U.S. Department of Labor | ||||||
Occupational Safety & Health Administration |
This proposed guidance reflects the current thinking on the stockpiling of respirators and facemasks for the purpose of pandemic influenza preparedness. The information contained in this document is distributed solely for the purpose of pre-dissemination public comment. It has not been formally disseminated by DOL. It does not represent and should not be construed to represent any agency determination or policy.
Proposed Guidance on Workplace Stockpiling of Introduction: In the event of an influenza pandemic, employers will play a key role in protecting employees' health and safety as well as in limiting the impact on the economy and society. Employers will likely experience employee absences, changes in patterns of commerce and interrupted supply and delivery schedules. To further preparedness efforts, the Department of Labor (DOL) proposes to publish this information on stockpiling respirators and facemasks in occupational settings as an appendix to the DOL and the Department of Health and Human Services (HHS) jointly issued Guidance on Preparing Workplaces for an Influenza Pandemic (February 2007). This proposed guidance is designed to encourage employers in the private and public sectors to purchase and stockpile facemasks and respirators in advance of an influenza pandemic, because manufacturing capacity at the time of an outbreak would not meet the expected demand for respiratory protection devices during the pandemic. Through advanced planning and stockpiling, employers will be able to better protect their employees as well as lessen the impact of a pandemic on their business, society, and the economy. As is explained in more detail in this guidance, employers should consider stockpiling facemasks and respirators. More specifically, it is recommended that employees at very-high risk and high risk of exposure to pandemic influenza use respirators, while employees at medium risk of exposure use facemasks. Neither facemasks nor respirators are recommended for employees at lower risk of exposure to pandemic influenza. This guidance is advisory in nature and informational in content. It is not a standard or a regulation, and it neither creates new legal obligations nor alters existing obligations created by OSHA standards or the Occupational Safety and Health Act (OSH Act). Pursuant to the OSH Act, employers must comply with safety and health standards as issued and enforced either by OSHA or by an OSHA-approved State
Plan. In addition, Section 5(a)(1) of the OSH Act, the General Duty Clause, requires employers to provide their employees with a workplace free from recognized hazards likely to cause death or serious physical harm. Employers can be cited for violating the General Duty Clause if there is a recognized hazard and they do not take reasonable steps to prevent or abate the hazard. However, failure to implement any specific recommendations in this guidance is not, in itself, a violation of the General
Duty Clause. Citations can only be based on standards, regulations, or the General Duty Clause.
Pandemic Influenza and the Workplace: For most employers, protecting their employees during an influenza pandemic will depend on emphasizing proper hygiene (cleaning hands and decontaminating surfaces) and practicing social distancing. Social distancing means reducing the frequency, proximity, and duration of contact between people (both employees and customers) to reduce the chances of spreading pandemic influenza virus from person-to-person. There are additional protective measures, including engineering changes, procedure changes, and the use of personal protective equipment, which employers and employees can implement based upon the occupational exposure risk profile of their job tasks in the work place. Use of respiratory protection (respirators) and barrier protection (facemasks) are components of a comprehensive plan to prepare workplaces for an influenza pandemic. To assist employers in preparing for a pandemic, DOL and HHS have issued Guidance on Preparing Workplaces for an Influenza Pandemic. That document, referred to here as “Preparing Workplaces” provides information that employers and employees can use to evaluate their workplace and reduce the risk of being exposed to the pandemic influenza virus. DOL has also developed a guidance document to help healthcare employers protect their employees during an influenza pandemic: Pandemic Influenza Preparedness and Response Guidance for Healthcare Workers and Healthcare Employers can be found at http://www.osha.gov/Publications/3328-05-2007-English.html. It is important to note that in addition to occupational exposure risks, employees will also have non-occupational exposure risks. Such non-occupational exposure risks could include commuting to and from work on public transportation (e.g., bus or train) or other community exposures (e.g. shopping). By addressing non-occupational exposure risks, employers and employees can minimize the chances of an employee bringing illness into the workplace. Additional information on strategies to reduce community exposures to pandemic influenza can be found on www.pandemicflu.gov Employee risks of occupational exposure to influenza during a pandemic may vary from very high to high, medium, or lower (caution) risk. The level of risk depends in part on whether or not jobs require close proximity to people potentially infected with the pandemic influenza virus, or whether they are required to have either repeated or extended contact with individuals or groups.
