Regulations/Legal

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August 2018
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FDA: Class I recall of Medtronic’s MindFrame Capture LP revascularization device

Editor's Note The Food and Drug Administration (FDA) on May 18 identified the recall of Medtronic’s MindFrame Capture LP revascularization device as Class I, the most serious. Medtronic is recalling the device because there is a risk of the delivery wire breaking or separating during use. The clot retriever, which…

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By: Judy Mathias
May 21, 2018
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AAMI releases new standard on sterilization quality management

The Association for the Advancement of Medical Instrumentation (AAMI) has released a sterilization standard on quality management for central service (CS) sterile processing. The new standard, ANSI/AAMI ST90: 2017 Processing of Health Care Products: Quality Management Systems for Processing in Health Care Facilities, provides guidelines to support quality management systems…

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By: Susan Klacik, BS, CRCST, CHL, CIS, ACE, FCS
May 18, 2018
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Planning eases compliance with CMS emergency preparedness rules

As of November of 2017, healthcare providers—including ambulatory surgery centers (ASCs)—receiving reimbursement from the Centers for Medicare & Medicaid Services (CMS) were expected to comply with the 2016 Emergency Preparedness Requirements. And as with most government regulations, there are multiple pages of instructions to dissect and understand to satisfy the…

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By: Janet M. Boivin, BSN, BSJ, RN
May 18, 2018
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Joint Commission reduces requirements applicable to telehealth services in ambulatory care

Editor's Note The Joint Commission on May 16 announced that approximately 25% of applicable elements of performance (EPs) in its ambulatory care program will no longer apply to organizations that primarily provide surgical and nonsurgical services via a telehealth platform. Among the reductions: 12 EPs in the Environment of Care…

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By: Judy Mathias
May 17, 2018
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FDA: Class I recall of Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit

Editor's Note The Food and Drug Administration (FDA) on May 11 announced the Class I recall, the most serious, of Vyaire Medical Inc's (Lake Forest, Illinois) AirLife Resuscitation Device & Broselow Convenience Kit. The recall was initiated because of an error in product design that may result in difficulty or…

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By: Judy Mathias
May 14, 2018
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FDA: AuroMedics Pharma recalls two lots of Piperacillin and Tazobactam for Injection

Editor's Note The Food and Drug Administration (FDA) on May 8 announced the recall by AuroMedics Pharma (Windsor, New Jersey) of two lots of Piperacillin and Tazobactam for Injection, USP 3.375 g in a single-dose vial. The vials were found to contain particulate matter after reconstitution that was confirmed to…

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By: Judy Mathias
May 14, 2018
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FDA: Class I recall of Fabius Anesthesia Machines by Dräger Medical

Editor's Note The Food and Drug Administration (FDA) on May 9 announced a Class I recall, the most serious, of Fabius Anesthesia Machines by Dräger Medical. The recall was initiated because of excessive oil that was not removed at the time of production. Excess oil may interfere with the position…

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By: Judy Mathias
May 11, 2018
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FDA sends letter to healthcare providers on neurovascular stents

Editor's Note The Food and Drug Administration (FDA) on May 8 sent a letter to healthcare providers that included recommendations on the use of neurovascular stents for stent-assisted coiling in the treatment of unruptured brain aneurysms. The FDA has received reports associated with these devices that suggest events of peri-procedural…

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By: Judy Mathias
May 9, 2018
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Preventability of early vs late readmissions

Editor's Note Early readmissions (within 7 days of discharge) were more likely to be preventable and amenable to hospital-based interventions, and late readmissions (8 to 30 days after discharge) were less likely to be preventable and more amenable to ambulatory and home-based interventions, this study finds. In this study of…

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By: Judy Mathias
May 9, 2018
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FDA: AuroMedics recalls two lots of Ampicillin and Sulbactam for Injection

Editor's Note The Food and Drug Administration (FDA) on May 8 announced the recall by AuroMedics Pharma (Windsor, New Jersey) of two lots of Ampicillin and Sulbactam for Injection USP, 3 g single-dose vials. The recall was issued because of customer complaints of the presence of red particulate matter in…

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By: Judy Mathias
May 9, 2018
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