FDA designates Class 1 recall for pacemakers
Editor’s Note The US Food and Drug Administration (FDA) has designated Boston Scientific Corporation’s recall of Accolade Pacemaker devices a Class 1, the most severe category indicating serious risk of injury or death. According to the agency’s February 21 announcement, the recall was motivated by a manufacturing issue that could…
Session: Hoisting the Sails—Winning Strategies for Growing Service Lines in an ASC
Editor's Note In this session, Deb Yoder, MHA, BSN, RN, CNOR, CASC, vice president of facility development, Compass Surgery Partners, provided a comprehensive overview of selecting, implementing, and managing service lines in ambulatory surgery centers (ASCs) while considering factors such as block time utilization, staff readiness, equipment needs, financial viability,…
Why active implants demand proactive management
What happens when a surgeon uses the monopolar instrument set on 30-W coagulation mode to create an upper midline incision in a patient with a pacemaker? Pacemaker function is interrupted, causing a heart block that results in hemodynamic instability—or at least, this is what could happen without taking the necessary…
In-house 3D printing reduces hospital surgery times, costs
Editor's Note The medical 3D printing market is expected to double from $2 billion in 2022 to $4 billion by 2026, driven by customization, lower costs, and quick turnarounds, according to analysis from GlobalData. In a July 24 report on the analysis, Medical Device Network outlined this growth as well…
FDA: Surgical mesh mini-slings comparable to mid-urethral slings for stress urinary incontinence
Editor's Note Mini-slings for stress urinary incontinence (SUI) are similarly effective to mid-urethral slings over a 36-month timeframe, according to an April 11 announcement from the US Food & Drug Administration (FDA). FDA reached this conclusion after an in-depth, systematic literature review of post-market surveillance (“522”) studies required last year…
Unveiling ECRI’s 2024 top 10 health technology hazards list
What is the purpose of the top 10 health technology hazards list, released every year by ECRI? “Our number one goal at ECRI is to reduce preventable harm,” stresses Jason Launders, MSC, former director of operations, device evaluation, at ECRI. “We know that every healthcare provider has a lot they…
Transcatheter therapy system becomes first to earn FDA approval for treating tricuspid regurgitation
Editor's Note Patients with severe cases of tricuspid regurgitation (in which a critical heart valve fails to close properly) now have a new treatment option thanks to the recent US Food and Drug Administration (FDA) approval of the ENVOQUE tricuspid valve replacement system, according to a February 2 press release…
Session: Outpatient surgery trends—What’s on the horizon?
Editor's Note Why do robotics matter? Jamie Clow, senior analyst and partner at Cleveland Research Company in Ohio, opened this session with that question, spurring an insightful deep dive into key trends in the orthopedic landscape with a focus on robotics and enabling technology. “There can be some fatigue around…
Surgeons design implant coating to combat infections
Editor's Note: A point-of-care, antimicrobial coating for orthopedic implants could soon make implant-associated infections a problem of the past, UCLA Health reported on January 3. Developed by two UCLA surgeons, the coating is designed to kill or slow the spread of micro-organisms in order to prevent post-surgical infections. According to…
FDA safety alert targets shoulder implant packaging
Editor's Note: Equinoxe Shoulder System joint replacement devices manufactured by Exactech between 2004 and 2021 are at risk of premature wearing or failure due to defective packaging, according to a January 16 safety alert from the US Food and Drug Administration (FDA). The bags used to package the devices were…
Free Daily News
- Robotic surgery transforms ORs as market expands
- Study: Wildfire smoke raises hospital borrowing, patient care costs
- Study: Hospital bed shortage looms as aging population drives demand
- FDA designates Class 1 recall for pacemakers
- Chinese medical devices threaten US healthcare cybersecurity
- Preoperative SGLT2i use does not raise DKA risk in emergency surgery
- AI boosts accuracy in surgical reports, outperforming surgeons
- AI models improve prediction of surgical complications using preoperative clinical notes
- Ambient AI healthcare documentation gains traction as capabilities expand
- Healthcare M&A faces tighter review as FTC retains guidelines