Patent on Mosaicplasty Implants Issued to CPG Researchers
US Patent 9,289,302 was issued on March 22, 2016 to CPG researchers. The patent describes designs and methods for making implants for focal cartilage tears in load bearing implants, such as hips and knees. The construct designs make use of a surgical procedure termed mosaicplasty, whereby a plug of healthy osteochondral plug is removed from […]
FDA Draft Guidance Document on UHMWPE
The FDA issued a draft guidance document on the required testing for devices using ultra high molecular weight polyethylene (UHMWPE) in February 2016. The guidance document separates UHMWPE into four categories: (1) conventional UHMWPE; (2) highly crosslinked UHMWPE; (3) Vitamin E stabilized UHMWPE; and (4) other forms of UHMWPE, including porous UHMWPE. In each category, […]
Potential FDA Ban on Powdered Gloves
The FDA recently released a statement proposing a ban on most powdered surgical gloves in the United States. The powder, usually in the form of corn starch, is added to facilitate putting on the gloves and taking them off, as well as providing some comfort. The FDA’s concerns about the powder stems from its use […]
Residual Solvents in Pharmaceuticals
Residual solvents can sometimes be found in pharmaceuticals after processing. These solvents are sometimes used during manufacturing to synthesize, purify or blend the active pharmaceutical ingredient (API) with excipients, or may be used elsewhere in the manufacturing process, from solvents to clean equipment or solvents used in the packaging process. Often, these solvents can be […]
Duck, Deformulated
The ubiquitous bathtub duck, historically referred to as a rubber duck, is actually often made from plasticized polyvinyl chloride. Our scientists measured the composition of commercial bathtub ducks, investigating the base resin with infrared spectroscopy, plasticizers with gas and liquid chromatography, and fillers with energy dispersive spectroscopy. And, because it is important to know if […]
Degradation Products from In Vivo Studies
Multiple degradable thermoplastics are being used for implant or other in vivo use in the medical industry. Polycaprolactone, polylactic acid, poly lactic-co-glycolic acid and polydioxanone are just four examples of polymers that will biodegrade when placed in the body through a hydrolysis reaction. The benefits of these polymers for biomedical applications depend on their degradation […]