Wireless security flaw is detected in defibrillator-pacemaker Mar 15, 2008
Another participant in the project, Dr. William Maisel, a cardiologist who is director of the Medical Device Safety Institute at the Beth Israel Deaconess Medical Center in Boston, said the results had been shared last month with the Food and Drug Administration but not with Medtronic. The FDA had already begun stepping up scrutiny of radio devices in implants. (International Herald Tribune -- Technology)
Study looks at off-label use of biliary stents Jan 21, 2008
Our study found that more than 1 million patients received biliary stents for off-label treatments between 2003 and 2006, explains cardiologist William Maisel, MD, MPH, Director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center (BIDMC) and senior author of the study. We also found that more than 80 percent of the reported adverse events and device malfunctions associated with these products have occurred during off-label use. (EurekAlert!)
Healthcare Faces Pivotal Year in 2008, Says PricewaterhouseCoopers' Health Research Institute in Its Annual Review of the Top Health Industry Issues Dec 19, 2007
FDA Tightens Drug and Medical Device Safety Standards Congress granted the U.S. Food and Drug Administration increased authority to require, not just request, increased safety standards from drug companies, and it gave the FDA increased authority over post-market drug safety. Under new FDA guidance, the pharmaceutical industry will face even more regulatory burdens, which could be costly. (Primezone Releases)
US, China to hold high level talks next week, yuan appreciation pledge not seen Dec 8, 2007
Outside of financial services, US officials said this week that they expect general agreements that will facilitate information sharing on food, feed, drug and medical device safety. The safety of Chinese exports to the US has emerged as a top issue of the SED in light of this year's wave of discoveries of unsafe toys and food products. (Forbes -- Markets)
Hamilton Medical Issues a Medical Device Safety Alert on certain RAPHAEL Ventilators Jun 13, 2006
Hamilton Medical Issues a Medical Device Safety Alert on certain RAPHAEL Ventilators ... Hamilton Medical Issues a Medical Device Safety Alert on certain RAPHAEL Ventilators. (U.S. Food and Drug Administration -- Alerts)
Class I Apr 19, 2006
A medical device safety alert is issued in situations where a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls. (U.S. Food and Drug Administration -- Alerts)
