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Non-PVC medical device

Kelly P Coleman, Thomas P Grailer, Lori R McNamara, Beau L Rollins, Nicholas J Christiano, Helena Kandárová, Wim H De Jong
A round robin study using reconstructed human epidermis (RhE) tissues was conducted to test medical device polymer extracts for skin irritation potential. Test samples were four irritant and three non-irritant medical device polymers. Five of these polymer samples were developed and two were obtained commercially. The three non-irritant samples were comprised of 100% 80A polyurethane, one-part silicone, and polyvinyl chloride (PVC). The polyurethane samples were made using a hot-melt process, while the silicone samples were created by mixing and casting...
February 2, 2018: Toxicology in Vitro: An International Journal Published in Association with BIBRA
Christian Pellevoisin, Christelle Videau, Damien Briotet, Corinne Grégoire, Carine Tornier, Alain Alonso, Anne Sophie Rigaudeau, Charbel Bouez, Nathalie Seyler
According to ISO 10993 standards for biocompatibility of medical devices, skin irritation is one of the three toxicological endpoints to be always addressed in a biological risk assessment. This work presents a new protocol to assess this endpoint in vitro rather than in vivo. The protocol was adapted to medical devices extracts from the OECD TG 439 with the SkinEthic™ RHE model as test system. It was challenged with irritant chemicals, Sodium Dodecyl Sulfate, Lactic Acid and Heptanoic Acid spiked in polar solvents, sodium chloride solution or phosphate buffer saline and non-polar solvent, Sesame Oil...
January 13, 2018: Toxicology in Vitro: An International Journal Published in Association with BIBRA
Joanna Lenik
Electrochemical sensors are very convenient devices, as they may be used in a lot of fields starting from the food industry to environmental monitoring and medical diagnostics. They offer the values of simple design, reversible and reproducible measurements, as well as ensuring precise and accurate analytical information. Compared with other methods, electrochemical sensors are relatively simple as well as having low costs, which has led to intensive development, especially in the field of medicine and pharmaceuticals within the last decade...
2017: Current Medicinal Chemistry
Nicole Marsh, Joan Webster, Gabor Mihala, Claire M Rickard
BACKGROUND: A peripheral venous catheter (PVC) is typically used for short-term delivery of intravascular fluids and medications. It is an essential element of modern medicine and the most frequent invasive procedure performed in hospitals. However, PVCs often fail before intravenous treatment is completed: this can occur because the device is not adequately attached to the skin, allowing the PVC to fall out, leading to complications such as phlebitis (irritation or inflammation to the vein wall), infiltration (fluid leaking into surrounding tissues) or occlusion (blockage)...
June 12, 2015: Cochrane Database of Systematic Reviews
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