AAMI Publication to Focus on Risk Management

The rapid influx of increasingly complex and sophisticated technology poses many challenges for healthcare delivery organizations. In this environment, comprehensive risk management is essential for determining whether the benefits of a given product outweigh any potential risks to patients. The critical process of risk management begins during the design of medical devices and continues into postmarket surveillance of product performance.

Recognizing the importance of risk management in healthcare technology, the Association for the Advancement of Medical Instrumentation (AAMI) is dedicating the spring edition of its award-winning Horizons magazine to this multifaceted subject. The concepts and approaches of articles in the issue will include the following:
• Myths and misunderstandings surrounding risk management
• Best practices in applying risk management terminology
• Embracing a new risk management paradigm to identify, analyze, and control risks effectively
• Moving beyond FMEA (failure mode and effects analysis) to more comprehensive risk management approaches
• Assessing risk management compliance as it relates to IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• A case study describing programmatic risk assessment in the context of one health system’s clinical technology program

Thus far, eight organizations have signed on as supporters and will promote the publication to their members and customers to expand the visibility of the articles and issues:
• American College of Clinical Engineering (ACCE)
• College of Healthcare Information Management Executives (CHiME)
• Human Factors and Ergonomics Society (HFES)
• Healthcare Information and Management Systems Society (HIMSS)
• Healthcare Technology Foundation (HTF)
• Integrating the Healthcare Enterprise (IHE)
• Medical Device Innovation, Safety, & Security Consortium (MDISS)
• National Patient Safety Foundation (NPSF)

An estimated 10,000 healthcare technology management professionals, including all AAMI members and those who attend spring biomedical association and industry meetings, will have access to this edition of Horizons. AAMI also will distribute the publication—slated for publication in March—at its 2015 Conference & Expo, June 5-8, 2015 in Denver.

Source: AAMI

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