## Prevalence of Respiratory Protective Devices in U.S. Healthcare Systems

Lindsay Stradtman, MPH, CPH
ASPPH/CDC Public Health Fellow January 7, 2014

Disclaimers: This report was supported by Cooperative Agreement Number U36/CCU300430 from t he Centers for Disease Control and Prevention and the Association of Schools and Programs of Public Health. The findings and conclusions of this report do not necessarily represent the official views of CDC or ASPPH. Mention of product names does not imply endorsement.2

Intro duction Several emerging infectious disease outbreaks in the past decade , including S evere Acute Respiratory S yndrome (SARS) in 2003 and I nfluenza A (H1N1 ) in 2009, have highlighted the need for

an increased focus on influenza pandemic planning ( 1 )

. Planning efforts have accelerated, especially for those most at r isk during a pandemic, such as healthcare workers (HCWs). According to the Occupati onal Safety and Health Administration (OSHA), HCWs are at very high or high exposure risk during an influenza pandemic ( 2 )

. Recent findings suggest that HCW s not only have an increased risk of influenza but were among the most burdened during the H1N1 pande mic ( 3 , 4 )

. Engineering controls are the preferred meth od for protecting HCWs but may not be adequate or even p ossible during a pandemic ( 5

- 7 )

. In addition, certain administrative controls, such as vacci nation, may not be attainable in the beginning of the pandemic, as i t usually takes 4

- 6 months to develop a vaccine targeting a novel type of influenza ( 5 )

. Ther efor e , p ers onal protective equipment (PPE), especially respiratory protectiv e devices (RPDs), will likely serve as an important source of worker protection during a pandemic.
Due to the expected importance of RPD use among HCWs during a pandemic, the U.S. Department of Health and Human Services (HHS) recommends that healthcare facilities stockpile a 6

- 8 week supply of disposable N95 filtering facepiece respirators (N95 FFRs) ( 8 )

. However , it has been widely documented that this recommendation has been a challenge for many healthcare facilities. Noted barriers to stockpiling N95 FFRs include: lack of storage space, limited use within normal working parameters, possible expiration issues, a nd working against the typical “just

- in

- time” procurement and manufacturing model , which only allows for a limited number of on

- hand supplies ( 9

- 12 )

. This is problem atic due to the sheer number of RPDs that will be needed during a pandemic ( 13 )

. According to the Centers for Disease Control and Prevention (CDC), an estimated 90 million N95 FFRs would be needed to protect healthcare workers during a 42

- day pandemic ( 14 )

. The rapid increase in RPD usage was even apparent during the 2009 H1N1 pandemic. For example, s eve ral hospitals in Vancouver , Canada experienced a 107% increase in N95 FFR use during the pandemic ( 15 )

. PPE usage may also increase beyond pandemic recommendations due to HCW concerns about disease transmission ( 16 )

. M any HCWs also reported that N95 FFRs were not readily available at their healthcare facility during the H1N1 pandemic for various reasons, including inability of suppliers a nd manufacturers to meet demand ( 9 , 17 , 18 )

. It should also be noted that there were also shortages of N95 FFR fit testing equipment ( 12 , 19 )

.3

Regardless of the lessons learned during the H1N1 pandemic, healthcare faci lities are still not prepared for the next pandemic

. The C enter for Biosecurity of UPMC con ducted a 2

- year assessment of HHS’ Hos pital Preparedness Program . It was concluded that the U.S. healthcare system is not prepared for a catastrophic health event, which is defined as, “any natural or man made incident... that results in a number of ill or inj ured persons sufficient to overwhelm the capabilities of immediate local and regional emergency response and health care systems” ( 20 )

. This lack of preparedne ss also applies to RPDs; f or example, Rebmann et al. found that 50.7% of hospitals do not currently have a stockpile of N95 FFRs ( 21 )

. These finding s are worrisom e considering recent reports sugges t that HCWs would be less willing to work during a pandemic if adequate PPE was not available , including RPDs ( 7 , 22

