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For patient safety, it is important that a medical device can safely and reliably perform its intended purpose. The challenge in medical technology is that medical devices are heterogeneous systems and thus no widely applicable standard concepts for functional safety exist in medical technology. This is also reflected in the regulatory landscape, with its rather generally applicable standards. Patient safety is currently achieved by performing continuous risk management with an acceptable level of residual risk. Functional safety and its design concepts, as applied in other industries, have so far found little application in the field of medical technology. In this paper, the automotive safety concept "EGAS" is analyzed with regard to its applicability for medical devices. Based on the investigated example of a medical ventilator, important parallels were found between the automotive and the medical device sector, indicating the possibility of successfully applying the EGAS safety concept to medical devices.

Objectives: To use industry-specific denominators to more accurately examine trends in prevalence rates for occupational cases of elevated blood lead levels (eBLLs) in Pennsylvania., Methods: We used adult (aged ≥16 years) blood lead level data from Pennsylvania (2007-2018) and industry-specific denominator data from the US Census Bureau's County Business Patterns to calculate prevalence rates for eBLLs, defined as ≥25 µg/dL., Results: Of the 19 904 cases with eBLLs, 92% were due to occupational lead exposure, with 83% from workers in the battery manufacturing industry. In 2018, the prevalence rate of eBLLs for battery manufacturing (8036.4 cases per 100 000 employed battery manufacturing workers) was 543 times the overall Pennsylvania prevalence rate. The prevalence rate for battery manufacturing steeply declined 71% from 2007 to 2018., Conclusions: The battery manufacturing industry had the highest burden of occupational lead exposure in Pennsylvania, illustrating the importance of using industry-specific denominators to accurately identify sources of lead exposure. Although the prevalence rate of eBLLs declined over time, lead exposure remains a major concern among battery manufacturing workers., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Occupational use of disinfectants among healthcare workers has been associated with asthma. However, most studies are cross-sectional, and longitudinal studies are not entirely consistent. To limit the healthy worker effect, it is important to conduct studies among early- to mid-career workers. We investigated the prospective association between use of disinfectants and asthma incidence in a large cohort of early- to mid-career female nurses., Methods: The Nurses' Health Study 3 is an ongoing, prospective, internet-based cohort of female nurses in the USA and Canada (2010-present). Analyses included 17 280 participants without a history of asthma at study entry (mean age: 34 years) and who had completed ≥1 follow-up questionnaire (sent every 6 months). Occupational use of high-level disinfectants (HLDs) was evaluated by questionnaire. We examined the association between HLD use and asthma development, adjusted for age, race, ethnicity, smoking status and body mass index., Results: During 67 392 person-years of follow-up, 391 nurses reported incident clinician-diagnosed asthma. Compared with nurses who reported ≤5 years of HLD use (89%), those with >5 years of HLD use (11%) had increased risk of incident asthma (adjusted HR (95% CI), 1.39 (1.04 to 1.86)). The risk of incident asthma was elevated but not statistically significant in those reporting >5 years of HLD use and current use of ≥2 products (1.72 (0.88 to 3.34)); asthma risk was significantly elevated in women with >5 years of HLD use but no current use (1.46 (1.00 to 2.12))., Conclusions: Occupational use of HLDs was prospectively associated with increased asthma incidence in early- to mid-career nurses., Competing Interests: Competing interests: CAC reports grants from NIOSH/CDC and NIH during the conduct of the study. JEC reports grants from National Institute of Occupational Safety and Health, grants from National Institute of Environmental Health Sciences and grants from National Heart, Lung and Blood Institute during the conduct of the study., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Carbon monoxide (CO) exposure levels encountered by wildland firefighters (WLFs) throughout their work shift can change considerably within a few minutes due to the varied tasks that are performed and the changing environmental and fire conditions encountered throughout the day. In a U.S. Forest Service study during the 2009-2012 fire seasons, WLFs from 57 different fires across the U.S. were monitored for CO using CO data-logging detectors while an observer recorded worker tasks, fire characteristics, and environmental conditions at scheduled intervals. Exposures to CO for 735 WLF's work shifts were analyzed to assess the effect of variations among work tasks, fire characteristics, and environmental conditions. Geometric mean full shift time-weighted averages were low at 2.4 parts per million (ppm) and average length of work shift was 11 hr and 15 min. The task with the highest mean CO exposure was sawyer/swamper at 6.8 ppm; workers performing that task had an estimated 9 times higher odds of a having a 1-min CO measurement exceeding 25 ppm than the referent pump task (OR = 8.89, 95% CI = 1.97, 40.24). After adjusting CO exposure limits for shift length, elevation, and work level, 2% and 4% of the WLF's work shifts exceeded the National Institute for Occupational Safety and Health's recommended exposure level and the American Conference of Governmental Industrial Hygienist's threshold limit value, respectively. In regression modeling, variables that were significantly associated with elevated levels of CO exposure included: task, fuel model, wind orientation, crew type, relative humidity, type of attack, and wind speed. In the absence of instruments such as CO detectors that can determine and alert WLFs to elevated CO levels, recognition of the conditions that lead to elevated levels of CO exposure can assist WLFs to effectively use administrative controls, such as work rotations, to minimize exposures.

