FDA and AAMI Announce S3 Challenge 2014


The Association for the Advancement of Medical Instrumentation (AAMI) and the Food and Drug Administration (FDA) announce plans for S3 Challenge 2014, a dynamic new conference set for March 2014 that will focus on how to improve the safety of healthcare technology and reduce the time it takes to bring new medical devices to market. The keywords for the S3 Challenge 2014 are standards, synthesis and solutions.

We are excited that this approach will allow us to address constructively those issues that complicate the path to standards compliance, and therefore patient safety, says Carol Herman, AAMI senior vice president of standards policy and programs.

The inaugural conference will focus on three broad issues that affect most medical devices: biocompatibility, sterility and risk management. In addition, participants will explore how the combination of these three factors can apply to a specific class of device.

The conference will bring together industry compliance, design, engineering, and quality systems professionals to work side by side with FDA staff to analyze contributing factors for each issue. Participants will then recommend actions and solutions that address each. AAMI and the FDA plan to release a report on the conference that details the work and recommendations for eachissue.

This is a unique opportunity to positively impact standards and also provide direct feedback to the FDA on specific compliance issues, Herman adds. Both industry and government want standards that are clearly understood and workable, and S3 is a process that should be used to achieve that.

S3 Challenge 2014 is scheduled for March 11-12, 2014 at the Hyatt Dulles in Herndon VA. For more information, visit: www.aami.org/s3.

Source: Association for the Advancement of Medical Instrumentation (AAMI)

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