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…
After 10 years, EHRs don’t live up to promise
Editor's Note The US government claimed that digitization of healthcare records would improve the quality and value of healthcare; however, 10 years after legislation fast-tracked the move to electronic healthcare records (EHRs), even the architects of the effort agree that the $36 billion investment has not delivered as expected, the…
Cleveland Clinic launches new artificial intelligence center
Editor's Note The Cleveland Clinic has launched a new Center for Clinical Artificial Intelligence, which will focus on applying machine learning to healthcare diagnostics, predictive analytics, and treatment planning, the March 13 Health IT Analytics reports. As part of the Cleveland Clinic Enterprise Analytics division, the new center will analyze…
Effect of PPE doffing errors on healthcare worker self-contamination
Editor's Note The risk of hand contamination was higher when healthcare workers (HCWs) removed their gloves before their gowns during personal protective equipment (PPE) doffing, and HCWs who made multiple PPE doffing errors were more likely to have contaminated clothes after patient interactions, this study finds. In this analysis of…
Study: TAVR equal to or better than surgery
Editor's Note This study comparing transcatheter aortic valve replacement (TAVR) with standard open-heart surgery found no difference in stroke or death from any cause at 2 years follow-up. The findings were presented March 17 at the American College of Cardiology’s Annual Scientific Session in New Orleans. A total of 1,468…
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…
Effect of hospital intervention, state legislation on postop opioid prescribing practices
Editor's Note After a hospital-wide intervention and state-wide legislation, this community hospital in Michigan achieved a 60%-70% decrease in postoperative opioid prescriptions and less variation in opioid prescription practices. This retrospective study of opioid naïve adult patients who had one of five general surgical procedures between 2015 and 2017 found…
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…
ORBMC gets business leaders off to a strong start in 2019
San Diego in January is a place where many people would rather be, and the 475 healthcare business and industry leaders who gathered there for the 2019 OR Business Management Conference (ORBMC) enjoyed the mild climate along with high-quality presentations and fun networking events. Conference attendance rises each year, yet…
Savvy leaders know how to 'read' themselves and their staffs
Managing the OR is similar to playing a game of poker. To win, a player must be able to read the others around the table, and to succeed, managers must be able to read their staff members and colleagues. Most importantly, they all must know the rules and when it’s…