Employers of critical infrastructure and key resource employees (such as law enforcement, emergency response, or public utility employees) may consider upgrading protective measures for these employees beyond what would be suggested by their exposure risk due to the necessity of such services for the functioning of society as well as the potential difficulties in replacing them during a pandemic (for example, due to extensive training or licensing requirements). To help employers determine appropriate work practices and precautions, OSHA has divided workplaces and work operations into four risk zones, according to the likelihood of employees' occupational exposure to pandemic influenza. We show these zones in the shape of a pyramid to represent how the risk will likely be distributed. The vast majority of American workplaces are likely to be in the medium exposure risk or lower exposure risk (caution) groups. Occupational Risk Pyramid for Pandemic Influenza Very High Exposure Risk:
High Exposure Risk:
Medium Exposure Risk:
Lower Exposure Risk (Caution):
After discussing the relative advantages and disadvantages of respiratory protection options, we will propose guidance for estimating facemask and respirator usage during a pandemic for workplaces in each of these exposure risk zones. Facemasks and Respirators: As employers evaluate their workplace, facemasks and respirators are the two types of protection that should be considered for use in occupational settings during an influenza pandemic. While the degree of protection offered by these devices in a pandemic environment is uncertain at this time, use of these devices during an influenza pandemic is a recommended part of a comprehensive strategy of personal protection. Facemasks: Respirators: Air purifying respirators are the type of respiratory protection recommended to reduce exposure risk to pandemic influenza in certain occupational settings. Air purifying respirators can be divided into several types. Each of these is described below; Table 1 provides a comparison of these respirator types.
Replacing Disposable Respirators: Disposable respirators are designed to be disposed after use. Once worn in the presence of an infectious individual, the respirator should be considered potentially contaminated with infectious material. Touching the outside of the device should be avoided to prevent self-inoculation (touching the contaminated respirator and then touching one's eyes, nose, or mouth). It should be noted that a once-worn respirator will also be contaminated on its inner surface by the microorganisms present in the exhaled air and oral secretions of the wearer. In the above scenario, users should discard respirators when they become unsuitable for further use due to excessive breathing resistance (e.g., particulate clogging the filter), unacceptable contamination/soiling, or physical damage. In the context of pandemic influenza, some have proposed reusing disposable respirators for prolonged periods of time (e.g., weeks or months) in the event supplies are limited. However, data on decontamination and/or safe reuse of respirators for infectious diseases are currently not available. Although filtering facepiece respirators have been reused during public health crises in resource-limited settings, the safety and efficacy of this approach has yet to be confirmed. It is not possible to give definitive guidance on the safety or efficacy of reuse or decontamination of disposable respirators. In the interim, plans should be based on single use of equipment according to manufacturers' instructions, FDA label claims, and NIOSH user instructions. Respirator users should not attempt to decontaminate filtering facepiece respirators as it may create a health hazard for the user and it may render the respirator ineffective in providing respiratory protection. Reuse may increase the potential for contamination through contact transmission. The risk of contaminating the inside of the respirator through improper handling must be weighed against the need to provide respiratory protection. Thus, in preparing for an influenza pandemic, employers who anticipate providing respiratory protection to employees for the duration of the pandemic could instead consider using reusable respirators that are designed to be cleaned, repaired and reused. Information on proper cleaning and maintenance of respirators (both elastomeric respirators and PAPRs) is model specific and provided by the manufacturer as part of the NIOSH-certified user instructions. Purchasing reusable respirators also may reduce or eliminate the impact of potential shortages of filtering facepiece respirators and may be more cost effective over the duration of the pandemic. If an employer chooses to use reusable elastomeric respirators, the employer should take into account the initial training needed to teach employees how to properly clean such respirators as well as the time needed for employees to clean the respirators after use. Replacing Elastomeric Respirator and PAPR Filters: In the case of elastomeric respirators and PAPRs, the respirator body and PAPR case is designed to be decontaminated and reused in accordance with the manufacturer's use instructions. If the filters are used in an environment where pandemic influenza is the sole air contaminant of concern, then the filters should last a long time if they are not physically damaged or soiled and are handled appropriately to control risk of contamination. In most workplaces, two to three filter sets should last for the duration of the pandemic. However, in certain work environments where there is a significant potential for physical damage or soiling of the filters (e.g., with blood or body fluids), employers may want to stockpile additional filter sets to ensure adequate protection of their employees for the duration of a pandemic. The following table summarizes the forgoing information about the advantages and disadvantages of facemasks and of the specific types of respirators previously described, as well as providing rough cost estimates. Employers may find this summary helpful in considering purchasing options for fulfilling the specific recommendations addressed in the remainder of this guidance. Table 1: Advantages and Disadvantages of Respirators and Facemasks
* Cost estimates are current as of publication and intended only for planning purposes. Actual pricing will vary depending on the make, model and quantity of respiratory protection devices selected. Estimating Employee's Occupational Exposure Status: The best method for assessing the number of employees at risk of occupational exposure and their particular level(s) of risk is for the employer to evaluate the workplace and develop a site-specific pandemic influenza plan. Then, the employer should assess the occupational exposure risk for each job classification and specific work tasks (for example, aerosol-generating medical procedures). Once an employer has classified jobs and tasks into very high, high, medium, and lower exposure risk categories, she/he should then estimate the number or percentage of employees who fall into each category. For example, not all hospital-based healthcare workers provide direct patient care. In addition changes in work practices during a pandemic (such as the cohorting or grouping of patients with pandemic influenza to reduce the number of healthcare workers and non-pandemic patients who may be exposed to pandemic patients) may further affect the number of persons with high risk exposures. In addition, a single employee may at times be at low risk whereas at other times they may have medium or high risk exposures. For example, a law enforcement officer's risk would be different when patrolling in a car (low risk), interacting with persons in the community (medium risk) or transporting someone who may be ill with pandemic influenza (high risk). Respirator and Facemask Planning Assumptions: We recognize that the number of employees with occupational exposure is difficult to predict because of uncertainty of the size or scale of an influenza pandemic. However, using the assumptions listed below, Table 2 provides rough estimates of the percentage of employees potentially exposed to pandemic influenza and their potential respiratory protection needs for some specific occupational sectors.
