Medical device warehouse

Ethylene oxide (EO or EtO) is a widely used gas sterilant, for devices that cannot take the heat of steam. To promote efficiency in the distribution of these devices, which often are shipped to the customer pre-sterilized, inventory is kept in strategically located warehouses.

Best practices for EtO sterilization recommend sufficient aeration of the load after being treated with the ethylene oxide. Such aeration is needed since the load could emit gas otherwise, creating a possibly unsafe condition. Indeed, proper aeration is programmed into most sterilizers being used in hospital sterile processing departments.

However, in the case of bulk medical device sterilization as done or ordered by the device manufacturers themselves, the process is most often performed by large contract sterilizer companies. Suffice to say that concerns about aeration in this environment are not always rigorous enough.

Thus, it is not uncommon that such loads will be delivered to the warehouse still emitting some ethylene oxide. We discovered this years ago during a visit to one of our continuous EtO monitoring system customers. This company was a device manufacturer based in New England. During the site visit, I asked where the sterilizers were located, only to discover that the company did not have any sterilizers. Rather, it had to monitor its warehouse area for EtO, based on emissions from the devices sterilized elsewhere.

The present day experience of our customers mirrors this situation. We have coordinated with them on a comprehensive program to protect their warehouse employees.

As trucks arrive with the sterilized devices, our portable analyzers are used to determine the extent of emissions right at the source. If a particular EtO level is exceeded, the truck’s cargo area must remain open to allow further aeration, and nothing is to be brought into the warehouse.

Continuous monitors are installed within the warehouse, and can activate increased ventilation, if necessary. As an added precaution, certain employees—identified as being the most likely to be exposed to EtO—are outfitted with monitoring badges, to get another handle on their personal exposure.

We’ve helped out several warehouse operators, faced with this situation. May we do the same for you? Feel free to contact us for a free consultation.

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