Olympus redesigned duodenoscope linked to new infection outbreak
Editor's Note A new outbreak of infections outside the US have been tied to a duodenoscope Olympus modified last year to reduce the risk of transmitting bacteria between patients, the March 22 Los Angeles Times reports. The outbreak of Klebsiella pneumoniae in five patients occurred at the end of December…
FDA: Class I recall of HeartStart MRx Monitoy/Defibrillator
Editor's Note The Food and Drug Administration (FDA) on March 24 identified the recall of the HeartStart MRx Monitor/Defibrillator by Phillips Healthcare (Amsterdam) as Class I, the most serious. The recall was initiated because of electrical and battery connection issues that may prevent the device from powering up, charging, and…
FDA updates data on breast implant-associated anaplastic large cell lymphoma
Editor's Note In a March 21 Safety Alert, the Food and Drug Administration (FDA) updated its data on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) to reflect the World Health Organization designation of BIA-ALCL as a rare T-cell lymphoma that can develop following breast implants. At this time the data…
FDA Safety Alert on Absorb GT1 Bioresorbable Vascular Scaffold
Editor's Note The Food and Drug Administration (FDA) on March 18 issued a Safety Alert for Abbott Vascular’s (Santa Clara, California) Absorb GT1 Bioresorbable Vascular Scaffold (BVS). The alert was issued to inform healthcare providers of an increased rate of major adverse cardiac events in patients receiving the BVS, when…
FDA: Class I recall of Medtronic implantable drug infusion pumps
Editor's Note The Food and Drug Administration (FDA) on March 14 categorized the recall by Medtronic (Minneapolis) of its SynchroMed II and SynchroMed EL implantable drug infusion pumps as Class I, the most serious. The pumps are being recalled because a software problem may cause unintended delivery of drugs during…
FDA issues alert on use of angioplasty devices in TVAM
Editor's Note The Food and Drug Administration (FDA) on March 8 issued a Safety Alert about the use of balloon angioplasty devices to perform an experimental procedure, called transvascular autonomic modulation (TVAM). TVAM consists of threading a catheter into a patient’s venous system, such as the jugular vein, where a…
Joint Commission evaluating use of non-powdered gloves
Editor's Note As a result of the Food and Drug Administration’s ban on powdered gloves that went into effect January 18, the Joint Commission is now evaluating organizations on the implementation of non-powdered glove use during accreditation surveys, the Joint Commission announced March 7. Instances of noncompliance are being cited…
FDA: Avella recalling injectable products labeled ‘latex free’
Editor's Note The Food and Drug Administration (FDA) on February 24 announced that Avella Specialty Pharmacy of Houston is recalling all unexpired sterile injectable products labeled “latex free” that were produced at Advanced Pharma’s Houston location between September 1, 2016 and February 16, 2017. Avella and Advanced Pharma have been…
FDA: Class I recall of Zimmer Biomet Comprehensive Reverse Shoulder
Editor's Note The Food and Drug Administration (FDA) has categorized the recall by Zimmer Biomet (Warsaw, Indiana) of its Comprehensive Reverse Shoulder as Class I, the most serious. The recall was issued because the devices are fracturing at a higher rate than is stated in the labeling. Fractures may result…
Joint Commission checking for compliance with FDA powdered gloves ban
Editor's Note The Joint Commission announced February 15 that it will now evaluate all accredited organizations for compliance with the January 18 Food and Drug Administration (FDA) ban on powdered gloves. Citations will be listed under Leadership (LD) 04.01.01 element of performance (EP) 2: “The organization provides care, treatment and…
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