What Products Require Ethylene Oxide Residuals Testing
#1: Have You Considered Alternative Sterilization Methods?
Ethylene oxide (also know as EtO or EO) sterilization isn’t the only sterilization method out there. Common alternatives to EtO sterilization include radiation sterilization via gamma irradiation or electron beam. Consider sterilization alternatives with our sterilization comparison chart prior to committing to EtO sterilization.
#2: Have You Considered Alternative Materials For Your Device?
Materials vary in their ability to absorb, retain and release ethylene oxide. Additionally, materials that contain a source of free chloride ions exhibit a wide degree of variation in the concentration of ethylene chlorohydrin (ECH) residual formed following EtO sterilization. If you are planning to use EtO sterilization for your device, consider choosing device materials that are low in EtO absorption and retention.
#3: Is Your Device In Contact With The Patient?
If your device isn’t in contact with the patient, there is no need to perform EtO residuals testing.
If your device is in contact with the patient, EtO sterilized devices are placed into one or more of three exposure categories based on the duration of contact a medical device has with a patient. These categories are limited exposure (less than 24 hours), prolonged exposure (1 day to 30 days), and perpetual exposure (lifetime limit). If you device does require EtO residuals testing, determine which ethylene oxide extraction method is best for your device, learn how to calculate your ethylene oxide residuals, and find out how to prepare your samples for testing. If you need ways to reduce your ethylene oxide residuals to meet the required limits, please visit our article on key factors that influence EtO residuals levels.
#4: Is Your Device A Multi-System Device?
If your device is a multi-system device, EtO and ECH limits apply to each individual device that is in contact with the patient. Make sure that all devices within your system are evaluated appropriately for EtO residuals testing following sterilization.
#5: Does Your Device Fill A Special Category?
There are six special categories that have exceptions to the EO and ECH residual limits specified in ISO 10993.
These six categories are:
- Intraocular Lenses
- Blood Cell Separators (used in donor and patient blood collection)
- Blood Oxygenators & Blood Separators
- Cardiopulmonary Bypass Devices
- Extracorporeal Blood Purification Devices
- Drapes Contacting Intact Skin
Ethide Labs is a contract testing organization that specializes in Sterilization Validations and EO Residual Testing. Ethide Labs provides in-vitro cytotoxicity tests in-house and outsources in-vivo cytotoxicity work for toxicity testing of medical devices, products, and drugs. Ethide Labs also offers Microbiology Testing, Bioburden Testing, Environmental Monitoring, Bacterial Endotoxin Testing, Package Integrity Testing & Cytotoxicity Testing services for medical device companies and allied industries. Ethide is an ISO 13485 certified facility.
References
International Organization for Standardization. Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals. Geneva (Switzerland): ISO; 2008. (ISO 10993-7:2008).
