NIOSH Report Contains Interesting Information

The National Institute for Occupational Safety and Health (NIOSH) released a report in August of last year titled, “Evaluation of Worker Exposures to Peracetic Acid-Based Sterilant during Endoscope Reprocessing.” The document analyzes a 2006 visit to a hospital that requested a health hazard evaluation because of health problems being reported among employees in their sterile processing department. The report contained a few interesting things relevant to the work that is currently taking place at ChemDAQ.

First was NIOSH’s acknowledgement of the possibility of chemical spills, leaks and processor malfunctions. The report states that exposure is “unlikely”, however at the same time instructs hospital managers to “make sure that processors are inspected periodically for worn parts that can cause leaks” and urges employees to “follow standard operation procedures for processor problems, leaks, and sterilant spills.” While many manufacturers will assure their customers that continuous monitoring of sterilant gases is unnecessary because their equipment cannot malfunction, the NIOSH report makes it very clear that is not the case. According to the report, “processor malfunctions and improper handling and disposal of … containers can result in dermal or inhalation exposures”, as can what NIOSH terms “nonroutine events.”

The second is that this particular hospital had inadequate ventilation of their sterilization rooms and the employees had insufficient training. Without proper training, these workers could experience increased exposure in the event of an adverse incident, which was what prompted the NIOSH evaluation in the first place.

This report once again confirms that sterilizers can and do malfunction and that many workers have insufficient training when it comes to dealing with chemical leaks in the workplace. Without a continuous gas monitoring system, employees would have no way of knowing when chemical sterilants are in the air. This particular report mentions detection of Peracetic Acid by odor, but if you can smell it, it is too late as exposure has already occurred. Furthermore, with inadequate ventilation of the workplace, as in this case, odors from various other chemicals could be in the air, making it difficult to distinguish the harmful from the innocuous. Continuous monitoring enables immediate notification of a leak, allowing employees to exit the area quickly and safely.

To read the full report, visit:
http://www.cdc.gov/niosh/hhe/reports/pdfs/2006-0298-3090.pdf

Environmental Working Group Study

In December 2007, Environmental Working Group published a study entitled “Nurses’ Health and Workplace Exposures to Hazardous Substances”. The study was based on a survey of nurses who reported varying levels of exposure to common chemicals found in hospitals. What they found was quite remarkable, and speaks to the importance of area monitoring in the workplace. A few interesting excerpts:

“Participating nurses who were exposed frequently to sterilizing chemicals, housekeeping cleaners, residues from drug preparation, radiation, and other hazardous substances report increased rates of asthma, miscarriage, and certain cancers, as well as increases in cancers and birth defects, in particular musculoskeletal defects, in their children.”

“Asthma rates increased by up to 50 percent for nurses reporting high exposure to disinfecting and sterilizing agents (glutaraldehyde and ethylene oxide), housekeeping chemicals, and latex, relative to nurses with lower exposure to these hazards.”

“Nurses reporting high exposures to ethylene oxide and antineoplastic drugs also reported up to 20 percent higher incidence in miscarriage, on average, than nurses with lower or no exposure.”

“46 percent of nurses report feeling that the administrations at their health care facilities are not doing enough to protect them from hazardous exposures, and 37 percent do not think that occupational health is taken seriously at their place of employment.”

In light of these results, Environmental Working Group offered suggestions and recommendations to improve worker safety, saying that “(health care facilities) should monitor the air, surfaces, and even nurses’ bodies for chemicals. They should educate nurses on the hazards and safe use of chemicals and other hazardous agents. And they should not wait for these actions to be mandatory.”

We couldn’t have said it better ourselves.

To read the entire study, visit http://www.ewg.org/reports/nursesurvey.

AAMI Announces Teleconference Dates

The Association for the Advancement of Medical Instrumentation has announced dates for two important teleconferences next month in order to review remaining comments on their standards. The call for Working Group 40: Steam Sterilization Hospital Practices, will take place on Tuesday, July 20 from 10am – 2pm (EDT). The call for Working Group 61: Chemical Sterilants Hospital Practices will take place 2 days later on Thursday, July 22 from 10am – 2pm (EDT). The two documents being reviewed are ST79 and ST58, respectively.

As you might recall from an earlier post, the meetings in May were not long enough to allow discussion on many of our company’s comments concerning the standards. While we all know that exposure to chemical sterilants can be very harmful, the standards are inconsistent when it comes to how they should be monitored. Our goal is to introduce consistency in the documents on how all sterilants should be monitored, with employee safety at the forefront.

We look forward to healthy discussion via the teleconferences at the end of July.

ChemDAQ Continues Work to Protect Employees from Exposure to Peracetic Acid

It’s been a busy week here at ChemDAQ. On June 15, our company applied for a Peracetic Acid (PAA) sensor to add to our Steri-Trac® gas monitoring system. To read the entire press release, visit: http://www.chemdaq.com/Press/paa_pending.html. Along with Ethylene Oxide, Hydrogen Peroxide, and Ozone (which we also produce sensors for), PAA can be a potentially dangerous chemical if employees are exposed to it in the workplace. While the effects of PAA are known to authorities, they are largely unknown by the general public. Here at ChemDAQ, we’ve done our due diligence to research exactly how harmful exposure to PAA vapor can be.