- 24 )

. Furthermore, the lack of RPD stockpiles at healthcare facilities emphasize s the importance of the RPDs in cluded in the Strategic National Stockpile (SNS). Strategic National Stockpile The SNS is, “...th e Federal cache of pharmaceuticals, vaccines, medical supplies, equipment, and other items established to augment local supplies of critical medical countermeasures that may be needed for a publi c health emergency or disaster” ( 25 )

. The SNS is overseen by the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) , with the CDC managing medical countermeasure (MCM) procurement and maintenance, i ncluding RPDs ( 25 )

. In April 2009 , the U.S. Government concluded that the H 1N1outbreak was a public health emergency. As a protective measure, the SNS deploye d 25% of influenza control supplies, including 39 million RPDs (i.e

. N95 FFRs and masks)

. In October 2009, an additional 59.5 million N95 FFRs were deployed from the SNS ( 26 )

. Overall, 75% of the SNS’ N95 FFRs were deployed during the pandemic ( 27 )

. As RPDs from the SNS were distributed to healthcare facilities, several notable issues occurred. In many cases, t he N95 FFR s received from the SNS did not match healthcare facilities’ current stock of models . Thus, there was a need to fit t est HCWs for these new devices as well as conduct training, which was a time

- consuming process ( 27

- 29 )

. Another issue that occurred was that many of the SNS’ N95 FFR s were certified by the National Institute for Occupational Safety and Health (NIOSH) but not cleared by the U.S. Food and Drug Administration (FDA) ( 27 )

. This had l egal ramifications that will be further discussed. Because the SNS’ supply of N95 FFRs was drastically reduced during the H1N1 pandemic, as well as the issues that occurred during the deployment of RPDs, the PHEMCE has tasked CDC w ith completing an assessm ent. More sp ecifically, in FY14, CDC will assess the quantity and4

composition of the SNS’ RPDs, and determine if RPD stockpiling should even continue ( 30 )

. During this assessment process , it has become apparent that there is a need for data on the types of RPDs currently be ing used in healthcare settings. An important factor in this assessment is the prev alence of NIO SH

- certified and FDA

- cleared RPDs in healthcare settings.
NIOSH
- C ertified and FDA
- C leared RPDs In terms of RPDs, NIOSH’s responsibility is to certify a device’s level of respiratory protection, not its ability to prevent disease. In order for an RPD to be marketed as a device that prevents disease, it must be cleared and regulated by the FDA ( 31 )

. FDA

- cleared respirators, also known as Surgical N95s, must be NIOSH

- approved and meet certain fluid and flammability protection standards ( 5 , 6 )

. However, Surgical N95s are not required to meet any specific standar ds in regards to the prevention of disease

. Many of the current FDA requirements for Surgical N95s relate to their intended use during surgical procedures ( 6 )

. Furthermore, FDA regulations are primarily aimed at manufacturers an d how medical devices are sold. For instance , manufacturers are not permitted to market their produ ct for a use that has not been approved by the FDA

. Once a medical device is cleared, the FDA cannot regulate the ways in which it is used ( 32 )

. Employers and employees using medic al devices such as Surgical N95s , however, must follow OSHA regulations ( 6 )

. During a pandemic, OSHA recommend s that healthcare facilities provide HCWs with NIOSH

certified respirators that are rated N95 or hi gher. However, OSHA also recommends that HCWs use Surgical N95s if respiratory and fluid protecti on are needed ( 5 )

. As afo rem entioned, healthcare facilities struggled to maintain an adequate supply of RPDs during the H1N1 pandemic ( 9 , 17 , 18 )

. Both NIOSH

app roved N95 FFRs and FDA

- cleared S urgical N95s were in short supply. Additionally, m any of the R PDs deployed from the SNS were not FDA

