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Section 3: Ancillary Respirator InformationFrequently asked Questions and Answers about respirators, the Science behind Respirator Function and Performance, and a listing of all NIOSH-approved and FDA cleared surgical N95 respirators.
The Basic FAQsWho is NIOSH and what do they have to do with respirators?The National Institute for Occupational Safety and Health (NIOSH) is the federal agency responsible for conducting research and making recommendations to prevent workplace injuries and illnesses. As part of the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS), NIOSH helps assure safe and healthful working conditions by conducting scientific research, developing guidance and authoritative recommendations, disseminating information, and responding to requests for workplace health hazard evaluations. The National Personal Protective Technology Laboratory (NPPTL) is the division within NIOSH responsible for the certification and approval of respirators for use in occupational settings, including those under the jurisdiction of the Occupational Safety and Health Administration (OSHA). This authority is implemented through regulations in Part 84 of Title 42 of the Code of Federal Regulations (42 CFR 84). This NIOSH regulation defines the following authority:
What is a respirator?A respirator is a personal protective device that is worn on the face, covers at least the nose and mouth, and is used to reduce the wearer’s risk of inhaling hazardous airborne particles (including dust particles and infectious agents), gases, or vapors. Respirators are considered as a "last line of defense" in the occupational hierarchy of controls. They are recommended when engineering and administrative controls are not feasible or sufficient to control the hazard, or until these other controls can be put in place. Respirators protect the user in two basic ways; either by filtering contaminated ambient air or by providing a clean source of air. Respirators that remove contaminants from the air are called air-purifying respirators (APRs). APRs include particulate respirators, which filter out airborne particles, and “gas masks,” which remove gasses and vapors from ambient air. View the OSHA Respirator Types Video The classification of air-purifying respirators can be further subdivided into three categories:
The other type of respirators, which protect by supplying clean air from another source are called air-supplying respirators (ASRs). This type of respirator is comprised of airline, or supplied air, respirators (SARs), which use compressed air from a remote source; and self-contained breathing apparatuses (SCBAs), which include their own breathing gas (compressed air or oxygen) supply. What is an N95 respirator?The NIOSH respiratory protection approval regulation (42 CFR 84) defines the term “N95” to refer to a filter class, not a respirator. However, many filtering facepiece respirators have an N95 class filter and many people refer to them, and have come to know them, as N95 respirators. A filtering facepiece respirator that filters out at least 95% of airborne particles during “worse case” testing using a “most-penetrating” sized particle is given a 95 rating.1 There are nine classes of NIOSH-approved particulate filtering respirators available at this time. 95% is the minimal level of filtration that will be approved by NIOSH. The N, R and P designations refer to the filter's oil resistance as described in the table below.
All NIOSH-approved filtering facepiece respirators are marked with the manufacturer’s name, the part number (P/N), the protection provided by the filter (e.g., N95, P100), and “NIOSH.” Some filtering facepiece respirators approved by NIOSH may have the NIOSH approval number (TC-84A-xxxx) as an additional identification marking. This information is printed either on the face, exhalation valve (if one exists), or head straps (see Figure 1). The lot number or date of manufacture may appear on the respirator or may be located on the packaging. View a listing of all NIOSH-approved particulate filtering facepiece respirators. NIOSH also maintains a separate database of all NIOSH- approved respirators, inclusive of all respirator types on the Certified Equipment List. If a particulate filtering facepiece respirator does not have these markings as identified above and does not appear on one of these lists, it has not been certified by NIOSH for occupational use.  Figure 1 1 Reference: Rengasamy,S.,W.P.King, B.C.Eimer and R.E. Shaffer.(2008). Filtration performance of NIOSH-approved N95 and P100 filtering facepiece respirators against 4 to 30 nanometer-size nanoparticles. Journal of Occupational and Environmental Hygiene 5(9):556-564. Healthcare-Related FAQs
Is a surgical mask an N95 respirator?No. Surgical masks are not designed for use as particulate respirators and do not provide as much respiratory protection as an N95 respirator. Surgical masks provide barrier protection against droplets including large respiratory particles. Most surgical masks do not effectively filter small particles from the air and do not prevent leakage around the edge of the mask when the user inhales.2 The NIOSH Science Blog: N95 Respirators and Surgical Masks, posted 10/15/2009, provides an explanation of the science behind and the similarities/differences between NIOSH-approved particulate respirators and surgical masks. 2 Reference: Rengasamy,S., B.C.Eimer, and R.E.Shaffer. (2009) Filtration performance of FDA-Cleared surgical masks. Journal International Society Respiratory Protection 26; 54-70. OSHA Video: The Difference Between Respirators and Surgical Masks What is a surgical N95 respirator?A surgical N95 respirator is a NIOSH-approved N95 respirator that has also been cleared by the Food and Drug Administration (FDA) as a surgical mask. These products are noted in red font on the table of NIOSH-approved N95 respirators. For your convenience, a comprehensive table of these products appears below. If you have a product that you believe is FDA cleared that does not appear on this table, you should verify the FDA clearance by contacting the FDA at 1-800-638-2041. The National Institute for Occupational Safety and Health (NIOSH) is the U.S. Government agency responsible for the certification and approval of respiratory protective devices for occupational use. The authority is granted to NIOSH in accordance with conditions and standards established in Title 42 of the Code of Federal Regulations (CFR), Part 84. It also addresses quality assurance requirements for the manufacturing of respiratory protective equipment. The approach to approval is that anybody can manufacture and sell any type of respiratory protective device, but only those that meet or exceed all of the requirements established in the 42 CFR 84 standards are acknowledged by NIOSH, and only those that have been NIOSH certified may be marketed as a NIOSH-approved respirator. The Food and Drug Administration (FDA) is the U.S. Government agency that oversees most medical products, foods, and cosmetics. Within the FDA, the Center for Devices and Radiological Health (CDRH) oversees the safety and effectiveness of medical devices. Medical devices intended for use in preventing and treating disease is subject to regulation under the device provisions of the Federal Food, Drug, and Cosmetic Act. This includes surgical masks and surgical N95 respirators. The FDA has no role in the approval or clearance of N95 respirators not intended for use as a medical device. This table of Surgical N95's is provided as a courtesy. If you have a product that you believe is FDA cleared that does not appear on this table, you should verify the FDA clearance by contacting the FDA at 1-800-638-2041.
