BACKGROUND: Plastic-containing medical devices are commonly used in critical care units and other patient care settings. Patients are often exposed to xenobiotic agents that are leached out from plastic-containing medical devices, including bisphenol...
IMPORTANCE: The primary objective of any newly developed medical device using artificial intelligence (AI) is to ensure its safe and effective use in broader clinical practice.
The procurement of medical equipment is a critical concern for healthcare organizations striving to deliver comprehensive patient care. Thus, the procurement process, including performance evaluation and selection of medical equipment suppliers, pose...
The supply of safe pipeline medical devices is of paramount importance. Opportunities exist to transform reusable medical devices for improved processing that meets diverse patient needs. There is increased interest in multi-actor hub frameworks to m...
BMC medical informatics and decision making
Mar 11, 2025
BACKGROUND: In the future, more medical devices will be based on machine learning (ML) methods. In general, the consideration of risks is a crucial aspect for evaluating medical devices. Accordingly, risks and their associated costs should be taken i...
BMC medical informatics and decision making
Feb 8, 2025
BACKGROUND: In Japan, reporting of medical device malfunctions and related health problems is mandatory, and efforts are being made to standardize terminology through the Adverse Event Terminology Collection of the Japan Federation of Medical Device ...
Health policy (Amsterdam, Netherlands)
Feb 1, 2025
The swift progression of AI within the realm of medical devices has precipitated an imperative for stringent regulatory oversight. The United States, the European Union, and China stand as vanguard entities in the regulatory landscape for AI-enhanced...
This manuscript delineates the pathway from in-house research on Artificial Intelligence (AI) to the development of a medical device, addressing critical phases including conceptualization, development, validation, and regulatory compliance. Key stag...
Technology and health care : official journal of the European Society for Engineering and Medicine
Nov 25, 2024
BackgroundHealthcare institutions throughout the world rely on medical devices to provide their services reliably and effectively. However, medical devices can, and do sometimes fail. These failures pose significant risk to patients.ObjectiveOne way ...
BACKGROUND: The reporting of adverse events (AEs) relating to medical devices is a long-standing area of concern, with suboptimal reporting due to a range of factors including a failure to recognize the association of AEs with medical devices, lack o...
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