The concept of applying risk analysis tools such as failure mode, effects, and criticality analysis (FMECA) to the design and development process where human safety is a factor is nothing new to many industries such as nuclear power, aviation, and the automotive industry. Safety and reliability engineers are well versed in the implementation of risk management tools as critical components of ad...

Introduction: The lack of a terminology to compare medical devices together with the arbitrary and opaque nature of product registration systems are major obstacles to a more informed decision process regarding the use and acquisition of new medical devices. This paper describes the systematization of information to help in the identifi cation of similar cardiovascular implantable devices. Meth...

OBJECTIVES This article reports on the progress made in addressing pediatric medical device needs through the establishment of the Pediatric Device Consortia Grant Program. Pediatric practitioners should be aware of both the imperative for well-studied devices for children and the existence of recently created resources to help foster the development of such products. METHODS This article dis...

BACKGROUND Regulators must act to protect the public when evidence indicates safety problems with medical devices. This requires complex tradeoffs among risks and benefits, which conventional safety surveillance methods do not incorporate. OBJECTIVE To combine explicit regulator loss functions with statistical evidence on medical device safety signals to improve decision making. METHODS In ...

Here we set out the European product liability regime as it applies to medical devices and examine key cases that indicate how the legislation is likely to be interpreted. Despite the fact that the strict liability regime has been in existence for many years, numerous issues have yet to be resolved and there continues to be a lack of harmonisation between the EU member states. We highlight a nu...

We are concerned with systems, particularly safety-critical systems, that involve interaction between users and devices, such as the user interface of medical devices. We therefore developed a MISRA C code generator for formal models expressed in the PVSio-web prototyping toolkit. PVSio-web allows developers to rapidly generate realistic interactive prototypes for verifying usability and safety...

Safety case is one of system safety lifecycle products and should be consistent with other lifecycle products like hazard analysis results. In this paper we present a method of safety case integration with hazard tables based on the use of parametrized argument patterns. We describe a hazard table metamodel, a safety argument pattern and a mechanism of pattern instantiation using a linking tabl...

Issue: Understanding the chemical composition of container glass is critical to recycling for a number of reasons. First, the chemistry has significant implications for managing the behavior of molten glass in any remelt application, from large-scale container manufacturing down to cottage-industry pressed glass. Second, the composition has important implications for evaluating health concerns ...