Where to Go for EtO Info

Medical Device & Diagnostic Industry
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An MD&DI September 1997 Column

HELP DESK

When facing the task of sterilizing their devices, manufacturers need to understand the types of sterilization processes available as well as the effects such processes have on the devices and their packaging. In addition to the information provided by sterilization equipment manufacturers and sterilization service providers, third-party sources, such as publications and trade associations, also offer valuable information.

James M. Gibson, a sterilization consultant with J. M. Gibson Associates (Odessa, FL), has found one reference to be particularly helpful for determining the absorption properties and aeration times of typical engineering plastics when sterilized with EtO. And, when searching for an Internet source on the effects EtO has on polyvinyl chloride (PVC), David R. Dills, corporate senior quality assurance engineer for Xomed Surgical Products (Jacksonville, FL), found a Web site set up by a key trade organization. The two experts describe these sources in their answers to the following questions.

Do you have any information about the absorption properties and aeration times for typical engineering plastics with regard to EtO?

Sterilization cycle parameters and the particular degassing techniques used influence how much EtO plastics absorb and how much time is needed to aerate the plastics so that the EtO dissipates. The configuration of the device, such as its thickness and shape, as well as its packaging also influence final EtO levels. The best general source I have found for such information is The Effects of Sterilization Methods on Plastics and Elastomers, published by the Plastics Design Library (Norwich, NY). Available in hard copy or on CD-ROM, the publication collects plastic manufacturers' data and published literature. It describes all sterilization methods for specific plastic formulations.

Is there a good Internet source of information regarding the effects of EtO sterilization on PVC?

The Ethylene Oxide Sterilization Association (EOSA; Washington, DC), a trade organization for parties interested in ethylene oxide and its uses, is in the process of establishing an Internet site to answer technical questions and to publicize important meetings. According to the association's administrator, the site will include synopses of health and safety data as well as references to articles on EtO sterilization. To handle specific questions, the site will include a list of EtO experts, their areas of specialization, and how to contact them. The association was formed to promote the benefits of using ethylene oxide for sterilization and to represent other common interests of its members. Some of its objectives include sharing information, monitoring regulatory activities, undertaking advocacy positions, addressing proposed government regulations, and fostering reasonable regulations and communications regarding EtO. EOSA's Web site address is http://www.eosa.org.


"Help Desk" solicits questions about the design, manufacture, regulation, and sale of medical products and refers them to appropriate experts in the field. A list of topics previously covered can be found in our Help Desk Archives. Send questions to Help Desk, MD&DI, 11444 W. Olympic Blvd., Ste. 900, Los Angeles, CA 90064, fax 310/445-4299, e-mail [email protected]. You can also use our on-line query form.

Although every effort is made to ensure the accuracy of this column, neither the experts nor the editors can guarantee the accuracy of the solutions offered. They also cannot ensure that the proposed answers will work in every situation.

Readers are also encouraged to send comments on the published questions and answers.


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