Policy Research and Implementation: Healthcare Systems, Standards, and Certification
The emergence of 2009 H1N1 influenza and the ensuing dilemmas regarding personal protective equipment (PPE) for healthcare personnel highlighted challenges in healthcare delivery policy at institutional, state, regional, and national levels as well as policies about the relevant standards and certification processes. This chapter highlights issues regarding standards and policies for PPE for healthcare personnel and summarizes the experience and literature on the 2009 H1N1 pandemic relevant to PPE. The chapter also provides the committee’s recommendations on the next policy and regulatory steps needed to address the current challenges and improve PPE for healthcare personnel.
PPE STANDARDS AND CERTIFICATION
As described in Chapter 1 (with more detail provided in Box 5-1), a number of state and federal agencies and organizations have regulatory, standards-setting, and policy responsibilities regarding PPE for healthcare personnel. 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) impact workplace access to
PPE and voluntary consensus standards. A Final Rule, issued in November 2007, requires employers to provide PPE at no cost to their employees; this change took the burden of responsibility off the employees, who in some cases had been paying for their own protective equipment (29 Code of Federal Regulations [CFR] 1910.132; OSHA, 2007). In September 2009, a Final Rule was promulgated to address various revisions of the voluntary consensus standards as they applied to several types of PPE, including eye and face protection (29 CFR 1910.133), head protection (29 CFR 1910.135), and foot protection (29 CFR 1910.136; OSHA, 2009). Because many consensus standards are updated on a regular basis, the new OSHA regulations state that the employer needs to supply PPE that meets the current voluntary consensus standard or either of the past two versions of that standard; thus employers do not have to purchase new PPE every time a consensus standard is revised.
In October 2009, the National Institute for Occupational Safety and Health (NIOSH) proposed total inward leakage (TIL) requirements for the certification of negative-pressure, tight-fitting respirators. The new regulation would require that half-facepiece, air-purifying respirators (including filtering facepiece respirators such as the N95 respirator) be fit tested to an anthropometrically selected panel of wearers. Respirators would need to be able to achieve an acceptable fit to a wide range of faces. Two public meetings have been held, and the docket for public comments closed in September 2010 (NIOSH, 2010a). NIOSH will evaluate the comments received and may then release a final standard. 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 aerosol-transmissible diseases standard (California Code of Regulations, 2010). This standard uses Centers for Disease Control and Prevention (CDC) guidelines and terminology to classify whether an aerosol-transmissible disease requires droplet precautions (use of face masks is permitted) or requires aerosol precautions (respiratory protection is required using N95s at a minimum, and where aerosol-generating procedures are performed, a powered air-purifying respirator [PAPR] or greater level of protection is required) (Siegel et al., 2007). Thus, by adopting the CDC guidelines, healthcare employers in California would, for example, protect personnel against seasonal influenza using face masks, while exposures to measles virus would require respirators (N95s or greater). For novel or unknown pathogens (e.g., the 2009 H1N1 pandemic influenza
virus), the California standard sets the default protection level at airborne precautions where use of respirators would be required (California Code of Regulations, 2010).
Recent efforts have also focused on voluntary consensus standards development and on third-party conformity assessment. ASTM International announced in April 2010 the establishment of a working group that will develop test methods to assess the effectiveness of antimicrobial gloves (ASTM International, 2010a). Additionally, a task group within the subcommittee on consumer rubber products has begun developing standards that focus on preventing the transfer of microorganisms through the use of antimicrobial agents (ASTM International, 2010c). Furthermore, an ASTM International subcommittee is focused on developing a product certification process for protective clothing and equipment that would include an option for third-party independent verification that the product met the relevant performance standards (ASTM International, 2010b).
Existing Standards, Guidelines, and Certification Processes
Food and Drug Administration (FDA)
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. PPE devices used in healthcare environments are considered medical devices and are regulated as either Class I or Class II devices. Class I devices are considered low risk to the user, and the basic requirement is that the manufacturer meet general standards for good manufacturing processes. Some Class I devices require that the manufacturer provide a 510(k) submission and demonstrate that the device meets specific voluntary standards and is substantively equivalent to a similar “predicate” device currently on the market. Examples of Class I devices that require a 510(k) submission include surgeon and examination gloves. Class II devices are considered intermediate risk and must be cleared through the 510(k) process before they are allowed to be marketed. Surgical gowns, face masks, and respirators are also categorized as Class II devices.
