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Sterilant gas monitoring


Sterilant gas monitoring is the detection of hazardous gases used by health care and other facilities to sterilize medical supplies that cannot be sterilized by heat or steam methods. The current FDA approved sterilant gases are ethylene oxide, hydrogen peroxide and ozone.Sterilization means the complete destruction of all biological life (including viruses and sporoidal forms of bacteria), and sterilization efficacy is typically considered adequate if less than one in a million microbes remain viable.

Since sterilant gases are selected to destroy a wide range of biological life forms, any gas which is suitable for sterilization will present a hazard to personnel exposed to it. The NIOSH immediately dangerous to life and health values (IDLH) for the three sterilant gases above are 800 ppm, 75 ppm and 5 ppm for ethylene oxide, hydrogen peroxide and ozone respectively. For comparison, the IDLH of cyanide gas (hydrogen cyanide) is 50 ppm. Thus exposure to even low levels of sterilant gas should not be treated casually and most facilities go to great lengths to adequately protect their employees.

In addition, the sterilizer manufacturers go to great lengths to make their products as safe as possible, but sterilizers (as with any mechanical device) can and sometimes do fail and leaks have been reported (see for example FDA's Manufacturer and User Facility Device Experience Database. Continuous gas monitors are used as part of an overall safety program to provide a prompt alert to nearby workers in the event that there is a leak of the sterilant gas.

The monitor alarms are typically set to warn if the concentrations exceed the OSHA permissible exposure limits (PELs), 1.0 ppm for ethylene oxide and 1.0 and 0.1 ppm for hydrogen peroxide and ozone respectively. The PELs are calculated as 8 hour time weighted average values (i.e. the average exposure over a typical shift).


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