Standards/Regulations

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October 2017
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FDA: Label changes for use of general anesthetic, sedation drugs in young children

Editor's Note The Food and Drug Administration (FDA) on April 27 issued a Safety Alert saying the agency had approved label changes on the use of general anesthetic and sedation drugs in children younger than 3 years. The changes include: A new warning that exposure to these drugs for lengthy…

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By: Judy Mathias
April 28, 2017
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Joint Commission announces first Physician Leader Forum Challenge Award

Editor's Note The Joint Commission announced April 26 that Select Medical, based in Mechanicsburg, Pennsylvania, is the first recipient of its Physician Leader Forum Challenge Award. The award recognizes Select Medical’s leading practice for wound care and prevention of pressure ulcers in patients throughout the system. An improvement project lowered…

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By: Judy Mathias
April 26, 2017
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FDA: Hospira recalls 25% Dextrose Injection

Editor's Note The Food and Drug Administration (FDA) on April 24 announced the recall by Hospira (Lake Forest, Illinois) of one lot of 25% Dextrose Injection, USP, (infant) prefilled syringes because of the presence of particulate matter identified as human hair. The affected lot is NDC: 0409-1775-10, Lot 58382EV, Expiry…

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By: Judy Mathias
April 25, 2017
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Joint Commission seeking eCQM success stories

Editor's Note The Joint Commission announced April 19 that it is seeking hospital success stories about electronic clinical quality measure (eCQM) capture and submission to share with other accredited hospitals via the new 2017 Pioneers in Quality: Proven Practices Collection. Hospitals whose submissions are selected also will be recognized as…

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By: Judy Mathias
April 20, 2017
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Joint Commission: Michigan hospital, home care earn first Medication Compounding Certification

Editor's Note The Joint Commission announced on April 12 that Genesys Regional Medical Center, Grand Blanc, Michigan, and Home IV Care, Inc, Madison Heights, Michigan, are the first organizations to receive its new Medication Compounding Certification. The certification is based on standards from the US Pharmacopeial Convention (USP) to help…

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By: Judy Mathias
April 19, 2017
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Joint Commission: Top 10 Challenging Standards for ambulatory care and office based surgery organizations

Editor's Note The Joint Commission on April 13 unveiled its Top 10 Challenging Standards for Ambulatory Health Care and Office-Based Surgery accredited organizations in 2016. Leading the top 10 are: IC.02.02.01: The organization reduces the risk of infections associated with medical equipment, devices, and supplies. HR.02.01.03: The organization grants initial,…

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By: Judy Mathias
April 18, 2017
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CMS releases proposed FY 2018 inpatient payments, policies

Editor's Note The Centers for Medicare & Medicaid Services (CMS) on April 14 issued a proposed rule that would update FY 2018 Medicare inpatient payments and policies. Among the changes, the rule: would increase payment rates by 1.6%, after accounting for inflation and other adjustments required by law includes an…

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By: Judy Mathias
April 18, 2017
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FDA: Recall of Isomeric sterile compounded products

Editor's Note The Food and Drug Administration (FDA) on April 6 announced the recall of all lots of sterile products compounded and packaged by Isomeric Pharmacy Solutions (Salt Lake City, Utah). The recall was issued because of FDA concerns of a lack of sterility assurance, which were brought to Isomeric’s…

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By: Judy Mathias
April 11, 2017
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FDA: Recall of Medtronic’s StrataMR adjustable valves and shunts

Editor's Note The Food and Drug Administration (FDA) on April 8 announced the recall of all StrataMR adjustable valves and shunts manufactured by Medtronic (Dublin, Ireland). The recall was issued because of a postimplantation problem that can lead to under-drainage of cerebrospinal fluid, which can lead to headaches, nausea, vomiting,…

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By: Judy Mathias
April 11, 2017
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FDA: Class I recall of Merit Medical’s sheath introducer

Editor's Note The Food and Drug Administration (FDA) on March 31 labeled Merit Medical Systems' (South Jordan, Utah) recall of the Prelude Short Sheath Introducer as Class I, the most serious. The recall was issued because of a manufacturing defect that may cause the tip to separate from the sheath…

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By: Judy Mathias
April 7, 2017
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