Biocompatibility and performance of medical devices by Jean-Pierre Boutrand

By Jean-Pierre Boutrand

Implant and gadget brands are more and more having to stand the problem of proving that their implants or units are safe/biocompatible and practice as promised. it's also important that brands can competently and effectively predict the biocompatibility in their units ahead of they're implanted. The overseas staff of individuals and editor describe and clarify the standards that impact the biocompatibility of fabrics and clinical units. Introductory chapters supply an advent to biocompatibility, examine the evaluate and characterization of biocompatibility in clinical units and overview checking out and interpretation of clinical gadget performance.  The end explains the histopathological rules for biocompatibility and function stories.

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Overall biological safety conclusions for the medical device. 3 Examples of device recalls or alerts during the last decade in which biocompatibility issues were considered Although biocompatibility evaluation provides frequent examples of bioincompatibility of materials, the real challenge to address is whether the current methods/strategies are able to prevent major biocompatibility issues. One of the better known examples of harmful effects arising from orthopedic implantation concerned the extensive granulomatous responses seen with the polytetrafluoroethylene (PTFE) used by Charnley in his first joint prosthesis.

Such an event also raises the issue of the genotoxic effect of the released species, as the mutagenic effect of hexavalent chromium or cobalt is well established. This long-term harm was probably unpredictable through the biological testing program performed on the individual components of the implant, but should have been addressed through the risk assessment procedure. 2 Residues of solutions used for reprocessing medical devices In 2004, MHRA issued a MDA concerning Cidex (MDA ortho-phtalaldehyde high-level disinfectant solution: OPA), used for reprocessing urological instruments that may have resulted in hypersensitivity in some patients with history of bladder cancer undergoing repeated cystoscopy.

That the shelf-life concept has to be applied to all characteristics of a device (sterility, packaging, mechanical and physical properties, toxicological evaluation in the worst case scenario of the risk assessment). 4 Opacification of intraocular lenses Of 868 implanted hydrophilic intraocular lenses, from a single UK manufacturer, 233 (27%) have been explanted due to problems of opacification. The phenomenon appeared to be related to the migration of silicone from the packaging onto the surface of the lens.

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