Objective This study aimed to examine the relationship between occupational use of high-level disinfectants (HLD) and fecundity among female nurses. Methods Women currently employed outside the home and trying to get pregnant (N=1739) in the Nurses' Health Study 3 cohort (2010-2014) were included in this analysis. Occupational exposure to HLD used to disinfect medical instruments and use of protective equipment (PE) was self-reported on the baseline questionnaire. Every six months thereafter women reported the duration of their ongoing pregnancy attempt. Multivariable accelerated failure time models were used to estimate time ratios (TR) and 95% confidence intervals (95% CI). Results Nurses exposed to HLD prior to and at baseline had a 26% (95% CI 8-47%) and 12% (95% CI -2-28%) longer median duration of pregnancy attempt compared to nurses who were never exposed. Among nurses exposed at baseline to HLD, use of PE attenuated associations with fecundity impairments. Specifically, women using 0, 1, and ≥2 types of PE had 18% (95% CI -7-49%), 16% (95% -3-39%), and 0% (95% -22-28%) longer median durations of pregnancy attempt compared to women who were never exposed. While the use of PE varied greatly by type (9% for respiratory protection to 69% for protective gloves), use of each PE appeared to attenuate the associations of HLD exposure with reduced fecundity. Conclusion Occupational use of HLD is associated with reduced fecundity among nurses, but use of PE appears to attenuate this risk.

BACKGROUND High-level disinfectants (HLDs) are used throughout the healthcare industry to chemically disinfect reusable, semicritical medical and dental devices to control and prevent healthcare-associated infections among patient populations. Workers who use HLDs are at risk of exposure to these chemicals, some of which are respiratory and skin irritants and sensitizers. OBJECTIVE To evaluate exposure controls used and to better understand impediments to healthcare workers using personal protective equipment while handling HLDs. DESIGN Web-based survey. PARTICIPANTS A targeted sample of members of professional practice organizations representing nurses, technologists/technicians, dental professionals, respiratory therapists, and others who reported handling HLDs in the previous 7 calendar days. Participating organizations invited either all or a random sample of members via email, which included a hyperlink to the survey. METHODS Descriptive analyses were conducted including simple frequencies and prevalences. RESULTS A total of 4,657 respondents completed the survey. The HLDs used most often were glutaraldehyde (59%), peracetic acid (16%), and ortho-phthalaldehyde (15%). Examples of work practices or events that could increase exposure risk included failure to wear water-resistant gowns (44%); absence of standard procedures for minimizing exposure (19%); lack of safe handling training (17%); failure to wear protective gloves (9%); and a spill/leak of HLD during handling (5%). Among all respondents, 12% reported skin contact with HLDs, and 33% of these respondents reported that they did not always wear gloves. CONCLUSION Findings indicated that precautionary practices were not always used, underscoring the importance of improved employer and worker training and education regarding HLD hazards.

