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1 Introduction
Pages 19-48

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From page 19...
... . In response to product shortages during the 2009 influenza pandemic, the Strategic National Stockpile distributed more than 85.1 million N95 disposable filtering facepiece respirators (sometimes referred to as N95s)
From page 20...
... This report specifically focuses on one type of respirator -- half-facepiece reusable elastomeric respirators1 -- and explores the efficacy, effectiveness, and implementation issues associated with this type of respiratory protection in both routine use and during a public health emergency. STUDY BACKGROUND AND SCOPE In 2005, the National Personal Protective Technology Laboratory (NPPTL)
From page 21...
... Brief biographies of each of the 16 members of the committee can be found in Appendix B BOX 1-1 Statement of Task An ad hoc committee will conduct a study to examine the use of half-mask elastomeric respirators by health care workers.
From page 22...
... GUIDING PRINCIPLES After examining the complexities and challenges surrounding the use of reusable elastomeric respirators in health care, the committee identified the following set of principles to guide its work: • All health care workers in all settings are important. Health care workers' safety and good health are vital to the health of the public and patients, as well as to our economy and national secu rity, both on a day-to-day basis and during public health emer gencies and in a range of settings -- from homes to hospitals and in rural to urban areas.
From page 23...
... . Following its Statement of Task, this study instead took an in-depth look at reusable elastomeric respirators and considered the use of these respirators both in routine health care settings and during public health emergencies.
From page 24...
... range from 1.7 billion to 3.5 billion disposable filtering facepiece respirators (Patel et al., 2017)
From page 25...
... During a public health emergency, such as an influenza pandemic, health care workers, their families, and their employers will be forced to address complex, ethical quandaries associated with the prioritization of workplace health and safety. A 2008 Institute of Medicine (IOM)
From page 26...
... DEFINITIONS AND TERMINOLOGY Health Care Workers In the context of this report the committee has chosen to use the definition of health care worker or health care personnel provided in the 2011 IOM report Preventing Transmission of Pandemic Influenza and Other Viral Respiratory Diseases: Personal Protective Equipment for Healthcare Personnel. According to that report, health care personnel encompass all workers in direct patient care and support services who are employed by private and public healthcare offices and facili ties as well as those working in home healthcare and emergen cy medical services, including those who are self-employed.
From page 27...
... 6,001,810 Nursing and residential care facilities 3,324,640 Offices of physicians 2,547,640 Home health care service 1,396,570 Offices of dentists 932,040 Outpatient care centers 880,400 Offices of other health practitioners 876,010 Other ambulatory health care services 298,580 Medical and diagnostic laboratories 266,010 Total 16,523,700 SOURCE: BLS, 2018. Routine and Surge Use This report examines two distinct circumstances in which reusable elastomeric respirators could be considered for use in health care settings -- routine use and surge use.
From page 28...
... but where there is a critical need for respiratory protection that could go beyond the health care system's ability to respond and would necessitate being prepared. During a public health emergency response, protecting health care workers from infectious disease transmission is essential, given that these workers provide clinical care to those who fall ill, have a high risk of exposure, are limited in number, and need to be assured of workplace safety.
From page 29...
... The benefits to having reusable elastomeric respirators available during surge events include potentially averting a shortage of effective respiratory protection and sending a signal to health care workers that the institution is investing in their safety and well-being. During and after a public health crisis, "the survival rates of victims will be dependent upon the ability of hospitals and ambulance services to ‘surge up' and allocate scarce resources" (Veneema et al., 2018, p.
From page 30...
... Face seal Not designed to fit and seal to Designed to fit and seal requirements the face tightly to the face Fit-testing None Annual fit testing required requirements User seal check No user seal check possible User seal check recomrequirements mended before each use Certification FDA reviews 510(k) submission Approved by NIOSH requirements and clears for marketing under 42 CFR 84 Sizing Generally only one size is Multiple sizes are available available NOTES: Face seal, seal check, and fit-testing requirements apply only to tightfitting respirators and not to loose-fitting PAPRs.
From page 31...
