The “No Fit Test” Respirator Research Workshop

Posted on by Ed Fries and Ron Shaffer, PhD

respiratorThe number and quality of responses to previous NIOSH Science Blog posts on Frequency of Respirator Fit Testing and Influenza Pandemic and the Protection of Healthcare Workers with Personal Protective Equipment was so encouraging and informative that we decided to utilize the blog again as we continue to address the issue of respirator fit testing. To further the discussion, NIOSH is hosting the “No Fit Test” Respirator Research Workshop on November 6, 2008. The workshop aims to examine how the latest material technology (shape-changing polymers, adhesives, etc.) may be leveraged to improve current and future respirator designs including the long-term possibility of moving away from current fit-testing requirements, while preserving user protection. We would like your input as we finalize the workshop agenda.

An estimated 5 million workers wear respirators in 1.3 million U.S. workplaces to provide protection against various airborne hazards. Respiratory protection is critically dependent upon the fit of the respirator to the user’s face. A fit test is required to assure that a given respirator fits an individual.1 Reports from the National Academies’ Institute of Medicine (IOM) recommend research toward better-fitting respirators, with the ultimate goal of finding a way to obviate the need for initial and annual fit testing.2, 3, 4 In response to the IOM report on “Preparing for an Influenza Pandemic: Personal Protective Equipment for Healthcare Workers,” NIOSH prepared an action plan that includes initial steps toward assessing what research needs to be conducted to achieve this goal. The “No Fit Test” Respirator Research Workshop is one element of the action plan.

maskThe workshop will discuss the nature and process of product innovation and development in negative-pressure, half-facepiece respirators. The workshop aims to gauge the current state of the art and to stimulate new designs or approaches for improved respirator fit. The results of this workshop will lead to a better understanding of how future NIOSH research can encourage ongoing development of better fitting respirators without compromising comfort and long-term protection.

NIOSH would appreciate input on the following draft workshop topics and questions, as well as additional areas for discussion. Please provide comments through the NIOSH Science Blog before September 1, 2008.

Draft Workshop Topics

Define Fit

Explore and define fit for half-facepiece respirators:

  • What anatomical or physiological features affect the fit of half-facepiece respirators?
  • What role does comfort play in the fit of a respirator?
  • Historically, what improvements have led to better-fitting respirators?
  • What role has fit testing played in the development of better-fitting respirators?
  • What features of current respirator design need further improvement?
  • What requirements must be met for a no fit test respirator?

Market and User Needs

Identify the incentives and barriers for innovations in respirator design and the role respirator users play in encouraging and motivating design improvements:

  • How have users been involved in the past and how will they be involved in the future in testing new respirator designs?
  • Do respirator manufacturers understand the needs of current and future users?
  • Are there barriers that prevent respirator manufacturers from responding quickly to user needs?
  • Are users looking for improvements for which technology does not yet exist?

Scientific or Technologic Advances

Determine how scientific findings or new technologies can be encouraged in the future:

  • What are the deficiencies in current respirator designs or fit testing methods that warrant changes or improved technologies?
  • What current or new technologies are available for improving the fit of current respirator designs?
  • What material properties are required to optimize fit and what materials exist today to optimize fit performance?
  • Are technological improvements from other fields applicable to today’s respirators?
  • Are there research directions (e.g., new materials, anthropometrics, manufacturing techniques), fit test methods, or regulatory approaches that could encourage future scientific or technologic innovation?

The full day-workshop is scheduled for November 6, 2008, at the Embassy Suites Airport in Pittsburgh, PA. More details, including registration information, can be found at the “No Fit Test” Workshop webpage.

—Ed Fries and Ron Shaffer, Ph.D.

Mr. Fries serves as the Assistant Coordinator for the NIOSH PPT Program in the NIOSH National Personal Protective Technology Laboratory (NPPTL) Office of the Director.

Dr. Shaffer is Chief of the Technology Research Branch in the NIOSH National Personal Protective Technology Laboratory (NPPTL).

