AIMC Topic: Equipment and Supplies

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A Machine Learning-Based Clustering Analysis to Explore Bisphenol A and Phthalate Exposure from Medical Devices in Infants with Congenital Heart Defects.

Environmental health perspectives
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...

Generalizability of FDA-Approved AI-Enabled Medical Devices for Clinical Use.

JAMA network open
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.

A decision-making framework for evaluating medical equipment suppliers under uncertainty.

Scientific reports
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...

Embracing a Penta helix hub framework for co-creating sustaining and potentially disruptive sterilization innovation that enables artificial intelligence and sustainability: A scoping review.

The Science of the total environment
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...

Risk-based evaluation of machine learning-based classification methods used for medical devices.

BMC medical informatics and decision making
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...

Exploration of the optimal deep learning model for english-Japanese machine translation of medical device adverse event terminology.

BMC medical informatics and decision making
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 ...

Regulatory approaches towards AI Medical Devices: A comparative study of the United States, the European Union and China.

Health policy (Amsterdam, Netherlands)
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...

The translation of in-house imaging AI research into a medical device ensuring ethical and regulatory integrity.

European journal of radiology
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...

Advancement of post-market surveillance of medical devices leveraging artificial intelligence: Patient monitors case study.

Technology and health care : official journal of the European Society for Engineering and Medicine
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 ...

AI as a Medical Device Adverse Event Reporting in Regulatory Databases: Protocol for a Systematic Review.

JMIR research protocols
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...