Insights into Extractables & Leachables Testing: Ensuring Medical Device Safety
In the realm of medical device testing, ensuring safety is paramount. Extractables & Leachables testing (ISO 10993-18) plays a pivotal role in this process, offering a comprehensive assessment of potential risks associated with materials and compounds used in medical devices. In this blog post, we delve into the intricacies of Extractables & Leachables testing, exploring its definitions, examples of tests, and the significance in ensuring device safety.
Defining Extractables & Leachables
Extractables are compounds that can be extracted from a medical device material under laboratory conditions, while Leachables are compounds that migrate from the device material into the product or surrounding environment during actual use or storage. Both Extractables and Leachables pose potential risks to patient health and safety and must be thoroughly evaluated to ensure regulatory compliance and patient well-being.
Examples of Tests in Extractables & Leachables Testing
Volatile Organic Compounds (VOCs): VOC testing is typically performed using headspace Gas Chromatography-Mass Spectrometry (GC-MS). This method detects volatile compounds that may be present in device materials and have the potential to leach into the product or environment.
Semi-Volatile Organic Compounds (SVOCs): SVOC testing is typically performed using Gas Chromatography-Mass Spectrometry (GC-MS). This method detects semi-volatile compounds that may leach from device materials and pose risks to patient health.
Non-Volatile Organic Compounds (NVOCs): NVOC testing is typically performed using Liquid Chromatography-Mass Spectrometry (LC-MS) or High Resolution Accurate Mass (HRAM) LC-MS. This method detects non-volatile organic compounds that may leach from device materials and require sensitive analytical techniques for detection.
Elemental Impurities (Metals): Elemental impurity testing is typically performed using Inductively Coupled Plasma-Mass Spectrometry (ICP-MS). This method detects trace levels of metals that may leach from device materials and pose risks to patient safety.
Extractables: potential negative impact on medical device safety
Contamination of Drug Formulations: Extractables from packaging materials or device components can leach into drug formulations, contaminating the product and potentially compromising its efficacy or safety. For example, plasticizers or additives from tubing used in intravenous drug delivery systems can leach into pharmaceutical solutions, leading to chemical interactions or adverse effects in patients.
Toxicological Risks: Extractables may contain toxic compounds or substances that can pose health risks to patients upon exposure. For instance, chemicals leaching from adhesive components in medical tapes or adhesives used in wound dressings can lead to skin irritation, allergic reactions, or systemic toxicity if absorbed into the bloodstream.
Degradation of Device Performance: Extractables from device materials can cause degradation or deterioration of device performance over time. For instance, extractables from elastomeric components in infusion pumps or seals in medical implants may lead to mechanical failure, loss of functionality, or inaccurate dosing, posing risks to patient safety and treatment efficacy.
Leachables: potential negative impact on medical device safety
Patient Exposure to Harmful Substances: Leachables migrating from medical device materials into patient fluids or tissues can expose patients to potentially harmful substances. For example, leachables from plastic tubing used in blood transfusion sets may contaminate blood products, leading to adverse reactions or transfusion-related complications in recipients.
Adverse Tissue Reactions: Leachables from implantable medical devices, such as orthopedic implants or cardiovascular stents, can elicit inflammatory responses or tissue reactions in contact with the device. For instance, leachables from metal implants may induce metal hypersensitivity reactions or contribute to implant-related infections, jeopardizing patient outcomes and device longevity.
Interference with Therapeutic Agents: Leachables can interact with therapeutic agents or medications, altering their pharmacokinetics or pharmacodynamics. For instance, leachables from drug delivery devices, such as inhalers or syringes, may bind to drug molecules, reducing their bioavailability or potency, thereby compromising treatment efficacy and patient outcomes.
Interpreting Test Results
Interpreting Extractables & Leachables test results requires careful analysis and consideration of several factors. The Acceptable Exposure Limit (AET) and Threshold Toxicological Exposure (TTE) values are established based on toxicological assessments and regulatory guidelines. Test results are compared against these values to determine the potential risks associated with Extractables & Leachables. If the levels of identified compounds exceed the AET or TTE values, further evaluation and risk assessment are necessary to determine the appropriate risk mitigation strategies.
Summary and Conclusion
In conclusion, Extractables & Leachables testing is a critical aspect of ensuring the safety and efficacy of medical devices. By thoroughly evaluating the potential risks associated with device materials and compounds, Extractables & Leachables testing helps mitigate hazards, comply with regulatory requirements, and safeguard patient health. At NABI, we are committed to providing comprehensive and reliable Extractables & Leachables testing services, supporting the development and regulatory approval of safe and effective medical devices.