- cleared . In order for the deployed NIOSH

- approved N95 FFRs to be used by HCWs for disease prevention purposes , the FDA issued an Emergency Use A uthorization (EUA) . During the H1N1 pandemic, EUAs were issued for 15 non - FDA cleared, NIOSH

approved N95 FFRs ( 6 , 27 , 29 , 33 )

. The Federal Food, Drug, and Cosmetic Act, which was amended by t he Project BioShield Act of 2004 , sanctions the use of EUAs , which allow s for increased access to available MCMs during public health emerg encies ( 25 , 34 )

. The FDA commissioner can sanction EUAs for either unapproved medical devices or unapproved uses of FDA

- approved m edical devices ( 34 )

. It should be noted that, “An EUA is an authorization for certain uses of MCMs during specified emergencies and is not a form of produ ct approval” ( 35 )

. In Jun e 2010, the EUA for N95 FFRs was5

terminated ; thus returning to regulations that state non

- FDA cleared RPDs cannot be used for the prevention of infectious diseases ( 33 )

. T he issue of using FDA

- cleared vs. non - FDA cleared RPDs in healthcare facilities has received increased a ttention among indus try officials

. HCWs have voiced concern over the need for FDA

- cleared RPDs in healthcare settings, bearing in mind the shortages faced during the H1N1 pandemic ( 36 )

. Officials at the Institute of Medicine have also suggested that the fluid and flammability requirements for FDA

- cleared RPDs are not necessary in most situations in order to protect HCWs from infectious disease s, such as influenza ( 6 )

. In addition to disposable FFRs, other types of RPDs are being used in healthcare s ettings, such as powered air purifying respirators (PAPRs) and elastomeric half

- facepiece respirators ( EHFRs )

. PAPRs and EHFRs ar e typically used by HCWs with facial hair and those that have problems fit testing with disposable FFRs ( 6 , 10 )

. Currently, only disposable FFRs are FDA

cleared; accordingly, there are no FDA

- cleared PAPRs or EHFRs. Moreover, there is very little data regarding t he prevalence of FDA

- cleared vs. non - FDA cleared RPDs in healthcare settings. To our knowledge, there ha s only been one study that has examined this issue. In 2011, i nfection control professionals and safety/employee health administrators were surveyed to determine if FDA

- cleared S urgical N95s were used at their facilities. Twenty

- four percent of infection control professionals and 38% of safety/employee health administrators reported that their faci lities were using at least one S urgical N95. More importantly, approximately 50% of each group did not know or were not sure if FDA

- cleared RPDs were used in their facilities ( 36 )

. There is also no available data on specific FDA

cleared and non

- FDA cleared RPD models used in hea lthcare settings. This data is imperative because it has implications for replenishment of the SNS as well as the need for EUAs during the next pandemic.
Needs & Goals Thus, there is a need for the following in order to enhance influenza pandemic preparedn ess:

 Data on the prevalence of FDA

- cleared S urgic al N95s in healthcare settings, including specific models and the number of HCWs using these devices.

 Data on the prevalence of non

- FDA cleared RPDs ( i.e. EHFRs , PAPRs, an d N95 FFRs ) in healthcare settings, including specific models and the number of HCWs using these devices.6

The goals of this report are to:

 Assess the prevalence of FDA

- cleared and non

- FDA cleared RPDs, including specific models , in healthcare settings.

 Provide data for working groups that a re making recommendations and/or decisions involving RPD supplies and usage during an influenza pandemic. Disposable N95 FFRs A 2012 analysis of the North American RPD market indicates that disposable respirators account for 26.4% of the overall market. I t should be noted that this analysis provides an overview of the entire RPD market and does not account for healthcare settings. Overall demand for disposable respirators has become stagnant, with 3M, Moldex, and Honeywell as the top manufacturers for thes e devices ( 37 )

. According to NIOSH, there are currently 69 different models of FDA

- cleared Surgical N95 respirators being produced by approximately 23 manufacturers ( 38 , 39 ) . As aforementioned, there has only been one study to our knowledge that has assessed the prevalence of FDA

