By Michael Nevin Helmus
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Extra resources for Biomaterials in Design and Reliability of Medical Devices (Tissue Engineering Intelligence Unit)
Additional requirements of high tear strength are required for balloons utilized in stent expansion and placement. During the design process the potential effect of unique clinical settings and diagnostic procedures on the device may need to be considered. As magnetic resonance imaging (MRI) has become more popular, including the evolving development of magnetic resonance angiography, the magnetic susceptiblity of the metallic alloys utilized in a device may need to be considered. Generally ferromagnetic and paramagnetic materials may be at risk for movement and heating in intense magnetic fields.
Also, the 510k paradigm document has been finalized10 and provides for two faster “gateways for approval: “special 510K” and "abbreviated 510K". The “special 510K” is available if the device is a modification of a predicate device and entails submission of summaries of design control compliance. Devices that include changes in energy sources, software and dimensions are suitable for this pathway. The “abbreviated 510k" is available to devices that are amenable to device-specific guidance documents, special controls, or FDArecognized consensus standards.
Specialty suppliers are available. The use of new materials without extensive implant history will require extensive testing to demonstrate long-term durability. Degradation and loss of integrity can result from hydrolysis, including enzymatic hydrolysis, particularly in the polyurethanes and polyester-based copolymers. Degradation can also occur, as discussed, by oxidation from enzymes released in wound healing and from distortion and weakening from absorption of lipids. Polymeric materials are complex materials with ranges of molecular weights and utilizing additives to control polymerization, stability and processing.