OSHA: EtO rule still needed to protect HCWs

Need to remain vigilant to prevent exposures

Overexposures to ethylene oxide (EtO) still occur and a regulatory standard remains necessary to protect workers, the U.S. Occupational Safety and Health Administration (OSHA) concluded after an extensive review of the standard.1

“Although we think the risk has gone down since the [implementation of the] standard, we do know that overexposures and accidental releases continue to occur,” says Joanna Friedrich, MS, program analyst and project officer on the look-back review.

The EtO review was part of a systematic review of longstanding regulations. After considering comments, medical research, and exposure data, OSHA decided that more guidance would be helpful in promoting compliance. “Difficulty in understanding or interpreting some requirements of the standard was reported in the hospital sector, which contains the majority of affected small entities,” OSHA reported.

In fact, hospital exposures have begun to increase after years of decline, a trend that corresponds with a decline in enforcement action by OSHA,2 says researcher Anthony D. LaMontagne, ScD, MA, MEd, associate professor at the Centre for the Study of Health & Society at the University of Melbourne in Australia. “It’s even more urgent that they continue to act on this standard. There’s evidence that, if they don’t keep an eye on it, the problems could come back.”

The EtO standard clearly has been effective in reducing exposures since 1985, when it was implemented. At that time, hospital employees were exposed during spills, cartridge changes, and other handling of the sterilizers and chemicals in central processing facilities.

“Based on exposure monitoring data from several sources indicating that occupational exposure to EtO has fallen markedly since the EtO standard went into effect, workers are being protected,” OSHA stated.

LaMontagne evaluated more than 130,000 personal breathing zone samples — data from employee monitors — collected from 1984 to 2001. In 2001, about 12% of hospitals had exceeded the short-term limit of 5 ppm in a 15-minute period.

During that time frame, enforcement activity changed dramatically. In 1989, OSHA issued 250 citations from 70 inspections, LaMontagne found. In fiscal year 2002, OSHA issued 10 citations related to ethylene oxide stemming from four inspections.

LaMontagne contends OSHA should have considered lowering the permissible exposure limit (PEL) to reduce exposures. At the least, the agency needs to maintain active enforcement, he notes. “Following the declines in exposures, we now see some evidence of a turnaround, so it’s even more important that OSHA get active. Vigilance is required.”

OSHA officials said they are not aware of an increase in exposures. “What we found was that the exposures were actually below the PEL,” Friedrich explains.

Still, the OSHA review stated, “OSHA enforcement program data documenting that overexposures and accidental releases of EtO continue to occur at workplaces that are not in compliance with the standard underscore the continuing need for the standard.” Hospitals have wrestled with ways to reduce EtO use and control exposures. OSHA plans to offer guidance that will help hospitals improve employee training and will clarify the emergency alert requirement.

“There are a range of issues we’re currently considering in regard to compliance materials in response to [comments],” says John Smith, director of OSHA’s Office of Evaluation and Audit Analysis.

Dartmouth-Hitchcock Medical Center in Lebanon, NH, represents a success story. The hospital has completely eliminated EtO exposures among staff through a variety of strategies:

• Making EtO reduction a part of purchasing specifications. Dartmouth-Hitchcock tries to choose products that do not require EtO sterilization, says Lindsey C. Waterhouse, manager of safety and environmental programs. (A similar effort has greatly reduced the hospital’s use of glutaraldehyde.) For example, some products are pre-sterilized and disposable.

• Reviewing items that currently are sterilized with EtO. In some cases, there may be an acceptable alternative method of sterilization, he says.

• Using a contractor for necessary EtO sterilization. Dartmouth-Hitchcock found it couldn’t completely eliminate the use of EtO. So the hospital contracts with a processing facility, which allows it to remove the use of EtO from within the hospital itself.

“If properly controlled, EtO is a very effective cold sterilant and has helped health care a lot,” Waterhouse adds. “But in any kind of occupational health and safety program, you need to try to reduce occupational exposures.”

Fortunately, newer sterilizers have safety features that reduce potential exposures, he notes.

But hospitals still need to focus on monitoring employees and controlling the hazard, cautions LaMontagne. “There’s a whole range of things hospitals are dealing with, but this [hazard] won’t go away. All you have to do is maintain some level of attention. If you forget about it, it can come back to haunt you.”


1. Occupational Safety and Health Administration. Regulatory Review of the Occupational Safety and Health Administration’s Ethylene Oxide Standard. Washington, DC; March 2005.

2. LaMontagne AD, Oakes JM, Turley RNL. Long-term ethylene oxide exposure trends in U.S. hospitals: Intervention needed to preserve gains made following 1984 OSHA standard. Am J Public Health 2004; 94:1,614-1,619.