The FDA does not conduct tests on medical devices; the agency reviews data submitted by manufacturers to demonstrate that the product has been tested (by the manufacturer or an independent testing organization) to meet specified consensus standards. Respirators are required to be certified by the National Institute for Occupational Safety and Health (NIOSH) and must meet additional requirements for flammability and fluid protection. The FDA does not have any specific PPE requirements for protection against infectious diseases such as influenza. Therefore, masks and respirators have requirements that are
specifically geared for surgical room use, not for protection against influenza or other viral respiratory diseases. The FDA has begun clearing such devices that make claims for antiviral protection.
FDA regulations are designed to control the manufacture and sale of PPE. These regulations do not specifically apply to employers or employees. Requirements regarding the use of PPE in the healthcare workplace are overseen by the Occupational Safety and Health Administration (OSHA), along with state and local agencies and employers.
National Institute for Occupational Safety and Health
NIOSH is the principal governmental agency with responsibility for testing and certifying respirators. The National Personal Protective Technology Laboratory (NPPTL) establishes the testing requirements and performs tests on respirators submitted by manufacturers. Testing and certification requirements are incorporated in the Code of Federal Regulations (42 CFR Part 84). Once a respirator is certified, the manufacturer is not required to resubmit the device for further testing unless modifications are made.
NIOSH respirator testing and certification requirements are specific to the type of respirator (e.g., air-purifying, self-contained breathing apparatus) and are not specific to the type of workplace where they will be used. There is no specific certification of respirators for healthcare personnel or for protection against infectious agents such as influenza. However, as discussed in Chapter 3, NPPTL staff and other researchers have studied the performance of certified filters against nanoparticles that would be applicable to virons and also have conducted some research with antiviral filters. The NIOSH certification process does not evaluate or indicate the efficacy of antiviral treatments that may be applied to filters on certified respirators.
NIOSH does not certify other forms of PPE, such as gloves and goggles, that would be relevant to the protection of healthcare personnel. NIOSH staff do participate in the development of voluntary consensus standards for other PPE and perform some research in these areas (IOM, 2010).
Occupational Safety and Health Administration
OSHA has the primary responsibility for enforcing the proper use of PPE in the workplace, including in healthcare facilities. 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), and training. OSHA requires that other types of PPE meet specified voluntary consensus standards (in some cases—e.g., for eye and face protection—OSHA regulations include additional specifications as noted in 29 CFR 1910.133). OSHA does not have specific standards covering the use of PPE by healthcare personnel and does not require that such PPE be cleared by the FDA.
Other Agencies and Organizations
A number of other organizations also impact the use of PPE by healthcare personnel. The Centers for Disease Control and Prevention (CDC) provides in
fection control guidance, including guidance on the use of respirators and masks by healthcare personnel for protection against influenza. During the 2009 H1N1 pandemic, the CDC infection control guidelines for healthcare personnel during seasonal influenza (which recommend droplet infection control precautions, e.g., a face mask for non-aerosol–generating procedures) were changed to recommend airborne precautions involving the use of respirators (respirators are recommended for aerosol-generating procedures in both). However, some state health agencies or local healthcare facilities continued to recommend face masks consistent with seasonal influenza guidelines for the use of respirators and masks. 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).
The Joint Commission provides accreditation for many hospitals and a variety of other employers of healthcare personnel, such as home healthcare agencies. The use of PPE is included in the Joint Commission’s requirements for employers.
State and local health agencies provide guidance and licensing to employers of healthcare personnel. These agencies provide assistance to employers in the case of pandemic influenza that may include stockpiling of PPE and offering guidance on what type of PPE is appropriate for specific tasks.
Standards development organizations (such as the American National Standards Institute and ASTM International) work through professional organizations and standards development committees to develop voluntary consensus standards that specify testing methods and performance expectations. Standards-development committees include experts who represent manufacturers, employers, users, and government regulators. Each standards-development organization has its own rules about the balance of these committees and voting. Most standards must be updated on a regular basis (e.g., 5 years) or they are withdrawn. Standards may specify whether PPE must be tested by an independent third party or whether the manufacturer can perform the testing.
