Papers by Keyword: Medical Device

Abstract: As medical technology continues to advance, concerns about associated risks to both patients and healthcare providers arise. Ensuring high-quality healthcare delivery stands as a paramount objective for every healthcare institution. Among the essential attributes required to meet this goal is the safety of all stakeholders. Nevertheless, numerous instances arise wherein unintended incidents occur involving healthcare personnel during the delivery of patient care. This study utilized a mixed-methods approach incorporating interviews, observations, and statistical analysis to investigate the occurrence of adverse events related to medical equipment in hospitals. The findings reveal that, despite 84% of surveyed nursing personnel indicating no experience with adverse events caused by medical equipment, factors such as inadequate preventive maintenance, lack of training, budget constraints, and staff shortages support the need for the development of patient safety support tools, as all the aforementioned factors increase the likelihood of unintentional errors during patient care. Based on these findings, a tailored reporting tool was developed to streamline the documentation of equipment failures and adverse events within hospitals. Designed based on identified needs and characteristics, this tool aims to facilitate timely notification of critical events, especially those with the potential to impact patient safety.

Abstract: In the medical industry the medical device sector is a domain dynamic and growing, that involved important efforts performance for imposing new material to support the development of new products. Manufacturers of medical devices for single use, are constantly looking for new products and new materials to expand their capabilities.

Abstract: The paper presents a development methodology for a new bio-composite medical device used in extensive anatomical reconstructions. Current surgical techniques and devices include auto transplant, surgical meshes or even acellular devices. Due to the high degree of reconstruction and large amount of exposed tissue, the surgeries tend to have high re-intervention rates, leading to severe complications and even death. A functional approach is proposed to develop an improved medical device for the treatment of these severe traumatic lesions. A six step methodology is presented, validating the first three with the development of several concepts. The general need is accurately identified using the APTE instrument and a FAST diagram is constructed for one product existence stage. Nine concepts are generated using the proposed methodology and three were preliminarily kept for development. Further research will be undertaken for manufacturing and testing of the final selected concept.

Abstract: Medical devices become increasingly part of the network, a variety of network reliability, safety and management issues are continuing to emerge in medical healthcare. The networked healthcare environment risk management standard IEC 80001 addresses the current task. Both the definition of roles and responsibilities and procedures of medical IT-network risk management of IEC 80001 are furthered analyzed.

Abstract: This paper deals with implementation of wireless communication into a biomedical system including presentation of acquired experience. The aim of the paper is usage of universal wireless system for advanced biomedical applications. There are many biomedical applications with prospect of implementation of wireless communication. IEEE 802.11 wireless module WISMC01 by Laird is one of commercially available wireless solutions. Module provides various communication interfaces and inputs - RS232, analog to digital converters and digital GPIO pins among others. Module supports proprietal scripting language for user defined scripts. Various aspects of hardware and software development and wireless security are discussed in this paper.

Abstract: This paper describes design, methods and practical realization of advanced power supply with battery management in a portable medical device for diagnostic of the patient. The device can measure biosignal from the patient and it can save data in removable storage. Methods for selection of DC / DC converters and methods for increase in patient safety are described as well. The paper also proposes a complex application of battery management circuit and methods for reduction of electromagnetic interference. The device was tested in several charging cycles and the standard operation time was approached.

Abstract: Nitinol (NiTi) is a biocompatible nickel titanium alloy widely used in medical applications and devices. In anterior cruciate ligament (ACL) reconstruction surgery of the knee, fine wires of NiTi are used because of its high elasticity and good memory shape behavior. In surgical procedures these wires are exposed to mechanical stress and high deformations. This paper presents the results of the tests performed on fine NiTi wires of 1.1 mm and 0.73 mm in diameter, exposed to tensile load, which frequently appears in orthopedic surgery. The tests were done at a temperature of 37o C, in order to observe the influence of tensile stress on the mechanical properties of NiTi. The obtained material properties are in good correlation with data from manufacturers. These results are useful in durability evaluation of fine NiTi wires utilized in surgical procedures.