Storage and Availability of Elastomeric Respirators in Health Care.

Use of reusable respirators, such as elastomeric half-face respirators (EHFRs), may serve as one solution to combating the problem of N95 respirator shortages experienced during infectious disease emergencies. To clarify whether logistical issues like respirator storage and availability are barriers to implementation of healthcare respiratory protection strategies that include EHFRs, this study aimed to evaluate the availability, storage, and respirator and filter replacement practices of EHFRs used in healthcare settings under routine use. Healthcare workers using EHFRs were surveyed about their use practices. To explore whether issues related to storage and availability of EHFRs affected compliance with assigned respirator use, responses were compared between concordant users and EHFR users who were assigned to use EHFRs but currently use different respirators ("discordant users"). Most concordant EHFR users reported that their respirator was always available when needed (63.8%). Almost two-thirds of concordant but only half of discordant users reported storing their EHFRs conveniently in the patient care area (p = <0.001). Among mobile workers, discordant users had higher odds (aOR = 3.2, 95% CI [1.4,7.5]) of reporting that their respirator was not stored in the patient care area, suggesting that storage location has a significant impact on compliance with expected practice, particularly in this group. Storage and access are barriers to optimal elastomeric respirator use in healthcare. Strategies to assure ready availability and storage of respirators will permit EHFR inclusion in pandemic and routine respiratory protection programs.

Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel. Final order.

The Food and Drug Administration (FDA or Agency) is publishing this final order to exempt certain surgical apparel from premarket notification requirements, subject to conditions and limitations. FDA is limiting the exemption to single-use, disposable respiratory protective devices (RPD) used in a healthcare setting and worn by healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. These devices, commonly referred to as N95 filtering facepiece respirators (FFRs) and surgical N95 respirators (herein collectively referred to as N95s) are currently regulated by FDA under product code MSH. This exemption will decrease regulatory burden on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. All other class II devices classified under FDA's surgical apparel classification regulation continue to be subject to premarket notification requirements. FDA is also amending the codified language for the surgical apparel devices classification regulation to reflect this final determination.

Occupational exposures and symptoms among firefighters and police during the carmel forest fire: the Carmel cohort study.

BACKGROUND: From 2 to 5 December 2010, Israel experienced the most severe forest fire In its history, resulting in the deaths of rescue workers. Little research exists on the health risks to emergency responders during forest fires, and there is no published research to date on occupational health among firefighters in Israel. OBJECTIVES: To describe the exposures experienced by emer gency responders to smoke, fire retardants and stress; the utilization of protective equipment; and the frequency of corresponding symptoms during and following the Carmel Forest fire. METHODS: A cohort of 204 firfighers and 68 police who took part in rescue and fire-abating activites during the Carmel Forest fire were recruited from a representative sample of participating stations throughout the country and interviewed regarding their activities during the fire and their coinciding symptoms. Unpaired two-sample t-test compared mean exposures and symptom frequency for firefighters and police. Chi-square estimates of OR and 95%CI are provided for odds of reporting symptoms, incurring injury or being hospitalied for various risk factors RESULTS: Of the study participants, 87% reported having at least one symptom during rescue work at the Carmel Forest fire,with eye irritation (77%) and fatigue (71%) being the most comon. Occupational stress was extremely high during the fire; the average length of time working without rest was 18.4 hours among firefighters. CONCLUSION: Firefighter and police were exposed to smoke and ocupational stress prolonged periods during the fire. Further research is needed on the residual health effects from exposure to forest fires among emergency responders, and to identify areas for improvement in health preparedness.

Respiratory protection.

Respiratory protection is used as a method of protecting individuals from inhaling harmful airborne contaminants and in some cases to supply them with breathable air in oxygen-deficient environments. This article focuses on the use and types of personal respiratory protection (respirators) worn by individuals at workplaces where airborne hazardous contaminants may exist. Respirators are increasingly also being used in nonindustrial settings such as health care facilities, as concerns regarding infectious epidemics and terrorist threats grow. Pulmonologists and other clinicians should understand fundamental issues regarding respiratory protection against airborne contaminants and the use of respirators.

Using CO(2) to determine inhaled contaminant volumes and blower effectiveness in several types of respirators.