Moving Forward on PPE Standards and Certification
Many of the issues that require activity by regulatory agencies for worker protection regarding PPE use during pandemic influenza involve respirators and masks. Face (eye), hand, and body protection issues all involve barriers, such as goggles or face shields, gloves, and gowns, which should provide an adequate barrier against influenza transmission provided that they cover the exposed area.
A major challenge in preventing influenza transmission continues to be clarifying the modes of transmission (Chapter 2). Occupational safety and health principles emphasize the importance of protecting the worker, particularly when dealing with hazards of unknown severity or health
impacts. For novel respiratory viruses, the committee reiterates the statements in the 2008 Institute of Medicine report regarding transmission of influenza A: “[w]ithout knowing the contributions of each of the possible route(s) of transmission, all routes must be considered probable and consequential” (IOM, 2008, p. 53).
As reiterated throughout this report, PPE is one part of a comprehensive infection control program that includes engineering, administrative, and workplace controls, including vaccination. Because transmission of influenza occurs in the community and does not just occur in healthcare settings from patients and coworkers, vaccination—when effective—is a preventive measure that offers protection that is not tied to a specific workplace setting or on-the-job practices and equipment.
Face Masks and Face Shields
As discussed throughout this report, one of the most contentious issues regarding PPE to prevent influenza transmission is the use of masks versus respirators. Protection of healthcare personnel is paramount in these discussions. For employers, the issues to consider include purchase and training costs. 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.
OSHA’s respiratory protection standard (29 CFR 1910.134) includes requirements for the selection, use, and maintenance of respirators. Since face masks are not respirators, they are not covered by this standard. OSHA general PPE standard (29 CFR 1910.132) applies to face shields and face masks; however, specific performance standards or other design or performance criteria for these products are not included in this OSHA regulation. To move forward with this issue, OSHA could work with other agencies and organizations to identify relevant voluntary consensus standard requirements and consider if selection, maintenance, storage, and inspection requirements for face masks and face
shields should be detailed in OSHA regulations to provide further protection for healthcare personnel.
Fit and fit testing Several significant policy and regulatory issues exist regarding respirator fit and fit testing that could impact healthcare worker safety and health in the midst of an influenza pandemic or an outbreak of a novel viral respiratory disease. During an emergency situation, employers may run out of respirators that have been fit tested on personnel and may be unable to obtain additional supplies from the same manufacturer or an emergency stockpile. If supplies of other types of respirators are available, then OSHA requirements stipulate the need for repeat fit testing with the new type of respirator to ensure proper fit and protection (29 CFR 1910.134). The challenge during an emergency situation could be the need to do fit testing for large numbers of workers in a short period of time. 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). Therefore, a respirator may be NIOSH certified for filtration efficiency, but have poor-fitting characteristics and be unable to fit a large number of workers. When health agencies or employers stockpile respirators, they may choose devices based on cost and availability but may not have the knowledge about how well the device will fit their population. This issue became widely recognized during the 2009 H1N1 pandemic when a California stockpile of respirators was used and healthcare personnel could not obtain a satisfactory fit (NIOSH, 2010b). The proposed respirator TIL regulations would assist in addressing this issue and provide employers and workers with better fitting respirators.
PAPRs During an influenza pandemic, some healthcare personnel who do not normally wear respirators may need to wear them. These individuals are unlikely to be able to obtain a respirator fit test in a timely manner. In addition, some individuals may have facial hair or other facial
features that do not allow them to be fitted adequately to a typical N95 or other tight-fitting respirator. These individuals would need to be assigned a loose-fitting PAPR. These types of respirators provide forced-flow filtered air but currently have high noise levels that are not conducive to healthcare tasks and patient interactions, including speech perception and listening to chest sounds. Efforts are underway by the National Personal Protective Technology Laboratory (NPPTL) to develop regulations for testing and approving lower flow PAPRs that would provide acceptable respiratory protection in a healthcare environment but emit less noise and thus be more useful for healthcare work that requires communication with patients. Expediting these efforts is critical to improving PPE for healthcare personnel.
