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April 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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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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You may also be interested in these sessions at the OR Manager Conference this September in Nashville, TN

The Road to Zero! Meeting Compliance After TJC Survey Using the SAFER Matrix

After this session you’ll be able to: Explain the SAFER Matrix used by The Joint Commission (TJC)., Discuss how to assess risk using mitigation strategies for compliance to the SAFER Matrix., Identify tools for creating and implementing required corrective action plans., Why this is important: The SAFER Matrix has been…

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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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Joint Commission: March 15 is deadline for CY 2018 eCQM data submission

Editor's Note The Joint Commission on March 6 reminded organizations submitting CY 2018 electronic clinical quality measure (eCQM) data that the deadline is 8 pm CT on March 15. Two submission methods are available: Listed ORYX eCQM Vendor. Direct Data Submission Platform. There will be no extensions, and data cannot…

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By: Judy Mathias
March 7, 2019
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FDA: Class I recall of RVO 2.0 Raindrop near vision inlay

Editor's Note The Food & Drug Administration (FDA) on March 5 identified the recall by RVO 2.0, Inc (Aliso Viejo, California) of its Raindrop near vision inlay as Class I, the most serious. All lots of the inlay are being recalled because data from the post-approval study showed an increased…

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By: Judy Mathias
March 6, 2019
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You may also be interested in these sessions at the OR Manager Conference this September in Nashville, TN

2019 Update on Sterilization & Disinfection Standards

After this session you’ll be able to: Describe new changes to sterilization standards and guidelines., Discuss high non-compliance areas related to sterilization and disinfection., Identify how these changes can be incorporated into departmental procedures., Why this is important: With the increased complexity in medical devices that comes with advanced research,…

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