Objective: To analyze characteristics of, and trends in, work-related carbon monoxide (CO) fatalities in the US., Methods: Records of unintentional, non-fire related fatalities from CO exposure were extracted from the Bureau of Labor Statistics' Census of Fatal Occupational Injuries and the Occupational Safety and Health Administration's Integrated Management Information System for years 1992-2008 and analyzed separately., Results: The average number of annual CO fatalities was 22 (standard deviation=8). Fatality rates were highest among workers aged≥65, males, Hispanics, winter months, the Midwest, and the Fishing, Hunting, and Trapping industry subsector. Self-employed workers accounted for 28% of all fatalities. Motor vehicles were the most frequent source of fatal CO exposure, followed by heating systems and generators., Conclusions: CO has been the most frequent cause of occupational fatality due to acute inhalation, and has shown no significant decreasing trend since 1992. The high number of fatalities from motor vehicles warrants further investigation., (Copyright © 2013 Wiley Periodicals, Inc.)

Background: Lead hazards continue to be encountered in the workplace. OSHA's Integrated Management Information System (IMIS) is the largest available database containing sampling results in US workplaces., Methods: Personal airborne lead sampling results in IMIS were extracted for years 1979-2008. Descriptive analyses, geographical mapping, and regression modeling of results were performed., Results: Seventy-nine percent of lead samples were in the manufacturing sector. Lead sample results were highest in the construction sector (median = 0.03 mg/m(3) ). NORA sector, year, OSHA region, number of employees at the worksite, federal/state OSHA plan, unionization, advance notification, and presence of an employee representative were statistically associated with having a lead sample result exceed the PEL., Conclusions: Lead concentrations within construction have been higher than any other industry. Lead hazards have been most prevalent in the north and northeastern US. IMIS data can be useful as a surveillance tool and for targeting prevention efforts toward hazardous industries., (Copyright © 2011 Wiley-Liss, Inc.)

A chemical exposure assessment was conducted for a cohort mortality study of 6157 chemical laboratory workers employed between 1943 and 1998 at four Department of Energy sites in Oak Ridge, Tennessee, and Aiken, South Carolina. Previous studies of chemical laboratory workers have included members within professional societies where exposure assessment was either limited or not feasible, or chemical processing employees where laboratory and production workers were combined. Because sufficient industrial hygiene records were unavailable for all four sites, weighted duration of employment was used as a surrogate for the magnitude of exposure. Potential exposure indices were calculated for each worker using number of days employed and weighting factors for frequency of contact and year of employment. A total of 591 unique laboratory job titles indicative of a chemical laboratory worker were collapsed into 18 general job title categories. Through discussions with current and retired workers, along with examination of historical organizational charts and job descriptions, the percentage of time with activities involving the direct handling of chemicals in the laboratory was estimated for each job title category. Scaled weighting factors of 1, 0.6, 0.3, and 0.05 were assigned to the job title categories representing 100%, 60%, 30%, and 5% of daily activities handling chemicals, respectively. Based on limited industrial hygiene monitoring data, personal radiation monitoring records, and professional judgment, weighting factors that declined 4% annually were applied to each year to account for improvements in laboratory technique, advancements in instrumentation, improvement in engineering controls, and increased safety awareness through time. The study cohort was separated into three categories of chemical exposures based on department level information: (1) inorganic, (2) mixed inorganic and organic, and (3) unknown. Potential exposure indices ranged from 0.15 to 6824.5 with a median value of 377.5 and a mean equal to 884.2. This exposure assessment method is useful for epidemiologic analyses when quantitative exposure data are absent or insufficient.