Can the products with an exhalation valve be used in healthcare?Respirators with exhalation valves can be used in a healthcare setting when it is not important to maintain a sterile field (an example of an acceptable practice would be when taking the temperature or blood pressure of a patient). Respirators with exhalation valves should not be used in situations where a sterile field is required (e.g. during an invasive procedure in an operating or procedure room) because the exhalation valve allows unfiltered exhaled air to escape into the sterile field. Do N95 respirators come in different sizes?Yes. The sizing differs with each respirator model. Some of the sizing options include small, small/medium, medium, medium/large, and large. Particulate filtering facepiece respirators, including those commonly referred to as N95s, are available in multiple size configurations that are variable and not standardized across models. How do I know what size I need?Fit testing is needed to determine if a particular size and model of respirator provides you with an acceptable fit. Fit testing is model specific. Before you wear a respirator in an occupational setting, you must be fit tested in each respirator model you will wear. Do N95 respirators come in different styles?Yes. Filtering facepiece respirators are available in a wide range of colors, shapes, and styles. Some styles will fit individuals better than others and certain styles may be more comfortable and have better fitting characteristics. As long as the N95 is NIOSH-approved, has been fit tested, and is being used in accordance with the requirements of an OSHA-compliant respirator program, including appropriately donned by the user, then the wearer should receive the expected protection factor regardless of color, shape, or style. Below are some of the styles available.
Photos courtesy of 3M, Kimberly-Clark, and Moldex. Back to topWhy do some N95 respirators have an exhalation valve on the front?The use of an exhalation valve reduces exhalation resistance, which makes it easier to breathe (exhale). Some users feel that a respirator with an exhalation valve keeps the face cooler and reduces moisture build up inside the facepiece. Does moisture build up in respirators?The wearer’s respiratory secretions and moist exhaled breath can lead to moisture build-up in a respirator. While it is possible for moisture to build up in a respirator with or without an exhalation valve, preliminary research shows that this is unlikely. Back to topWhat are the differences among these products?
How long can you wear the same N95 respirator?The current NIOSH service-time-limit recommendations for non-powered particulate filter respirators are that filter elements should be replaced at the following frequencies:
Can a N95 respirator be used from Operating Room (OR) case to OR case or from patient to patient?Used respirators are considered contaminated and ideally should be discarded after each patient encounter. Disposable N95 respirators worn during aerosol-generating procedures should be discarded after the procedure. Healthcare facilities can extend the use of disposable N95 respirators by training personnel to wear them during serial patient encounters without removing or re-donning between encounters. There is the risk of respirator contamination and contact transmission with this practice where extended use of disposable N95 respirators could entail a risk of contact transmission by touching a contaminated surface of the respirator and subsequently touching the mucous membranes of the face or a hypothetical risk of re-aerosolization of virus from a used respirator. The risk will be minimized if HCWs perform hand hygiene every time before and after touching the respirator. For healthcare applications where use is for protection against confirmed or suspected 2009 H1N1, please refer to Interim Guidance on Infection Control Measures for 2009 H1N1 Influenza in Healthcare Settings, Including Protection of Healthcare Personnel and Questions & Answers Regarding Respiratory Protection for Infection Control Measures for 2009 H1N1 Influenza among Healthcare Personnel for recommendations for the duration of wear for protection against the 2009 H1N1 exposure hazards. Back to topIs cross contamination a concern if I wear the same N95 from patient room to patient room?Yes, especially if the respirator was worn in a room with any type of aerosol generating procedure, or if the patient is suspected of or confirmed with having the 2009 H1N1 virus. Although this practice has the potential benefit of providing respiratory protection with limited supplies of respirators, there is the risk of respirator contamination and contact transmission. Extended use (i.e. use without removing or re-donning between encounters) of disposable N95 respirators could entail a risk of contact transmission by touching a contaminated surface of the respirator and subsequently touching the mucous membranes of the face or a hypothetical risk of re-aerosolization of virus from a used respirator. The precise balance between risk of contact transmission and benefit of extended use is unknown, although the risk will be minimized if HCWs perform hand hygiene every time before and after touching the respirator. In general, wearing an N95 respirator over multiple encounters (while minimizing touching, removing, or re-donning between encounters) would be favored over re-use, as this strategy is expected to involve less touching of the respirator and therefore less risk of contact transmission. For healthcare applications where use is for protection against confirmed or suspected 2009 H1N1, please refer to Interim Guidance on Infection Control Measures for 2009 H1N1 Influenza in Healthcare Settings, Including Protection of Healthcare Personnel and Questions & Answers Regarding Respiratory Protection for Infection Control Measures for 2009 H1N1 Influenza among Healthcare Personnel for recommendations for the duration of wear for protection against the 2009 H1N1 exposure hazards. Can I take a N95 respirator off in between patients or Operating Room cases?Used respirators are considered contaminated