Ethylene oxide sterilization in the medical‐supply manufacturing industry: Assessment and control of worker exposure

Abstract

In 2005, the Taiwan Institute of Occupational Safety and Health started an on-site consulting program for the medical supplies manufacturing industry, which use ethylene oxide (EO) as a sterilant, with the goal of enhancing occupational hygiene practices and controlling EO-related risks. This study presents EO exposure assessment results and examines the effectiveness of control measures. Detailed surveys, including exposure monitoring, were conducted at 10 factories. Airborne EO was collected using an HBr-coated charcoal tube and analyzed using GC/MS. Sterilizer operators had an average short-term EO exposure level of 27.61 ppm during unloading; mean time-weighted average workshift exposure was 7.35 ppm. High EO concentrations were also present throughout the facilities. Specifically, mean EO concentrations in the aeration area, near the sterilizer and in the warehouse were 10.19, 5.75, and 8.78 ppm, respectively. These findings indicate that immediate controls are needed, and that EO emissions from sterilized products during storage cannot be overlooked. Worker short-term exposures during unloading was inversely correlated (p < 0.05) with the numbers of poststerilization purge cycle applied. The specific controls implemented and their usefulness is discussed. Increasing the number of poststerilization purge cycles is a simple approach to eliminating extremely high exposure during unloading. Improvements to ventilation, particularly in the aeration area and warehouse, were also effective in minimizing worker exposures. Use of effective respirator is recommended until the EO exposure levels, averaging 3.41 ppm after the controls, fall below the permissible exposure limit.