These same planning assumptions underlie the estimates of respirator and facemask usage for planning and stockpiling purposes provided in the subsequent sections of this proposed guidance. Table 2: Stockpiling Estimates for Respirators and Facemasks
1 In hospital settings, it is expected that known or suspected pandemic influenza patients will be cohorted (i.e., pandemic patients share rooms only with others pandemic patients in order to reduce the exposure risk to non-pandemic patients; cohorting patients may also include designating specific areas such as a hospital floor or wing for pandemic patient care). Through the cohorting of patients, hospitals are also expected to reduce the number of healthcare providers and support staff who might be exposed to pandemic influenza and thus reduce the number of employees who will need respirators. 2 Four respiratory protection devices per shift is the estimate used for most healthcare and emergency response settings where employees are in contact throughout the shift with pandemic influenza patients. For example, employees might use one respirator from the start of the shift until a mid-morning break, a second respirator from the break until lunch, a third respirator from lunch to a mid-afternoon break, and the fourth respirator from the mid-afternoon break until the end of the work shift. If the work flow is not conducive to regular breaks, it may be necessary to modify the estimates used to determine stockpiling recommendation. In the following sections, formulas are provided to calculate respirator stockpiling needs for very high and high exposure risk employees. These formulas can adapted to a specific workplace by substituting estimates of daily respirator needs that are tailored to the work flow and schedule in your place of employment. 3 Includes employees in various retail and other settings where frequent and close contact with other people, whose pandemic infection status is unknown, is unavoidable. The purpose of this estimate is for purchasing and stockpiling of respirators and facemasks. During an actual pandemic the distribution of employees exposed at each risk level, and the distribution of respirators and facemasks necessary to protect employees will likely be less at the beginning and end of a pandemic wave and greater during the middle of a wave. These estimates are intended to provide an average over the duration of the pandemic in the absence of a work site-specific pandemic influenza plan. Estimating Respirator Usage in Workplaces Classified at Very High Exposure Risk for Pandemic Influenza: Employees Covered:
Respirators are recommended to protect healthcare workers performing aerosol-generating medical procedures on patients known or suspected to be infected with pandemic influenza as well as certain laboratory personnel. Although a reduction in the level of exposure can be provided by a filtering facepiece respirator (e.g., N95, N95 surgical respirator), a reusable elastomeric respirator or a powered air purifying respirator (PAPR) will provide a further reduction in the level of exposure. If using disposable N95 or surgical respirators for aerosol-generating medical procedures, healthcare institutions should estimate the total number of such procedures that the facility might reasonably expect to perform during in a severe pandemic and the average number of employees involved in each procedure. Employers should plan on stockpiling: 1 N95 respirator per employee per aerosol-generating procedure. If using elastomeric respirators for aerosol-generating medical procedures, healthcare institutions should estimate: 1 elastomeric respirator with 3 or more sets of filters per employee, depending on frequency of use. If using PAPRs for aerosol generating medical procedures, healthcare institutions should estimate:
For example: 1 patient/treatment room X 4 HCWs/patient = 4 PAPRs per treatment room + 4-8 sets of filters per PAPR (changing filters every 15-30 pandemic work days, depending on frequency of use). When PAPRs are used in the workplace, it is possible for several employees to share a single PAPR blower unit and battery. For example, if a hospital employs 5 healthcare workers to provide continuous coverage of a single staff position (e.g., a nurse) over the course of a week, they might purchase 1 blower unit, 2 batteries (one is a spare for recharging while other is in use), and 5 reusable hoods in order to protect the 5 employees. Note: PAPRs and elastomeric respirators may also be used for other patient care activities normally covered under the high risk section of this document. Estimating Respirator Usage in Workplaces Classified at High Exposure Risk for Pandemic Influenza: Employees Covered:
