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.

Respirators

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 protection 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.

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 quantities 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 reviewed 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.