Aerosol-transmissible disease standard As noted above, California adopted an aerosol-transmissible diseases standard in 2009 (California Code of Regulations, 2010). The standard includes a list of diseases and pathogens that require airborne precautions as outlined by CDC, including “novel or unknown pathogens” (California Code of Regulations, 2010). The scope of airborne precaution measures includes the requirement for “at least the use of an N95 respirator” (Jensen et al., 2005). During the 2009 H1N1 pandemic, the California standard was the only workplace standard in the United States that required a mandatory level of worker protection to be provided to healthcare personnel. 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) (OSHA, 2010). OSHA needs to work toward the development of an aerosol-transmissible diseases standard that would provide adequate protection for healthcare personnel and that would, in situations of unknown or novel pathogens, default to providing full respiratory protection until more was known about the lethality or contagiousness of the disease.
Other regulatory issues To gain approval for marketing as a medical device, the Food and Drug Administration (FDA) stipulates that the respirators must be NIOSH certified and meet flammability and fluid pro-
tection standards; these standards are not relevant for most situations in which workers must be protected from influenza. During the recent pandemic, the FDA identified non-cleared respirators that would be acceptable for healthcare personnel. To alleviate this issue for future crises, the FDA could consider a separate 510(k) requirement that allows manufacturers to market any appropriate NIOSH-certified respirator during an influenza pandemic. This would rapidly allow all certified respirators to be available for use by healthcare personnel.
LESSONS LEARNED FROM 2009 H1N1 POLICIES RELEVANT TO PPE FOR HEALTHCARE PERSONNEL
The arrival of novel H1N1 influenza A in 2009 was accompanied by a number of policy questions relevant to PPE. The lack of precise information about the modes of influenza transmission, the contagiousness, the virulence of novel H1N1 influenza A, the at-risk population, and the efficacy of different devices in preventing transmission led to a variety of recommendations at different times by federal and local government public health agencies. Delayed and/or disparate recommendations often led to confusion among healthcare personnel and their employers, who had to decide what to tell personnel about what type of PPE to wear and when. In addition, little research was available to guide health system officials in making decisions about the quantities of various types of PPE needed to protect their workforce. A major problem encountered was a slow response in tailoring recommendations as more knowledge about virulence and affected populations became available.
The committee looked to two examples of response to 2009 H1N1 (New York City [NYC] and Northern Virginia), 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. To address supply chain shortfalls, the 14 member hospitals of the Northern Virginia Hospital Alliance (NVHA) agreed to follow CDC respirator guidelines until no longer practical. As a matter of practice, hospitals modified the CDC guidelines in regards to PPE requirements for non-high-risk workers, especially as it became clear in fall 2009 that the virulence of 2009 H1N1 was similar to seasonal influenza viruses (Personal communication, Zachary Corrigan, NVHA, 2010).
In NYC, the fire department emphasized the need for paramedics and emergency medical technicians to use N95 respirators as they work in the pre-hospital environment where environmental controls do not exist. When the H1N1 virus first emerged, the NYC Department of Health and Mental Hygiene and the New York State department of health initially recommended N95 respirators but then scaled back the recommendations to face masks to be consistent with seasonal influenza recommendations once it was determined that the virulence and transmissibility were similar to seasonal influenza. 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. The NYC health department also put in place a program to provide additional N95 respirators from a local government stockpile for healthcare facilities experiencing supply shortages during the 2009 pandemic (Personal communication, David Prezant, New York City Fire Department).
PPE Policies During the Novel H1N1 Influenza Pandemic
During the initial phase of the 2009 H1N1 influenza pandemic, infection control guidelines from some of the major public health organizations differed, primarily as related to respiratory protection (Table 5-1). The World Health Organization (WHO) recommended standard and droplet precautions (including a face mask, a gown, gloves, eye protection, and hand hygiene) for those working in direct contact with patients, and additional precautions for aerosol-generating procedures, including wearing a facial particulate respirator (WHO, 2009). The WHO recommendations took into account the need for sustainability in a variety of countries and encouraged each country to issue its own guidelines. CDC recommended a fit tested, disposable N95 respirator or better for healthcare personnel who enter the rooms of patients in isolation with suspected or confirmed novel H1N1 influenza (CDC, 2009b). For emergency medical responders, CDC recommended a fit tested, disposable N95 respirator for those personnel “who are in close contact” with patients with confirmed or suspected 2009 H1N1, for personnel “en-
gaged in aerosol generating activities,” and for personnel involved in the “interfacility transfer” of patients with suspected or confirmed 2009 H1N1 (CDC, 2009a). The Public Health Agency of Canada used a tiered approach that recommended N95 use for aerosol-generating procedures with direct patient contact only (PHAC, 2009a,b,c,d).
