Regulations/Legal

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October 2019
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FDA: Class I recall of Teleflex/Sheridan Endotracheal Tubes

Editor's Note The Food & Drug Administration (FDA) on August 2 identified the recall by Centurion Medical Products of its Airway Kit containing Teleflex/Sheridan Endotracheal Tubes as Class I, the most serious. The recall was initiated because of the potential for the tube connector to dislodge from the endotracheal tube,…

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By: Judy Mathias
August 8, 2019
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Joint Commission clarifies survey process for telehealth organizations

Editor's Note The Joint Commission announced August 7 that the applicability of its Ambulatory Health Care Accreditation standards for telehealth organizations, which provide remote services, deploy in-person staff, and/or have equipment used between patients, is being evaluated. In the meantime, areas of noncompliance related to infection control, equipment and utility…

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By: Judy Mathias
August 8, 2019
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NYT: Experts call for single-use, sterilization or redesign of duodenoscopes, bronchoscopes

Editor's Note Contaminated duodenoscopes have transmitted drug-resistant infections to hundreds of patients, and now some experts are urging the Food & Drug Administration to force manufacturers to develop duodenoscopes that can be properly sterilized or single-use duodenoscopes or take duodenoscopes off the market, the August 6 New York Times Reports.…

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By: Judy Mathias
August 6, 2019
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FDA: Class I recall of Ellipse Implantable Cardioverter Defibrillators

Editor's Note The Food & Drug Administration on August 5 identified the recall by Abbott (formerly St Jude Medical Inc) of its Ellipse Implantable Cardioverter Defibrillators as Class I, the most serious. The recall was initiated because electrical failures have been identified that are due to a faulty manufacturing process…

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By: Judy Mathias
August 5, 2019
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CMS proposes giving Medicare patients better access to cutting-edge devices

Editor's Note In its proposed rule, the Centers for Medicare & Medicaid Services (CMS) would give Medicare patients better access to innovative devices beginning next year, the July 30 MassDevice reports. CMS also says it might pay more for “certain transformative new devices” for inpatients, using a new technology add-on…

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By: Judy Mathias
August 1, 2019
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Joint Commission issues new Sentinel Event Alert on managing risks of direct oral anticoagulants

Editor's Note In response to an increase in adverse events related to direct oral anticoagulants (DOACs), the Joint Commission, on July 31, issued a new Sentinel Event Alert on managing DOAC risks. The alert: provides guidance for safe use and management of DOACs stresses understanding the risks, benefits, side effects,…

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By: Judy Mathias
August 1, 2019
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CMS maintains site-neutral cuts in 2020 proposed rule

Editor's Note The Centers for Medicare & Medicaid Services (CMS) on July 29 issued the 2020 proposed payment rule for ambulatory surgery centers (ASCs) and hospital outpatient departments (HOPDs), which would increase Medicare hospital outpatient prospective payment system rates by 2.7%. CMS is also proposing to add eight codes to…

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By: Judy Mathias
July 31, 2019
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FDA issues final guidance for drug-device combo products

Editor's Note The Food & Drug Administration (FDA) on July 22 issued a final guidance for makers of products that combine devices and drugs or biologics. The guidance clarifies how manufacturers should comply with recordkeeping requirements and how they should submit safety reports and avoid duplication.

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By: Judy Mathias
July 25, 2019
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Joint Commission names five hospitals as 2019 Pioneers in Quality Expert Contributors

Editor's Note The Joint Commission on July 24 named five hospitals/healthcare systems as 2019 Pioneers in Quality Expert Contributors for their leadership efforts in using electronic clinical quality measure (eCQM) practices to drive their quality improvement. The five are: Baptist Health (Jacksonville, Florida) Johns Hopkins Health System (Baltimore, Maryland) Memorial…

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By: Judy Mathias
July 25, 2019
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Changes in hospital referral patterns to skilled nursing facilities under HRRP

Editor's Note The Hospital Readmission Reduction Program (HRRP), which penalizes hospitals for higher-than-expected readmission rates, did not prompt substantial changes in hospital referral patterns to skilled nursing facilities (SNFs), this study finds. However, readmissions for patients referred to SNFs decreased more than for other patients. In this analysis of nearly…

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By: Judy Mathias
July 24, 2019
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