Posted on by Ed Fries and Ron Shaffer, PhDTags ,

24 comments on “The “No Fit Test” Respirator Research Workshop”

Comments listed below are posted by individuals not associated with CDC, unless otherwise stated. These comments do not represent the official views of CDC, and CDC does not guarantee that any information posted by individuals on this site is correct, and disclaims any liability for any loss or damage resulting from reliance on any such information. Read more about our comment policy ».

    The fit test, and indeed, all SCBA testing, Don/Doff allows responders and users a chance to review, and revitalize their depth of knowledge. We should absolutely use whatever advances there are in physical chemistry to protect the user – but don’t do away with fit testing altogether! that time spent training – even if it costs corporations money – saves us human lives.

    Based upon my many years of experience, the key to on-going fitting of a APR is training. The fit-test requirement is of little value in most cases.

    Respirator training is an important component for an effective respirator program. The very best way to evaluate employee understanding of the training, and in particular the donning procedure, is to conduct a fit test. In this way, the fit test serves as a “hands-on” final exam for training. This can be particularly important for employees who wear respirators infrequently. Depending upon the type of respirator to be worn, fit testing also serves other purposes.

    Will it be possible to phone in and listen to and/or participate in the “No Fit Test” Respirator Research Workshop on November 6, 2008? I believe that many members of the respirator community would call in if this option is available.

    I am happy to see advances in better fitting respirators, but like some others the fit test was the hook that made supervisors bring workers in from the field so that the safety person/IH can discuss fit and usage and respirator related issues. If fit-test free respirators become available I would like to see a mandatory annual training requirement -with a minimum time set, added to the std. Yes there is mandatory training, but I can see this degenerating to 5 minutes of directives right before the respirator is handed out. I would also like to see clear data on life span of the respirator if it is not single use and field level testing of it to determine that the respirator is viable if it is multple use. Here in the south crew supply trucks reach well over 200deg F in the summer, will these products withstand the temps and still perform?

    I to would like to know if it will be possible to phone in to the No Fit Testing Respirator Research Workshop on November 6, 2008.

    Thank you for your suggestion. NIOSH is exploring options to accommodate remote participation at this workshop. If we identify a feasible option, we will post the information on the various NIOSH websites and send out an announcement from our list-server. You may subscribe to our listserv. Stay tuned for more updates.

    Ideally a proper fitting and functioning respirator will not allow the wearer to inhale air contaminants having concentrations above the occupational limits. A Fit Factor is determined for each respirator worn by an individual. Fit testing is therefore required in industrial work environment to ensure that the selected respirator provides an adequate fit to the wearer’s face. It comes also a real need to harmonize standards according to an agreed physiological value: medical surveillance (required pulmonary funtion tests); discern degree of contre-indication (visual, hearing, respiratory, cardiovascular, psychological)

    Christine Branche, Ph.D.
    Acting Director
    National Institute of Occupational Safety and Health

    Dear Dr. Branche:
    Thank you for the opportunity to comment on NIOSH’s November 6th Respirator Research workshop through the NIOSH Science blog. The American Thoracic Society (ATS) is an 18,000 member scientific medical organization dedicated to the prevention, treatment, cure and research of pulmonary, critical care and sleep related illnesses through research, education, and patient advocacy. As a professional society of respiratory health specialists, the ATS has a keen interest in the appropriate use of respirators. The following are workshop questions that the ATS would like to provide comment on:

    1.Define Fit
    One of the key challenges to improved respiratory protection is ensuring appropriate use of respirators, including appropriate fit. Research has shown that only about 50% of users wear respirators appropriately to provide adequate protection against respiratory pathogens such as tuberculosis and influenza.

    There are significant differences between the two main types of half-face-piece respirators, the elastomeric and the filtering face-piece, or N95. The elastomeric respirator provides more protection than some of the much lighter, smaller N95 respirators, and this should be articulated in NIOSH definitions.

