FDA: Class I recall of GlideScope Titanium Single-Use Video Laryngoscope
Editor's Note The Food and Drug Administration (FDA) on March 18 announced the Class I recall of the GlideScope Titanium Single-Use Video Laryngoscope by Verathon (Bothell, Washington). Class I is the most serious. The recall was initiated because of a potential disruption in the video feed from the laryngoscope blade…
FDA: Reprocessing instructions validated for Olympus duodenoscope models TJF-160F and TJF-160VF
Editor's Note The Food and Drug Administration (FDA) on March 15 announced that Olympus (Center Valley, Pennsylvania) has issued updated, validated manual reprocessing instructions for the TJF-160F and TJF-160 VF duodenoscope models to replace those provided in the original device labeling. The FDA reviewed the updated reprocessing instructions and the…
FDA: Class I recall of Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits
Editor's Note The Food and Drug Administration (FDA) on March 11 announced the Class I recall of Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits by Teleflex Incorporated (Wayne, Pennsylvania). Class I is the FDA’s most serious recall classification. The Kits are being recalled because the sheath body…
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…
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…
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…
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…
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,…
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…
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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