- cleared RPDs in healthcare settings. Study findings suggest that many involved with healthcare respiratory protection programs do not know the prevalence of FDA

- cleared RPDs in their facilities ( 36 )

. In terms of non

- FDA cleared, NIOSH

- approved N95 FFRs, there are currently 314 different models being produced by approximately 36 manufacturers ( 38

- 40 )

. Available data from the Association of State and Territorial Health Officials (ASTHO) suggests that state governments might be also be collecting data on the types of N95 FFRs used in healthcare settings. A 2010 ASTHO report indicated that at least one state health department had surveyed healthcar e facilities to determine preferred types of N95 FFRs. Based on survey findings, the state health department then stockpiled preferr ed N95 FFR models for emergency pur poses . The report does not indicate which types of N95 FFRs were stockpiled; thus, it could not be determined whether the devices were FDA

- cleared ( 12 )

. PAPRs As aforementioned, PAPRs are a viable choice for HCWs that have facial hair, cannot be fit tested or wear a disposable FFR or EHFR ( 6 )

. PAPRs may become an important o ption for respiratory protection during an influenza pandemic because they do not require fit testing . HCWs that normally do not need respiratory protection may need an RPD during a pandemic; and fit testing may not feasible7

( 6 )

. PAP Rs also provide increased protection and are perceived by some individuals to be more comfortable than disposable FFRs ( 37 , 41 )

. PAPRs account for 10.9% of the overall RPD market in North America. There has been major growth in the market for loose

- fitting head protection, including PAPRs. Moreover, the PAPR segment accounts for some of the highest revenue growth in the market. The top PAPR manufacturers are: 3M, MSA, Bullard, Honeywell, and Scott Safety ( 37 )

. There are currently 235 types of NIOSH

- approved PAPRs , including those p rotecting against gases and vapors, being produced by 18 manufacturers ( 39 , 42 )

. In October 2013, the National Personal Protective Technology Laboratory (NPPTL) conducted a review of the various PAPR systems sold by top medical supply distributors. An initial list of top medical supply distributo rs was created based on several sources: NPPTL staff with expertise in healthcare, a 2012 Gartner report on the top 25 healthcare companies based on supply chain capabilities ( 43 ) , and a contact at the Heal thcare Industry Distributors Association. Fourteen distributors were identified b ased on the aforementioned information . Distributors were included if the needed information was readily available on the company’s website , or if the information was provided by a customer service representative. Accordingly, 11 distributors were included on the final list 1

. The review determined that 7 distributors were selling the following 8 PAPR systems as well as related items (i.e. replacement hoods and battery packs):

 3 MTM Air

- MateTM

 3MTM PowerflowTM Face

- Mounted PAPR

 3MTM VersafloTM

 BullardTM EVATM

 BullardTM PA20TM (Discontinued) 2

 BullardTM PA30TM (Discontinued)

 North® by Honeywell PAPR System, Universal, Li

- Ion

 North® Compact AirTM PAPR

1 The 11 distributors reviewed were: Buffalo Hospital Supply, Cardinal Health, Henry Schein, McKesson, Medline, MMS Medical, Owen s & Minor, Physicians Sales & Service, Puerto Rico Hospital Supply Inc., Seneca Medical, and Twin Med Medical.

2 According to Bullard’s website, the PA20TM and the PA30TM are discontinued.8

EHFRs Similarly to PAPRs, EHFRs can be use d by HCWs that have trouble fit testing with disposable FFRs ( 10 ) . EHFRs are also similar to N95 FFRs in that they provide approximate ly the same level of protection ( 41 )

. Non

- disposables, which include EHFRs, account for 25% of th e North American RPD market, and have some of the greatest revenue growth. In 2011, 307,000 EHFRs were sold in North America; and by 2016, that number is expected to increase to nearly 346,000. The top non