    It is clear that there is a need for research data on the most effective way to combine both fit testing and training. Appropriate training may, in fact, reduce the need for fit testing of respirators. Issues to be addressed in comprehensive training should include selection of an appropriate respirator, how to fit the respirator on the face, how long a respirator should be used and when it should be replaced. Training should be tailored to specific situations, such as infectious disease outbreaks and potential exposures to contaminants. If fit testing is eliminated, training should be enhanced.

    ATS Recommendations:
    ■The ATS recommends that NIOSH clarify and more specifically define the different types of respirators used, including distinguishing among the various types of “half face piece” respirators.
    ■The ATS recommends that NIOSH develop draft regulations to ensure that all healthcare staff and other workers potentially exposed to airborne respiratory pathogens receive training in respiratory protection as part of standard training in workplace safety. Training should also be tailored to specific situations, such as outbreak response or potential daily exposure to environmental contaminants.
    ■The ATS recommends that NIOSH help develop specific guidance for respiratory protection for children, particularly in emergency situations.

    2.Market and User Needs
    Research has shown that many users find respirators uncomfortable and inconvenient to use and that these opinions are major determinants in actual respirator use. One specific physiologic concern is that respirators increase sweat on the face, creating physical discomfort. Research and findings about user needs should be incorporated into plans for respirator design improvements.

    Ultimately, better design of respirators is the key factor to improved respiratory protection. Respirators also need to be designed to meet various user needs, including protection from infectious disease, for health care workers, and protection from airborne contaminants for industrial workers who are exposed to particulates, chemicals, lead and other potentially harmful contaminants.

    One barrier that may be preventing respirator manufacturer innovation is NIOSH’s regulatory requirements for certifying respirators. These requirements are inflexible to the point that the types of respirators authorized are very limited and do not reflect the availability of new technology. Greater flexibility, while maintaining important safety standards, would allow more suitable and more comfortable respiratory protection to workers, which in turn could result in greater overall respiratory protection for healthcare and other workers.

    ATS Recommendations:
    ■The ATS recommends that NIOSH seek to update the regulations certifying respirators to enable greater innovation in respiratory protection.

    3.Scientific or Technological Advances and Research Directions
    As mentioned previously, there is a need for research data on the most effective way to ensure both adequate fit testing and adequate training.

    Further operational research to ensure worker protection in various environments is needed. There is a specific need for more research data on the infectious disease/respiratory health threats to which healthcare workers are exposed. More data on the needs of this population could speed development of respirators with greater efficacy in preventing disease. A specific intervention study may be needed to determine if optimal protection of the greatest number of people is achieved through a fit test program or through a no fit test program.

    ATS Recommendations:
    ■The ATS recommends that the National Occupational Research Agenda (NORA) include studies to provide direction on the most effective training/strategies for optimal respiratory protection in healthcare and industrial workers.
    The ATS appreciates this opportunity to comment. Please contact Nuala S. Moore, Sr. Legislative Representative, for more information on respiratory protection or other respiratory health issues.

    I am following this blog and comments with great interest. “No-Fit-Test” is one of the objective when we set out to design a new respirator-mask after the SARS in 2003. The transparent and reusable mask is now called TOTOBOBO, it is possible to see through the mask and visually examine the face seal. During a fit-test exercise involved 20 health care workers in a hospital, we compare the fit-test results of TOTOBOBO against typical disposable N95/N99 mask. We observe there was a high correlation between the visual-fit-check and official fit-test result (i.e. Porta-Count + N95 adapter). I wonder if the “No Fit Test” workshop would like to look into this solution for inspiration?

    Thank you for the comment. NIOSH encourages manufacturers and other interested parties to register for the workshop and introduce technological advances to stimulate discussion. Please contact the meeting organizers to determine how you may participate in the workshop. NIOSH is interested in the presentation of concepts, data, and alternatives that advance the science related to fit testing. We should note that the mention of your product in this blog does not constitute a commercial endorsement by NIOSH, and that the product has not been submitted to NIOSH or tested by NIOSH under our respirator testing and certification program.

