Wednesday, July 21, 2010

Should OSHA Update Regulations of Chemical Sterilants?

The first and most obvious reason why OSHA should update its regulations is to increase employee safety. Since the federal permissible exposure limits were first promulgated in 1971, new data has emerged about both the short and long-term effects of exposure to chemical sterilants, and this new data should be reflected in the OSHA standards. One of the reasons that many hospitals are phasing Ethylene Oxide (EtO) out of their sterile processing is that the risks associated with EtO are very well known (carcinogen, mutagen, spontaneous abortions, etc). As EtO is phased out, alternatives like hydrogen peroxide, ozone, and peracetic acid are often thought to cause fewer health risks in part because the regulations concerning them are less specific than those that regulate the use of EtO. However, these chemicals can be just as, if not more, dangerous than EtO.

With the exception of a few standards for carcinogenic compounds like EtO, the OSHA PELs of today are largely unchanged from when they were first adopted from the ACGIH TLV values back in 1972. The OSHA PELs should be updated to reflect the new chemical hygiene information of almost four decades and new chemicals used in the work place. If OSHA were to update their regulations reflecting that fact, hospitals would likely be more educated and responsible with their use as the transition to such alternatives continues.

Consistent OSHA enforcement of their regulations is equally important for ensuring workplace safety. A study conducted in 2004 that was published in the American Journal of Public Health followed long-term EtO exposure trends in US hospitals and its relationship with OSHA regulatory and enforcement actions. The study found that exposures declined steadily for the first several years after OSHA set new standards and measurement and monitoring increased. Between 1996 and 2004, however, the probability of exceeding the short-term exposure limit increased while measuring and monitoring decreased, coinciding with a decline in enforcement of the EtO standard. The study’s conclusion states that the data “indicates the need for renewed regulatory and other intervention efforts to protect health care workers from EtO’s carcinogenic, allergic-sensitizing, reproductive, and other hazards.” We argue that the same logic applies to other chemical sterilants in addition to EtO. Furthermore, as the study suggests, updated regulations alone would not automatically reduce the risk of worker exposure; enforcement is equally as important.

In summary, to improve workplace safety for those who use chemical sterilants in healthcare, we need to have updated regulations that reflect the current chemicals used and the current knowledge of their exposure risks and consistent enforcement of those regulations. Thus, while proper regulations and enforcement are important, what actually protects employees is having all parties concerned focusing on creating and maintaining a safe work environment, meeting the regulations, providing the engineering controls (ventilation, continuous gas monitors etc), using the personal protective equipment, and developing and using good work practices.

For more information about the American Journal of Public Health study, visit:

Wednesday, July 14, 2010

Are Federal Ozone Standards About to be Lowered?

Currently, the Environmental Protection Agency is in the process of reviewing the ozone national ambient air quality standard. The regulations were last updated in March of 2008, when the agency established a standard of 0.075 parts per million for average exposure over an 8-hour period. In January of this year, the EPA proposed lowering the standard to one in the range of 0.060 to 0.070 ppm in order to “provide requisite protection of public health and welfare,” i.e. the ozone concentration above which exposure is potentially harmful. Since that time, the agency has been accepting comments and supporting materials as well as public submissions both in favor of and opposing the proposed increase in standards. The EPA is due to release the final rules by August 31, 2010.

As you know from our last post, Ozone is currently used as a sterilant gas in the healthcare industry. Because of the health affects that exposure to ozone can have on the eyes and respiratory system, OSHA has set an 8 hour time-weighted average permissible exposure limit (PEL) of 0.1ppm. The OSHA PEL has not been updated for nearly forty years, and perhaps it is time for OSHA to revise its PEL for Ozone in light of the current scientific data. With such minute amounts of gas able to cause significant health problems (the NIOSH immediately dangerous to life and health limit is just 5ppm), it would be extremely difficult if not impossible to immediately identify a leak without a continuous area monitor. Continuous monitoring is about to become even more important to employee safety, assuming the proposed regulations become final.

For access to the proposed regulations and supporting materials, visit:

Thursday, July 8, 2010

Why Do We Have Ozone Action Days?

Yesterday, over 50 cities in the United States declared Air Quality Action Days to protect their population from potential over exposure to hazardous gases and particles in the air. One such harmful gas found in the air we breathe is Ozone (O3). Here in Pittsburgh, we’re in the middle of quite the heat wave, with high temperatures in the low to mid 90’s the last several days. Yesterday’s Air Quality Index (AQI) reached 115, which converts to 81 parts per billion of Ozone in the air. The government considers this number to be unhealthy for sensitive groups, such as those with lung diseases (including asthma), children, older adults, and people who are active outdoors.

According to, even low levels of ozone can cause health effects for those exposed. These effects include:
• Difficulty breathing deeply
• Shortness of breath or painful breathing
• Coughing and sore throat
• Inflammation and damage to lung lining
• Aggravation of lung diseases
• Increased frequency of asthma attacks
• Continuing damage to the lungs even when the symptoms have disappeared

In terms of occupational exposure, OSHA set an 8 hour permissible exposure limit at 0.1 parts per million, which is only .019 parts per million higher than what was in the air in Pittsburgh yesterday. Furthermore, NIOSH set an Immediately Dangerous to Life and Health number at 5 parts per million.

What should we take away from this? The government monitors the air we all breathe because of the harmful effects of gases like Ozone. Shouldn’t employers monitor the air that workers breathe too? Considering that Ozone sterilizers used in healthcare can have tens of thousands parts per million in the chamber, it wouldn’t take much of a leak to cause serious health problems or even death!

Visit to learn more about Air Quality Action Days, and other harmful effects of air pollution.

Tuesday, July 6, 2010

Sterilization Industry Trends

Last week, MD Publishing posted a new Roundtable discussion about sterilization equipment, in which 3 experts explained trends in the industry. Dr. Richard Warburton, our CTO and General Counsel, used the opportunity to discuss a major trend in the sterilization industry that the experts neglected to point out: that of increased awareness of employee safety. Dr. Warburton explains that “With greater education and awareness of the hazards, improved design of the sterilizers, increased use of continuous gas monitors, and wider implementation of engineering controls and PPE, the use of sterilant chemicals in healthcare is becoming safer every day.” Unfortunately, while this seems to be one of, if not the, most important trends over the last several decades, it was barely mentioned in the article.

To read Dr. Warburton’s full comments, as well as the article, visit: