Today, the Government Accountability Office (GAO) released a report entitled “Medical Devices: FDA Ordered Postmarket Studies to Better Understand Safety Issues, and Many Studies Are Ongoing.” According to the report, “GAO was asked to report on the characteristics and status of postmarket studies. This report describes (1) the types of devices for which FDA has ordered … Continue Reading
The Occupational Safety and Health Administration (OSHA) recently announced an initiative affecting inspections at in-patient care facilities. The Agency plans to: Expand the resources OSHA directs for inspections at these sites, and Direct inspectors to focus on five recently identified “key hazard” areas: (1) musculoskeletal disorders related to patient and resident handling; (2) bloodborn pathogens; (3) workplace … Continue Reading
The FDA announced that it will be holding a public 2-day workshop on September 29-30, 2015, from 8:00 a.m. to 5:00 p.m. titled, “Medical Device Patient Labeling.” The purpose of the public workshop is to discuss issues associated with the development and use of medical device patient labeling including content, testing, use, access, human factors, … Continue Reading
On September 17, 2009, the White House released a "Patient Safety and Medical Liability Reform Demonstration" Fact Sheet, which outlines a new $25 million Department of Health and Human Services initiative designed to help states and health care systems identify new models for managing medical liability claims. The three-pronged initiative will support competitive grants to states and health systems with a focus on the development, implementation and evaluation of alternatives to improve health care quality and patient safety while reducing medical liability.… Continue Reading
