Rules and Regulations
FDA pilot program aims to expedite high-risk medical device recall communication
Editor's Note The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has initiated a pilot program to improve the speed of public notifications regarding high-risk medical device recalls. According to a November 21 announcement, this initiative aims to minimize the time between the FDA's awareness…
FDA Class 1 recalls target anesthesia workstations, ambulatory infusion pumps, ventilators
Editor's Note The US Food and Drug Administration (FDA) has designated Class 1 recalls—the most severe category indicating risk of serious injury or death—involving three systems: Atlan anesthesia workstations from Draeger, CADD-Solis ambulatory infusion pumps from Smiths Medical, and Trilogy Evo ventilators from Philips Respironics. FDA issued all three announcements…
Practice updates ease steam sterilization balancing act
Reliable and robust enough for daily use on most medical devices, steam is the most common sterilant in healthcare facilities. However, using steam properly requires a balancing act. For example, too much moisture can lead to wet packs, while steam that is too dry might not be sufficient to achieve…
Tardiness policies fine-tune rural OR reform efforts
When a speaker at a recent conference asked if anyone had achieved a first-case on-time start (FCOTS) rate above 90%, Jay Parker, BSN, RN, could have been the only one in the room with his hand up. However, Parker was not inclined to call attention to himself. As director of…
GAO urges HHS to strengthen cybersecurity oversight
Editor's Note A November 13 report from The Government Accountability Office (GAO) identifies critical gaps in the Department of Health and Human Services' (HHS) ability to manage cybersecurity risks in the healthcare and public health sector. HHS, the lead federal agency for cybersecurity in this sector, faces challenges in monitoring…
AMA urges stronger radiation protections
Editor's Note Amid growing concerns about healthcare workers’ exposure to ionizing radiation and its associated cancer risks, the American Medical Association (AMA) House of Delegates called for increased protective measures and standardized guidelines, including improved exposure metrics, during their interim meeting in Orlando, Florida. MedPage Today reported the news November…
Third-party vendors drive healthcare cybersecurity risks
Editor's Note Cybersecurity threats in healthcare are increasingly driven by third-party vendors, affecting millions of patients and hospital systems globally, experts John Riggi and Richard Staynings emphasized at the HIMSS Healthcare Cybersecurity Forum. Healthcare Finance News reported on the experts’ testimony November 5. According to the article, cyberattacks have surged…
Trump vs. Harris: Key differences in healthcare proposals for Medicaid, Medicare, private insurance, abortion
Editor's Note When it comes to the 2024 presidential election, “Neither candidate addresses a return to the fundamental tenet of healthcare: the patient-physician relationship,” reads the closing line of an “election guide” from Richard Menger MD MPA. In the preceding paragraph, Menger also argues that both candidates also neglect issues…
Updated AAMI standard addresses chemical sterilization safety, compliance
Editor's Note New guidance from The Association for the Advancement of Medical Instrumentation (AAMI) addresses regulatory and safety concerns for hospitals using ethylene oxide (EO) for medical device sterilization—a pressing concern due to EO’s effectiveness but associated health risks. ANSI/AAMI ST58:2024, an update on chemical sterilization and high-level disinfection practices…
Feds warn of increased healthcare cyber threats from Iranian actors
Editor's Note Iranian cyber actors employing techniques such as brute force, password spraying, and multifactor authentication (MFA) "push bombing" to compromise healthcare and other critical infrastructure sectors, the American Hospital Association (AHA) reported October 17. The report cites an October 16 joint advisory issued on October 16 by the FBI,…
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