Glutaraldehyde Exposures Among Workers Making Bioprosthetic Heart Valves

Abstract

Exposure to glutaraldehyde is a recognized cause of work-related asthma. An investigation was undertaken to describe exposure to glutaraldehyde among workers making bioprosthetic heart valves and to make recommendations for prevention. At the two largest heart valve manufacturing facilities in California, the work process was observed; employer representatives and glutaraldehyde-exposed workers were interviewed; and employer written records, including company-generated industrial hygiene data, were analyzed. Approximately 600 female workers had continuous airborne exposure to glutaraldehyde over the course of every work shift and the routine potential for skin and eye contact with glutaraldehyde while making heart valves. Employee short-term (15-min) glutaraldehyde exposures were all well below the current regulatory ceiling level (0.20 ppm). Overall, approximately 40% of the glutaraldehyde-related job tasks involved exposures above the American Conference of Industrial Hygienists threshold limit value ceiling of 0.05 ppm; the majority (71.4% and 83.3%, depending on the company) involved exposures greater than 0.015 ppm. At one company, two cases of physician-diagnosed asthma were recorded by the employer in the previous 5-year period; these reports met the surveillance case definition for new-onset, work-related asthma associated with a known asthma inducer. Factors that contributed to worker exposure included large exposed surface areas of glutaraldehyde under agitation; working with glutaraldehyde-treated tissue in proximity to workers' breathing zones; manual pouring and disposal of glutaraldehyde solutions without local exhaust ventilation, eye protection, and waste neutralization; and prolonged use of latex gloves. Workers making bioprosthetic heart valves are at risk for occupationally acquired asthma. Employers should implement additional engineering controls to minimize workers' exposures to at least below a level of 0.015 ppm, an appropriate glove to prevent workers' skin exposure to glutaraldehyde, consistent and universal use of eye protection, and a medical surveillance program for glutaraldehyde-exposed workers.

Thresholds in chemical respiratory sensitisation

“…Water et al (2003) and Cohen and Patton (2006) reported that workers exposed to glutaraldehyde at concentrations ranging from 0.4 to 1.98 mg/m 3 had associated respiratory effects. Two confirmed cases of occupational asthma attributable to glutaraldehyde were reported with exposures ranging from below the limit of detection to 3.32 mg/m 3 (Sutton et al, 2007). However, in another study reported by Teta et al (1995), where exposure levels ranged from 0.04 to 1.36 mg/m 3 of glutaraldehyde, no cases of occupational asthma were identified.…”

Exposure of health workers in primary health care to glutaraldehyde

“…Factors that contribute to exposure of glutaraldehyde are inadequate and unsafe working practices [17], insufficient ventilation [18], and the failure to use goggles, protective clothing and gloves [19]. …”

Glutaral

“…1 The Panel reviewed newly available studies since that assessment along with updated frequency and concentration of use information (Table 1). 2 –46 The Panel determined to not reopen this safety assessment and confirmed the original conclusion of glutaral.…”