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In a special Dear Colleague letter aimed at risk managers and other hospital leaders, the Food and Drug Administration warns that some electrically powered hospital beds may pose a risk of fire.
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Can we collect insurance information after triage in the emergency department but before the medical screening examination? We hear conflicting explanations about whether this violates the Emergency Medical Treatment and Labor Act.
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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.
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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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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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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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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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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.
