A critical component to the success of software systems is the incorporation of the end user. Ensuring that the end user can use the system effectively and efficiently is an important consideration. Failure to do this can lead to user error which in turn can have serious or even fatal consequences. To address this issue in the medical domain, where the risk to patient and user safety is quite h...

In this study, we show how medical devices used for patient care can be made safer if various cognitive factors involved in patient management are taken into consideration during the design phase. The objective of this paper is to describe a methodology for obtaining insights into patient safety features--derived from investigations of institutional decision making--that could be incorporated i...

Nanotechnology is widely used in many aspects of the design and manufacture of medical devices. To date, many of these new medical devices, referred to as nano medical devices, have been submitted to health authorities for premarket regulatory review. There are ongoing discussions between medical device manufacturers and regulatory authorities regarding the standards and methods required for th...

& Drug Administration (KFDA) in 2009 and the Ministry of Knowledge Economy (MKE) and Korea Industrial Technology Foundation (KOTEF) through the Human Resource Training Project for Strategic Technology and the Seoul R&BD Program, Republic of Korea (10526) and the Brain Korea21 Project for Medicine Science Yonsei University, Republic of Korea. JuHyun Kim is with the Brain Korea 21 Project for Med...

Patients are increasingly reliant on implantable medical device systems today. For patients with diabetes, an implantable insulin pump system can greatly improve their quality of life. As with any device, these devices can and do suffer from software and hardware issues, often reported as a safety event. For a forensic investigator, a safety event is indistinguishable from a potential security ...

Testing and restoring technical-functional safety is an essential part of medical device reprocessing. Technical functional tests have to be carried out on the medical device in the course of the validation of reprocessing procedures. These ensure (in addition to the hygiene tests) that the reprocessing procedure is suitable for the medical device. Functional tests are, however, also a part of ...

Between 1990 and 2000, over 600,000 implantable cardiac pacemakers and cardioverter defibrillators were recalled. 41% of these devices were recalled due to device software issues. Software-related recalls are increasing with the growing complexity of medical device software, which is responsible for the life-critical operation with the organ. Currently, there are no formal methods to test and v...

In July 2011, the United States Food and Drug Administration issued draft guidance concerning the regulation of mobile medical applications (applications on a wireless device that are used as accessories to medical devices or to convert a mobile platform to a medical device). While the suggestion of regulation is rooted in patient safety, concerns about limits on innovation and discovery as wel...

The benefits of effective verification and validation activities in the medical device domain include increased usability and reliability, decreased failure rate and recalls and reduced risks to patients and users. Though there is guidance on verification and validation in multiple standards in the medical device domain, these are difficult for the manufacturer to implement, as there is no cons...

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