    I am following this blog and comments with great interest. “No-Fit-Test” is one of the objective when we set out to design a new respirator-mask after the SARS in 2003. The transparent and reusable mask is now called TOTOBOBO, it is possible to see through the mask and visually examine the face seal. During a fit-test exercise involved 20 health care workers in a hospital, we compare the fit-test results of TOTOBOBO against typical disposable N95/N99 mask. We observe there was a high correlation between the visual-fit-check and official fit-test result (i.e. Porta-Count + N95 adapter). I wonder if the “No Fit Test” workshop would like to look into this solution for inspiration?

    Last spring, I was involved in designing and executing a “mass fit testing” exercise involving health care N95 respirators. One of the key variables in achieving a reliable fit was determined to be how consistently a respirator wearer could conform the metal nose band to the contours of his or her nose bridge area. Before a fit test commenced, each fit test subject was asked to don and adjust the nose band without assistance while the PortaCountPlus/N95-Companion was in “count mode”. Many fit test subjects used an improper technique, and failed to attain an acceptable seal, until they were re-instructed in how to bend the metal nose band properly. Since most health care workers don’t wear N95 respirators on a regular basis, this is a significant issue in terms of maintaining proficiency in performing this critical adjustment.

    Therefore, re-training would be an important respiratory protection program element before N95 respirators are used in a public health emergency. At the present time, we were only able to identify one manufacturer of health care N95 respirators that uses a molded nose bridge. However, these respirators appear optimized for narrow nose bridges. It would also be useful to have molded nose cup health care N95 respirator models that fit a wider range of nose bridge shapes, especially wider. Moreover, one area for improvement in filtering facepiece respirator design would be to use new materials in the nose bridge area that would conform to the user’s nose bridge and then retain its shape, thus fitting a wider range of nose bridge shapes and eliminating the metal nose band. The following comments were made as an individual, and do not represent the position of my employer.

    I view fit testing as an integral part of respirator training. It’s the final exam that proves the person knows how to don the respirator and has been issued the proper size. A “no fit test respirator” would also have to be a “no training respirator,” which is very hard to imagine. I believe that we need to eliminate the objections to fit testing (too time consuming) rather than eliminate fit testing. The current OSHA fit test protocols take too long. NIOSH should develop a quantitative fit test method that industry can live with, yet still provides an effective final exam in concert with mandatory training.

    I would like to thank you for the opportunity to comment.

    The “No fit testing workshop” is definitely encouraging. I would also encourage NIOSH and Manufactures to monitor and develop a respirator that also takes into account the facial features and health of the aging work force. Specifically, the over 45 year old female healthcare worker. Fit testing in many health care facilities has become a “fit for duty” issue. The aging workforce and employees with small facial features are few but it is concerning that a job may be rescinded if an employee cannot meet this requirement.

    Fit testing requires a qualified tester.($$$$) Fit testing may require outside testing ($$$$$) Fit testing isn’t being done in construction. I recently retired and very rarely saw fit testing or proper respirator use. I have been an activist to inform and educate workers about protection.

    I see workers cutting concrete, sanding concrete and chipping concrete using no protection.

    Employers are more worried about workers fainting from using a respirator than the long term effect of silicosis or other diseases caused by not using a respirator.

    The idea of fit testing encourages employers to just ignore the problem.

    OSHA needs to man up and do more to encourage employers to follow NIOSH recommendations and supply proper fitting PPE.

    I think that I understand the reasoning for the workshop – because of the need to make sure everyone’s mask really does fit, but without supposed enormous costs associated with that.

    Before the workshop question is asked, though, shouldn’t a completely different set of questions should be asked and answered?