and ideally should be discarded after each patient encounter. A user should never touch the contaminated front of the respirator with his or her bare hands. Hands should always be washed after donning and doffing the respirator. Healthcare facilities implementing steps to extend the existing supply of disposable N95 respirators by training personnel to re-use them (i.e. removing and re-donning between patient encounters) refer to Questions & Answers Regarding Respiratory Protection for Infection Control Measures for 2009 H1N1 Influenza among Healthcare Personnel for recommendations for the possible re-use of respirators between patient encounters when used for protection against the 2009 H1N1 exposure hazards. How should I store my N95 in between patient encounters, in a healthcare setting?The manufacturers provide instructions for cleaning, sanitizing, repairing, inspecting, and storing their respirators. The respirators should be packed or stored so that the respirators do not become damaged or deformed. Never store disposable respirators in pockets, plastic bags, or other confined areas. Infectious material deposited on personal protective equipment may cause it to become a vehicle for direct or indirect transmission. In those situations, care is needed when removing and storing personal protective equipment to avoid contaminating skin, clothing, and mucous membranes. Remove the respirator and either hang it in a designated area or place it in a bag. (Consider labeling respirators with a user’s name before use to prevent reuse by another individual.) In healthcare settings where the patients have confirmed or suspected 2009 H1N1 influenza, please refer to Questions & Answers Regarding Respiratory Protection for Infection Control Measures for 2009 H1N1 Influenza among Healthcare Personnel for recommendations for the possible storage of respirators between patient encounters when used for protection against the 2009 H1N1 exposure hazards. Back to topCan I infect myself from the droplets that accumulate on the outside of the respirator?Respirators protect by capturing particles with the filter of the N95 respirator. Some aerosols can pose a contact hazard for infection. The accumulation of particles on the external surface of the respirator may be an exposure hazard from contact with the filter, including becoming a fomite for infectious agents. Users should be cautious and follow appropriate procedures to avoid self-inoculation from contact with these surfaces. Hand hygiene and infection control practices should be followed before and after touching the outside of the respirator when it is used in the presence of infectious agents. Do I need special training to wear an N95 or do I put it on and wear it like a surgical mask?The NIOSH certification requires respirators to be put on, used and maintained in accordance with the manufacturer instructions and a respiratory protection program that meets the requirements of the OSHA respiratory protection standard (29 CFR 1910.134). Training for all users is a mandatory part of OSHA’s respirator program requirements. Training is usually done at the same time that fit testing takes place. The OSHA standard contains required training elements. The manufacturer instructions for donning and doffing for each brand and model may be model-specific and must be followed. These instructions are located in the User Instructions provided, on the box or individual package of the respirators. The manufacturer’s instruction for putting on (donning) the respirator is also included in the information provided in the NIOSH listing for approved disposable respirators. Can we use an N95 that has not been cleared by the FDA in a patient setting?NIOSH-certified N95 respirators that have not been cleared by the FDA can be used for respiratory protection to reduce the exposures of healthcare personnel in a patient setting to hazardous particulates. These respirators have not been evaluated by FDA to determine whether they meet the fluid and flammability resistance as required for FDA clearance as medical devices. For this reason, they are not intended for use in exposure settings where the performance of a surgical mask to maintain a sterile field is required. What does it mean if a respirator is approved by NIOSH and cleared by the FDA?N95 respirators that are both certified by NIOSH and cleared by FDA as medical devices for use by healthcare personnel are called “surgical N95 respirators.” As with all NIOSH-certified N95 respirators, these products have been evaluated by NIOSH certification process and have demonstrated that they can filter out a minimum of 95% of airborne particles under worse case test conditions. These products have also been evaluated by the FDA to have demonstrated an acceptable level of fluid and flame resistance, which may be important in healthcare occupational settings, such as surgical suites. The FDA clearance process also requires that these products have labeling that is relevant to healthcare personnel, such as information about the presence of natural rubber latex. Medical Evaluation FAQs
Are medical evaluations a must?Yes, a medical evaluation is an element of the written respiratory protection program that is required by the Occupational Safety and Health Administration (OSHA) (29 CFR 1910.134). The standard requires that if you are required to wear a respirator due to a potential hazard in your work environment, you must be fit-tested, trained, and medically evaluated prior to having a respirator issued. View the OSHA Medical Evaluations for Workers Who Use Respirators video Is a medical evaluation required for voluntary use of a respirator (i.e., when respirator use is not required by your employer)?It depends on the type of respirator to be worn. A written respirator program, including medical evaluation, is required for the voluntary use of any respirator except filtering facepiece respirators. An N95 respirator often used by healthcare personnel is an example of a filtering facepiece respirator. Can the medical evaluation be completed when fit testing is performed or does it have to be completed prior? Does it have to