Regulations/Legal

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June 2018
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FDA approves firmware update for Abbott ICDs, CRT-Ds

Editor's Note The Food and Drug Administration (FDA) on April 17 announced that it had approved a firmware update that is now available for certain Abbott (formerly St Jude Medical) implantable cardiac devices (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The update is a corrective action (recall) to reduce the…

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By: Judy Mathias
April 18, 2018
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FDA alert: Coastal Meds recalls all sterile products

Editor's Note The Food and Drug Administration (FDA) on April 13 announced the recall by Coastal Meds (Biloxi, Mississippi) of all nonexpired products marketed as sterile because of visible particles in some of the drug vials for injection and poor sterile production practices. The FDA on April 5 requested the…

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By: Judy Mathias
April 16, 2018
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FDA: Premier Pharmacy Labs recalls certain sterile injectable products

Editor's Note The Food and Drug Administration (FDA) on April 12 announced the recall by Premier Pharmacy Labs (Weeki Wachee, Florida) of certain lots of sterile injectable products because of a potential lack of sterility assurance. The products include morphine sulfate (2 mg/mL and 3 mg/mL), hydromorphone HCL 1 mg/mL,…

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By: Judy Mathias
April 16, 2018
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Joint Commission releases 2017 top 5 most challenging requirements

Editor's Note The Joint Commission on April 11 released the top 5 requirements identified most frequently as “not compliant” during surveys and reviews that took place from January 1 to December 31, 2017. New to the table is data on Perinatal Care Certification. The top 5 for Hospital Accreditation are:…

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By: Judy Mathias
April 13, 2018
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FDA: Recall of Acrodose Plus and PL systems by Haemonetics

Editor's Note The Food and Drug Administration (FDA) on April 13 announced the recall by Haemonetics (Braintree, Massachusetts) of certain lots of its Acrodose Plus and PL Systems because the company has received reports of low pH readings for platelets stored in CLX HP bags. In some instances the drop…

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By: Judy Mathias
April 13, 2018
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Hysterectomy complication rates after FDA warning against power morcellation

Editor's Note In this study, 30-day complications rates increased after the Food and Drug Administration (FDA) warned against the use of power morcellation in women undergoing hysterectomy for benign gynecologic indications. In a cohort of 75,487 women who had hysterectomies, statistically and clinically significant increases in major (1.9% to 2.4%)…

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By: Judy Mathias
April 11, 2018
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FDA: System 83 Plus AERs complete validation testing

Editor's Note The Food and Drug Administration (FDA) on April 10 notified healthcare facilities that Custom Ultrasonics (Ivyland, Pennsylvania) has completed validation testing of the System 83 Plus (ie, System 83 Plus, System 83 Plus 2, and System 83 Plus 9) automated endoscope reprocessors (AERs) with specific duodenoscopes. The FDA…

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By: Judy Mathias
April 11, 2018
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CMS issues final rule to increase access to affordable health plans

Editor's Note The Centers for Medicare & Medicaid Services (CMS) on April 9 issued the Health and Human Services Notice of Benefit and Payment Parameters for 2019 final rule. CMS says the rule will mitigate the harmful effects of Obamacare and empower states to relax the rules on what insurers…

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By: Judy Mathias
April 10, 2018
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Important ASC Medicare quality reporting deadlines approaching

Editor's Note All eligible Medicare-certified ambulatory surgery centers (ASCs) that want to avoid future penalties must complete a new electronic form by April 14 via the Centers for Disease Control and Prevention’s National Healthcare Safety Network website in order to report on ASC-8: Influenza Vaccination Coverage among Healthcare Personnel, the Ambulatory…

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By: Judy Mathias
April 10, 2018
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Joint Commission: Zero harm is achievable through high reliability

Editor's Note Joint Commission president Mark R. Chassin, MD, FACP, says he doesn’t want healthcare organizations to just imagine a day of zero harm, he wants them to achieve it, the Joint Commission announced on April 4. Dr Chassin talked about “Leading the Way to Zero” in an article for…

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By: Judy Mathias
April 9, 2018
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