If devices are exposed to gamma radiation such as catheters is it possible to resterilize. If it is not possible what would be the explanation?

thanks
Gina

Hello Gina!

The statement that you cannot ETO sterilize an item that was previously sterilized by radiation was proven false over 25 years ago. I wonder how it does manage to continually survive? Or is it time for a new look at this issue. Today there are so many new medical devices on the marked made by new materials, unkown 25 years ago. A thought that made me rethink and "surf".
On the Help Desk of the Medical Device & Diagnostic Magazine, Jun 1999, Susanne Edel Satter gave the following interesting answer to "our" question:
Different product and packaging materials have been successfully validated for both radiation and ETO gas sterilization. However, exposing some materials to ETO after radiation can result in toxic byproducts. Manufacturers of finished devices must determine each product's biocompatibility based on its intended use after being subjected to a full sterilization process. which may include radiation processing followed by one or more ETO processes. In all cases, the product must be validated for materials compatibility, functional efficacy, and biocompatibility following the complete sterilization cycle intended for routine use."
Gina, in any case, the much more important question to ask is, "Should you re-process these devices?"

Kind regards
Josy

Gina

Your question makes no mention of ethylene oxide or the old myth of sterilizing a device with one, and then the other. A device sold new as sterile can be resterilized if it was designed to be resterilized. Your only concern is if the device was designed as a "Single Use Only." In this case, you should not resterilize it after its first use.

User facilities lack the design information for the device. You don't know if the device is going to react negatively with ethylene oxide, liquid disinfectants, vaporized hydrogen peroxide, dry heat or steam. You don't know if physically it can hold up to a second sterilization process. In addition, unless you have validated your cleaning process so that all devices going into the resterilization process have controlled bioburdens, you are going to harm the patients.

There is literature available from online sources regarding attempts by hospitals to resterilize catheters. It is a loaded question.

Paul J. Sordellini

PS: Some devices are Gamma sterilized because ethylene oxide gas cannot penetrate and contact all surfaces. In these cases, unless you have your own irradiator, you cannot reprocess them.