Within sterile processing departments, the predominant modality for ethylene oxide sterilization is the sealed EtO cartridge approach, as sold by 3M. In its Product Profile on the Steri-Gas™ EO cartridges, 3M puts forth these recommendations: Keep all sources of ignition such as matches, lighted cigarettes, sparks and static discharge away from the sterilizer and cartridges.…
In recent months, we have seen certain people touting systems using gas chromatography (provided with a photo-ionization detector) for area monitoring of ethylene oxide in Supply, Processing, and Distribution (SPD) departments. [Sometimes SPD stands for Sterile Processing Department or Sterile Processing and Distribution.] Such systems, despite their expense, were reasonably popular 20-25 years ago. However,…
Sometimes, we are asked about the 0-50 ppm measuring range offered on our ethylene oxide (EtO) instruments. After all, a founding principle for direct-reading instruments, used in occupational health work, was that the range should be set up to cover one-tenth to 10 times the TLV-TWA, or as OSHA would later call it, the PEL…
Gas detection methods have been changing and evolving and awareness has heightened as well, along with the ever changing methods of sterilization. To answer your question regarding what “most” hospitals are using to monitor EtO, a fair response would be narrowed down to either electrochemical sensors or gas chromatographs (GCs). Interscan has sold close to…
On 30 April 2009, OSHA released a comprehensive document entitled “Small Business Guide for Ethylene Oxide.” This new publication is available as a spiffy pdf (14.2 MB) or as a more browsable web page. The agency considers it to be a “guidance document,” in that it is advisory in nature, is informational in content, and…
EPA and FIFRA While most matters regarding occupational exposure to toxic compounds—in the United States—fall under the purview of the Occupational Safety & Health Administration (OSHA), in some cases, other federal agencies are also involved. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 United States Code §§ 136-136y (2008), the EPA has re-registered…
The original reference for periodic leak testing comes from 29 CFR 1910.1047 App A, and is entitled “Substance safety data sheet for ethylene oxide (non-mandatory).” Section VII-2-i of the document states: Leak detection. Sterilizer door gaskets, cylinder and vacuum piping, hoses, filters, and valves must be checked for leaks under full pressure with a Fluorocarbon…
Monitoring badges are integrating rather than real-time devices, yielding an accumulated value—often incorrectly interpreted as an “average”—calculated over the time period the badge was active. The advantage of real time monitoring is that it WILL keep track of spikes and excursions, while a badge will merely accumulate this information into the total. Since OSHA does…
Written in response to a particular inquiry, this article is posted since it is of general interest. Calibration is a very important issue. One of Interscan’s competitors recommends calibrating its EtO monitor with CO (Carbon Monoxide). There is nothing wrong with using CO to calibrate an analyzer, assuming it is a CO analyzer that you…
Background In the continuing regulatory assault on ethylene oxide, more rules now apply. Fortunately, these latest statutes are not at all difficult to comply with. The new rule is called “National Emission Standards for Hospital Ethylene Oxide Sterilizers.” It was published on 28 December 2007 as 40 CFR Part 63, with particular notice given to…