be done by a physician?The medical evaluation determines your ability to use a respirator. It is required to be completed before you are fit tested and before the decision is made that you are required to use a respirator in the work environment. It is mandatory that you be evaluated by a physician or other licensed healthcare professional (PLHCP) who provides a written recommendation regarding your ability to use respirators. The physician or other licensed healthcare professional (PLHCP) needs to be an individual whose legally permitted scope of practice (i.e., license, registration, or certification) allows him or her to independently provide, or be delegated the responsibility to provide, some or all of the healthcare services required in the medical evaluation. If your employer opts to perform medical evaluations utilizing a medical questionnaire, the completed questionnaire is sent to the healthcare professional for review. Depending on your answers to the questionnaire, you may be required to have a follow-up medical evaluation before being allowed to wear a respirator. How frequently does the medical evaluation have to be completed?Medical evaluation is required once, prior to initial fit testing and use, if you are required to use a respirator in your workplace. However, the medical evaluation may need to be repeated if you, your supervisor, or your respiratory program administrator recognize signs or symptoms that may affect your ability to use the assigned respirator, or a physician or other licensed healthcare professional (PLHCP), determines that a condition exists which causes you to need another medical evaluation. Selection FAQs
What is the appropriate respirator to use in a particular environment?Your employer is responsible for selecting an appropriate respirator for you. Your employer’s designated respiratory protection program administrator can assist you with respirator selection. He/she administers and oversees the respiratory protection program at your workplace according to the Occupational Safety and Health Administration’s (OSHA) respiratory protection standard at (29 CFR 1910.134). The following resources may also be helpful:
What do you do with employees who have facial hair? (What if the beard or mustache is small enough that it is contained inside the respirator?)Tight-fitting respirators require the wearer’s face to be clean shaven where the respirator’s seal comes in contact with the skin. If the facial hair does not extend far enough to interfere with the device’s seal in any way, or interfere with the function of the exhalation valve, the wearer may wear it with the approval of the respiratory protection administrator. Loose-fitting respirators, such as Powered Air-Purifying Respirators (PAPRs) with loose-fitting hoods, do not form a tight seal with the face and, therefore, do not require the wearer to have a clean shaven face. Loose-fitting respirators (i.e. respirators with loose-fitting hoods or helmets) are the only type of respirators that may be worn with facial hair and do not require fit testing. What is the difference between air-purifying and air-supplied respirators?Air-purifying respirators (APR) work by removing contaminants from the air. APRs include particulate respirators, which filter out airborne particles, and “gas masks,” which filter out vapors and gases. Air-supplying respirators (ASR) protect employees by supplying clean breathable air from another source. ASRs include airline respirators, which use compressed air from a remote source; and self-contained breathing apparatuses (SCBAs), which include their own air supply. View more information about air-purifying and air-supplied respirators. What is the difference between a filtering facepiece respirator and an elastomeric?As the name implies, a filtering facepiece respirator is one in which the entire facepiece is comprised of the filter material. Elastomeric respirators are comprised of a molded facepiece to which replaceable filtering cartridges are attached. View more details and photos of the different types of respirators. We are having a hard time getting our usual brand of N95 respirators. If we purchase another brand or model, do we need to fit test all of our employees again?Yes. A fit test only qualifies the user to put on (don) one specific brand/make/model/size of respirator. However, it is only necessary to fit test those employees whose duties require them to wear a respirator. Therefore, you may not need to fit test “all” of your employees. If “all” employees are likely to be at risk of exposure to airborne contaminants you may want to consider a phased in fit testing program allowing the facility to have more time to eventually properly fit test the employees. You should only wear the specific brand, model, and size respirators you wore during successful fit tests. [Note: respirator sizing is variable and not standardized across models or brands. For example, a medium in one model may not offer the same fit as a different manufacturer’s medium model.] Respirator Manufacturer Prior NamesDue to the transitive nature of company holdings, if the manufacturing company you are looking for does not appear, please refer to the parent company listed under the notes column for product information. A list of Respirator Manufacturer Prior Names is provided as a service to users and may not be all inclusive due to NIOSH not being notified of name changes, mergers, etc. Can I use an N95 filtering facepiece respirator for protection against exposures to gases or vapors, such as glutaraldehyde or formaldehyde?N95 filtering facepiece respirators do not provide protection against gas and vapor exposures. N95 filtering facepiece respirators should not be used for respiratory protection in workplaces where hazardous gases or vapors are present, unless the concentration of the gases or vapors is below the NIOSH recommended exposure limit (REL) or OSHA permissible exposure limit (PEL). An N95 is designed to remove particles from the air you breathe, such as metal fumes (for example, fumes cause by welding), mineral or dust particles, or even biological particles like