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5 Policy Research and Implementation: Healthcare Systems, Standards, and Certification
Pages 133-156

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From page 133...
... This section highlights several recent and ongoing efforts with potential impact on PPE for healthcare personnel, some of which require further attention and action. Recent and Ongoing Changes to Standards and Regulations Two recent regulatory changes implemented by the Occupational Safety and Health Administration (OSHA)
From page 134...
... The goal is to improve the fit of respirators. In 2009, California became the first state in the nation to issue a standard requiring employers to protect healthcare personnel from influenza and other viral respiratory diseases when it promulgated its aerosoltransmissible diseases standard (California Code of Regulations, 2010)
From page 135...
... Medical device legislation beginning in 1937 and amended in 1976 makes the FDA the principal agency for clearing personal protective equipment (PPE) for use by healthcare personnel.
From page 136...
... The two main regulations relevant to PPE use by healthcare personnel relevant to viral respiratory diseases are 29 CFR 1910.134, which governs the use of respirators, and 29 CFR 1910.132, which governs the use of PPE other than respirators. All respirators used by healthcare personnel must be NIOSH certified, and their use must be part of a respiratory protection program that includes attention to issues regarding medical clearance, fit testing (where applicable)
From page 137...
... In summer 2010, the CDC guidelines were revised to reflect the seasonal infection control precautions based on availability of an effective vaccine and updated knowledge about the risk of hospitalization and death from 2009 H1N1 influenza (CDC, 2010)
From page 138...
... As discussed in Chapter 3, more research is needed to determine the extent and nature of the protection that face masks and face shields can provide against viral respiratory disease transmission; a role in providing contact and droplet spray has been suggested but remains unclear. As information becomes available that clarifies the PPE role that face masks and face shields play in preventing transmission of viral respiratory diseases, voluntary consensus standards and certification processes will need to be developed, implemented, and refined so that healthcare personnel and other consumers will have information on the effectiveness of these products.
From page 139...
... Therefore, a user seal check or other quick method of determining the fit of a respirator needs to be developed and recommended by NIOSH and/or OSHA as a temporary measure to be used during emergencies until the required fit testing can be completed. A second issue is that the current NIOSH respirator certification program has no requirement for a TIL test for filtering facepiece respirators (e.g., many N95 respirators)
From page 140...
... Other state and local health departments had access to the CDC and OSHA guidance, but practices at healthcare facilities varied in whether and when they followed airborne or droplet infection control precautions. In May 2010, OSHA issued a Federal Register notice requesting information on occupational exposure to infectious agents in health care and related settings (e.g., laboratories, medical examiner offices)
From page 141...
... , with information provided by committee members, workshop speakers, and individual interviews. Northern Virginia hospitals, for example, developed standardized infection control policies that included a definition of high-risk workers.
From page 142...
... However, once CDC published its interim infection control guidance in October 2009, the New York city and state departments of health revised their guidance to be consistent with the federal recommendations for N95 respirators. In anticipation of the second wave of H1N1 returning in Fall 2009, the city health department, working with the NYC Office of Emergency Management, convened regular healthcare emergency planning meetings to improve hospital and primary care preparedness.
From page 143...
... Given the many PPE policy issues during TABLE 5-1 Overview of 2009–2010 H1N1 Policies and Practices Regarding Personal Protective Equipment and H1N1 Influenza Public CDC CDC Health Guidance Guidance CDC Agency of 4/29/09 10/15/09 Guidance for Canada Novel Novel Seasonal Guidance Pandemic Pandemic Influenza WHO for Novel Influenza Influenza 9/20/10 Guidance H1N1 Recommended Standard Standard Adhere to Standard Tiered level of infection and contact and droplet standard and droplet approach control precautions precautions and droplet precautions precautions and eye precautions protection Recommended NIOSH- NIOSH- Face mask Face mask Face mask respiratory certified certified except for except for except for PPE N95 N95 aerosol- aerosol- aerosol respirator respirator generating generating generating procedures, procedures procedures use N95 or better Did the respi- Yes -- Yes -- Yes -- Yes Yes ratory PPE direct care direct care direct care recommenda- versus versus versus tion differ by indirect indirect aerosol work task? patient patient generating contact contact procedures NOTE: CDC = Centers for Disease Control and Prevention; NIOSH = National Institute for Occupational Safety and Health; PPE = personal protective equipment; WHO = World Health Organization.
From page 144...
... Because PPE is one part of infection control strategies, some of the communications and emergency planning aspects are part of a larger discussion on pandemic planning (see, e.g., Daugherty et al., 2010)
From page 145...
... . The Northern Virginia Regional Hospital Coordinating Center, the operational arm of the Northern Virginia Hospital Allliance Emergency Preparedness and Response Program, reported that member hospitals developed regional stockpiles of respiratory PPE based on a risk stratification of their personnel.
From page 146...
... This area of research and modeling could provide practical insights, particularly as effective decontamination processes become defined. H1N1 Experiences with Use of PPE by Healthcare Personnel Evidence of transmission to healthcare personnel was reported during the pandemic, indicating the need for comprehensive PPE policies.
From page 147...
... The hospital then instituted strict infection control measures, including N95s, gowns, gloves, goggles, and hand hygiene, and noted that no additional workers became ill with influenzalike illness, although 26 did have varied respiratory symptoms and were treated with oseltamavir. Focus group discussions with a group of infection preventionists in the United States pointed out the logistical issues that were faced in the first months of the pandemic in trying to fit test a large number of staff (Rebmann and Wagner, 2009)
From page 148...
... SUMMARY OF PROGRESS Preparations and implementation of infection control plans for 2009 H1N1 influenza brought into sharp focus the efforts by healthcare professionals, emergency planners, professional associations, healthcare facilities, policy makers, government agencies, labor unions, and others to address PPE policies and logistics. Articles continue to be published on the recent experience and the challenges and successes in providing face masks, respirators, and other PPE to healthcare personnel.
From page 149...
... Standardssetting, regulatory, training, and research efforts continue to move toward improved respiratory protection, and recent work has begun to focus on the specifics of how to tailor PPE devices and PPE training to address the specific needs of healthcare personnel. FINDINGS AND RESEARCH NEEDS This chapter has provided an overview of the many policy and regulatory issues relevant to developing and improving PPE for healthcare personnel.
From page 150...
... test panel, where such data exist. Recommendation: Clarify PPE Guidelines for Outbreaks of Novel Viral Respiratory Infections NIOSH, other CDC divisions, OSHA, and other public health agencies should develop a coordinated process to make, announce, and revise consistent guidelines regarding the use of PPE to be worn by healthcare personnel during a verified, sustained national/international outbreak of a novel viral respiratory infection.
From page 151...
... . • NIOSH should work with other agencies and standards setting organizations to develop voluntary consensus standards and independent third-party testing and certification processes for face shields and face masks, with specific tests for assessing prevention of transmission of viral respiratory diseases.
From page 152...
... 2009b. Interim guidance on infection control measures for 2009 H1N1 influenza in healthcare settings, including protection of healthcare personnel.
From page 153...
... 2008. Preparing for an influenza pandemic: Personal protective equipment for healthcare workers.
From page 154...
... 2009. Updating OSHA standards based on national consensus standards; personal protective equipment.
From page 155...
... 2007. Personal protective equipment and antiviral drug use during hospitalization for suspected avian or pandemic influenza.


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