2006 December - HospitalBuyer

Kessler to Chair FDA Medical Device Practices Harmonization Task Force

Dr. Larry Kessler, a senior FDA scientist and manager, will chair the Global Harmonization Task Force (GHTF) for the next eighteen months, announces the agency. Dr. Kessler, director of the Office of Science and Engineering Laboratories (OSEL) in FDA's Center for Devices and Radiological Health (CDRH), assumed the chair on Dec, 22, 2006, replacing the Europeans as part of a rotation scheme among its five founding members (the U.S., Europe, Canada, Japan and Australia). GHTF is a voluntary group of representatives of national medical device regulatory authorities and trade associations of medical device manufacturers. Its main goals of GHTF are to advance the safety, effectiveness, performance and quality of medical devices; encourage technological innovation; foster international trade; and serve as a forum for exchange of information that can be of help to countries that are developing their own regulatory systems. more...

December 27, 2006 Related topics: Legal & legislative, People

Maryland Looks at ER Crowding

The Maryland Health Care Commission (MHCC) published yesterday a report titled Use of Maryland Hospital Emergency Departments: An Update and Recommended Strategies to Address Crowding (pdf). It states that In fiscal year 2006, there were about 2.3 million visits to Maryland hospital emergency departments or about 398 visits per 1,000 persons. About 18 percent of these visits resulted in an admission to the hospital. Visits to Maryland emergency departments increased by 18 percent during the 1990's and another 23 percent between 2000 and 2006. The number of hours on ambulance diversion has ramped up along. 18.1 percent of visits to MD ER departments were classified as non-emergent while another 17.3 percent were emergent but treatable by primary care, which totals to more than a third of ER visits not being actual emergencies (see this PDF for charts and data tables). Patients end up in the ER because they don't have access to a doctor over the weekend or at night for instance. more...

December 21, 2006 Related topics: Trends

Hospital Buyer

News for healthcare procurement decision makers

Kessler to Chair FDA Medical Device Practices Harmonization Task Force

Maryland Looks at ER Crowding

Small Suppliers Afraid of Competitive Bidding

FDA Approves Possis AngioJet Ultra Thrombectomy System

Boston Scientific Announces Nationwide Recall of 51 Mach 1 Guide Catheters

Extended Shifts Increase Error Rate

Von Eschenbach Confirmed as FDA Head

Drug-Eluting Stents Reviewed by AHRQ, FDA

Manufacturers List Their Top Regulatory Issues

Medtronic to Spin Off Defibrillation Business