viruses; however, it will do nothing to remove glutaraldehyde, formaldehyde, or other gases or vapors. If harmful gases are present in amounts greater than the exposure limits, you will probably need a respirator that uses special cartridges or canisters containing specially treated charcoal to remove the harmful gas before you inhale it into your lungs. To find what level of a particular chemical is harmful and what protection you should use, consult the NIOSH Pocket Guide to Chemical Hazards or the chemical’s Material Safety Data Sheet (MSDS). Why do I need to know the concentration of a contaminant that may present an inhalation hazard?The concentrations of harmful gases, vapors, or particulates is part of the information used to determine what type of respiratory protection (i.e., the class of respirator) is needed to protect you from inhaling them in hazardous concentrations. The concentrations of infectious bioaerosols are generally not easily measured or determined. Therefore, the determination of an appropriate type of respiratory protection to be used for bioaerosol exposures is generally made using professional judgment. How do I figure out what protection I need the respirator to provide? Why can’t I just buy a respirator that will protect me from everything?An air-purifying respirator (APR) that would remove all types of hazardous contaminants from the air you breathe (universal respiratory protection) just does not exist. The respirator that comes closest would be an air-supplying respirator (ASR), which uses “clean” breathing air either from a remote source or carried by the wearer. ASRs are either self-contained breathing apparatus (SCBA) with cylinders of breathing gases or supplied air respirators (SAR), also known as airline respirators that use air supplied from a remote location. For most healthcare situations, ASRs require significantly more maintenance and provide much higher protection than needed for the respiratory hazards. Fit Test FAQs
What is a respirator fit test?A fit test is a test protocol conducted to verify that a respirator is both comfortable and correctly fits the user. Fit testing uses a test agent, either qualitatively detected by the wearer’s sense of taste, smell or involuntary cough (irritant smoke) or quantitatively measured by an instrument, to verify the respirator’s fit. See questions related to qualitative and quantitative fit testing for more specific information. View the OSHA Respirator Fit Testing video Why is fit testing necessary?Fit testing each model of respirator the employee is to use in workplace tasks before their use is important to assure the expected level of protection is provided by minimizing the total amount of contaminant leakage into the facepiece. The benefits of this testing include better protection for the employee and verification that the employee is wearing a correctly-fitting model and size of respirator. Higher than expected exposures to a contaminate may occur if users have poor face seals with the respirator, which can result in excessive leakage. Are there different methods for respirator fit testing?Yes. Fit test methods are classified as either qualitative or quantitative, and there are multiple protocols of each classification that are OSHA-accepted, ANSI-accepted, or NIOSH-recommended. A qualitative fit test is a pass/fail test to assess the adequacy of respirator fit that relies on the individual’s sensory detection of a test agent. A quantitative fit test numerically measures the effectiveness of the respirator to seal with the wearer’s face, without relying on the wearer’s voluntary or involuntary response to a test agent. What is the difference between a qualitative and quantitative fit test?Qualitative fit testing (QLFT) relies on the respirator wearer’s senses to determine if there is a gap in the seal of the respirator to the wearer’s face. The test agents used in the OSHA-accepted and ANSI-accepted qualitative fit testing protocols are:
The test protocols include testing at a sensitivity level that demonstrates the user will be able to appropriately sense the presence of the test agent within the respirator by taste, smell or the urge to cough. Quantitative fit testing (QNFT) uses fit testing instrument(s) to provide quantitative, or numerical measurements of the amount of face seal leakage present when a given respirator is donned by a particular user. How is qualitative fit testing performed?The Occupational Safety and Health Administration (OSHA) has included the acceptance of respirator fit test protocols in it’s regulations at 29 CFR 1910.134. The OSHA-accepted fit test protocols can be found at 29 CFR 1910.134 appendix A. The American National Standards Institute’s ANSI Z88.10, Respirator Fit Testing Methods provides the step-by-step explanations for conducting the ANSI-accepted fit tests. While the OSHA regulations and ANSI Z88.10 provide the procedures that must be used to conduct each of the accepted protocols, a general description of how the protocols are conducted is provided below for the convenience of the reader. Qualitative fit testing (QLFT)
How is quantitative fit testing performed?The Occupational Safety and Health Administration (OSHA) has included the acceptance of respirator fit test protocols in it’s regulations at 29 CFR 1910.134. The OSHA-accepted fit test protocols can be found at 29 CFR 1910.134 appendix A. The American National Standards Institute’s ANSI Z88.10, Respirator Fit Testing Methods provides the step-by-step explanations for conducting the ANSI-accepted fit tests. There are several methods with significantly different protocols for conducting Quantitative fit testing (QNFT). While the OSHA regulations and ANSI Z88.10 provide the procedures that must be used to conduct each of the accepted protocols, a general description of the most common methods used in the protocols are provided below for the convenience of the reader. In order to do these measurements, a small sampling tube is positioned to sample the air within the facepiece of the respirator and attached to a fit testing instrument able to calculate the percentage of particles leaking into the facepiece.
