Recognized by many jurisdictions around the world, the standard ANSI/AAMI/ISO 13485:2016, Medical Devices; Quality management systems; Requirements for regulatory purposes, provides structured guidance to help organizations meet regulatory requirements.

In this episode, international quality and regulatory compliance consultant Eamonn Hoxey describes the major differences between the 2003 and 2016 editions of 13485. As we near the end of a three-year transition period for medical device developers and manufacturers to comply with requirements set forth in the 2016 edition of the standard, Hoxey discusses how the new updated version clarifies expectations for manufacturers, providing a much more global, comprehensive, and harmonized approach to meeting requirements.
Learn more at AAMI.org

What’s the optimal way to perform medical device maintenance? Although implementing an AEM program can save healthcare facilities time and money, the concept has caused confusion for many in the healthcare technology management community. To start, the Centers for Medicare & Medicaid Services defines AEM as “alternate equipment management,” whereas The Joint Commission uses “alternative equipment maintenance.” Through the recent publication, AEM Program Guide: Alternative PM for Patient Safety, author Matthew Baretich seeks to cut through the confusion by offering practical, real-world guidance for implementing a well-crafted AEM program and remaining compliant with applicable standards and regulations.

With cybersecurity attacks on the rise in healthcare and a growing appreciation for the threats posed to patients, patch management is more important than ever—yet it remains a challenge for most hospitals.  Why? “I don’t think there’s any other industry that has such a diversity of different devices from different manufacturers run in an environment where the pieces are so dependent on each other. That makes it difficult to, for example, take one device down, patch it and reboot it without affecting other devices,” said Axel Wirth a distinguished technical architect for Symantec Corporation and a member of the BI&T Editorial Board. A cybersecurity expert, Wirth share his tips for patch management and his “defense in depth” framework that he believes all healthcare facilities should adopt. This podcast is sponsored by Nuvolo.

Produced by the Association for the Advancement of Medical Instrumentation and the studios of Healthcare Tech Talk.