Standards/Regulations

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October 2017
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FDA to staff new digital health unit

Editor's Note The Food and Drug Administration (FDA) is filling 13 positions in a new digital health unit that was created as part of the FDA Reauthorization Act of 2017, the September 11 FierceHealthcare reports. The FDA intends to build a group of experts who are experienced with software lifecycle…

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By: Judy Mathias
September 13, 2017
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FDA: Class I recall of Datascope/MAQUET intra-aortic balloon pumps

Editor's Note The Food and Drug Administration (FDA) on September 6 categorized the recall by Datascope/MAQUET of its CS100i, CS100, and CS300 intra-aortic balloon pumps as Class I, the most serious. The recall was initiated because of a false blood detection alarm and ingress of fluid into the balloon pump.…

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By: Judy Mathias
September 11, 2017
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FDA: Genetech recalls three lots of Activase

Editor's Note The Food and Drug Administration (FDA) on September 7 announced the recall by Genetech (South San Francisco, California) of three lots of Activase (alteplase) 100 mg vials that were co-packaged with sterile water for injection. The vials of water, manufactured by Hospira Inc (Lake Forest, Illinois), may be…

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By: Judy Mathias
September 11, 2017
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FDA: Recall of Hydromorphone HCL and Levophed Injection by Hospira

Editor's Note The Food and Drug Administration (FDA) on September 5 announced the recall by Hospira Inc (Lake Forest, Illinois) of one lot of Hydromorphone HCL injection, USP, CII 2 mg/mL and four lots of Levophed (norepinephrine bitartrate) injection because of a lack of sterility assurance resulting from a damaged…

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By: Judy Mathias
September 6, 2017
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CMS grants exceptions for quality reporting to ASCs in Harvey’s path

Editor's Notes The Centers for Medicare & Medicaid Services (CMS) will grant exceptions for quality reporting requirements for ambulatory surgery centers (ASCs) located in the path of Hurricane Harvey, the September 1 ASCA News reports. ASCs in affected counties and parishes in Texas and Louisiana will get exceptions without having…

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By: Judy Mathias
September 6, 2017
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FDA issues alert for alcohol pads, benzalkonium chloride antiseptic towelettes by Foshan Flying Medical Products

Editor's Note The Food and Drug Administration (FDA) on September 1 issued a Safety Alert notifying healthcare professionals and patients not to use alcohol pads or benzalkonium chloride antiseptic towelettes made by Foshan Flying Medical Products Co Ltd (China) because of lack of sterility and other quality issues. Use of…

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By: Judy Mathias
September 6, 2017
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FDA: Hospira recalls one lot of vancomycin hydrochloride

Editor's Note The Food and Drug Administration (FDA) on August 31 announced the recall by Hospira Inc (Lake Forest, Illinois) of one lot of vancomycin hydrochloride for injection, USP, 750 mg/vial (NDC 0409-6531-02) lot 632153A. The recall was initiated because of a customer report of the presence of particulate matter,…

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By: Judy Mathias
September 5, 2017
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Joint Commission temporarily suspends accreditation surveys in Houston

Editor's Note The Joint Commission announced on August 30 that because of flooding in Houston and surrounding areas, it is temporarily suspending accreditation survey activity for organizations severely affected by Hurricane Harvey. Joint Commission Online Weekly Newsletter

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By: Judy Mathias
September 1, 2017
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FDA recommends use of thermal regulating systems during surgery

Editor's Note The Food and Drug Administration (FDA) on August 30 issued a Safety Alert reminding healthcare providers that using thermal regulating systems, including forced air systems, during surgical procedures has been shown to result in less bleeding, faster recovery times, and decreased risk of infections for patients. The FDA…

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By: Judy Mathias
September 1, 2017
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Joint Commission issues R3 Report on pain assessment and management standards for hospitals

Editor's Note The Joint Commission has issued a new R3 Report to help accredited hospitals better understand and comply with its new and revised pain management standards, which are effective January 1, 2018. This R3 Report provides in-depth rationale, references, and evidence used in the development of the new and…

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By: Judy Mathias
August 30, 2017
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