Are respirator fit tests required?Yes. The Occupational Safety and Health Administration (OSHA) (29 CFR 1910.134) requires a respirator fit test to confirm the fit of any respirator that forms a tight seal on the wear’s face before it is to be used in the workplace. That same OSHA respirator standard also prohibits tight fitting respirators to be worn by workers who have facial hair that comes between the sealing surface of the facepiece and the face of the wearer. How often must fit testing be done?Because each brand, model, and size of particulate facepiece respirators will fit slightly differently, a user should engage in a fit test every time a new model, manufacture type/brand, or size is worn. Also, if weight fluctuates or facial/dental alterations occur, a fit test should be done again to ensure the respirator remains effective. Otherwise, fit testing should be completed at least annually to ensure continued adequate fit. Once I am fit tested can I use any brand / make / model respirator as long as it is the same size?No. A fit test only qualifies the user to put on (don) the specific brand/make/model of respirator with which an acceptable fit testing result was achieved. Users should only wear the specific brand, model, and size respirators that he or she wore during successful fit tests. [Note: respirator sizing is variable and not standardized across models or brands. For example a medium in one model may not offer the same fit as a different manufacturer’s medium model.] What is a respirator user seal check?It is a procedure conducted by the respirator wearer to determine if the respirator is properly seated to the face. The user seal check can be either a positive pressure or negative pressure check, which are generally performed as follows: The positive pressure user seal check is where the person wearing the respirator exhales gently while blocking the paths for exhaled breath to exit the facepiece. A successful check is when the facepiece is slightly pressurized before increased pressure causes outward leakage. The negative pressure user seal check is where the person wearing the respirator inhales sharply while blocking the paths for inhaled breath to enter the facepiece. A successful check is when the facepiece collapses slightly under the negative pressure that is created with this procedure. A user seal check is sometimes referred to as a fit check. A user seal check should be completed each time the respirator is put on (donned). It is only applicable when a respirator has already been successfully fit tested on the individual. When should a user seal check be done?Once a fit test has been done to determine the best model and size of respirator for a particular user, a user seal check should be done by the user every time the respirator is to be worn to ensure an adequate seal is achieved. How do I do a user seal check on a particulate respirator?A user seal check may be accomplished by using the procedures recommended by the manufacturer of the respirator. This information can be found on the box or individual respirator packaging. There are positive and negative pressure seal checks and not every respirator can be checked using both. You should refer to the manufacturer’s instructions for conducting user seal checks on any specific respirator . The following positive and negative user seal check procedures for filtering facepiece respirators are provided as examples of how to perform these procedures. Positive pressure check –Once the particulate respirator is properly put on (donned), your hands over the facepiece, covering as much surface area as possible. Exhale gently into the facepiece. The face fit is considered satisfactory if a slight positive pressure is being built up inside the facepiece without any evidence of outward leakage of air at the seal. Examples of such evidence would be the feeling of air trickling onto the your face along the seal of the facepiece, fogging of your glasses, or a lack of pressure being built up inside the facepiece. If the particulate respirator has an exhalation valve, then performing a positive pressure check may be impossible. If so, then do a negative pressure check. Negative pressure check – Negative pressure seal checks are conducted on particulate respirators that have exhalation valves. To conduct a negative pressure user seal check, cover the filter surface with your hands as much as possible and then inhale. The facepiece should collapse on your face and you should not feel air passing between your face and the facepiece. Do Powered Air-Purifying Respirators (PAPRs) require fit testingThe answer to this question depends on the type of facepiece that the respirator has. Any facepieces that form a tight seal to the wearer’s face, e.g. half-masks and full facepieces must be fit tested regardless of the mode of operation. The PAPR fit test is conducted with the blower turned off. Loose fitting respirators, such as PAPRs, in which the hood or helmet are designed to form only a partial seal with the wearer’s face or hoods which seal loosely around the wearer’s neck or shoulders, do not require fit testing. Training FAQsWhy do I have to be trained to use a respirator?Respirators, including filtering facepiece respirators such as N95s, have model-specific user instructions including donning instructions and use limitations. Respirators are frequently misused for purposes in which they provide little to no protection. It is important to know what respirator to use and how to use it correctly so that it can provide the protection that is expected of it. OSHA (29 CFR 1910.134) regulations require that respirator training be provided prior to requiring an employee to use a respirator in the workplace. The training must be comprehensive, understandable, and recur at least annually – or more often if necessary. OSHA identifies the following as minimum knowledge a respirator user should have upon completing respirator training:
