Supply Chain/Technology

Latest Issue of OR Manager
December 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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Mobile devices: A menace to propriety and patient privacy

Imagine this scenario in your ambulatory surgery center (ASC): A husband and wife in their early 80s arrive for the husband’s knee replacement surgery. His wife will drive him home after surgery, and their daughter will arrive from out of state the next day to help at home while he…

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By: Leslie Flowers
August 22, 2017
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FDA: Bella Pharmaceuticals recalls all sterile drug products

Editor's Note The Food and Drug Administration on August 18 announced the recall by Bella Pharmaceuticals (Chicago, Illinois) of all lots of unexpired sterile drug products because of a lack of sterility assurance. Affected products include all lots distributed April 17, 2017, to August 10, 2017, nationwide. Products are packaged in…

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By: Judy Mathias
August 21, 2017
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FDA: Class I recall of Zenith Alpha Thoracic Endovascular Graft by Cook Medical

Editor's Note The Food and Drug Administration (FDA) on August 16 classified the recall by Cook Medical Inc (Bloomington, Indiana) of its Zenith Alpha Thoracic Endovascular Graft as Class I, the most serious. Cook Medical is aware of reported cases where the graft became blocked or closed with blood clots…

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By: Judy Mathias
August 17, 2017
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