A Comparison Of FDA And EMA Policies For EO Sterilized Devices
EMA & FDA See Eye to Eye on Ethylene Oxide
Medical device regulations for products sold within the United States of America (USA) do not always equate to the regulations needed for medical devices to be sold within the European Union. The European Medical Association (EMA) and the Food & Drug Administration (FDA), the governing bodies for medical device regulations for Europe and the USA respectively, do not always see eye to eye. However, when it comes to EO sterilization, the EMA and FDA do. Both the EMA and the FDA consider IS0 11135:2014 to be the go-to standard for medical device sterilization. Furthermore, both the EMA and FDA consider ISO 10993 to be the governing standard for EO residual testing of medical devices. This is good news for medical device companies choosing EO as the sterilization method for their medical devices! Indeed, medical devices that meet the EO sterilization criteria in the USA will also meet the sterilization criteria in Europe (and vice versa).
Thus, no additional expenditure of time or money is necessary to meet EO sterilization in both the USA and Europe.
ISO 11135:2014 Summary
For those of you new to EO sterilization and its associated guidelines, ISO 11135:2014 replaced the previous ISO 11135:2007 in 2014. This document details EO sterilization principles and current requirements for medical device manufacturers choosing to use EO as their final form of sterilization. ISO 11135:2014 details criteria for the entire EO sterilization process from pre-conditioning through aeration. For those looking to invest in a new EO sterilization system or those looking to see if a pre-existing EO sterilization system meets the current standard, ISO 11135:2014 details equipment and installation requirements for EO sterilization. Additional considerations for EO sterilization of medical devices are also detailed. Some of these EO considerations include the type of materials used for the medical device, packaging of the device, and the loading configuration of packaged devices in the EO sterilization chamber. Medical device companies should evaluate medical device materials, packaging, and load configuration prior to selecting EO as a final form of sterilization.
ISO 10993 Summary
Concerned about the level of EO residual left on your device following EO sterilization? Look no further than ISO 10993. ISO 10993 details everything you need to know about EO residual testing to avoid EO toxicity of your device following sterilization. This guidance provides acceptable levels of EO and ECH residuals left following EO sterilization. These EO and ECH residual levels must be met for up to three categories of use. These categories of use are limited exposure (less than 24 hours of use), prolonged exposure (between 1 day and 30 days of use), and permanent exposure (a lifetime limit consisting of more than 30 days of use). Use the ISO 10993 standard to determine which categories of use qualify for your device and eliminate EO residual concerns for your device.
Bringing It All Together
The FDA and EMA agree with the ISO 11135:2014 and ISO 10993 guidelines for EO sterilization and EO residual testing. Medical device companies should consider the impact EO sterilization will have on the materials chosen for their medical device prior to choosing EO sterilization over alternative sterilization methods. Consideration should also be taken for packaging of devices and device load configuration. Both packaging and load configuration can cause significant differences in sterilization quality and EO residual content of the final sterilized product. Overall, it is recommended that medical device companies seek professional guidance when evaluating their EO residuals to ensure all regulatory qualifications are met and documented.
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. Sterilization Of Health-Care Products – Ethylene Oxide – Requirements For The Development, Validation And Routine Control Of A Sterilization Process For Medical Devices. Geneva (Switzerland): ISO; 2014. (ISO 11135:2014).
International Organization for Standardization. Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals. Geneva (Switzerland): ISO; 2008. (ISO 10993-7:2008).