Overview of Recent Policy Research
Research on healthcare policies and their implementation is lacking as it pertains to the use of PPE. 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
the initial stages of 2009 H1N1, more papers are likely to be forthcoming as healthcare institutions document their experiences and researchers have the opportunity to publish their findings. This section reviews some of the research and summaries published since 2007 regarding policies on PPE use. 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).
Supplies of PPE
One issue faced during 2009 H1N1 was ensuring that healthcare facilities had adequate supplies of PPE and other supplies. As noted in an article by Rebmann and Wagner (2009), less than a month after the first case of laboratory-confirmed novel H1N1 was reported in the United States, CDC had deployed 25 percent of the Strategic National Stockpile (SNS) of N95 respirators. A focus group study of infection control specialists identified issues faced in the first months of the pandemic (Rebmann and Wagner, 2009). Supply issues of prime concern included running out of respirators or certain sizes of respirators and facing back orders early in the pandemic. Similar supply issues were seen in the early months of the pandemic in Australia, with concerns noted about the amount of time and quantity of PPE supplies retrieved from the SNS (Eizenberg, 2009).
Determining the quantities of PPE required was the focus of a report by Murray and colleagues (2010) that examined the use of facial protective equipment from late June through mid-December 2009 in three Vancouver, Canada, hospitals. During that time, 865 patients with suspected cases of H1N1 influenza were admitted, with 149 patients having laboratory-confirmed H1N1 influenza infection; 134,281 masks and 173,145 N95 respirators were used. Comparisons were made of the number of respirators, masks, and protective eyewear used within the same period in 2008, with increases of 107 percent in the number of respirators, 70 percent in the number of eyewear, and 196 percent in the number of masks. The authors reported that the Ministry of Health plans for pandemic influenza called for hospitals to have a 10-week supply of PPE equipment, but they did not account for increases in the supplies that would be needed.
Two reports provide detailed descriptions of the planning process used by the U.S. Department of Veterans Affairs to determine the quanti-
ties and types of PPE needed to respond to pandemic influenza. This process included considerations of many factors that weighed into those decisions, such as the anticipated number of patients, the number of healthcare worker contacts per patient, PPE needs, and cost (Koenig et al., 2007; Radonovich et al., 2009).
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. They used OSHA’s occupational risk pyramid for pandemic influenza to estimate the numbers of personnel at higher risk and then used a formula that considered the size of the facility and the number of providers to get final estimates for distribution. Supplies of PAPRs, reusable elastomeric N95 respirators, disposable N95 respirators, and surgical masks were provided to member hospitals from regional stockpiles (Personal communication, Zachary Corrigan, NVHA, 2010).
Several studies have made initial attempts to estimate the quantity of PPE needed, but further work on predictive models is needed. Swaminathan and colleagues (2007) conducted a simulation study in nine Australian hospital emergency departments designed to evaluate the number of contacts between patients and healthcare personnel and to determine the number of types of PPE that would be required. Compliance of healthcare personnel in using the appropriate PPE was also examined. The study focused on only the first 6 hours of contact1 with a suspected case. The researchers reported an average of 12 close contacts, with 19 exposures per “case,” and estimated that approximately 20 N95 respirators, 22 gowns, and 25 gloves would have been required to protect healthcare personnel during the first 6 hours of care. Given the rates of compliance noted in this study, up to 40 percent of healthcare personnel may have required post-exposure prophylaxis. This study provides some initial objective evidence regarding the numbers of PPE sets that might be required, but it was limited by its short duration of only 6 hours and by the simulation of a patient who was not critically ill. Similar types of research that extend the observation duration and simulate more severe illness would be helpful in estimating PPE requirements.
