Regulations/Legal

Latest Issue of OR Manager
April 2019
Home Regulations/Legal

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…

Read More

By: Judy Mathias
March 7, 2019
Share

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…

Read More

By: Judy Mathias
March 6, 2019
Share

FDA issues Safety Communication on using surgical robots in women’s health

Editor's Note The Food and Drug Administration (FDA) on February 28 issued a Safety Communication on the safety and effectiveness of using robotically-assisted surgical devices in mastectomy procedures or in the prevention or treatment of cancer in women. The FDA cited limited, preliminary evidence that the use of robotically-assisted surgical…

Read More

By: Judy Mathias
March 5, 2019
Share

CMS updates Star Ratings, proposes future changes

Editor's Note The Centers for Medicare & Medicaid Services (CMS) on February 28 updated its Overall Hospital Star Ratings on the Hospital Compare website and posted potential changes to the Hospital Star Ratings methodology for public comment. The proposed changes would make hospital comparisons more precise and consistent, and allow…

Read More

By: Judy Mathias
March 4, 2019
Share

Association of overlapping surgery with outcomes

Editor's Note In this multicenter study, overlapping surgery was not significantly associated with in-hospital mortality or postoperative complication rates, but it was significantly linked to increased surgery time. Researchers from Stanford University, University of Michigan, University of Pennsylvania, and Harvard, analyzed 66,430 procedures, of which 8,224 were overlapping. Overlapping surgery…

Read More

By: Judy Mathias
February 28, 2019
Share

FDA: Class I recall of Physio-Control LIFEPAK 15 Monitor/Defibrillator

Editor's Note The Food & Drug Administration (FDA) on February 27 identified the recall by Physio-Control, Inc (Redmond, Washington) of its LIFEPAK 15 Monitor/Defibrillator as Class I, the most serious. The recall was initiated because the device may “lockup” (freeze) after a shock is delivered. Once it freezes, it cannot…

Read More

By: Judy Mathias
February 28, 2019
Share

Joint Commission accepting applications for leaders in eCQM proven practices

Editor's Note The Joint Commission announced on February 27 that in support of organizations adopting electronic clinical quality measures (eCQMs), it is accepting applications from accredited hospitals and health systems for the “2019 Pioneers in Quality Proven Practices Collection.” The organizations’ success stories can be used as learning tools to…

Read More

By: Judy Mathias
February 28, 2019
Share

CMS releases opioid prescribing mapping tool updates

Editor's Note The Centers for Medicare & Medicaid Services on February 22 released an update to its Medicare Part D opioid prescribing mapping tool and a new Medicaid opioid prescribing mapping tool. The Medicare tool is an interactive, web-based resource that shows geographic comparisons of opioid prescribing rates at state,…

Read More

By: Judy Mathias
February 26, 2019
Share

FDA: Class I recall of ICU Medical’s ChemoLock Vial Spike

Editor's Note The Food & Drug Administration (FDA) on February 22 identified the recall by ICU Medical (San Clemente, California) of its ChemoLock Vial Spike (20 mm) as Class I, the most serious. The recall was initiated because of the potential for plastic particles to break off the protective cap.…

Read More

By: Judy Mathias
February 25, 2019
Share

FDA: Class I recall of Smiths Medical Sterile Saline and Water for Inhalation

Editor's Note The Food & Drug Administration (FDA) on February 4 identified the recall by Smiths Medical (Minneapolis, Minnesota) of certain lots of Sterile Saline and Water for Inhalation as Class I, the most serious. The recall was initiated because of potential exposure to infectious agents (bacillus infantis and staphylococcus…

Read More

By: Judy Mathias
February 21, 2019
Share
Upcoming Webinars
Live chat by BoldChat