Editor's Note Telehealth providers are divided over whether to continue serving Medicare patients after reimbursement expired alongside the federal government shutdown, Modern Healthcare October 9 reports. The impasse has forced organizations to weigh patient access against financial risk, with many issuing advance beneficiary notices warning patients they may be responsible…
Editor's Note The Food and Drug Administration (FDA) on October 10 classified a cybersecurity correction involving Abiomed’s Automated Impella Controller as a Class I recall, the most serious type, according to the FDA Medical Device Recalls and Early Alerts database. While devices are not being removed from clinical settings, the…
Editor's Note The Food and Drug Administration (FDA) has expanded its early alert recall program to include all medical devices, speeding up how quickly the public learns about high-risk safety issues, Modern Healthcare October 9 reports. The initiative allows the FDA to post early alerts within days of manufacturers notifying…
Editor's Note According to a Healthcare Financial Management Association (HFMA) analysis, the US healthcare system is in “serious condition,” with affordability collapsing and provider financial risk escalating, HealthLeaders September 19 reports. The group’s new Healthcare Vitals Tracker scored the industry just 35.9 out of 100, compared to a peak of…
Editor's Note Sterile processing departments (SPDs) face chronic staffing shortages and underinvestment that put surgical patients at risk, according to a Surgical Directions September 18 report. It emphasizes that sterile processing technicians, who decontaminate, inspect, and sterilize every surgical instrument, remain under-recognized despite their central role in surgical safety. Per…
Know the law. It could save your patients’ lives and your staff members’ practices. This is the advice of several medical legal experts to OR leaders to prevent lapses in patient protections that risk injury or even death. Beyond ensuring safe surgery and preventing litigation, perioperative nursing experts who advance…
Editor's Note A recent article in AORN Journal underscores the need for vigilance and thorough documentation to manage postoperative mental status changes and prevent harm to both patients and staff. As detailed in the article, cognitive disturbances such as delirium and agitation can complicate recovery after surgery. Delirium is characterized…
Editor's Note The US Food and Drug Administration (FDA) issued early alerts August 6 for three medical devices due to safety concerns: Medline ReNewal’s reprocessed St. Jude Medical electrophysiology catheters, Boston Scientific’s ENDOTAK RELIANCE defibrillation leads with ePTFE-coated coils, and Boston Scientific's WATCHMAN Access Systems. The Medline alert involves specific lots…
Editor's Note Two workers at an ambulatory surgery center (ASC) are facing federal charges after allegedly interfering with an Immigration and Customs Enforcement (ICE) arrest, The Independent July 27 reports. The federal agents reportedly arrested one of the workers and are pursuing the other after both were accused of assaulting…
Editor's Note Philips Respironics BiPAP A30, A40, and V30 Auto ventilators are subject to a Class 1 recall—the US Food and Drug Administration’s (FDA’s) most severe category indicating risk of serious injury or death—due to the risk for a failure in the Ventilator Inoperative alarm, which can cause therapy interruption…