- disposable manufacturers are: 3M, MSA, Honeywell, and Scott Safety ( 37 )

. There are currently 2,000 types of EHFRs , including those protecting against gases and vapors, being produced by 10 manu facturers ( 39 , 42 ) . The previously mention ed NPPTL review of top medical supply distributors determined that 6 distributors were selling the following 14 types of EHFRs and related supplies:

 3MTM 6000 series half facepiece

 3MTM 6500 Rugged Comfort series half facepiece

 3MTM 6500 Rugged Comfort serie s half facepiece with quick latch

 3MTM 7500 series half facepiece

 3MTM half facepiece reusable respirator drop down

 3MTM half facepiece reusable respirator assembly, P100

 Aearo UnistarTM quarter

- mask reusable respirator

 AO Safety® AO 5Star® air

- purifying/airl ine respirator

 AO Safety® Flexi

- Star® air

- purifying half mask respirator

 Moldex 8000 series

 MSA Advantage® 200 LS half

- mask respirator

 North® 5500 series

 North® 7700 series silicone respirator with half mask

 North Safety CFR

- ITM Comfort Fit
It should also b e noted that some of the aforementioned distributors also sell full

- mask non

- disposables. EHFRs have gained some popularity in healthcare settings as evidenced by the Veterans Health Administration ’s (VHA) recent order for 65,000 EHFRs

– the Honeywell Sper ian® Survivair Blue 1 H

version. Significantly , t he VHA is the largest integrated healthcare system in the U.S. ( 44 )

.9

NPPTL Study Despite all the information gathered on the prevalence of RPDs in healthca re settings, there is no available data on the specific models of each type of RPD being used. NPPTL was tasked with conducting a survey in order to better understand the types of RP Ds used in major U

. S

. healthcare systems. More specifically, the survey aimed to answer the following questions:

 A re healthcare systems using N95 FFRs , PAPRs or EHFRs?

 How many HCWs are using each of these devices?

 Which RPDs, including specific models, ar e most commonly used in healthcare settings?

 How many of th ese devices are non

- FDA cleared? Methods
An online , 10

- question quantitative survey was created for pilot testing purposes. The survey was multiple choice and m any of the answer options were inform ed from various sources:

 A p revious NPPTL

- affiliated study regarding respirator y protection practices in healthcare settings ( 45 )

.

 The aforementioned NPPTL review of the top medical supply distributors

.

 The VHA’s recent EHFR order

.

 N95 FFR models known to have been in the SNS during the H1N1 pandemic ( 33 )

.

 NPPTL staff with expertise in RPD use in healthcare systems

.

 Past studi es that have examined RPDs ( 10 , 46 , 47 )

. The survey was first pilot tested for accur acy by 5 NPPTL staff members and approved by the NPPTL Director. Infection control and respiratory protection program administrators for top U.S. healthcare systems were then approached to participate in the survey. H ealth care systems were initially select ed based on the following :

 The top 3 ranked hospital systems in each size category (e.g. small, medium, and large; based on total operating expenses) in the 2013 Truven Health Analytics Top 15 Health System study ( 48 )

.

 Six healthcare systems selected by t he Joint Commission as having innovative respiratory protection programs.10

 NPPTL staff contacts at highly ranked healthcare facilities. Eighteen healthcare systems were initially approached with the aim of having 9 complete the survey. Acquiring correct contact information for many of the healthcare systems proved to be difficult; thus, only 11 healthcare systems were effectively reached and indicated willing ness to participate in the survey. Willing part icipants were then e

- mailed a link to the online survey, which was administered via Survey Monkey, and given 5 business days to complete the survey. Participants were also provided a worksheet to facilitate the gathering of necessary data for the survey. T he worksheet was developed due to co nversations with potential survey participants; several individuals stated that they would need to gather the information from different facilities in their healthcare system.
Results Overall, 9 healthcare systems compl eted the survey for a participation rate of 81.8 %. Only those healthcare systems that indicated willingness to participate in the survey, and received a link to the online survey, were included in the participation rate calculation. Respondents’ respective healthcare systems were located in the following states : California, Colorado, Iowa, Nebraska, North Carolina, Oklahoma, and Virginia. The majority of respondents reported that employees in their healthcare systems had used N95 FFRs (88.9%) and PAPRs (77. 8%) in the past year; o nly one respondent indicated that their healthcare system had used EHFRs

