tip #4: Regularly check the respirator’s approval status on NIOSH’s Certified Equipment List (CEL).

The Certified Equipment List shows every respirator with an active NIOSH approval. It’s extremely important to consult the Certified Equipment List for both your initial purchase and as part of a routine to ensure that the respirators you already purchased still have an active NIOSH approval. If the approval is identified as being obsolete, consider making efforts to use these products ASAP (see NIOSH Conformity Assessment Notice 2022-1044).  If the manufacturer no longer maintains their approval, this could lead to lack of customer support in cases of degraded product, issues with individual products or entire product lots, or a lack of attention to necessary recalls. Therefore, we encourage you to proactively confirm that your stockpiled respirators remain approved by NIOSH.

See Tip #2 of this blog regarding implications of using a respirator that is no longer approved by NIOSH. Make it a habit to check NIOSH’s Certified Equipment List  and to also check our Conformity Assessment Notices, and specifically our Respiratory Protective Device Information (RPD Info) Notices, which flag rescinded and revoked approvals. Sign up to receive alerts when a new NIOSH Notice is posted along with other important information.

 

[1] Rescinded – The approval holder voluntarily requests the certificate of approval be withdrawn for a product.

[2] Revoked – NIOSH reserves the right to revoke, for cause, any certificate of approval issued pursuant to the provisions of 42 CFR Part 84. Such causes include, but are not limited to, misuse of approval labels and markings, misleading advertising, and failure to maintain or cause to be maintained the quality control requirements of the certificate of approval.

[i] For the purpose of this blog, a NIOSH approval holder (e.g., the manufacturer granted the approval from NIOSH) is referred to as “the manufacturer.”

Authors:

Susan Moore, PhD, is the Associate Director for Science in the NIOSH National Personal Protective Technology Laboratory.

Lee Greenawald, PhD, is the former Evaluation and Testing Branch Chief in the NIOSH National Personal Protective Technology Laboratory.

Jackie Cichowicz, MA, is the Lead Health Communication Specialist in the NIOSH National Personal Protective Technology Laboratory.