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March 2025

FDA issues tissue, cell donation recommendations to reduce Zika virus risk

Editor's Note The Food and Drug Administration (FDA) on March 1 released new guidelines to prevent the transmission of the Zika virus from human cells, tissues, and cellular and tissue-based products. The guidance addresses both living and deceased donations of corneas, bone, skin, heart valves, hematopoietic stem/progenitor cells, gestational tissues…

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By: Judy Mathias
March 3, 2016
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Total hip too soon after steroid injection increases SSI risk

Editor's Note The risk of developing a surgical site infection (SSI) increased significantly in patients who had a total hip within 3 months of receiving a steroid injection in the hip joint, finds this study presented March 2 at the annual meeting of the American Academy of Orthopedic Surgeons. Analyzing…

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By: Judy Mathias
March 2, 2016
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Olympus to pay $623.2 million to settle kickback allegations

Editor's Note Olympus Corporation (Center Valley, Pennsylvania) has agreed to pay $623.2 million to resolve civil and criminal allegations that it paid kickbacks to hospitals and physicians in exchange for purchasing its endoscopes and equipment, the March 1 Modern Healthcare reports. The government alleged that Olympus lacked training and didn’t…

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By: Judy Mathias
March 2, 2016
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FDA: Abbott issues safety notice for MitraClip Delivery System

Editor's Note The Food and Drug Administration on February 29 announced a safety notice issued by Abbott (Abbott Park, Illinois) to reinforce the proper procedures used to operate and deploy its MitraClip Delivery System. The company has received nine reports of device malfunction where the user was unable to separate…

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By: Judy Mathias
March 2, 2016
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Study: Surgery, anesthesia not associated with cognitive functioning in elderly

Editor's Note This study of 8,503 middle-aged and elderly twins in the Netherlands found no clinically significant association of major surgery and anesthesia with long-term cognitive dysfunction. The findings suggest that preoperative cognitive functioning and underlying diseases have stronger influence on postoperative cognitive abilities. The study provided a powerful approach…

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By: Judy Mathias
March 1, 2016
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New use for old drug to reduce blood loss during total joints

Editor's Note An old drug, tranexamic acid (TXA), which has been used in heart surgery, to treat hemophilia, and to stop excessive uterine bleeding is now being used to reduce the need for blood transfusions during total joint replacements. Researchers from the Hospital for Special Surgery in New York City…

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By: Judy Mathias
March 1, 2016
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FDA to require premarket approval for metal-on-metal hips

Editor's Note The Food and Drug Administration (FDA) on February 18 issued a final order to require the filing of a premarket approval (PMA) application for two types of metal-on-metal total hip replacement devices: hip joint metal/metal semi-constrained, with a cemented acetabular component hip joint metal/metal semi-constrained, with an uncemented…

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By: Judy Mathias
March 1, 2016
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Cleveland Clinic performs first uterus transplant

Editor's Note A team of Cleveland Clinic surgeons on February 24 performed the nation’s first uterus transplant. The 9-hour procedure was performed on a 26-year old patient who had uterine factor infertility. The transplanted uterus came from a deceased organ donor. Further information will be released this week in a…

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By: Judy Mathias
February 29, 2016
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CMS extends ‘meaningful use’ deadline to July 1

Editor's Note The Centers for Medicare & Medicaid Services on February 26 once again extended the deadline for hardship exemptions for the “meaningful use” requirement of the electronic health records incentive payment program, Modern Healthcare reports. The new deadline for hospitals, critical access hospitals, physicians, and other eligible professionals is…

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By: Judy Mathias
February 29, 2016
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FDA issues Safety Communication on neurosurgical head holders

Editor's Note The Food and Drug Administration (FDA) on February 25 issued a Safety Communication on neurosurgical head holders (skull clamps) and device slippage. From January 2009 to January 2016, the FDA received more than 1,000 reports of slippage or movement of skull clamps before and/or during surgical procedures. The slippage,…

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By: Judy Mathias
February 29, 2016
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