    1.What measures are being taken to limit the spread of infectious agents/hazardous materials? What monitoring is done? What reporting? To whom? What actions? How effective?
    2.Why aren’t efforts made to eliminate and enclose all of those hazardous operations and activities? What is being done in this area?
    3.Have the costs that are assumed to be high really ever been calculated? How have the cost savings (ie prevention of disease and ancillary costs) been accounted for?
    Until hazardous operations are enclosed, local exhaust ventilation provided, or other means of eliminating or reducing the hazard are implemented, the respirator is absolutely critical for protection and it is the seal between the mask that is the critical link in that process. And since it is absolutely the last protective barrier between the inhalation hazard and worker, I cannot imagine why this step would be even considered to be eliminated.

    I define ‘fit’ as providing a tight seal or specifically referring to the fit of a respirator that is in accordance with the CSA standard for fittest pass levels, a half-mask respirator achieving a fit factor of 100 and a fullface respirator achieving a fit factor of 1000 with the 6 different test maneuvers.

    My 10 years experience with Portacount quantitative fit-testing of over 1000 people has shown that:

    a.Some (only a few) specific manufacturer’s facepieces (full and half mask) are definitely more likely to fit than others (ie pass the fit test (FF of 100 for halfmask and FF 1000 for full face) in greater than 95% of the time with little training and some manufacturer’s facepieces are definitely more likely to fail. With only one exception, in my experience, there is always a need for a second or third respirator manufacture’s model to fit any group of workers. The major leak points are at the bridge of the nose for half-mask respirators and at the temples (from the slight indentation in bone structure) for full face respirators.
    b.Testing is absolutely needed to independently prove to both worker and employer that the mask makes an effective seal and provides the level of protection needed (not rely upon worker’s sensations of odor or air movement, which are not reliable).
    c.The time it takes is not at all onerous for Portacount quantitative fittesting, averaging about 10-15 minutes per person per facepiece. Costs are minimized when batching worker groups.
    d.Elastomeric half mask respirators very often (estimate > 75% of the time) produce fit factors greater than that required for full-face respirators (ie > 1000); [3 orders of magnitude or 1000-fold reduction in particle concentration inside the facepiece compared to the levels outside the facepiece]. The Portacount does have the ability to differentiate very good fits from poor mask fits. I anticipate that this will become more important for workers given the increasing prevalence of allergies in the workplace and the likely increasing need for respiratory protection.
    e.Once the training and quantitative fit-testing are done once or twice, little additional gains in worker protection are observed in my experience (ie. corrections to use of respirator, identifying masks that don’t fit or workers that aren’t trained). I have also noticed that there are spillover effects such as increased RPE use at home and with hobbies.
    f.Comfort does not play a role in the fit of a respirator but does affect how long it will be worn without complaints; the more uncomfortable, the less it will be worn.
    g.’Better fitting respirators’ are by far, in my experience, the elastomeric type, with simple designs and easy to adjust straps.
    h.Many respirator manufacturers are lax in providing clear labels of make and model of respirator as well as individual parts and part numbers.
    i.Improvements are needed to make it easier to do the positive and negative user seal checks with cartridges in place (eg. cartridge openings small enough for hands to cover easily).
    If individual confirmation of a mask seal is the goal, then individual testing is needed. I actually cannot imagine any possible means of independently evaluating that effectiveness of mask seal to an individual’s face without actual testing, because of myriad of possible interactions between individual face shapes and mask configurations.

    Testing is especially important because of the numerous and various vested interests at work in the fittesting world every step of the way producing a myriad of ways of interpreting the same information: manufacturers marketing their wares in ways that buyers must beware, employers minimizing their operational costs, OHS/fittest consultants trying to comply with their clent’s requests, and even the workers, actually compromising their own safety by wanting to please their employer.

