Standards/Regulations

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October 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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Voluntary bundled-payment models shifting to outpatient procedures

Editor's Note Though the Centers for Medicare & Medicaid Services (CMS) is rolling back mandatory bundled-payment programs, it is expected to release more voluntary, outpatient-focused programs, which shifts power from hospitals to physicians, the August 21 Healthcare Finance News reports. Physician-focused does not require a hospitalization, which creates a complete…

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By: Judy Mathias
August 24, 2017
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Joint Commission deletes standard related to performance on ORYX measures

Editor's Note The Joint Commission announced August 21 that Standard PI.02.01.03: “The hospital improves its performance on ORYX accountability measures” and the Standard's one Element of Performance: “The hospital achieves a composite performance rate of at least 85% on the ORYX accountability measures transmitted to the Joint Commission” will be…

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By: Judy Mathias
August 22, 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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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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Few outcome measures meet criteria for accuracy, validity assessment

Editor's Note This study from the Joint Commission finds that criteria for assessing whether outcome measures are accurate and valid enough to use for public reporting, payment, and accreditation are not well-defined. The authors propose four criteria to assess outcome measures: Strong evidence should exist that good medical care leads…

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By: Judy Mathias
August 17, 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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Joint Commission: Quick Safety on noises, distractions in ORs

Editor's Note The Joint Commission on August 16 announced a new Quick Safety that focuses on noise and distractions in the OR and how they can make it difficult to hear and discern information or communicate effectively. ORs are prone to high levels of noise, which can be distracting and…

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By: Judy Mathias
August 17, 2017
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CMS proposes canceling two bundled payment models, scaling back a third

Editor's Note The Centers for Medicare & Medicaid Services (CMS) on August 15 announced a proposed rule that would cancel two bundled-payment models and reduce the number of providers required to participate in a third. The proposed rule would cancel the Episode Payment Models and the Cardiac Rehabilitation incentive payment…

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By: Judy Mathias
August 16, 2017
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