OBJECTIVES Issues related to lack of system usability and potential safety hazards continue to be reported in the health information technology (HIT) literature. Usability engineering methods are increasingly used to ensure improved system usability and they are also beginning to be applied more widely for ensuring the safety of HIT applications. These methods are being used in the design and i...

Guiding principles for the proof testing of safety instrumented systems (SIS) in the chemical industry have been developed through research into the practices of proof testing. The proof testing of SIS is an integral component of the management of functional safety. Its purpose is to confirm the continued operation of the required safety instrumented function and to contribute to the maintenanc...

In phase II platform trials, 'many-to-one' comparisons are performed when K experimental treatments are compared with a common control to identify the most promising treatment(s) to be selected for Phase III trials. However, when sample sizes are limited, such as when the disease of interest is rare, only a single Phase II/III trial addressing both treatment selection and confirmatory efficacy ...

Abstract. We report on some of the development issues of a commercial “shrink-wrapped application”—DUST-EXPERTTM—that is of particular interest to the safety and software engineering community. Amongst other things, the following are reported on and discussed: the use of formal methods; advisory systems as safety related systems; safety integrity levels and the general construction of DUST-EXPE...

Virtual reality (VR) is the continuing standard in testing solutions for safety and other needs related to road and traffic planning. This is because of the cost effective nature and the ability to create an effective testing environment without compromising participant safety. This paper describes the components of a real-time VR simulation system, including: a software program for visualizati...

Recent attention has been given to the potential roles that metabolites could play in safety evaluations of new drugs. In 2002, a proposal was published on "metabolites in safety testing" ("MIST"), which suggested some guidelines regarding when it is necessary to provide greater assessment of the safety of metabolites. However, this proposal was based on relative abundance values, i.e., the per...

Safety-critical software must be thoroughly verified before being exploited in commercial applications. In particular, any TCAS (Traffic Alert and Collision Avoidance System) implementation must be verified against safety properties extracted from the anti-collision theory that regulates the controlled airspace. This verification step is currently realized with manual code reviews and testing. ...

This paper uses a set of “natural experiments,” created by the passage of a U.S. Department of Transportation drug-testing mandate and 13 state testing laws, to examine the effects of testing truckers for illicit substances on highway safety. Since truckers do not bear the full costs of their driving and employers cannot contract on all aspects of their behavior, drug testing may be one means f...

We analyze safety problems of complex systems using the methods of mathematical statistics for testing the output variables of a code simulating the operation of the system under consideration when the input variables are uncertain. We have defined a black box model of the code and derived formulas to calculate the number of runs needed for a given confidence level to achieve a preassigned meas...

This white paper lays out some foundational information about different approaches to safety: how various industries differ in their approaches to safety engineering, and a comparison of three general approaches to safety (system safety, industrial safety engineering, and reliability engineering). An attempt is made to lay out the properties of industries and systems that make one approach more...