Standards/Regulations

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October 2017
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FDA: Field corrective action for Medtronic’s Newport HT70, HT70 Plus ventilators

Editor's Note On April 5, the Food and Drug Administration (FDA) announced that Medtronic (Minneapolis) has notified its customers of a field corrective action for all Newport HT70 and Newport HT70 Plus ventilators manufactured since 2010. The field corrective action is being conducted after reports that the ventilator may reset…

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By: Judy Mathias
April 7, 2017
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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…

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By: Judy Mathias
March 29, 2017
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Proposed ASTM standard supports preclinical testing for disc replacement

Editor's Note A proposed international standard, “WK33006, Guide for Impingement Testing of Total Disc Prostheses,” being developed by ASTM’s committee on medical and surgical materials and devices could help manufacturers improve designs for total disc replacements. The proposed standard will guide manufacturers through the process of characterizing “impingement behavior” of…

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By: Judy Mathias
March 28, 2017
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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…

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By: Judy Mathias
March 27, 2017
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New toolkit on safe use of IT for patient identification released

Editor's Note The Joint Commission on March 22 announced the release of a free resource for patient identification using health information technology (IT) from the Partnership for Health IT Patient Safety. The toolkit details eight safe practice recommendations in two areas: Attributes−addresses information-gathering aspects of patient identification, such as fields…

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By: Judy Mathias
March 23, 2017
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DC hospital receives first Patient Blood Management Certification

Editor's Note The Joint Commission announced on March 22 that MedStar-Georgetown University Hospital in Washington DC received the first Patient Blood Management Certification by the Joint Commission and AABB (formerly known as the American Association of Blood Banks). The certification provides a third party evaluation of patient blood management programs…

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By: Judy Mathias
March 23, 2017
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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…

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By: Judy Mathias
March 22, 2017
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CMS interim rule delays bundled payment programs

Editor's Note In an interim final rule, the Centers for Medicare and Medicaid Services (CMS) has delayed expansion of the Comprehensive Care for Joint Replacement (CJR) bundled payment program and  implementation of its bundled payment programs for cardiac care from July 1 to October 1, 2017, the March 20 Modern…

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By: Judy Mathias
March 20, 2017
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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…

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By: Judy Mathias
March 20, 2017
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Joint Commission: TST for Hand-off Communications helps reduce readmissions

Editor's Note The Joint Commission’s Targeted Solutions Tool (TST) for Hand-off Communications provides a framework for what the communication process between hospitals and skilled nursing facilities should be to reduce potential patient readmissions, the Joint Commission said in a March 15 news release. “The TST helps organizations: Facilitate examination of…

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By: Judy Mathias
March 16, 2017
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