Medical Device Infections

FDA Issues Draft Guidance on Device Changes that Warrant New Premarket Review

The Food and Drug Administration today issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission. The 510(k) process is the most common review path to market for lower-risk medical devices. To ...More
July 26, 2011
Posted in News
Health District to Notify Patients About Potential Disease Transmission From Reused Needle Guides

The Southern Nevada Health District is coordinating with the Nevada State Board of Medical Examiners to identify patients who underwent prostate biopsies conducted by Dr. Michael Kaplan during the period from Dec. 20, 2010 through March 11, 2011. A joint investigation ...More
March 21, 2011
Posted in News
Explanted Re-Sterilized ICDs are Safe, Practical for Patient Use

Implantable cardioverter defibrillators (ICDs) removed for upgrades or infection may be reused safely in other patients, according to research being presented today at the American Heart Association's Scientific Sessions 2010, held in Chicago. Researchers sent explanted ...More
November 17, 2010
Posted in News, Disinfection & Sterilization