PAA is used in many different industries including waste water disinfection, aseptic food packaging, medical device sterilization and disinfection in hospitals to name a few. Production of our new sensor, therefore, will enable employers to protect a whole new category of workers from adverse health effects. According to the National Institute for Occupational Safety and Health (NIOSH), PAA is a primary irritant as well as a known tumorigen and mutagen. The New Jersey Dept. of Health and Senior Services released a study in 2004 citing it as a possible animal carcinogen with ties to cancer of the lungs. The study also found that PAA is very irritating to the skin, eyes, nose, throat, and lungs. In fact, the vapor is so irritating that permanent scarring of the skin, cornea, and throat can occur. Higher exposures in the short term can also cause pulmonary edema as well as liver and kidney effects. The entire New Jersey report can be found at http://nj.gov/health/eoh/rtkweb/documents/fs/1482.pdf.

According to the United States National Library of Medicine, exposure to PAA vapor can cause long term effects as well. Espophageal, gastric, and pyloric strictures and stenoses can occur, which may not appear until months or years later. In addition, exposure could cause circulatory collapse that, if not corrected, could lead to renal failure as well as lesions on the heart and liver.

Needless to say, PAA vapor can be quite harmful. As far as we know, the PAA sensor that we have just applied for a patent for is the first of its kind in the world. It will enable employers to continuously monitor for concentration of PAA in the air, allowing them to adhere to exposure guidelines that do exist. The EPA has issued Acute Exposure Guideline Levels (AEGLs) for PAA and OSHA has Permissible Exposure Limits (PELs) for Hydrogen Peroxide and Acetic Acid, the two main components of PAA. It is important to note that, according to the EPA, “although a contributing affect of acetic acid and hydrogen peroxide cannot be ruled out in the toxicity studies described in this report, it appears, however, that acetic acid and hydrogen peroxide are considerably less toxic than peracetic acid”.

Also mentioned in the EPA’s report is the Emergency Exposure Indices (EEI’s) developed by the Belgian PAA manufacturer, SOLVAY. The values correspond to the following:

SLV-EEI-3 (death/permanent incapacity) 50ppm: the threshold above which mortality and/or irreversible effects could be observed for an exposure of up to 60 minutes.
SLV-EEI-2 (disability) 3ppm: the threshold level above which intense lacrimation, extreme nose discomfort and transient incapacitation (inability of self protection but without residual consequences) could be observed for an exposure of up to 60 minutes.
SLV-EEI-1 (discomfort) 0.15ppm: the threshold level above which discomfort could be observed for an exposure of up to 8 hours per day.

Take it from the people who manufacture it – PAA can be quite hazardous, even in small amounts.
For further information, all of the EPA’s findings can be found at http://www.epa.gov/oppt/aegl/pubs/results80.htm.

If you or someone you know has had any adverse effects due to exposure to PAA vapor, we invite you to share them here.

Just What is a Part Per Million of Sterilant Gas?

As you know, here at ChemDAQ we produce toxic gas monitoring systems with the safety of workers as our first priority. You are also probably familiar with the current regulations pertaining to chemical sterilants. For example, the OSHA Permissible Exposure Limits (PELs) for Ethylene Oxide (EtO) and Hydrogen Peroxide (H2O2), two common sterilant gases, are 1.0 part per million (ppm). For Ozone, the PEL is 0.1ppm. In dealing with gas, which has an incredible amount of particles, it is difficult to understand just what a part per million really is. So to make it a little easier to comprehend, we’ve come up with a few analogies:

A ppm is…
The first step of a 380 mile walk.
One hair on your head and on the head of nine of your friends.
One second out of 11.6 days.
One penny out of 19 - 5 gallon water jugs filled with pennies.
One drop of water (.05ml) in a 13 gallon tank.

Now that you have an idea of just how small one ppm really is, consider this. The average sterilizer uses several percent by volume of the active sterilant gas in the chamber. Just one percent of that volume is equivalent to ~10,000ppm. Therefore, even the smallest leak or simply the off gassing of sterilized equipment could release an amount of toxic gas into the breathing zone capable of significantly affecting the health of those exposed. Without a continuous monitoring system, workers wouldn’t know that they were being exposed until the concentrations of gas in the air have reached levels far above the PELs, thus putting their health in jeopardy.

ChemDAQ Continues Work to Update AAMI Recommendations

On May 24th and 25th, representatives from Chemdaq attended the Association for the Advancement of Medical Instrumentation's (AAMI) committee meetings for the Chemical Sterilants Hospital Practices and Steam Sterilization Hospital Practices working groups to contribute to the revisions of ST58 and ST79, respectively. Seeing as these recommendations are only updated every 5 years, there was much to be discussed at the meetings. Understanding the serious health effects of chemical sterilants, and as a leader in the field of continuous gas monitoring, we are seeking to introduce consistency into AAMI's recommendations on how such sterilants are to be monitored. We feel that continuous gas monitoring of substances such as Hydrogen Peroxide, Ozone, and Peracetic Acid is the only way to effectively meet OSHA regulations given today's technology and seek to have those recommendations established by AAMI. Unfortunately, the meeting was not long enough to reach all of our points, and discussion will continue via teleconference in just a matter of weeks. Assuming the other members of the committees see these issues our way, revised versions of ST58 and ST79 will be voted on this coming November with our comments included. We'll keep you updated on our progress.

In the meantime, below I have posted an article writted by our own Dr. Richard Warburton concerning the misconceptions people have regarding today's chemical sterilants. It was published in May 2008 in Infection Control Today. Hopefully this article will provide further justification for why toxic gases should be continuously monitored in the workplace.

http://http://www.chemdaq.com/docs/ICT_ChemDAQ_May08_PDF.pdf