The current article examines the modern practices of reducing errors in medical laboratories. The paper sought to examine the methods that different countries are applying to reduce errors in medical laboratories. In addition, the paper examines the relationship between inadequate training of laboratory personnel and error causation in medical laboratories. A total of 17 research articles have ...

In order to effectively analyze and control use-related risk of medical devices, quantitative methodologies must be applied. Failure Mode and Effects Analysis (FMEA) is a proactive technique for error detection and risk reduction. In this article, an improved FMEA based on Fuzzy Mathematics and Grey Relational Theory is developed to better carry out user-related risk analysis for medical device...

Open-source hardware is hardware whose design is made publicly available so anyone can study, modify, distribute, make and sell the design or the hardware based on that design. Some open-source hardware projects can potentially be used as active medical devices. The open-source approach offers a unique combination of advantages, including reducing costs and faster innovation. This article compa...

About the Authors David Arney is a systems engineer with the Medical Device Plug-and-Play (MD PnP) Interoperability Program. Interoperability Program. Abhilasha Bhargav-Spantzel, Ph.D. CISSP, is a security architect at the Healthcare Solutions group at Intel, SC.

We describe here recent modifications to the French Coverage with Evidence Development (CED) scheme for innovative medical devices. CED can be defined as temporary coverage for a novel health product during collection of the additional evidence required to determine whether definitive coverage is possible. The principle refinements to the scheme include a more precise definition of what may be ...

Inadequate subject enrollment represents a significant obstacle during a medical device clinical investigation. It can lead to costly delays and jeopardise the success of an entire device development project. This article discusses the importance of devising an effective subject recruitment strategy so that clinical and regulatory requirements can be met.