Emory University Hospital officials say some patients and employees have been exposed to tuberculosis (TB) between November 7, 2010 and April 17, 2011.In a statement released Thursday, officials with the hospital say 680 patients and 100 employees have been contacted who were exposed by the infected person. They will be provided post care free of charge at each patient's local county health department. Hospital officials say the hospital takes many steps to ensure a safe place for patients and employees. However, hospital officials discovered that a hospital staff member, who unknowingly carried the infection, came in contact with the patients and employees.
Johns Hopkins plans to use a $10 million gift to launch an institute for patient safety, aiming to reduce medical mistakes that have long troubled healthcare facilities around the nation. The Armstrong Institute for Patient Safety and Quality will conduct research and develop methods for use at Hopkins and other hospitals around the globe that could prevent infections, misdiagnoses, improper treatments and other errors. It may be the first of its kind in the country, Hopkins and patient advocates say. "Fewer things are more important in health care right now than improving patient safety and the quality of health care," Edward D. Miller, MD, dean and CEO of Johns Hopkins Medicine, said in a statement. "All of us acknowledge these imperatives, but few of us have taken the steps to formally erect a framework that will tackle these issues head on." The donation came from C. Michael Armstrong, chairman of Johns Hopkins Medicine's board of trustees. He is the retired chairman of Comcast, AT&T, Hughes Electronics and IBM World Trade Corp.
Medical errors as extreme as operating on the wrong body part or the wrong patient are never supposed to happen. Systematic efforts to eliminate these "never events" began a decade ago, and yet such errors continue regularly in Oregon and across the U.S. The most thorough national study estimated 1,300 to 2,700 people are harmed every year by wrong site errors. The frequency in Oregon appears unchanged since the state began voluntary error reporting in 2006, when hospitals listed eight wrong site or wrong patient errors. In each of the past two years, Oregon hospitals reported 10 wrong site, wrong patient, or wrong procedure errors, one resulting in a patient death. Since reporting to the Oregon Patient Safety Commission is voluntary, it's only a rough indicator of the numbers. Researchers have found that it's very easy for surgeons to confuse left and right when standing over rather than facing a patient. For some procedures, such as spinal surgery, target sites are hard to distinguish from healthy sites. Identical or similar patient names cause mix-ups.
Acknowledging the need for greater transparency and coordination with manufacturers, the FDA stands by its stringent and notoriously slower 510(k) medical device approval process relative to other countries. Yet device manufacturers complain that the agency's unpredictable procedures, not its speed, are the key reason for industry's growing introduction of products outside the U.S. market. As the FDA gears up to make major changes to the approval process for medical devices in September, including a 25-step improvement plan, Northwestern University in Chicago released a study of 356 representatives of medical device manufacturers with experience in the FDA 510(k) approval process. The National Press Club hosted a forum this week with the study's lead investigators and a panel that included current and former executives from the FDA and medical industry, as well as consultants.
A surgeon at Stanford University, in a study released Wednesday, suggests that one of Medtronic's best-selling spinal products poses a risk of male sterility. That finding is in stark contrast to earlier research by doctors paid by Medtronic, who found no connection between the product, Infuse, and a condition that causes sterility. Infuse is a bioengineered bone growth protein that has been widely used in spinal fusion procedures since 2002. The Infuse label notes the sterility-related complication as a possible side effect, but the Medtronic-sponsored researchers in published reports attributed that complication to surgical technique, not the product itself. The Stanford surgeon, Eugene J. Carragee, MD, found that men treated with Infuse developed a condition that causes temporary or permanent sterility at a far higher rate than men who received a bone graft, another material that is used to fuse spinal vertebrae.
Antonitsa Vlahoulis knew as she slipped into unconsciousness on the operating room table that her surgeon would choose which medical device she would receive to fix her leaky heart valve. But when a warranty card arrived in the mail for the device stitched into her heart, Vlahoulis got the first of several shocks. The card referred to the device by its original name: the McCarthy Annuloplasty Ring. That's when she realized that Dr. Patrick McCarthy, her surgeon at Northwestern Memorial Hospital, had invented it. Vlahoulis, of Niles, said McCarthy had told her he would choose a ring from those listed in a booklet he gave her. She flipped through it, but this ring wasn't there. She checked the Food and Drug Administration's website, looking for the ring on the agency's list of approved devices. But she couldn't find it. When she contacted the FDA to ask about it, she received a startling email in reply.