Supply Chain/Technology

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January 2019
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Top 10 health technology hazards for 2019 named

The devices and systems we use when diagnosing and treating patients are invaluable to patient care—but they are not perfect. Patients and staff can be harmed if design flaws or system faults aren’t identified and rectified, equipment isn’t adequately maintained or prepared for use, or proper procedures aren’t followed. Preventing…

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By: ECRI
November 14, 2018
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FDA launches app for EHR data collection

Editor's Note The Food & Drug Administration (FDA) recently launched a new app to help streamline electronic health record (EHR) data collection for researchers, The November 7 EHR Intelligence reports. Using the MyStudies app, researchers can access patient-generated health data, EHR patient data, and claims and billing information for use in…

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By: Judy Mathias
November 13, 2018
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Joint Commission recognizes nine hospitals for eCQM evolution, utilization

Editor's Note The Joint Commission on November 6 released “Pioneers in Quality eCQM Proven Practices Collection: Recognizing Success 2017-2018.” The publication recognizes healthcare organizations that have successfully leveraged electronic clinical quality measures (eCQMs) and health information technology to drive quality improvement. Nine hospitals are featured:  BayCare Health System, Inc, Clearwater,…

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By: Judy Mathias
November 7, 2018
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FDA guidance updates UDI compliance policy

Editor's Note The Food & Drug Administration on November 5 released the guidance, “Unique Device Identification: Policy Regarding Compliance dates for Class I and Unclassified devices and Certain Devices Requiring Direct Marking,” which takes effect immediately. The new guidance includes updated Unique Device Identification (UDI) direct mark requirements and supersedes…

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By: Judy Mathias
November 6, 2018
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FDA: Class I recall of Cardiosave Hybrid and Rescue IABPs

Editor's Note The Food & Drug Administration on November 2 identified the recall by Maquet Datascope Corp/Getinge Group’s Cardiosave Hybrid and Cardiosave Rescue Intra-aortic Balloon Pumps (IABPs) as Class I, the most serious. The recall was initiated because of the potential for the autofill process to malfunction or fail during…

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By: Judy Mathias
November 5, 2018
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ECRI Institute announces new white paper on top value analysis challenges

Editor's Note ECRI Institute on October 30 announced a new white paper--Value Analysis: Addressing Top Challenges by Using the PICOTS Framework--which presents findings from national seminars on the top five challenges value analysis professionals face daily. The challenges are: Antiquated workflow C-suite buy-in Accessibility to data Physician engagement Bandwidth. The…

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By: Judy Mathias
October 31, 2018
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HHS opens Health Sector Cybersecurity Coordination Center

Editor's Note The Department of Health and Human Services (HHS) on October 29 opened the Health Sector Cybersecurity Coordination Center (HC3) at its headquarters in Washington DC. HC3 will play a vital role in early detection of cybersecurity attacks and coordination of information between the healthcare sector and the Department…

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By: Judy Mathias
October 31, 2018
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FDA: Class I recall of CyPass Micro-Stent Systems

Editor's Note The Food & Drug Administration (FDA) on October 24 classified Alcon Research’s recall of its CyPass Micro-Stent Systems as Class I, the most serious. The recall was initiated because of the risk of corneal endothelial cell loss with the system, which is used in conjunction with cataract surgery…

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By: Judy Mathias
October 30, 2018
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FDA: Safety Communication on Raindrop Near Vision Inlay

Editor's Note The Food & Drug Administration (FDA) on October 23 issued a Safety Communication on the increased risk of corneal haze associated with the Raindrop Near Vision Inlay, which is surgically implanted in the cornea of one eye to improve near vision. The notice is to alert eye care…

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By: Judy Mathias
October 25, 2018
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FDA: Promise Pharmacy recalls one lot of Prednisolone, Gatifloxacin Ophthalmic Solution

Editor's Note The Food & Drug Administration (FDA) on October 22 announced the recall by Promise Pharmacy (Palm Harbor, Florida) of one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3 mL vials (Lot Number 09042018@2, Exp 12/03/2018). The recall was issued because the product was found to have…

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By: Judy Mathias
October 24, 2018
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