This experiment was conducted to determine how much contaminant could be expected to be inhaled when overbreathing several different types of respirators. These included several tight-fitting and loose-fitting powered air-purifying respirators (PAPRs) and one air-purifying respirator (APR). CO(2) was used as a tracer gas in the ambient air, and several loose-and tight-fitting respirators were tested on the head form of a breathing machine. CO(2) concentration in the exhaled breath was monitored as well as CO(2) concentration in the ambient air. This concentration ratio was able to give a measurement of protection factor, not for the respirator necessarily, but for the wearer. Flow rates in the filter/blower inlet and breathing machine outlet were also monitored, so blower effectiveness (defined as the blower contribution to inhaled air) could also be determined. Wearer protection factors were found to range from 1.1 for the Racal AirMate loose-fitting PAPR to infinity for the 3M Hood, 3M Breath-Easy PAPR, and SE 400 breath-responsive PAPR. Inhaled contaminant volumes depended on tidal volume but ranged from 2.02 L to 0 L for the same respirators, respectively. Blower effectiveness was about 1.0 for tight-fitting APRs, 0.18 for the Racal, and greater than 1.0 for two of the loose-fitting PAPRs. With blower effectiveness greater than 1.0, some blower flow during the exhalation phase contributes to the subsequent inhalation. Results from this experiment point to different ways to measure respirator efficacy.

Inward leakage in tight-fitting PAPRs.

A combination of local flow measurement techniques and fog flow visualization was used to determine the inward leakage for two tight-fitting powered air-purifying respirators (PAPRs), the 3M Breathe-Easy PAPR and the SE 400 breathing demand PAPR. The PAPRs were mounted on a breathing machine head form, and flows were measured from the blower and into the breathing machine. Both respirators leaked a little at the beginning of inhalation, probably through their exhalation valves. In both cases, the leakage was not enough for fog to appear at the mouth of the head form.

A field study to determine the effectiveness of several respiratory protection masks on the styrene exposure during lamination activities.

PURPOSE OF THE STUDY: The purpose of this study is to examine the effectiveness of several types of personal respiratory protection equipment at styrene exposed laminators under real work place conditions. SUBJECTS AND METHOD: 99 male styrene exposed workers were examined. During their lamination activities the average styrene concentrations in air ranged between 30 to 60 ppm (maximum: 205 ppm). The laminators were followed during an usual workweek from Monday to Thursday. The external styrene exposure was measured by means of passive active carbon badges. The excretion of mandelic acid (MA) and phenyl glyoxylic acid (PGA) in end-of-shift urine samples was used to quantify the internal styrene load. During the work shift some laminators did not use respiratory protection masks. The majority used either a half face mask with active carbon filter or an air purifying respirator. RESULTS: The respiratory masks were worn during an average between 31% and 72% of the work time. The styrene concentrations of the ambient air were -depending on the activity- in the range of 30 to 60 ppm. The end-of-shift concentrations of MA and PGA in urine samples varied considerably, their means range from 153 to 606 mg/g creatinine. The comparison shows that workers with air purifying respirators experience the lowest internal styrene body burden in spite of high external exposures. Their effectiveness during usual working condition was around 83% whereas the use of half face masks with active carbon filters reduce styrene exposure only of 26% as an average. CONCLUSIONS: The use of styrene-containing resins in boatbuilding can be associated with increased external styrene exposure of the laminators. During the use of different types of respiratory protection masks it is shown that only the application of air purifying respirators leads to a significant reduction of the internal styrene body burden of 83% when worn during 72% of the total work time. In this way it is possible to comply with or to stay clearly below the biological limit value of 600 mg MA + PGA/g creatinine (BAT-value).

What do healthcare workers think? A survey of facial protection equipment user preferences.