. Of those reporting N95 FFR use, over half (62.5%) indicated that more than 500 employees had used this device in the last 12 months. For healthcare systems rep orting EHFRs and PAPRs, the majority (100% and 85.7%, respectively) reported that approximately 100 or less employees had used these devices in the past year. T he most common EHFR models reported were: 3MTM 6000 series ( 100%) , 3MTM 7500 series (100%) , and No rth® by Honeywell 7700 series Half Mask (100%)

. The most commonly reported PAPRs were: 3MTM Air

MateTM (85.7%) and 3MTM Breathe EasyTM (28.6%)

. It should be noted that one healthcare facility indicated they were considering the 3MTM Versa FloTM, which would have made this particular model one of the most commonly reported at 28.6%

. In terms of N95 FFRs , the most common models reported

were: 3MTM 1860/1860S (75%) and 3MTM 1870 (62.5%)

.11

Please list the state or states in which your healthcare system is located. St ate n (%) California 2 (22.2 ) Colorado 1 (11.1) Iowa 1 (11.1) Nebraska 1 (11.1) North Carolina 2 (22.2 ) Oklahoma 1 (11.1) Virginia 1 (11.1)

Have any of your employees used a _____ at least once in the past year? Type of RPD Yes n (%) No n (%) EHFR 1 (11.1 ) 8 (88.9 ) PAPR 7 (77.8 ) 2 (22.2 ) N95 FFR 8 (88.9) 1 (11.1)

Approximately how many of your employees have used a _____ in the past year? No. of Employees EHFRs n (%) PAPRs n (%) N95s n (%) < 10 0 ( 0 .0 ) 1 (14.3) 0 (0 .0) 11

– 100 1 ( 100 ) 6 (85.7 ) 0 (0 .0 ) 101

– 500 0 ( 0 .0 ) 0 (0 .0 ) 3 (37.5 ) > 500 0 ( 0 .0 ) 0 (0 .0 ) 5 (62.5 )

What are the three most common types of elastomeric half
- mask respirators used in your healthcare system? If not listed, please provide the name of the manufacture r and model number. EHFR Model n (%) 3MTM 6000 series 1 (100) 3MTM 7500 series 1 (100) Honeywell Sperian® Survivair® Blue 1 H

- version 0 (0.0) Honeywell Sperian® Survivair® Blue 1 S

- series 0 (0.0) North® by Honeywell 5500 series Half Mask 0 (0.0) No rth® by Honeywell 7700 series Half Mask 1 (100) Other (please specify) 0 (0.0)12

What are the three most common types of PAPRs used in your healthcare system? If not listed, please provide the name of the manufacturer and model number. PAPR Model n (% ) 3MTM Air

- MateTM 6 (85.7) BullardTM EVATM 0 (0.0) BullardTM PA20TM 0 (0.0) BullardTM PA30TM 0 (0.0) Syntech International MAXAIR 0 (0.0) Other (please specify)

 3MTM YL7160 3

 3MTM Breathe EasyTM

 3MTM Versaf

loTM

 3MTM Breathe EasyTM

 C onsidering 3MTM Versa FloTM 3 (42.9 )

What are the three most common types of N95 s used in your healthcare system? If not listed, please provide the name of the manufacturer and model number. N95 Model n (%) 3MTM 1860/1860S 6 (75.0) 3MTM 1870 5 (62.5) 3MTM 8210 0 (0.0) 3MTM 9210 1 (12.5) Gerson ® 1730 0 (0.0) Kimberly

