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In its recent initiative to minimize medical errors, William Beaumont Hospital in Royal Oak, MI, has made its patients Partners in Safety. Thats the name of the new program, which was launched in 2002.
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Surveys of emergency department (ED) patients indicate most patients present there in moderate to severe pain. But ED physicians have a difficult time knowing which medications will work best for their patients because research specifically targeted to emergency conditions is lacking.
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Developing and adhering to a solid risk management strategy is an important foundation for preparing for the possibility of clinical trial problems, including those pertaining to patient safety, regulatory issues, and civil suits, experts say.
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Christopher Gallen, MD, PhD, vice president and chief of operations for clinical research and development at Wyeth in Collegeville, PA, highlights some strategies developed at Wyeth that are designed to help improve the clinical trials process and manage risk.
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In March, members of the Havasupai Indian Tribe of northwestern Arizona filed two federal lawsuits seeking a total of $75 million in damages against Arizona State University (ASU), the Arizona Board of Regents, and three university researchers. The lawsuit claims that blood samples taken from tribe members as part of a diabetes study were destroyed, lost, or used in studies of schizophrenia, inbreeding, and population migration without the donors consent.
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A report in the March 25 Philadelphia Inquirer regarding the use of experimental treatment on an infant in connection with a heart repair highlights a series of issues related to both the use of devices not approved by the Food and Drug Administration (FDA) and, in turn, their use on minors, including infants.
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A San Francisco hospital is taking the Universal Protocol so seriously that it has threatened to suspend entire operative teams the surgeon, anesthesiologist, nurses, and anyone else in the room if the procedures to prevent wrong-site surgery are not followed.
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Enterprise liability is a legal concept that some advocates say can help health care organizations achieve patient safety, but it could represent another reason for risk managers to worry.