In Japan, Hashikura and Kizu (2009) used the severe acute respiratory syndrome outbreak as a paradigm for PPE use. The researchers re-
viewed the literature and the guidelines on PPE use from many countries, and then estimated the numbers of PPE ensembles that would be required during a pandemic, using information on the type of pandemic, type of healthcare worker, and numbers of PPE ensembles per classification per day. They estimated (using OSHA recommendations) that four sets (N95, gloves, gowns, and goggles) would be used per day by high-risk healthcare personnel, who are defined as persons performing high-risk procedures, such as intubations, suctioning, and manipulating respiratory equipment. Two sets of appropriate PPE was the estimate for medium-and low-risk healthcare personnel (this included an N95 respirator for medium-risk and a surgical mask for low-risk workers). The researchers also estimated that two surgical masks would be required for every inpatient and one for every out-patient. They then estimated the total numbers of PPE required for a 300-bed hospital during an 8-week pandemic—nearly 20,000 N95 respirators, 122,000 surgical masks, 21,000 goggles and gowns, and 172,000 pairs of gloves would be needed. This study provides an initial start on the question of estimated quantities, but is theoretical and based only on published recommendation guidelines. The methodology is logical, but needs to be validated. Data on actual use of PPE by a hospital is needed to compare the accuracy of the predictions.
A study comparing single-use versus reusable surgical gowns highlights another area of discussion regarding costs and quantity of supplies. Baykasoglu and colleagues (2009) conducted a cost/benefit study that considered a number of factors, including laundry, sterilization, and waste disposal costs, as well as the extent of protection and functionality. The study determined that the single-use sets had higher benefits, but when costs were considered, the more expensive reusable sets had higher benefit/cost ratios. 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. Santos and colleagues (2010) examined an NYC hospital’s absentee records for 3 months (April through June 2009) and compared the results with the same periods in 2007 and 2008. The researchers found that healthcare personnel in the adult and pediatric emergency departments
had the highest infection rate per department. The peak of influenza in healthcare personnel was noted to have lagged slightly behind the peak in the general public.
The literature on policies put in place during 2009 H1N1 will likely grow in the next several years. At this point only a few articles have been published that focus on PPE use during the initial phases of H1N1. Early in the epidemic, Perez-Padilla and colleagues (2009) reported their experience in Mexico City. They focused on the clinical presentation of H1N1, but also noted information on the transmission of disease to healthcare personnel. The report noted that 22 of 190 workers who became infected had been involved in caring for the first 3 H1N1 patients in a series of 18 patients admitted during the first month of the pandemic in spring 2009. These included 19 out of 104 emergency department workers who had been within 2 meters of a patient or had direct contact with a patient. These 22 workers had mild to moderate disease, and none required hospitalization. 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 influenza-like 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) as well as the challenges in determining whether and when to recommend the use of face masks or respirators. Of the focus group participants, approximately one-third said that PPE-use guidelines changed at their facilities about halfway through the event.
A survey of healthcare epidemiologists, administrators, and other members of the Society for Healthcare Epidemiology of America in May 2009 found that 19.3 percent of respondents strongly agreed and 52.7 percent agreed that “the recommendation for airborne precautions for suspected H1N1 cases was appropriate at the beginning of the H1N1 crisis” at his or her institution (Lautenbach et al., 2010, p. 3). When asked whether airborne precautions for suspected cases were appropriate throughout the H1N1 crisis, 7.5 percent strongly agreed and 17.5 percent agreed. Supplies of N95s were a concern with some respondents; 16.9 percent disagreed and 8.8 percent strongly disagreed with the statement that “N95 masks were readily available throughout the H1N1 crisis at my institution” (Lautenbach et al., 2010, p. 3).
Changes in PPE guidelines were an issue for healthcare personnel in Australia, as identified in a questionnaire and focus group study (Corley et al., 2010). Healthcare staff reported confusion over the changing requirements and noted that this led to staff feeling “undervalued” and “unprotected.” Discomfort in wearing a respirator for a 12-hour shift with maybe a 1- to 1.5-hour break was noted as a challenge, as was the considerable amount of time spent on donning and doffing PPE.
The need to reinforce education and communication about PPE and other infection control processes for pre-hospital healthcare personnel, including paramedics, was noted as one of the key lessons learned in the H1N1 pandemic by a group reviewing the response in Victoria, Australia (Smith et al., 2009).
