Researchers identify immunity-driven factors behind rejection of medical implants
Editor's Note Medical devices such as pacemakers, breast implants, or knee replacements often cause hostile immune responses that can damage not only the implants but also surrounding tissue in the patient. That rejection often leads to further intervention needed that may include medications such as immunosuppressants or additional procedures. Researchers…
AAMI: Time, temperature, humidity affecting cleanliness of instruments, medical devices
Editor's Note Researchers for a long time have expressed concern about how time and temperature might contribute to changes that affect the cleaning and sterilization of instruments. However, there have been few studies examining these claims. A September 2023 study in Biomedical Instrumentation and Technology from the Association for the…
Discrepancies in FDA clearance, marketing of AI-, ML-enabled medical devices
Editor's Note This study from New York University and NYU Langone Health, New York City, finds discrepancies between the marketing and 510(k) clearance of artificial intelligence (AI)- or machine learning (ML)-enabled medical devices, with some devices being marketed as having capabilities not approved by the Food and Drug Administration (FDA).…
CISA: New 'high-risk' cyber vulnerability for Medtronic cardiac device management system
Editor's Note On June 29, the Cybersecurity & Infrastructure Security Agency (CISA) issued a medical advisory alert "warning of a significant, high-risk vulnerability in Medtronic’s Paceart Optima System, which is used to compile and manage patients’ cardiac device data," the American Hospital Association (AHA) July 6 reports. According to CISA,…
Endoscope manufacturer Olympus Medical receives third warning from FDA
Editor's Note The FDA on March 15 issued its third warning letter to endoscope manufacturer Olympus Medical, following a manufacturing site inspection and 160 complaints of device failure, as reported by Beckers. The warning letter comes after a Tokyo, Japan facility inspection, where the Single-Use Distal Covers for Duodenoscopes and…
Study: Unsafe medical devices gain FDA approval through loophole
Editor's Note A study done by investigators from Yale, Harvard, and the University of California-San Francisco, published on January 10 in JAMA, found that “many medical devices subject to recall had received Food and Drug Administration (FDA) approval based, in part, on the products’ similarities to earlier devices,” Healthcare Purchasing…
ANSI/AAMI ST98 provides cleaning validation requirements for device manufacturers
Editor's Note The Association for the Advancement of Medical Instrumentation (AAMI) on August 24 announced the publication of a new standard: “ANSI/AAMI ST98:2022, Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices.” The new standard not only provides manufacturers with a formalized…
Legislation to improve medical device cybersecurity introduced, supported by AHA
Editor's Note On Friday, June 24, the American Hospital Association (AHA) voiced support for the Protecting and Transforming Cyber Health Care Act (PATCH Act)—legislation that would “require medical device manufacturers to meet certain cybersecurity requirements when seeking approval for devices that are internet connected or include software” in order to…
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