... . Respirator fit can also be used to classify respirators: tight-fitting respirators require fit testing and a tight seal to the face; loose-fitting respirators do not require fit testing.
From page 32...
... Although the term is lengthy, the committee wants to be clear in its descriptions and therefore chose to use the term "disposable filtering facepiece respirator." 2. Reusable elastomeric respirators: These respirators are made from elastomeric materials, which consist of long coiled polymer chains and which can withstand high elastic deformation without rupture (Cardarelli, 2008)
From page 33...
... The committee refers to this type of respirator as a "powered air purifying respirator," or "PAPR." Disposable filtering Reusable half-mask Loose-fitting powered facepiece respirator elastomeric respirator air-purifying respiraAPF=10 APF=10 tor (PAPR) Needs to be fit tested Needs to be fit tested APF=25 Does not need to be fit tested FIGURE 1-1 Major types of air-purifying respirators currently used in health care.
From page 34...
... Respirators and other PPE offer direct protection for health care workers who care for patients with airborne transmissible infections. Designated individuals are included in the facility's respiratory protection program.
From page 35...
... When caring for patients for whom it has been determined that airborne infectious isolation precautions are needed, these health care workers are expected to wear the specific respirator to which they have been fit tested and trained. In most hospitals, a loose-fitting PAPR, which does not require fit testing, is available for use during certain high-risk procedures or for staff who cannot wear a tight-fitting respirator (e.g., those who have beards)
From page 36...
... NOTE: HEPA = high-efficiency particulate air; PPE = personal protective equipment.
From page 37...
... The program shall cover each employee required by this section to use a respirator. As outlined by OSHA, the major components of respiratory protection programs are • A designated respiratory program administrator to oversee the program and conduct evaluations of the program's effectiveness; • A written respiratory program with procedures specific to the workplace; • The provision of respirators, training, fit testing, and medical evaluations at no cost to the employee; • Procedures for selection of an appropriate NIOSH-approved respirator; • Medical evaluations for employees required to use respirators; • Fit-testing procedures; • Procedures for the use and maintenance of respirators, including the cleaning, disinfecting, storing, and disposal of respirators; 229 CFR 1910.134.
From page 38...
... Key aspects of successful respiratory protection programs go beyond simply fit testing and providing the respirator. These programs should encompass commitment to worker safety and health by health care leaders, including the health care administration; development and implementation of data-driven policies; monitoring of compliance with respirator use by management; effective education and training in all aspects of a comprehensive respiratory protection program; and thorough program evaluation done on a regular basis that leads to appropriate modification of the program (Joint Commission, 2014; OSHA and NIOSH, 2015)
From page 39...
... Fit Fit testing assesses the ability of the respirator to seal around a user's face during use. OSHA requires that tight-fitting respirators be fit tested, either qualitatively or quantitatively, before they are used.
From page 40...
... Research has demonstrated that fit testing and the fitting characteristics of a respirator model are both associated with performance (Coffey et al., 2004; Lawrence et al., 2006)
From page 41...
... ; the most common uses are in emergency care and respiratory care situations. The majority of health care facilities in the United States have opted to provide their health care workers with disposable filtering facepiece respirators or PAPRs, with some limited use of reusable elastomeric respirators (Wizner et al., 2016)
From page 42...
... . This means that the PAPR provides greater protection than a disposable filtering facepiece respirator.
From page 43...
... Although PAPRs provide superior respiratory protection compared with disposable filtering facepiece and reusable elastomeric respirators, these battery-powered respirators may have physiologic and ergonomic impacts from the weight and noise of the devices (Lenhart et al., 2004; IOM, 2015)
From page 44...
... 2017. Evaluation of 9 health care organizations' respiratory protection programs and respiratory protective device practices: Implications for adoption of elastomerics.
From page 45...
... 2008. Preparing for an influenza pandemic: Personal protective equipment for healthcare workers.
From page 46...
... 2009. Assigned protection factors for the revised respiratory protection standard.
From page 47...
... 2008. Filtration performance of NIOSH-approved N95 and P100 filtering facepiece respirators against 4- to 30-nanometer-size nanoparticles.


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