Some heat-sensitive and moisture-sensitive medical devices must be sterilized with the use of a colorless gas known as ethylene oxide (EO). While there are other methods that have been developed, EO is still used in many cases due to its favorable properties.
Favorable Properties of EO
After a medical device has been treated with EO, any microorganisms lingering on the device will have been destroyed. The EO reacts to the microbe's DNA and destroys it. The effectiveness of EO when destroying the harmful microorganisms is based on the ability of the gas to be able to diffuse throughout the medical device. The device must be placed inside breathable packaging so that the gas is not blocked from treating the device.
EO does not degrade the product that it is used on and also preserves the integrity of the equipment. Some devices are also heat and moisture-sensitive and EO can be used in a manner that doesn't place these devices at risk. It can be used for medical products such as single-use medical devices and procedure kits.
When carrying out EO gas sterilization, the time necessary to achieve sterilization can often be shortened by increasing the temperature and the amount of gas used. However, this is not always suitable depending on the sensitivity of the equipment and the concerns over residual EO.
Minimizing Residual EO
While some residual EO left behind on the medical device is acceptable, you will want to make sure that you do not leave too much behind. This ensures that there are acceptable levels of EO so that patients do not experience an increased risk of cancer. However, when the use of EO is controlled and regulated, there is less of a risk that negative health problems will result from the use of EO.
If the methods used to sterilize an EO medical device change, the party responsible for the change needs to submit a PMA supplement so that the changes can be reviewed to determine if they meet the internationally recognized standards. Also, the facility that sterilizes the device might be inspected by the FDA to determine if the facility is using the right sterilization protocols. A state health department might also inspect the facility.
Consider Hiring a Sterilization Service
If you are concerned about whether you are meeting regulatory requirements when sterilizing your medical device, consider contacting an EO sterilization service to handle the process for you.
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