Data on healthcare workers'(HCWs) self-reported knowledge regarding selection of facial protection equipment, usage preferences and compliance are limited. We used a questionnaire on the use of facial protection equipment at a 700-bed adult tertiary care hospital employing approximately 7000 HCWs. Clinical areas targeted were those with frequent users of N95 respirators: intensive care unit, emergency room, respiratory services, and internal medicine. Respiratory therapists were also invited. In all, 137 questionnaires (68.5%) were returned. Most (72.8%) reported that training on the use of facial protection equipment was 'sufficient' to 'excellent'. The PFR95 and 3M 1860 Cone were used most frequently (56%) followed by the 3M 1870 Pocket (42%). While 95% reported having been fit-tested, only 60% were tested annually. PRF95 use exceeded the number of HCWs fit-tested for the item. Overall comfort and compliance scores were 13.6/20 and 21.5/25, respectively, for respirators and 7.7/10 and 18.5/25 for protective eyewear. No relationship between comfort and years of use of either respirators or protective eyewear was found. The results highlight potential failures in effectiveness in the use of personal protective equipment that could compromise HCW safety, and support observations that compliance in the workplace is usually less than in the research setting.

Medical devices; general hospital and personal use devices; classification of the filtering facepiece respirator for use by the general public in public health medical emergencies. Final rule.

The Food and Drug Administration (FDA) is classifying the filtering facepiece respirator for use by the general public in public health medical emergencies into class II (special controls). The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of the safety and effectiveness of these devices and is specifying what those special controls are. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled, "Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies." This guidance document will serve as one of the special controls, along with certification of the respirator by the National Institute for Occupational Safety and Health (NIOSH) in accordance with its regulations for non-powered air-purifying particulate respirators, found in 42 CFR part 84, as specified in the classification regulation.

The changing face of healthcare worker perceptions on powered air-purifying respirators during the SARS outbreak.

OBJECTIVES: Before the advent of severe acute respiratory syndrome (SARS), use of the powered air-purifying respirator (PAPR) in the setting of pulmonary tuberculosis has been controversial. Data regarding health care worker (HCW) perceptions and problems encountered with the use of the PAPRs were lacking. METHODOLOGY: A questionnaire-based survey was conducted of HCWs who had used the PAPR in clinical practice during the SARS outbreak, when use of the PAPR was mandatory and widespread. Evaluations of the question of whether HCWs were receptive to the use of the PAPR and their perceptions of common problems that were encountered were made. Perceptions of comfort, ease of use, visual, hearing, breathing and speech impairment, perceived protection against SARS and usage preferences were recorded. RESULTS: Only a minority of respondents found the PAPR uncomfortable, despite some interference with communication. Despite its much higher cost, the majority (84%) preferred to use the PAPR rather than the N-95 respirator when treating suspected SARS patients. However, opinions were equally divided regarding its use when treating patients with pulmonary tuberculosis; with 51% being in favour. CONCLUSIONS: With the advent of highly contagious diseases that pose a major occupational hazard to HCWs, the use of the PAPR has become more acceptable in clinical practice.

Fatal injuries in the United States involving respirators, 1984-1995.

There is little published information concerning the epidemiology of fatal injuries involving respiratory protection. We compiled a case series from U.S. Occupational Safety and Health Administration investigation reports from 1984 through 1995. For the 12-year period there were 41 incidents resulting in 45 deaths due to asphyxiation or chemical poisoning while wearing a respirator. There were 23 deaths related to airline respirators, 17 deaths involving use of negative pressure (air purifying) respirators, and 5 deaths involving self-contained breathing apparatus. Among the 23 deaths involving airline respirators, 15 were associated with compatible connection couplings for breathable air and inert gases. Three workers with beards died who wore tight-fitting respirators in an atmosphere that was immediately dangerous to life and health. Most of the fatalities involved regulatory and procedural violations, and would have been prevented by proper training and compliance with existing regulations. The information concerning the victims was limited but it did not appear that medical screening would have prevented any of the deaths.

[Justifying the choice of respirators for the protection of respiratory organs from toxic substances]. / K obosnovaniiu bybora respiratorov dlia zashchity organov dykhaniia cheloveka ot toksichnykh veshchestv.

The article deals with comparative characteristics of various types of respirators made in Russia and applied as light means protecting respiratory organs from toxic chemicals.

Quantitative fit testing techniques and regulations for tight-fitting respirators: current methods measuring aerosol or air leakage, and new developments.