Respirators are recommended to protect employees working closely with people/patients known or suspected to be infected with pandemic influenza. Such protection can be accomplished by a disposable filtering facepiece (e.g., N95, surgical respirator), a reusable elastomeric respirator or a powered air purifying respirator (PAPR). If using disposable N95 or surgical respirators to protect healthcare delivery and support staff, employers should plan for: 4 N95s/HCW/shift X 120 pandemic workdays = 480 N95s per exposed HCW. If using disposable N95 or surgical respirators to protect emergency medical service providers who treat/transport patients that are known or suspected to be infected with pandemic influenza, employers should plan for: 8 N95s/EMT/shift X 120 pandemic workdays = 960 N95s. The stockpiling recommendation for emergency medical service providers is noticeably higher than for other work environments and is based upon their dynamic and uncontrolled work environment. Employers may consider revising this estimate based upon work volume (e.g., municipalities with high patient volume may need more N95s while those with lower patient volume may need fewer respirators). If using elastomeric respirators for employees at high exposure risk (either healthcare workers or emergency medical service providers), employers should estimate: 1 reusable elastomeric respirator + 3 sets of filters per exposed employee. If using PAPRs for employees at high exposure risk (either healthcare workers or emergency medical service providers), employers should estimate: 1 PAPR per exposed employee + 3 sets of filters per exposed employee. Example of Stockpiling Needs and Comparative Costs for a Single High Exposure Risk Employee As previously discussed in Table 1: Advantages and Disadvantages of Respirators and Facemasks, each type of respirator offers different advantages and disadvantages that may aid in selecting an appropriate respirator for the work environment. Below is a comparison of three different options for providing respiratory protection and estimates of cost for each option. Option 1 - Using disposable N95 respirators: Option 2 - Using reusable elastomeric respirators: Option 3 - Using 1 PAPRs shared by 4 employees on shift work: (Note: hooded PAPRs do not need to be fit tested which can result in other programmatic cost savings) Estimating Facemask Usage for Patients in Workplaces Classified at High Exposure Risk for Pandemic Influenza: Healthcare providers should consider distributing facemasks to patients with influenza-like illness as a component of an overall pandemic influenza containment strategy. The number of facemasks stockpiled for such purposes are in addition to the numbers presented above for employees' health and safety. During periods of pandemic influenza activity in the community, facemasks should be offered as part of a respiratory hygiene/cough etiquette strategy to patients who are coughing and/or sneezing, have a fever or have other symptoms of influenza-like illness when they present for health-care services (for more information see Interim Guidance for the Use of Masks to Control Influenza Transmission). If tolerated, facemasks should be worn by these patients until:
Table 3: Stockpiling Estimates for Facemasks for Use by Ill Patients
4 Primary use will be when transporting patients to/from and outside of their room. When estimating the number of facemasks to stockpile for use by ill persons in a pandemic, consider estimating facemasks per ill patient per day for patients in hospitals (including possible essential visitors), long term care facilities and correctional facilities. When estimating the number of facemasks per patients encountered in other settings (e.g. in emergency rooms, outpatient offices or clinics, home healthcare, emergency services settings and by law enforcement and fire personnel), the stockpile should be sufficient to provide facemasks for each ill individual encountered. Estimating Facemask or Respirator Usage in Workplaces Classified at Medium Exposure Risk for Pandemic Influenza: Employees Covered:
Facemasks are recommended to protect employees with high-frequency close contact with the general public from sprays of potentially infectious liquid droplets (from talking, coughing, or sneezing). Employers should plan for: 2 facemasks/employee/shift X 120 pandemic workdays = 240 facemasks per exposed employee. Alternatively, employers may choose to provide respirators if there is an expectation of close contact with people who have symptomatic influenza infection or if the employer chooses to provide protection against the risk of airborne influenza transmission. For example, employers in critical infrastructure or key resource industry sectors (e.g., utilities or banking) may consider providing a higher level of protection based upon the essential nature of their services or the difficulty of replacing employees whose job requires extensive training or licensing. In such cases, employers should plan for: 2 N95s/employee/shift X 120 pandemic workdays = 240 N95s per exposed employee; While PAPRs would certainly be acceptable to use instead of an N95 or elastomeric respirator, they may be considered costly in the medium exposure risk work environment. Estimating Facemask or Respirator Usage in Workplaces Classified at Lower Exposure Risk (Caution): Facemasks and respirators are not recommended in lower exposure risk work environments. Stockpile Management: When stockpiling items, be aware of each product's shelf life and storage conditions. Stockpiles of supplies should be placed in clean, secure, temperature-controlled environments to prevent damage or contamination of the supplies (e.g., avoid storage areas that are damp or have temperature extremes). Where possible, incorporate product rotation (e.g., consume the oldest supplies first) into your stockpile management system. Surgical masks may or may not have expiration dates listed; however, product shelf-life should be taken into consideration to assure adequate inventory of supplies. |
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