Prior to the 2009 H1N1 pandemic, simulations and other planning efforts included a focus on PPE issues and policies. Phin and colleagues (2009) assessed a 24-hour simulation exercise in England and highlighted PPE cost and procurement issues as well as issues involving the storage of PPE supplies and increases in the amount of trash generated. The exercise noted unnecessary staff movement related to delivery of supplies and provision of services that also impacted PPE use. A review of emergency plans in three Ontario hospitals noted a number of PPE issues, including addressing fit testing requirements; regular training, including practice drills; stockpiling, warehousing, and inventory management; and storage and maintenance of PPE (Amaratunga et al., 2007). An extensive planning effort by a task force of the European Society of Intensive Care Medicine addressed a range of policy issues related to pandemic planning, including the need to develop protocols for safe performance of procedures (including aerosol-generating procedures) that might put personnel at risk (Sprung et al., 2010). Training regarding PPE and an organizational culture that promotes safety were also discussed.
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. As lessons
learned during that experience continue to add to the body of knowledge, incorporating this information into research, policy, and practice efforts will be important. In the initial phases of an epidemic or pandemic—when there are many unknowns about the virus or agent—one of the challenges is to determine PPE policy and then to adapt those policies as information is gained on the severity, transmission, and nature of the disease with an emphasis on communicating those changes. Standards-setting, 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. The committee’s findings (outlined in Box 5-2) and research needs and recommendations (below) point to the many opportunities available, making now a particularly urgent time to build on recent experiences and needs and to move forward with the policy research and regulatory changes that will improve protection for healthcare personnel.
The committee highlights the following research needs:
Lessons learned from the 2009 H1N1 policies relevant to PPE: Case studies of the implementation of 2009 H1N1 PPE-related policies should be gathered and evaluated.
PPE supply estimates: Studies are needed that compare theoretical models of estimating quantities of PPE for emergency preparedness with recent experience to inform future public health planning.
Cost-effectiveness research: Research is needed into cost-effectiveness issues relevant to PPE, including issues of disposable and reusable equipment.
Impact of public health guidance: Prospective research efforts should examine the impact of public health guidance on PPE compliance by state, local, and health system policy; clinical practice; and costs.
Recommendation: Move Forward on Better Fitting Respirators
NPPTL should continue rulemaking processes for TIL regulations that require respirators to meet fit criteria. To improve consumer and purchaser information on fit capabilities, NIOSH should establish a website to disseminate fit test results for specific respirator models on an anthropometric (NIOSH) 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. The agencies should tailor their guidance in a timely and coordinated manner as the virulence, contagiousness, and affected populations are further characterized.
Recommendation: Standards and Certification for Face Masks and Face Shields
NIOSH, OSHA, and standards-development organizations should develop the standards and certification processes
needed to assess the performance of face masks and face shields as PPE. The development of standards and certification processes should be guided by research regarding their efficacy as PPE.
OSHA and CDC should clarify that face masks are governed by the general PPE standard (29 CFR 1910.132) and not by the respiratory protection standard (29 CFR 1910.134).
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.
Recommendation: Establish PPE Regulations for Healthcare Personnel
CDC, including NIOSH, and OSHA should develop and promulgate guidelines and regulations that are consistent regarding the use of PPE by healthcare personnel for influenza and other viral respiratory diseases:
To assist employers in complying with the OSHA PPE standard, OSHA should specify the voluntary consensus standards that are required to be met for non-respirator PPE (e.g., gowns, gloves, face shields, face masks) in the event of influenza and other viral respiratory diseases.
OSHA, with input from CDC and other agencies and organizations, should work toward promulgating an aerosol-transmissible diseases standard that would include prevention of the transmission of influenza and other viral respiratory diseases.
As noted throughout the chapters, this report is an update of a prior IOM report. In surveying the landscape of research that has been conducted since the 2008 report and even in the wake of the 2009 H1N1 influenza pandemic, the committee was struck by the lack of urgency in addressing the basic, applied, and clinical research questions that, if an-
swered, would go a long way toward improving preparedness and prevention against future influenza epidemics and pandemics and outbreaks of other respiratory viral agents. Looking back is often a way to propel efforts in moving forward. The committee hopes that this review will jumpstart and strengthen improvements in PPE for healthcare personnel that could be relevant to a range of viral respiratory diseases.
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