Changing your medical device: 6 things you need to know

Medical device regulatory consultant Michael Drues has never liked the phrase “change management.” The words seem boring to him. “Not only does it not have to be boring, it is incredibly important—and can be exciting and dare I say fun,” says Drues, who is president of Vascular Sciences (Grafton, MA). Whether it involves a medical

Cosmed Group acquires ethylene oxide sterilization operation

Cosmed Group has bought an ethylene oxide sterilization operation from iuvo BioScience, ending an 12-year break from the marketplace. Ethylene oxide (ETO) is a colorless, flammable and explosive gas that is used as a low-temperature sterilant, according to a 2008 Disinfection and Sterilization Guideline article relayed by the CDC. Alkylation contributes to the microbicidal activity

New imaging technique could better spot ortho implant infections

Prosthetic joint infection is becoming a costly and rising problem in the U.S., simply because of the rising numbers of joint replacements occurring. University of California San Diego engineers suspect they have a new non-invasive method to detect the infections early, in orthopedic implants as well as prosthetics used by amputees. The new prosthetic infection