Editor's Note In this study, 30-day complications rates increased after the Food and Drug Administration (FDA) warned against the use of power morcellation in women undergoing hysterectomy for benign gynecologic indications. In a cohort of 75,487 women who had hysterectomies, statistically and clinically significant increases in major (1.9% to 2.4%)…

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Editor's Note The Food and Drug Administration (FDA) on April 10 notified healthcare facilities that Custom Ultrasonics (Ivyland, Pennsylvania) has completed validation testing of the System 83 Plus (ie, System 83 Plus, System 83 Plus 2, and System 83 Plus 9) automated endoscope reprocessors (AERs) with specific duodenoscopes. The FDA…

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Editor's Note The Food and Drug Administration announced that new data elements will be available on AccessGUDID, in the download files and in the APIs, as of April 2. Data for FDA Premarket Submission Number and FDA Premarket Supplement Number will not be provided until this summer. The FDA is…

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Author's Note The Food & Drug Administration on March 23 announced the Class I recall of Becton Dickinson (BD) Vacutainer® EDTA (ethylenediaminetetraacetic acid) blood collection tubes with lavender, tan, pink, and green rubber tube stoppers. Class I recalls are the most serious. The recall was initiated because of a chemical…

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Editor's Note The Food & Drug Administration (FDA) on March 12 issued a Safety Alert on the potential for increased artifact associated with magnetic resonance angiography (MRA) imaging for follow-up of certain post neurovascular embolization coil procedures. When MRA is performed on patients implanted with neurovascular embolization coils containing 304V…

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Editor's Note The Food & Drug Administration (FDA) on March 9 issued warning letters to all three duodenoscope manufacturers for failing to comply with federal requirements to conduct postmarket surveillance studies to assess the effectiveness of reprocessing their devices. Olympus failed to start data collection, and Pentax and Fujifilm failed…

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Editor's Note The Food and Drug Administration (FDA) on March 6 announced the recall by Sagent Pharmaceuticals (Schaumburg, Illinois) of 10 lots of methylprednisolone sodium succinate for injection, USP, 40 mg, 125 mg, and 1 g. The recall was initiated because of the discovery of high out of specification impurity…

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Editor's Note The Food & Drug Administration (FDA) on March 5 announced the recall by Hospira (Lake Forest, Illinois) of three lots of hydromorphone HCL injection, USP Cll 10 mg/mL, 1 mL in 2 mL single dose vials. The recall was initiated because units from these lots may be empty…

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Editor's Note The Food & Drug Administration (FDA) on March 2 issued a warning for healthcare professionals not to use drug products produced by Cantrell Drug Company (Little Rock, Arkansas), including opioids and other drugs intended for sterile injections. The FDA is concerned about serious deficiencies in Cantrell’s compounding operations,…

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Editor's Note The Food and Drug Administration (FDA) on February 22 issued a Safety Alert for clarithromycin (Biaxin) because of the potential increased risk of heart problems or death associated with this antibiotic in patients with heart disease. A large clinical trial with 10-year follow-up found an unexpected increase in…

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