- ClarkTM PFR95

- 170 (46727)/PFR95

- 174 (46827) 1 (12.5) Moldex® 2200 series 1 (12.5) Moldex® 3000 series 0 (0.0) Other (please specify)

 3MTM VFlexTM 1805

 Kimberly

- ClarkTM 62126

 Kimberly

- ClarkTM 62355

 Moldex® 1500

 Safe Life® B130

 Safe Life® B150

 Tronex 500N95D

 Tronex 511N95D 4 (50.0)

3 3MTM YL7160 is a battery charger for 3MTM PAPR systems and is not an actual model.13

As aforementioned, S urgical N95s are the only type of RPD that is c urrently FDA

- cleared. R espondents indicated using the following 9 types of FDA

- cleared surgical N95s :

 3MTM 1860/1860S

 3MTM 1870

 3MTM VFlexTM 1805

 Kimberly

- ClarkTM PFR95

- 170 (46727)/PFR95

- 174 (46827)

 Moldex® 1500

 Moldex® 2200 series

 Safe Life® B130

 Safe Life® B150

 Tronex 500N95D
As for non

- FDA cleared RPDs, participants reported using the following 10 types of RPDs in their healthcare sys tems:

 EHFRs

 3MTM 6000 series

 3MTM 7500 series

 North® by Honeywell 7700 series Half Mask

 PAPRs

 3MTM Air

- MateTM

 3MTM Breathe EasyTM

 3MTM Versa FloTM

 N95 FFRs

 3MTM 9210

 Kimberly

- ClarkTM 62126

 Kimberly

- ClarkTM 62355

 Tronex 511N95D
The 9 FDA

- cleared devices account for 69 .2% of the N95 FFRs used in healthcare systems included in our survey. Therefore, 30.8% of N95 FFRs used by respondents’ healthcare systems are not FDA

cleared. Overall, 52.6% of all reported RPDs are not FDA

- cleared.14

Implications Our findings suggest tha t N95 FFRs are still the most widely used RPD in healthcare settings. Even though a majority of N95 FFRs were FDA

- cleared, other types of RPDs that are not FDA

- cleared

are becoming more prevalent in healthcare settings. For instance, nearly 80% of particip ants reported using PAPRs in their healthcare systems within the past year. Importantly, over half of RPDs used in healthcare systems included in our survey were non

- FDA cleared devices. With many HCWs potentially using these devices each year, the increas ing prevalence of non

- FDA cleared RPDs could impact infection control efforts during the next pandemic. If this trend continues into the next pandemic, for example, it may necessitate an increase in EUAs for RPDs used in healthcare settings. Additionally, the increased prevalence of non

- FDA cleared RPDs, especially PAPRs, could widen the discrepancies between the RPDs in the SNS and those used in healthcare systems. This survey was only a pilot, and therefore, has several limitations. Because of its small s am ple size and non probability sampling method, the findings may not be generalizable to all U.S. healthcare systems. Additionally, non

- response bias may be present due to several potential participants’ lack of response to survey invitations

. Based on surv ey findings, as well as a review of the literature, it is apparent that future research regarding this issue is needed. Therefore, we recommend further investigation of the following :

 Because our survey was exploratory in nature , a larger study is needed i n order to gather more accurate data on the types of RPDs currently used in U.S. healthcare systems. Currently, NPPTL plans to partner w ith the American Association of Occupational Health Nurses (AAOHN) in order to conduct a larger sur vey. NPPTL has decide d to partner with AAOHN for the larger survey because the organization has known access to respiratory protection program managers at various U.S. healthcare facilities.

 Due to the discove ry that state governments may be collecting data on the types of RP D s used in healthcare settings, we suggest further investigation into this issue. State governments play a key role in deployment of SNS supplies to healthcare facilities during a pandemic. T herefore, they have the potential to be a key resource on this iss ue, and may be knowledgeable about the types of RPDs healthcare facilitie s within their state are using.15

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