Medical technology is intended to improve patient care, but even the best technology—if configured, used, or maintained improperly—can lead to problems. Hospitals must regularly examine their hazard control priorities to target the most pressing risks. ECRI Institute’s annual Top 10 Health Technology Hazards report identifies high-priority sources of danger or…
Editor's Note The Food & Drug Administration (FDA) on January 12 updated a Safety Alert about pneumothorax events associated with feeding tube placement procedures using the Cortrak 2 Enteral Access System (EAS) by Corpak Medsystems (Buffalo Grove, Illinois). Several of the events were associated with cardiopulmonary arrest, and there were…
Editor's Note The Centers for Medicare & Medicaid Services on January 11 issued a proposal to modify its national coverage determination for magnetic resonance imaging (MRI) to include patients who have implanted cardiac devices. Proposed changes include the expansion of coverage for patients with cardiac devices that are approved or…
Editor's Note The Food and Drug Administration (FDA) on January 12 announced a delay in enforcement of unique device identification (UDI) requirements for class I and unclassified devices until September 24, 2020. The FDA also will not enforce direct mark requirements for these devices until September 24, 2022. The guidance…
Editor's Note A Healthcare Market Reports analysis predicts the minimally invasive spine surgery market will see a compound annual growth rate of 7.57% through 2020, the January 4 Becker’s Spine Review reports. The increasing incidence of spinal disorders is boosting the market, and a key market trend is the minimally…
Editor's Note A Persistence Market Research report predicts the global arthroscopic devices market will exceed $1.7 billion by 2022, with a 5.1% compound annual growth rate, according to the January 3 Becker’s Spine Review. A rising demand for minimally invasive procedures and an increasing geriatric population are the main contributors…
Robotic-assisted surgery offers many potential advantages, including shorter operative time, less morbidity, and faster patient recovery. But rigorous comparisons with traditional surgical methods and cost-effectiveness analyses are still limited, and the price tag of the robot (in the neighborhood of $1 million) and annual maintenance contract (roughly $150,000) may give…
Editor's Note ECRI Institute on December 12 issued its list of Top 10 Health Technology Hazards for 2018. The list, which is available for free (registration required), identifies sources of technology dangers or difficulties and details steps to minimize the occurrence of adverse events. Topping the list is ransomware and…
Editor's Note Food and Drug Administration (FDA) commissioner Scott Gottlieb, MD, issued a statement December 4 on the FDA’s final guidance on medical device additive manufacturing, also known as 3D printing. The FDA has reviewed more than 100 devices currently on the market that were manufactured on 3D printers, including…
Editor's Note The Joint Commission on November 29 announced a new software tool, “Tracers with AMPTM plus CMS,” to help hospitals and critical access hospitals manage their Joint Commission accreditation and Centers for Medicare & Medicaid Services (CMS) compliance efforts. The tool is a web-based platform that stores a hospital’s…