When Temperature Matters – Cryo TEM
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Extraction Expertise for Medical Device Chemical Characterization
Medical Device Extraction Expertise
Extractable studies are performed on medical devices to evaluate potential chemical release from a medical device during clinical use.
The primary guidance for medical device extractable studies is ISO 10993-18 “Chemical characterization of medical device materials within a risk management process”. In this international standard, a number of extraction study approaches are laid out, which are applied to medical devices based on the intended device use.
EAG offers advanced expertise and a risk-based approach for medical device extractable study design and execution, including the latest FDA expectations.
Extraction Study Approaches for Chemical Characterization Testing
- Simulated-Use Extraction – Performed to estimate release of substances under clinical use, representing exposure under conditions of use.
- Exaggerated Extraction – Results in a greater number and amount of chemical constituents extracted from the device than what may be generated under clinical conditions. FDA recommends that both time and temperature exceed clinical use conditions for exaggerated extractions.
- Exhaustive Extraction – An iterative series of extractions, performed until the amount of material extracted in a subsequent extraction step is less than 10% extracted initially.
ISO 10993-18 provides guidance for the type of extraction study necessary for chemical characterization, based on device contact.
The three categories of medical device contact, each with specific extraction guidelines
- Limited Exposure – Duration of contact up to 24 hours. Simulated-use extraction is recommended by ISO, but FDA recommends exaggerated extractions or “clinically relevant worst-case conditions”.
- Prolonged Exposure – Duration of contact between one and 30 days. Exhaustive extractions are recommended, but exaggerated extraction may be justified in some cases.
- Long-term Exposure – Duration of contact exceeding 30 days. Exhaustive extraction is strongly encouraged.
Of course, many devices have unique considerations, including frequent replacement, reuse, and resorption. Even after determining the appropriate extraction type for a device, there are still decisions to be made about extraction solvents, temperature, duration, agitation, and sample preparation. These many factors must be balanced in experimental design to generate chemical data necessary and sufficient to support a toxicological risk assessment.
Our experts at EAG have had experience designing and executing extractable studies for hundreds of diverse medical devices and can help you make sure you’re performing the testing needed for your purposes. Whether for internal research, to support a manufacturing change, to demonstrate equivalency, or to present a complete chemical characterization submission to a regulatory agency, we will provide the most up-to-date recommendations for an extraction approach that is specific to your device and end goals.
Related Resources
- Webinar: Design an Effective Chemical Characterization Study for Your Device
- Webinar: Master the Toxicological Risk Assessment of Your Device with Better Chemistry
- Application Note: Extractable and Leachable Database Building for High Confidence Identification by Liquid Chromatography-Mass Spectrometry
- Brochure: Medical Device Testing
- Blog: For Medical Device Testing, Every Variable is Important
- Blog: Essentials of Particulate Testing: USP and AAMI TIR42
- Industry: Medical Devices
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