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Keywords: medical device

Exposure Assessment Framework for Materials Selection in Consumer Products

Liong M., Exponent, Inc., US
The use of exposure and risk assessment methodologies is crucial in materials selection for consumer products, particularly those involving long-term dermal contact. While biocompatibility test procedures designed for medical devices, such as those described in [...]

The use of Ag5IO6 as an antimicrobial agent in wound dressing against microbial biofilms

Incani V., Omar A., Prosperi-Porta G., Nadworny P., Innovotech Inc, CA
This work explores the unique antibiofilm activity of pentasilver hexaoxoiodate (Ag5IO6). Impregnated wound dressings with Ag5IO6 were designed and their antibiofilm activity was compared with various commercially available silver and non silver-containing dressings. Ag5IO6-wound dressings [...]

Physico-chemical Characterization of Extracts of Silver Nanoparticle Containing Medical Devices

Casey B.J., Jayanti P., Sussman E.M., Dair B.J., U.S. Food and Drug Administration, US
The main goal of this research was to gain a better understanding of the extraction profile of medical devices containing silver nanoparticles. Multiple silver nanoparticle containing medical devices were incubated in various extract solutions (water, [...]

Assessing the Antimicrobial Activity of Silver Nanoparticles Leached from Medical Devices

Casey B.J., Dair B.J., U.S. Food and Drug Administration, US
This work focuses on characterization the leachables released from substrates, e.g. medical devices, containing silver nanoparticles. Furthermore, antimicrobial experiments were conducted to determine how the structure of a silver nanoparticle impact antimicrobial activity. Proper characterization [...]

Effect of Medical Device Substrate Material on Nanoparticulate Silver Efficacy

Dair B.J., Kennedy K.M., Casas R.S., FDA, US
Silver is one of the oldest known natural antimicrobial materials, the active form being the Ag+ ion, which disrupts critical cell functions in bacteria. Reducing the size of silver particles to the nano-scale regime increases [...]

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