Standards/Regulations

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December 2017
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FDA: Recall of potassium phosphate and succinylcholine chloride by PharMEDium Services

Editor's Note The Food and Drug Administration on June 27 announced the recall by PharMEDium Services of specific lots of potassium phosphate and succinylcholine chloride because of a lack of sterility assurance. The products being recalled were compounded using certain Hospira products, which were recalled on June 15 because microbial…

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By: Judy Mathias
June 29, 2017
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FDA announces new digital health resources

Editor's Note The Food and Drug Administration (FDA) has announced the creation of a new centralized Digital Health Unit in its Center for Devices and Radiological Health, which together with draft guidance on software as a medical device, is designed to support technological innovation and advance digital health, the June…

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By: Judy Mathias
June 28, 2017
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Joint Commission: HLD, sterilization top challenges for ambulatory health care

Editor's Note Leading the Joint Commission’s Top Ten Challenging Standards for accredited ambulatory health care organizations during the past year was infection control standard IC.02.02.01, EP 2: The organization reduces the risk of infections associated with medical equipment, devices, and supplies by performing a high-level disinfection and sterilization. In 2016,…

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By: Judy Mathias
June 27, 2017
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Researchers call for end to legal mandates for MRSA, VRE contact precautions

Editor's Note Despite widespread adoption of contact precautions for methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE), there is no strong clinical trial evidence to support the mandated use of these precautions, three noted infection prevention researchers say. Without the support of evidence, policy makers from 2000 to 2010 passed…

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By: Judy Mathias
June 26, 2017
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FDA: Fagron Sterile Services recalls three lots of succinylcholine

Editor's Note The Food and Drug Administration (FDA) on June 23 posted the recall by Fagron Sterile Services (Wichita, Kansas) of three lots of succinylcholine chloride 20 mg/mL 5 mL syringes because of microbial growth detected during a simulation of the manufacturing process. This is a secondary recall of products…

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By: Judy Mathias
June 26, 2017
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Joint Commission offers free VTE compendium of resources

Editor's Note The Joint Commission on June 21 announced its new, free venous thromboembolism (VTE) compendium of resources. The compendium was developed to help clinicians, healthcare educators, and other healthcare professionals provide reliable and up-to-date patient education materials for VTE and anticoagulation therapy. Joint Commission Online Weekly Newsletter

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By: Judy Mathias
June 23, 2017
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National Accreditation Program for Rectal Cancer accepting applications

Editor's Note Hospitals with rectal cancer programs may now earn accreditation from the new National Accreditation Program for Rectal Cancer (NAPRC), the American College of Surgeons (ACS) announced on June 21. NAPRC is based on successful international models that have resulted in better outcomes and emphasize a multidisciplinary team approach…

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By: Judy Mathias
June 22, 2017
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FDA: Vascular Solutions recalls Venture Catheters

Editor's Note The Food and Drug Administration (FDA) on June 21 announced the recall by Vascular Solutions (Maple Grove, Minnesota) of its Venture Catheters. The recall was initiated because there is a risk of the catheter tip splitting or separating during use and entering the patient’s bloodstream. This can result…

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By: Judy Mathias
June 22, 2017
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Joint Commission redesigns ESC form

Editor's Note The Joint Commission announced on June 21 a redesign of its Evidence of Standards Compliance (ESC) form. The form was redesigned to help organizations focus on describing the critical aspects of corrective actions they have taken to resolve Requirements for Improvement, and to help ensure sustainability of those…

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By: Judy Mathias
June 21, 2017
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FDA: Alvogen recalls seven lots of clindamycin

Editor's Note The Food and Drug Administration (FDA) on June 16 announced the recall by Alvogen/Hospira Inc, a Pfizer company, of seven lots of Clindamycin Injection USP ADD-Vantage Vials. The recall was initiated because microbial growth was detected during a routine simulation of the manufacturing process, which represents the potential…

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By: Judy Mathias
June 21, 2017
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