A hybrid Bayesian network for medical device risk assessment and management

ISO 14971 is the primary standard used for medical device risk management. While it specifies the requirements for medical device risk management, it does not specify a particular method for performing risk management. Hence, medical device manufacturers are free to develop or use any appropriate methods for managing the risk of medical devices. The most commonly used methods, such as Fault Tree Analysis (FTA), are unable to provide a reasonable basis for computing risk estimates when there are limited or no historical data available or where there is second-order uncertainty about the data. In this paper, we present a novel method for medical device risk management using hybrid Bayesian networks (BNs) that resolves the limitations of classical methods such as FTA and incorporates relevant factors affecting the risk of medical devices. The proposed BN method is generic but can be instantiated on a system-by-system basis, and we apply it to a Defibrillator device to demonstrate the process involved for medical device risk management during production and post-production. The example is validated against real-world data

Product safety idioms: a method for building causal Bayesian networks for product safety and risk assessment

Idioms are small, reusable Bayesian network (BN) fragments that represent generic types of uncertain reasoning. This paper shows how idioms can be used to build causal BNs for product safety and risk assessment that use a combination of data and knowledge. We show that the specific product safety idioms that we introduce are sufficient to build full BN models to evaluate safety and risk for a wide range of products. The resulting models can be used by safety regulators and product manufacturers even when there are limited (or no) product testing data

Reflections on Past and Present: Addressing Racism from Within (Part 2/Day 1)

In Part Two we focus on “Reflections on Past and Present: Addressing Racism from Within.” While as a profession we have promoted the values of the dignity and worth of all, we have not always lived up to these values and sometimes have been on the wrong side of history in promoting social justice. In our Part Two symposium we will hear form four panels who will address the experiences of women of color in enduring and confronting racism, social work education’s accomplishments as well as missed opportunities in combatting racism in practice and theory, uprooting whiteness through calling out racism and transforming practice through resistance. These four panels touch on contemporary issues that are critical to our understanding of the profession and our role as change agents. This portion of the symposium features: 1. Welcome to the Symposium: Laura S. Abrams, Sandra Crewe, Alan Dettlaff, James Herbert Williams 2. Women of Color: Enduring and Confronting Racism within the Profession: Antonia R.G. Alvarez, Lakindra Mitchell Dove, Roberta Hunte, Jessica Rodriguez- JenKins, Gita R. Mehrotra & Alma M. Ouanesisouk Trinidad; Brittany Ribiero Brown, Tariro Nussinov & UniQue C Starks- Tanksley; Marva L. Lewis, Joan M. Blakey, Rebecca Chaisson & Rae Stevenson 3. Social Work Education: Combatting Racism in Practice and Theory: Adriana Aldana, Susan J. Nakaoka, Larry Ortiz & Nicole Vazquez; Jerome H. Schiele, Joshua Kirven, Sean Joe & Martell L. Teasley; Robert Fisher, Lukas Champagne & C.L. Dominique Court