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Safety 3: Radiation Oncology Safety Stakeholders


B Fraass

J Schewe
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C Negrut





B Fraass1*, J Schewe2*, C Negrut3*, (1) Cedars-Sinai Medical Center, Los Angeles, CA, (2) Philips, Fitchburg, WI, (3) Accuray, Sunnyvale, CA

SU-D-Salon AB-1 Sunday 4:00:00 PM - 6:00:00 PM Room: Salon AB

In recent years there has been an increased interest in patient safety in Radiation Oncology, in part due to highly-publicized errors such as those described in the New York Times. Clinical practitioners, professional organizations, manufacturers, and regulatory agencies have each responded to safety concerns in their own way, generating white papers, task group reports, new product safety features, regulatory changes, and an increased emphasis on training and credentialing. There has also been an increased interest in the use of techniques related to Risk Management, Human Factors, and Usability Engineering, both in industry and in the clinic. In particular, the TG-100 report recommends the use of Risk Management tools to identify and mitigate safety issues in clinical practice.

In addition to each group working independently, there has also been an increased interest in stakeholders from all areas working together in a coordinated way. The Radiation Oncology Safety Stakeholders Initiative (ROSSI) was created in 2010 by members of AAPM, ASTRO, and the RT Industry, with a mission “to recommend and facilitate safety improvements in radiotherapy through a common, independent and impartial vision broadly based on diversity of experience and knowledge among radiation oncology professionals."

The first speaker in this session will provide a summary of the history, goals, structure, progress to date, and future directions of the ROSSI collaboration. The second speaker will describe the role of Safety Risk Management in the development and support of medical devices, including a discussion of the similarities and differences in its use in industrial and clinical settings. The final speaker will give an overview of Usability and Human Factors issues in medical software, along with a review of recommendations from the ROSSI working groups on Usability and Error Messages.

Learning Objectives:
1. Understand the structure and mission of the Radiation Oncology Safety Stakeholders’ Initiative (ROSSI).

2. Learn about how the clinical community and vendors are collaborating to help improve the usability, quality, and safety of medical devices and clinical practice.

3. Understand the basics of Safety Risk Management, its relationship to the product lifecycle, and the similarities and differences in how it applies to products and clinical practice.

4. Understand the basics of Usability and its relationship to the safety of medical devices, including problems and recommended improvements with the content and frequency of software error messages.


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