Until a few years ago, only two quantitative fit testing (QNFT) techniques were available and accepted by U.S. Occupational Safety and Health Administration (OSHA) regulations. In the 1980s and 1990s, several new and fundamentally different QNFT methods were developed. Two of the newer methods are commercially available and are accepted by OSHA as suitable alternatives. In this article the principles of operation of the OSHA-accepted and of some newly developed but not yet approved QNFT techniques are explained, and each technique's major advantages and disadvantages are pointed out. Emphasis is given to negative-pressure air-purifying respirators, as they are in most frequent use today. The requirements and recommendations for fit testing positive-pressure respirators are discussed as well. Finally, the presently available QNFT standards and regulations are summarized to assist the user in making fit testing decisions.

An evaluation of respirator maintenance requirements.

A telephone survey was developed as part of a pilot study to evaluate the inspection, cleaning, maintenance, and storage aspects of respirator protection programs (RPP). Regulations and consensus standards such as those published by the Occupational Safety and Health Administration in the Code of Federal Regulations (CFR) or the American National Standards Institute (ANSI) require or recommend that RPP contain elements that ensure that the respirators provide proper protection. A great deal of research has been done to evaluate the effectiveness of new respirators; however, little research has been conducted to evaluate how respirators behave over time in real industrial settings Respirator inspection, cleaning, maintenance, and storage are significant factors in determining how well a respirator continues to perform. The telephone survey was developed by reviewing the requirements and recommendations of CFR 1910.134 and ANSI Z88.2-1980. Approximately 30 companies were selected based on their use of negative air-purifying respirators. Most of the companies represented the hardgoods manufacturing or service industries. Although the majority of companies were meeting requirements, responses indicated that the following improvements in RPP were necessary: (1) inspection of all respirator parts should be carried out before and after each use, (2) replacement parts should be made readily available on site, (3) regular cleaning should be performed, and (4) more hands-on practice with respirators and their maintenance should be incorporated into training sessions.

Respiratory protection in occupational health-update.

Respiratory protection is a complex field involving industrial hygiene, physics, physiology, toxicology, medicine, anthropology, engineering, law, and worksite administration. Although the use of respirators is widespread, they are the least effective and often the most costly method of protecting workers. Preferred methods of protection are engineering controls that eliminate exposure and substitution of the agent for one of lesser toxicity. However, in work situations where alternative methods are not available, a well-designed and well-monitored respiratory protection program can still provide a safe environment for the soldier and civilian worker. With the enactment and enforcement of the Occupational Health and Safety Act, worker protection has gained a much higher priority among employers and health officials. The field is dynamic and some of the medical screening procedures outlined in TB MED 502 (Respiratory Protection) are outdated. Industrial processes and state-of-the-art protective equipment change rapidly. Because certified occupational health physicians and nurses are not always available, health care workers need a fundamental understanding of respiratory protection.

Respiratory protection devices.

OSHA authority and responsibility have led to the requirement that health care workers potentially exposed to patients with active tuberculosis in situations where engineering controls are not feasible for protection must utilize personal protective equipment at least equivalent to HEPA respirators. ICPs generally believe that this approach is unnecessarily conservative and imposes undue burdens on patient care. The arguments on both sides of this controversy have some merit. Reported cases of tuberculosis and skin-test conversions among health care workers since 1988 and the absence of a demonstrated safe level of exposure have led many to the conclusion that HEPA respirators are justified. On the other side, tuberculosis currently is not a major problem in some areas of the country, and many believe that less stringent personal protective devices (e.g., DM respirators) may provide protection equivalent to HEPA filters--at least in terms of preventing infection if not in terms of filtration efficiency. They believe that the lesser discomfort and lower cost associated with DM respirators justify the argument for a more flexible standard. Perhaps additional research can help to resolve the remaining controversy. Definitive answers are unlikely to surface quickly, however, and it is likely that the controversy and confusion will continue for at least awhile longer.

Proteçäo respiratória e respiradores / Respiratory protection and devices

Säo apresentadas as características mais importantes dos equipamentos de proteçäo respiratória e os critérios técnicos para seleçäo dos respiradores e dos filtros contra contaminantes particulados e gasoos. É mostrado que somente se alcança a proteçäo prevista para um dado respirador quando ele é usado dentro de um Programa de Proteçäo Respiratória