By Thor Rollins, Biocompatibility Specialist, RM(NRCM), and Alexa Tatarian, B.S., Project Coordinator
Nelson Laboratories recently began providing Material Characterization with Extractable and Leachable testing services to help medical device manufacturers demonstrate that their products are safe and comply with government regulations. This testing can provide a significant reduction of cost and time compared to historical biocompatibility testing.
Outlined in the ISO 10993-17 and -18 standard, listed material characterization test options can help characterize the device material as well as evaluate extractable and leachable compounds that are extracted from the device.
If a medical device has direct or indirect contact with the human body, understanding the types and amounts of chemical compounds that may leach from the device becomes very important. Testing is required to ensure compounds are not harmful and to meet compliance.
Following the extractions, different compounds of concern are identified and quantified. Once quantified, a toxicological assessment can be made based on published data concerning toxic levels of the compounds. If needed, a board certified toxicologist may make a risk assessment concerning the results in terms of the overall safety of the levels of compounds.
Material characterization and evaluating extractable and leachable compounds characterizes and identifies what is coming off of a device to predict the biological response of those compounds and the levels observed. The material characterization test options listed below may be used in lieu of certain biocompatibility tests, saving the manufacturer time and money. In addition, this chemical analysis decreases the industry dependence on animals for testing.
- Direct Analysis
- Fourier Transform Infrared Spectroscopy (FTIR)
- Differential Scanning Calorimetry (DSC)
- Scanning Electron Microscope (SEM)
- Extractable/Leachable Profile
- Gas Chromatography Mass Spectrometry (GC/MS) for volatile and semi-volatile organic compounds
- Inductively Coupled Plasma Mass Spectrometry (ICP/MS) metals analysis
- High Performance Liquid Chromatography Mass Spectroscopy (HPLC/MS) for non-volatile compounds
- Physicochemical Testing per USP 661
- Gravimetric Analysis per ASTM F2459
Additional tests may also be included as part of a material characterization study not listed above. Each individual company and device will have a unique test plan based on the intended use of the device and compounds of concern.