Regulations/Legal

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August 2018
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Joint Commission: Loss of deemed status must be reported beginning July 1

Editor's Note The Joint Commission on June 6 announced that beginning July 1, it will need to be notified if an accredited organization loses its deemed status after a Centers for Medicare & Medicaid Services (CMS) complaint survey or validation survey. When CMS removes an organization’s deemed status and places…

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By: Judy Mathias
June 8, 2018
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FDA updates recommendations to reduce surgical fires

Editor's Note The Food & Drug Administration (FDA) on June 5 updated its Safety Communication: “Recommendations to Reduce Surgical Fires and Related Patient Injury.” Among the recommendations: Perform a fire risk assessment before each surgical procedure. Encourage communication among anesthesia personnel, surgeons, and OR staff. Practice safe use and administration…

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By: Judy Mathias
June 8, 2018
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AHRQ: Decline in HACs saves 8,000 lives, $2.9 billion

Editor's Note National efforts by the Centers for Medicare & Medicaid Services to reduce hospital-acquired conditions (HACs) helped prevent some 8,000 deaths and save $2.9 billion in costs between 2014 and 2016, according to a new report released June 5 by the Agency for Healthcare Research and Quality (AHRQ). Data…

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By: Judy Mathias
June 7, 2018
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FDA issues Class I Recall of CARDIOSAVE Hybrid Intra-aortic Balloon Pump by Maquet Datascope

Editor's Note The Food & Drug Administration on June 6 identified the recall by Maquet Datascope Corp of its CARDIOSAVE Hybrid Intra-aortic Balloon Pump as Class I, the most serious. The recall was initiated because of a design issue that allows fluid to seep into the device, which can lead…

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By: Judy Mathias
June 7, 2018
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FDA: New labeling for liquid-filled intragastric balloons

Editor's Note The Food & Drug Administration on June 4 announced that it had approved new labeling on potential risks for liquid-filled intragastric balloons by Apollo Endosurgery and ReShape Lifesciences. The new labeling for the Orbera and ReShape balloon systems includes more information about possible deaths linked to the use…

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By: Judy Mathias
June 6, 2018
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FDA: Recall of STAT-Check and Medline manual resuscitator bags

Editor's Note The Food & Drug Administration on June 1 announced the recall by SunMed Holdings of 18,808 units of its STAT-Check and Medline manual resuscitator bags. The recall was initiated because the patient port retaining ring of the bags may not fully seat, which could allow the patient port…

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By: Judy Mathias
June 5, 2018
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Joint Commission issues new Quick Safety to prepare healthcare organizations for disasters

Editor's Note The Joint Commission on May 31 issued a new Quick Safety advisory to help prepare healthcare organizations for disasters such as, power failure, fire, flood, industrial accident, or cyberattack. The advisory, "Quick Safety 41: Emergency management: Need for continuity of operations planning," provides risk factors, safety recommendations, and…

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By: Judy Mathias
June 4, 2018
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FDA: Class I recall of HeartWare HVAD system by Medtronic

Editor's Note The Food & Drug Administration on June 1 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) system as Class I, the most serious. The recall was initiated because of the possibility for an interruption to occur in the electrical connection between the system’s power…

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By: Judy Mathias
June 4, 2018
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FDA: Class I recall of HeartMate 3TM Left Ventricular Assist System

Editor's Note The Food and Drug Administration on May 22 identified the recall by Abbott of all lots of its HeartMate 3TM Left Ventricular Assist System as Class I, the most serious. The recall was issued because of a malfunction in the device’s outflow graft assembly that may cause the…

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By: Judy Mathias
May 22, 2018
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ECRI Institute research helped guide FDA report on medical device servicing

Editor's Note The ECRI Institute on May 21 announced that it had provided conclusive research to help guide the Food and Drug Administration’s (FDA) new “FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices.” The FDA report, which addresses concerns about the quality of service provided…

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By: Judy Mathias
May 22, 2018
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