Development of Tolerance Limits for an Industry -- Ethylene Oxide Sterilization of Medical Devices


Madden, Dale A.   (1992, ASQC)   Food and Drug Administration, Rockville, MD 20857

Annual Quality Congress, Nashville TN    Vol. 46    No. 0
QICID: 9895    May 1992    pp. 741-747
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Article Abstract

Food and Drug Administration (FDA) has developed guidelines to ensure that medical devices sterilized with Ethylene Oxide (EO) are truly sterile.

In the past, medical devices were made of metal and sterilized with high temperature steam. Standards were simple: heat to x degrees for y minutes. Now, many medical devices are made of paper and plastic that will withstand neither the temperatures nor humidity of steam sterilization. Such devices are sterilized by exposure to EO gas and the standards are not as clear.

The FDA inspected 292 establishments that use EO sterilization procedures. They collected sterilization data for specific batches of devices and plotted the results on probability plots. They studied both specified values and actual values for nominal values, upper and lower limits, and one-sided limits. The results generated standards for number of devices per load, time in the sterilizer, and optimum humidity levels.

These standards have since been shown to generalize to similar sterilization practices in other organizations and may be used to establish new procedures or check existing ones.


Graphical methods,Health care,Food and Drug Administration (FDA),Tolerances

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