Supply Chain/Technology

Latest Issue of OR Manager
October 2017
Home Supply Chain/Technology

FDA issues alert for alcohol pads, benzalkonium chloride antiseptic towelettes by Foshan Flying Medical Products

Editor's Note The Food and Drug Administration (FDA) on September 1 issued a Safety Alert notifying healthcare professionals and patients not to use alcohol pads or benzalkonium chloride antiseptic towelettes made by Foshan Flying Medical Products Co Ltd (China) because of lack of sterility and other quality issues. Use of…

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By: Judy Mathias
September 6, 2017
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FDA: Hospira recalls one lot of vancomycin hydrochloride

Editor's Note The Food and Drug Administration (FDA) on August 31 announced the recall by Hospira Inc (Lake Forest, Illinois) of one lot of vancomycin hydrochloride for injection, USP, 750 mg/vial (NDC 0409-6531-02) lot 632153A. The recall was initiated because of a customer report of the presence of particulate matter,…

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By: Judy Mathias
September 5, 2017
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Effect of mandatory reporting system on prevalence of intraop adverse events

Editor's Note After implementation of an anesthesia information management system (AIMS)-based mandatory quality assurance process for reporting of intraoperative adverse events at two academic medical centers, documented adverse events decreased significantly, this study finds. Over a 2-year period after implementation of mandatory reporting, the adverse event rate at Thomas Jefferson…

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By: Judy Mathias
September 1, 2017
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Barriers, benefits of using mobile health technology postoperatively

Editor's Note This survey of 800 patients identified a range of potential barriers and benefits to using mobile health technology to enhance recovery after surgery. Potential barriers included: protecting personal health information technology effectiveness and failure preference for face-to-face interaction with their surgeons level of effort required ability of older…

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By: Judy Mathias
August 30, 2017
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FDA: Abbott updates pacemaker firmware to address cybersecurity vulnerabilities

Editor's Note The Food and Drug Administration (FDA) announced on August 29 that it had approved a firmware update that is intended as a recall, specifically a corrective action, to reduce the risk of patient harm due to cybersecurity vulnerabilities for certain Abbott (formerly St Jude Medical) implantable cardiac pacemakers.…

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By: Judy Mathias
August 30, 2017
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FDA: Cook Medical issues recall correction, removal of certain sizes of Zenith Alpha thoracic endovascular graft

Editor's Note The Food and Drug Administration (FDA) on August 25 announced a recall correction to the instructions for use by Cook Medical (Bloomington, Indiana) for its Zenith Alpha thoracic endovascular graft. This correction removed the indication for blunt thoracic aortic injury (BTAI) because Cook has received an increase in…

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By: Judy Mathias
August 29, 2017
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Surgeons perform first magnetic compression anastomosis (magnamosis) in humans

Editor's Note In this pilot trial, surgeons used a pair of magnets (ie, Harrison rings) to create an intestinal anastomosis without sutures or staples in five patients. For each procedure, one Harrison ring was placed in the lumen of each intestinal segment, and then the rings were brought together and…

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By: Judy Mathias
August 24, 2017
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ECRI Institute releases free white paper on value analysis

Editor's Note The ECRI Institute on August 23 announced a new free white paper, “Value Analysis: Best Practices for Navigating the Evidence Maze,” to help value analysis committees bring an objective, systematic approach to the decision-making process for health technologies and interventions. The white paper includes three case studies that…

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By: Judy Mathias
August 23, 2017
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FDA: Vital Rx, dba Atlantic Pharmacy and Compounding recall all lots of compounded injectable drugs

Editor's Note The Food and Drug Administration (FDA) on August 18 announced the recall by Vital Rx, dba Atlantic Pharmacy and Compounding (Pompano Beach, Florida) of all lots of compounded injectable medications because of sterility assurance. During a recent FDA inspection, investigators observed unsanitary conditions, including poor sterile production practices.…

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By: Judy Mathias
August 22, 2017
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Ransomware attacks: How to protect your medical device systems

Ransomware is a form of computer malware used to make data, software, and information technology (IT) assets unavailable to users. It uses encryption of data to hold systems hostage with an associated ransom demand, often in Bitcoin (a virtual currency that is difficult to trace). This encryption is used to…

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By: OR Manager
August 22, 2017
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