How often do I have to be retrained?An employee should be trained annually, when exposure conditions change, when a new type or model of respirator is issued, or when the employee’s knowledge or use of the respirator indicates the need (e.g. the supervisor observes the wearer using the respirator improperly). Donning and DoffingAre all brands and models donned the same?No. Not all brands and models are donned (put on) the same way. That is why it is important that you always consult the manufacturer’s user instructions before putting on (donning) a new brand or model of respirator. Typically, for N95 particulate respirators, the proper placement of head straps means that the lower strap should be worn around the neck and below the ears. The top strap should sit above the ears and around the crown of the head, securing the filter piece to the user’s face. The facepiece should feel snug. On most N95 models, the nosepiece is meant to be molded to the user’s facial structure using his or her index fingers of both hands to press gently against the metal strip until it molds to a snug fit. Where do I find instructions for putting on (donning) a respirator?All respirators should come with manufacturer’s instructions specifically addressing how to properly put on (don) the selected respirator to provide expected protection. For more information on this topic please refer to the NIOSH-Approved Particulate Filtering Facepiece Respirators web page. Once on the page, select the type of respirator (e.g. N95) and it will provide a table with the manufacturer's donning procedure and user instructions for each approved respirator model. End-of-service-life FAQs
What is end-of-service-life?End-of-service-life is when a respirator no longer works correctly. It is when the filtering medium can no longer provide the expected level of protection from harmful air contaminants, has reached its capacity for capture and retention of the contaminant, when breathing while wearing the respirator becomes too difficult, or when the respirator becomes damaged, contaminated, or the integrity of the respirator is no longer intact. Do respirators have end-of-service-life indicators on them?Yes. Some do, for others like the N95 the “indicator” may be the appearance, whether the respirator is damaged, contaminated with visible blood or body fluids, or misshapen. For other types of respirators there are specific indicators integral in the device. All self-contained breathing apparatuses have an alarm that tells the wearer that he/she is going to run out of air from his cylinder and he/she must leave the contaminated area. Some gas- and vapor-removing air-purifying respirators are also equipped with end-of-service-life indicators (ESLI). The ESLI are usually specific to only one contaminant. The ESLI gives the wearer an indication, often a color change, that the contaminant will no longer be able to be removed by the cartridge or canister and that the cartridge or canister should be replaced. What is the service life of an N95 filter or filtering facepiece respirator?Unless the manufacturer identifies a specified duration of use, for example “single use only”, the service life of all filters is limited by considerations of hygiene, damage, and breathing resistance. All filters should be replaced whenever they are damaged, soiled, or causing noticeably increased breathing resistance. Follow manufacturer’s recommendations for specific information on the model you are using. How is a cartridge change out schedule calculated?In the absence of an ESLI, a cartridge/canister change out schedule is required for gas- and vapor-removing respirators and should be based on objective information or data that will ensure that canisters and cartridges are changed before the end of their service life. Usually, manufacturers have software to estimate a change out schedule for their cartridges or canisters. Changeout schedules are not the same from one manufacturer’s cartridges or canisters to that of another manufacturer. This is because the volume and type of adsorbent varies between manufacturers. Additionally, the Occupational Safety and Health Administration (OSHA) has mandatory changeout schedules for cartridges for certain substances like acrylonitrile, benzene, butadiene, formaldehyde, vinyl chloride, and methylene chloride. Workers depending on respiratory protection who are exposed to any of these contaminants at or above the OSHA Permissible Exposure Limit (PEL) must change cartridges/canisters according to OSHA’s requirements. In any case, workers should consult their Respirator Program Administrator regarding when to change their cartridges/canisters. OSHA provides guidance on using mathematical models OSHA has no accepted way to determine a cartridge’s service life when exposed to mixtures; computer models have been developed that can estimate service life if you know all the canister physical attributes, environmental factors, contaminants and levels, and work rates [Note: Other research has been conducted to develop models for contaminant mixtures, but they have not yet been adopted by OSHA.] NIOSH has developed a computer tool for estimating breakthrough times and service lives of air-purifying respirator cartridges manufactured to remove toxic organic vapors from breathed air that can be used with the cartridge/canister manufacturer’s recommendations for multi-gas use of the specific canister/cartridge being used. If respirators are required in your workplace, OSHA mandates that your employer establish and maintain a respiratory protection program that must describe the information and data relied upon and the basis for the canister and cartridge change schedule. Because of the complexity of factors involved in determining canister changeout schedules, consult your Respirator Program Administrator. Is canister/cartridge end-of-service life information available on the manufacturers’ website?Most manufacturers provide information on their website to help in determining the appropriate changeout schedule for their product. If I am using a combination cartridge