Standards/Regulations

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December 2017
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FDA: Maquet/Datascope recalls certain Intra-Aortic Balloon Pumps

Editor's Note The Food and Drug Administration (FDA) on June 19 announced the recall by Maquet/Datascope (Fairfield, New Jersey) of its System CS100, CS100i, and CS300 Intra-Aortic Balloon Pumps. The recall also applies to System 98 or System 98XT IABP that was converted to a CS100i or CS 300 IABP.…

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By: Judy Mathias
June 20, 2017
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New guideline targets total joint infections

Editor's Note The American College of Rheumatology (ACR) and American Association of Hip and Knee Surgeons (AAHKS) have released a new guideline to help reduce postoperative total hip and knee infections through the perioperative management of antirheumatic medications. Among the recommendations: Discontinuing biologic therapy before surgery in patients with inflammatory…

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By: Judy Mathias
June 19, 2017
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FDA: Hospira recalls Sodium Bicarbonate, Quelicin, and Potassium Phosphates injections

Editor's Note The Food and Drug Administration (FDA) on June 16 announced the recall by Hospira, Inc, a Pfizer company, of the following: 42 lots of 8.4% Sodium Bicarbonate Injection, USP, 50 mL vials 5 lots of Neut (Sodium Bicarbonate 4% additive solution) 5 mL vials 5 lots of Quelicin…

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By: Judy Mathias
June 19, 2017
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Joint Commission: Revisions to LS, EC chapters effective January 2018

Editor's Note Revisions to the Life Safety (LS) and Environment of Care (EC) chapters for Behavioral Health Care, Laboratory, Nursing Care Centers, and Office-Based Surgery accreditation programs, based on adoption of the 2012 editions of the National Fire Protection Association’s NFPA 101: Life Safety Code and NFPA 99: Health Care…

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By: Judy Mathias
June 16, 2017
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FDA issues Safety Alert for frameless stereotaxic navigation systems

Editor's Note The Food and Drug Administration (FDA) on June 15 issued a Safety Alert for frameless stereotaxic navigation systems because of navigational accuracy errors during surgical procedures. Some of these errors have led to patient deaths, serious or life-threatening injuries, and inaccurate, aborted, or prolonged surgical procedures. The FDA…

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By: Judy Mathias
June 16, 2017
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FDA releases list of reusable devices requiring new validated IFU, validation data

Editor's Note The Food and Drug Administration (FDA) on June 9 released a list of reusable devices that will require new validated instructions for use (IFU) and validation data in premarket notifications regarding cleaning, disinfection, and sterilization. These actions are effective August 8, 2017. The list includes: Bronchoscopes (flexible or…

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By: Judy Mathias
June 12, 2017
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FDA extends UDI compliance dates for Class I, unclassified devices

Editor's Note The Food and Drug Administration (FDA) has notified medical device labelers that the compliance dates for unique device identifier (UDI) requirements for Class I and unclassified medical devices has been extended from September 24, 2018, to September 24, 2020, and for direct mark requirements from September 24, 2020,…

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By: Judy Mathias
June 12, 2017
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Value-based reforms linked to readmission reduction

Editor's Note Hospital participation in value-based reforms was associated with greater reductions in 30-day readmissions, this study finds. In this analysis of 2,837 hospitals between 2008 and 2015, researchers found that participation in one or more voluntary Medicare value-based reforms, which included the Meaningful Use of Electronic Health Records program,…

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By: Judy Mathias
June 6, 2017
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CMS issues guide for quality payment programs

Editor's Note The Centers for Medicare & Medicaid Services (CMS) has issued a guide summarizing technical assistance resources available to small, underserved, and rural hospitals participating in the Merit-based Incentive Payment System (MIPS) and the Advanced Alternative Payment Model (AAPM). The guide also provides resources for quality innovation networks and…

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By: Judy Mathias
June 2, 2017
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Joint Commission revises Safety Goal on HAIs

Editor's Note The Joint Commission on May 31 announced the revision of requirements for National Patient Safety Goal (NPSG) 7: Reduce the risk of healthcare-associated infections. The changes are effective January 1, 2018. The requirements include: NPSG.07.03.01−Multidrug-resistant organisms. The changes help address infection prevention strategies to contain outbreaks, which now…

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By: Judy Mathias
June 1, 2017
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