Tag: FDA

FDA warns about magnetic interference between breast tissue expanders and ICDs, pacemakers

Editor's Note The Food and Drug Administration (FDA) on March 8 issued a warning about magnetic interference between breast tissue expanders with magnetic ports and implantable cardioverter-defibrillators (ICDs) or pacemakers in patients. The breast expanders can interfere with the functioning of these cardiac devices, causing them to go into "magnet…

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By: Judy Mathias
March 9, 2016
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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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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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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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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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FDA: Facilities should transition from Custom Ultrasonics endoscope reprocessors

Editor's Note The Food and Drug Administration (FDA) on February 23 updated its Safety Communication on the November 2015 recall of Custom Ultrasonics automated endoscope reprocessors. The update recommends that healthcare facilities transition to alternative methods to reprocess flexible endoscopes as soon as possible. In November, the FDA cited violations…

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By: Judy Mathias
February 25, 2016
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FDA: Pentax validates reprocessing instructions for ED-3490 TK Video Duodenoscope

Editor's Note The Food and Drug Administration (FDA) on February 19 announced that it had reviewed updated reprocessing instructions and validation data issued by Pentax Medical (Montvale, New Jersey) for its ED-3490 Video Duodenoscope. The FDA recommends that facilities train staff on the updated instructions and implement them as soon…

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By: Judy Mathias
February 22, 2016
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FDA: Baxter recalls one lot of 0.9% Sodium Chloride Solution for Irrigation

Editor's Note The Food and Drug Administration on February 18 announced the recall by Baxter (Deerfield, Illinois) of one lot of 0.9% Sodium Chloride Irrigation, USP, 500 mL, plastic pour bottle solution—Lot G120162, expiration 11/30/2018. The solution is being recalled because of a customer complaint of the presence of particulate…

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By: Judy Mathias
February 19, 2016
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FDA issues blood donation recommendations for Zika virus

Editor's Note The Food and Drug Administration on February 16 issued a new guidance recommending the deferral of individuals from donating blood if they have: been to areas with active Zika virus transmission potentially been exposed to the virus had a confirmed Zika virus infection. The FDA is issuing these…

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By: Judy Mathias
February 17, 2016
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FDA: Class I recall of Drager Oxylog Emergency Transport Ventilators

Editor's Note The Food and Drug Administration (FDA) on February 10 classified the recall of the Oxylog 2000 Plus, 3000, and 3000 plus Emergency Transport Ventilators by Drager Medical (Telford, Pennsylvania) as Class I, the most serious. The recall was initiated because of an electrical issue that may cause the…

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By: Judy Mathias
February 12, 2016
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