Regulations/Legal

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April 2019
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CDC: Healthcare-associated infections declining

Editor's Note The Centers for Disease Control and Prevention on March 19 released its current progress report on healthcare-associated infections, which includes state and national level statistics for 2017. Among the findings for acute care hospitals: Clostridium difficile infections declined by 13%. Central line-associated bloodstream infections fell by 9%. Methicillin-resistant…

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By: Judy Mathias
March 26, 2019
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FDA issues Safety Communication on cybersecurity vulnerabilities in Medtronic cardiac devices

Editor's Note The Food & Drug Administration on March 21 issued a Safety Communication on cybersecurity vulnerabilities identified in wireless telemetry technology used for communication between Medtronic’s implantable cardiac devices, clinic programmers, and home monitors. Medtronic (Dublin, Ireland) is working on updates to address the vulnerabilities and recommends that healthcare…

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By: Judy Mathias
March 25, 2019
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Joint Commission: eCQM Proven Practices must be submitted by April 5

Editor's Note The Joint Commission on March 20 announced that time is running out for organizations to submit applications for the 2019 Pioneers in Quality Proven Practices Collection. Applications must be submitted online by April 5. Among topics of interest: Demonstrating improvements in clinical performance or outcomes using electronic clinical…

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By: Judy Mathias
March 21, 2019
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FDA issues warning letters to two breast implant manufacturers

Editor's Note The Food & Drug Administration (FDA) on March 19 issued warning letters to two breast implant manufacturers (Mentor Worldwide LLC of Irvine, California, and Sientra, Inc of Santa Barbara, California) for failing to comply with post-approval study requirements. All manufacturers of approved silicone gel-filled implants are required to…

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By: Judy Mathias
March 21, 2019
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FDA: Class I recall of Cook Medical’s Transseptal Needle

Editor's Note The Food and Drug Administration on March 18 identified the recall by Cook Medical Inc (Bloomington, Indiana) of one lot of its Transseptal Needles as Class I, the most serious. The recall was initiated because of a manufacturing error that resulted in some needle tips missing the back…

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By: Judy Mathias
March 19, 2019
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You may also be interested in these sessions at the OR Manager Conference this September in Nashville, TN

Ace the Test: Strategies for a Successful Joint Commission Survey

After this session you'll be able to: Summarize 2019 Joint Commission (TJC) standards and Centers for Medicare & Medicaid Services (CMS) regulations pertinent to Surgical Services. Develop strategies to ensure ongoing compliance and survey readiness. Understand methodologies surveyors use to assess compliance. Why this is important: Is your team prepared…

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FDA: Hospira recalls 8.4% Sodium Bicarbonate Injection

Editor's Note The Food and Drug Administration (FDA) on March 15 announced the recall by Hospira, Inc (a Pfizer company) of three lots of its 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL). The recall was initiated because of the presence of particulate matter, confirmed as glass. The…

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By: Judy Mathias
March 18, 2019
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Joint Commission releases 2018 sentinel event stats

Editor's Note The Joint Commission on March 13 released its sentinel event statistics for 2018, the majority of which were voluntarily reported by an accredited or certified organization. Of the 10 most frequently reported events, falls and unintended retention of a foreign body were at the top with 111 reports…

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By: Judy Mathias
March 14, 2019
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FDA: Guardian Pharmacy ordered to stop producing sterile compounded drugs

Editor's Note The Food & Drug Administration on March 12 announced that a federal judge entered a consent decree against Guardian Pharmacy Services (Dallas, Texas) to stop the company from producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic (FD&C)…

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By: Judy Mathias
March 14, 2019
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FDA issues letter on risks linked with staplers, implantable staples

Editor's Note The Food and Drug Administration (FDA) on March 8 issued a letter to alert healthcare providers about an increasing number of medical device reports on surgical staplers for internal use and implantable surgical staples. The most common reported problems include opening of the staple line, malformation of staples,…

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By: Judy Mathias
March 11, 2019
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Joint Commission moves THKR performance measures

Editor's Note The Joint Commission on March 6 announced that it is moving the inpatient and outpatient Total Hip and Total Knee Replacement (THKR) implementation guides from the performance measure webpage to the 2019 Specifications Manual for Joint Commission National Quality Measures. The Manual was published in February. The move will…

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By: Judy Mathias
March 11, 2019
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You may also be interested in these sessions at the OR Manager Conference this September in Nashville, TN

2019 Regulatory and Quality Measure Reporting Update for ASCs

After this session you'll be able to: Discuss the most current updates to federal regulations and what to expect in 2020. Identify quality reporting for ambulatory surgery centers (ASCs) required by the Centers for Medicaid & Medicare Services (CMS). State the recent changes to the ASC quality reporting program. Why…

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