with a PAPR, how do I know when to change the cartridge? Can the cartridge be decontaminated to extend its useful life?The training you receive in the use of your assigned respirator as part of your employer’s respiratory protection plan will tell you the frequency of cartridge change that has been determined to be appropriate for the conditions in your worksite. The Occupational Safety and Health Administration’s Standard for Respiratory Protection (29 CFR 1910.134) requires employers to implement a change schedule for all cartridges used in the workplace for protection against vapors and gases when there isn't an end-of-service- life indicator on the cartridge. This schedule must be site specific and take into consideration worksite conditions such as humidity, worker breathing rate, as well as the contaminants and their concentrations. The cartridge can’t be decontaminated (i.e. reconditioned for reuse). The filter media in the cartridge has a finite capacity and the mechanism used to remove the contaminants from the air is usually not reversible. Why do we need to change the respirator cartridge before we can smell something?The purpose of this is to prevent contaminants from breaking through the respirator's sorbent (filtering) cartridge(s), and thereby exposing the wearer. Historically, respirator wearers have relied on the warning properties (e.g., odor, irritation) of a contaminant as a means to determine when it is time for replacing used cartridges. OSHA no longer allows the use of warning properties as the primary basis for changing respirator cartridges. The following factors shall be considered when developing a Respirator Cartridge Change Schedule which is required by OSHA and should be documented in the Respirator Protection Program:
Do we need to throw a filter (used with a PAPR) away when used for/with an H1N1 patient for only one hour?Powered air purifying respirator filters used for protection against viruses have no time limit as to their ability to remove viruses from the air stream. Their use is subject to other considerations by the infection control or safety officer in the healthcare facility. Therefore, it is recommended there be written facility standards for use and disposal of these filters. However, filters and cartridges cannot be cleaned, sanitized, or disinfected and should be properly disposed of after use. At this time, neither the Centers for Disease Control and Prevention (CDC) nor the World Health Organization (WHO) have provided any recommendations for cleaning, sanitizing, or disinfecting respirators used for novel H1N1 virus exposures. The Occupational Safety and Health Administration (OSHA) requires respirator users to follow either the respirator manufacturer’s instructions or OSHA’s general procedures for cleaning respirators in 29 CFR 1910.134 Appendix B-2; however, OSHA’s procedures are not specific for novel H1N1 virus and may not lead to disinfection. Refer to the User Instructions for the specific PAPR unit and headgear to identify the components that can be cleaned. Respirator Protection Program FAQsWhy is it important for me to know who my respiratory protection program administrator is?The safety officer, industrial hygienist or designee of your facility, is responsible to run the respiratory protection program and evaluate its effectiveness. He/she is trained to identify, assess, and control types of potential inhalation hazards in your work area. He/she must be familiar with the Occupational Safety and Health Administration’s (OSHA) Respiratory Protection Standard (29 CFR 1910.134) and the use and application of the respirators at the particular workplace. Also, he/she is responsible to ensure you are provided with an appropriate and suitable respirator that is provided at no cost by the employer to the employee, training, and medical evaluations to protect you from inhaling harmful contaminants (contaminants could include biologic agents such as bacteria and viruses). If you have questions like whether you should be wearing respiratory protection, what kind of respiratory protection you should be wearing, how to maintain this equipment or how to put on or take off this equipment, you should contact your administrator. What is a respiratory protection program?A respiratory protection program is a written program required by the Occupational Safety and Health Administration’s (OSHA) Respiratory Protection Standard (29 CFR 1910.134). The program includes procedures specific to your worksite intended to prevent you from inhaling harmful contaminants in your workplace. OSHA requires that each employer must provide respirators to protect workers from workplace hazards during work to prevent inhalation of hazardous materials that cannot be controlled by other measures (i.e. engineering or administrative controls). The employer must establish and maintain a respiratory protection program, which is compliant with the OSHA respiratory protection standard and provides respirators suitable for their intended purpose. What is involved/ what comprises/ what components make up a respiratory protection program?The fundamental goal of any respiratory protection program is to protect workers against any adverse health effect caused by inhalation of contaminants in the work environment. The Occupational Safety and Health Administration’s (OSHA) Respiratory Protection Standard (29 CFR 1910.134) requires that each respiratory protection program must include a written plan detailing how the program will be administered. In addition to having a written program, the employer must also be able to demonstrate that the program is enforced and updated as necessary. The OSHA small entity compliance guide
Additional Respiratory Protection ResourcesCDC / NIOSHRespirator Trusted-Source Information Page General Procedures for Properly Putting on and Taking Off a Disposable Respirator Guidance for the Selection and Use of Personal Protective Equipment (PPE) I Healthcare Settings
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