    In my experience, one of the big problems that I see is that typically, minimal effort is undertaken by employers to actually identify and assess the hazards in the first place, let alone assess the need and adequacy of RPE. The SARS experience and followup is a case in point. N95 masks have been repeatedly recommended by numerous organizations for protection from inhaled viruses but the literature is clear that the protection that they provide is not adequate for the hazard or even for influenza, known years earlier. While some gains have probably been made to demonstrate the inadequacy of surgical masks, it is also clear that the N95 masks do not provide a protection factor that comes close to the level needed for the exposure levels experienced by various hospital staff. I think a more relevant workshop question is: Why is the current practice of using N95 acceptable, when very reasonable and effective alternatives are readily available? What barriers exist to changing this practice?

    Please provide a qualified health professional who can provide and meet any standards regarding respirator “fit” in the Baltimore, Md. and/or Washington, DC area. Maybe you point me in the right direction. Thank you.

    Thank you, Mr. Gossert, for your comment. This is a general reply to those who seek qualified health professionals that can provide assistance with respiratory “fit.”

    OSHA standard 29 CFR 1910.134(c) states:
    Respiratory protection program. This paragraph requires the employer to develop and implement a written respiratory protection program with required worksite-specific procedures and elements for required respirator use. The program must be administered by a suitably trained program administrator. In addition, certain program elements may be required for voluntary use to prevent potential hazards associated with the use of the respirator. The Small Entity Compliance Guide contains criteria for the selection of a program administrator and a sample program that meets the requirements of this paragraph. Copies of the Small Entity Compliance Guide will be available on or about April 8, 1998 from the Occupational Safety and Health Administration’s Office of Publications, Room N 3101, 200 Constitution Avenue, NW, Washington, DC, 20210 (202-219-4667).

    Here are some suggestions on finding a health professional in a particular area:

    1.Contact a company in the area whose workers use respirators and ask to speak with the respirator program administrator.
    2.Contact a professional association like the American Industrial Hygiene Association (AIHA). AIHA’s website has a link to consultants who could provide the service you seek.
    3.Contact a local hospital administrator.

    “G. ‘Better fitting respirators’ are by far, in my experience, the elastomeric type, with simple designs and easy to adjust straps.”

    Why not just buy some respirator seals? They work for everyone and the failure rate gets thrown out the window. As long as you put the seal on straight, there is no leakage.

    A local company (in my hometown) in Baxter, MN sells them online now, Breathe Safely, LLC

    Our company quit using stand alone respirators now entirely. We really recommend it!

    Please note:
    NIOSH has not evaluated the seals (which are the subject of this comment) as part of any respirator certification. Paragraph 84.30(a) of the NIOSH respirator approval regulations, 42 CFR Part 84, requires NIOSH to approve only complete respirator assemblies. This paragraph states, “The Institute shall issue certificates of approval pursuant to the provisions of this subpart only for individual, completely assembled respirators which have been examined, inspected, and tested, and which meet the minimum requirements set forth in subparts H through L of this part, as applicable.” Consequently, attachment of the seals to a NIOSH-approved respirator’s facepiece sealing surface is considered an unauthorized change to the respirator’s approved configuration, creating an unapproved respirator. Approval of the seals for use in conjunction with any NIOSH approved respirator, would need to be evaluated under Paragraph 84.35, Changes or modifications of approved respirators; issuance of modification of certificate of approval, in order to assure the approved respirator performance is not adversely affected. This modification must be requested by the respirator manufacturer, not the manufacturer of the seal.

    References to products or services do not constitute an endorsement by NIOSH or the U.S. government.

    You certainly have some agreeable opinions and views. Your blog provides a fresh look at the subject.

    Newer technology in quantitative fit testing is faster and measures mask integrity simultaneously. CNP (controlled negative pressure) technology allows a user to be tested at different pressures simulating low-medium-high work rates in step with requirements such as NFPA breathing rates utilized on a POSI-Check. The technology also features adapters that eliminate probing the respirator. Major Fire departments, HAZMAT teams & our US military special operations as well as the law enforcement community have embraced the technology. All said is the decision logic on this subject in step with new and yet to be introduced newer tecnologies for fit testing or is it biased towards what has been in place for decades?

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