Editor's Note The number of US Food and Drug Administration (FDA) Class 1 recalls—the most serious classification—for medical devices has been trending upwards. Regulatory News, a publication of the Regulatory Affairs Professional Society (RAPS), reported the news April 25. According to the report, Anne Reid, program director of the Office…
Editor's Note New federal guidelines require obtaining written informed consent before conducting pelvic and other sensitive medical examinations, according to an April 2 Associated Press report. The new guidance from the US Department of Health and Human Services focuses specifically on medical students, nurse practitioners, and physician assistants performing breast,…
Editor's Note The Environmental Protection Agency (EPA) has finalized a rule to reduce chloroprene and ethylene oxide emissions that will impact over 200 chemical plants across the nation, including medical sterilization plants, according to an April 10 report from USA Today. Under the new rule, the EPA will cut more…
Editor's Note The US Food and Drug administration approved Zevtera for treating Staphylococcus aureus bacteremia (SAB) bloodstream infections, which are often acquired in healthcare settings. In the April 3 announcement, the agency notes the new antibiotic Zevtera (ceftobiprole medocaril sodium for injection) is effective for SAB-infected patients with right-sided infective…
Editor's Note Private payers initially deny reimbursement on 15% of claims, only to later approve more than half of those initial denials, according to a national survey of healthcare institutions published March 21 by Premiere, Inc. Additionally, the denied claims on average tend to be more prevalent for higher-cost treatments…
Editor's Note The US Food and Drug Administration (FDA) advises consumers to avoid topical analgesics marketed in violation of federal law by six different companies, including: TKTX Company: TKTX Numb Maximum Strength Pain Reliever, Mithra+ 10% Lidocaine, TKTX During Procedure Numbing Gel 40% and J-CAIN cream [LIDOCAINE] 29.9% SeeNext Venture,…
Editor's Note The Department of Homeland Security's Cybersecurity and Infrastructure Security Agency (CISA) proposed a new rule that would require hospitals and health systems to report any cyberattacks or ransomware attacks to the agency within 72 hours and any ransomware payments within 24 hours. The healthcare sector is one of…
What if a surgeon decided to perform a procedure on a patient that was not totally necessary? It happens more often that one might realize. As recently as August 2023, Forbes published an article that cited a Harvard Business Review report stating that over 50% of lumbar spine surgeries are…
Editor's Note New standards from The Environmental Protection Agency promise to cut nationwide emissions of ethylene oxide—employed to sterilize more than half of US medical devices—by more than 90 percent. According to a March 15 MedPage Today report, the aim is to reduce cancer risk among the 13 to 14…
Editor's Note Making good on plans announced by the Biden administration in December, federal agencies have launched a public inquiry into how private equity mergers and acquisitions impact patient outcomes, worker safety, and healthcare access and costs, including costs to taxpayers. As reported by Dotmed Healthcare Business News on March…