Supply Chain/Technology

Latest Issue of OR Manager
December 2021
Home Supply Chain/Technology

FDA: Class I recall of Boston Scientific’s VICI, VICI RDS Venous Stent systems

Editor's Note The Food and Drug Administration (FDA), on May 21, identified the recall by Boston Scientific Corporation of its VICI Venous Stent and VICI RDS Venous Stent systems as Class I, the most serious. The recall was initiated because of reports that the stents may migrate or move from…

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By: Judy Mathias
May 25, 2021
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Risk of COVID-19 transmission via electrocautery plume

Editor's Note In this Canadian experimental study, SARS-CoV-2 was not detectable in aerosolized electrocautery plume generated from any of the conditions investigated. The researchers mimicked surgery by applying electrocautery at 25 W using three different methods (monopolar cut, monopolar coagulate, and bipolar electrocautery) for 1 minute on raw chicken breast.…

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By: Judy Mathias
May 24, 2021
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CMS extends ASC quality data reporting deadline

Editor's Note The Centers for Medicare & Medicaid Services (CMS) announced May 17 that it has extended the Ambulatory Surgical Center Quality Reporting (ASCQR) program data submission deadline from Monday, May 17, to Monday, July 19, 2021. The extension provides ASCs with more time to obtain HARP [Health Care Quality…

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By: Judy Mathias
May 19, 2021
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ANSI/AAMI ST79 amendments refine sterilization practices

Amendments have been added to the Association for the Advancement of Medical Instrumentation (AAMI) standard ANSI/AAMI ST79, Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. The standard, which is used in healthcare facilities to guide their sterilization processes, is considered a useful resource to promote best…

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By: Susan Klacik, BS, CRCST, ACE, CIS, FCS
May 19, 2021
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The Joint Commission announces top 5 most challenging requirements for 2020

Editor's Note The Joint Commission, on May 12, listed the top 5 standards most frequently identified as “not compliant” during surveys and reviews from January 1 to December 31, 2020. The top five for accredited hospitals are: NPSG.15.01.01: Reduce the risk for suicide. EP1. IC.02.02.01: The hospital reduces the risk…

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By: Judy Mathias
May 13, 2021
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ECRI, national leaders collaborate on COVID-19 lessons for value analysis teams

Editor's Note ECRI and the Association for Healthcare Value Analysis Professionals (AHVAP) have partnered on a new white paper outlining key supply chain lessons and risk mitigation strategies learned from the COVID-19 pandemic. Among the lessons learned is the critical role physicians play in the value analysis process and that…

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By: Judy Mathias
May 13, 2021
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FDA: BD recalls certain lots of ChloraPrep

Editor's Note The Food & Drug Administration announced on April 20 that Becton, Dickinson and Company (BD) was recalling certain lots of its ChloraPrep Hi-Lite Orange 26 mL Applicator. ChloraPrep is used as an antiseptic to prepare a patient’s skin before surgery. The recall was initiated because the Applicator, which…

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By: Judy Mathias
May 11, 2021
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Hospira recalls one lot each of 0.5% Bupivacaine and 1% Lidocaine because of mislabeling

Editor's Note Hospira Inc, a Pfizer company, announced May 4 that it is recalling lot EG6023 of 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and lot EG8933 of 1% Lidocaine HCL Injection, USP 30 mL because of mislabeling. A portion of each lot was incorrectly labeled as the other product.…

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By: Judy Mathias
May 6, 2021
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FDA: Class I recall of Alaris Infusion Pump Module 8100

Editor's Note The Food and Drug Administration, on April 30, identified the recall of the Alaris Infusion Pump Module 8100 as Class I, the most serious. The Pacific Medical Group (DBA Avante Health Solutions) is recalling the infusion pump because the front bezel components may crack or separate, leading to…

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By: Judy Mathias
May 3, 2021
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FDA: Class I recall of Cordis Precise PRO Rx US Carotid System

Editor's Note The Food and Drug Administration (FDA), on April 26, identified the recall by Cordis Corporation of its Precise PRO Rx US Carotid System as Class I, the most serious. The Carotid System is being recalled due to a risk of separation of the atraumatic distal tip of the…

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By: Judy Mathias
April 27, 2021
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Latest Issue of OR Manager
December 2021
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