Healthcare Technology: A Strategic Approach to Medical Device Management

The constant evolution of medical technology has increased the demand for managing medical devices to ensure safety and effectiveness. In this paper I will investigate how biomedical engineering has addressed the issue of equipment management and identifies strategies to successfully maintain an inventory of medical devices. Through research, on-the-job experience, and in-depth discussions with various biomedical engineering managers, I have been able to document possible equipment strategies and best practices for managing medical devices. There is really no one size fits all to medical equipment management due to the various clinical environments, but there are many aspects that remain necessary to ensure proper equipment safety and function while meeting or exceeding various regulatory requirements

Privacy Concerns Related to Data Sharing for European Diabetes Devices

Background: Individuals with diabetes rely on medical equipment (eg, continuous glucose monitoring (CGM), hybrid closed-loop systems) and mobile applications to manage their condition, providing valuable data to health care providers. Data sharing from this equipment is regulated via Terms of Service (ToS) and Privacy Policy documents. The introduction of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) in the European Union has established updated rules for medical devices, including software. Objective: This study examines how data sharing is regulated by the ToS and Privacy Policy documents of approved diabetes medical equipment and associated software. It focuses on the equipment approved by the Norwegian Regional Health Authorities. Methods: A document analysis was conducted on the ToS and Privacy Policy documents of diabetes medical equipment and software applications approved in Norway. Results: The analysis identified 11 medical equipment and 12 software applications used for diabetes data transfer and analysis in Norway. Only 3 medical equipment (OmniPod Dash, Accu-Chek Insight, and Accu-Chek Solo) were registered in the European Database on Medical Devices (EUDAMED) database, whereas none of their respective software applications were registered. Compliance with General Data Protection Regulation (GDPR) security requirements varied, with some software relying on adequacy decisions (8/12), whereas others did not (4/12). Conclusions: The study highlights the dominance of non-European Economic Area (EEA) companies in medical device technology development. It also identifies the lack of registration for medical equipment and software in the EUDAMED database, which is currently not mandatory. These findings underscore the need for further attention to ensure regulatory compliance and improve data-sharing practices in the context of diabetes management

Healthy aims: developing new medical implants and diagnostic equipment

Healthy Aims is a €23-million, four-year project, funded under the EU’s Information Society Technology Sixth Framework program to develop intelligent medical implants and diagnostic systems (www.healthyaims.org). The project has 25 partners from 10 countries, including commercial, clinical, and research groups. This consortium represents a combination of disciplines to design and fabricate new medical devices and components as well as to test them in laboratories and subsequent clinical trials. The project focuses on medical implants for nerve stimulation and diagnostic equipment based on straingauge technology

Research exercise: Pathway Toward the End-of-life Options for Medical Devices and Equipment

At the end of life, medical equipment can follow three major paths. The first being destruction, medical equipment which cannot be sterilized and is contaminated, then are incinerated; an example of this would be surgical waste that is soaked in bodily fluids and cannot possible be re-used. Some equipment contains toxic elements such as mercury and are dealt with according to the proper regulations and standards. The second path is recycling option. For example, in the case of MRI machines and many medical devices, more than 90% by weight can be recycled for material content. The final major path medical devices take is refurbishment. Medical devices on this path are generally collected by the manufacturers, fixed, updated, supplied with a new warranty and resold to the secondary market at a large percent of the original sticker price.This research examines the current practices of incineration, landfill, reuse, and refurbishment for medical devices and how the the industry can best reduce the environmental impact of these practices, reduce costs for hospitals and consumers, and improve the humanitarian efforts which are already underway. In addition, this research will discuss the philanthropy efforts surrounding reusable medical equipment and government involvement and incentives to recycling, reuse, and donate medical devices. A trend of refurbishment rather than buying new could be emerging from hospitals due to the Affordable Care Act which often case exempts refurbishers from a new medical device tax that was implemented under the law.https://ecommons.udayton.edu/stander_posters/1576/thumbnail.jp

Quantitative Assessment of Effectiveness and Utilization of Medical Equipment

The problem of operational efficiency assessment of medical equipment is becoming crucial, due to its increasing requirement in hospitals. It has been observed that a significant amount of medical equipment is out of service for several reasons such as lack of training, maintenance and health technology management. The unexpected failures, downtime associated with breakdown and make ready, loss of production and poor maintenance costs of medical equipment are the major drawback in any hospital. Quality of diagnostic and treatment care provided to patients largely depends on the reliability, availability and maintainability of sophisticated medical equipment. Aim of the present study is to determine quantitatively overall effectiveness and utilization of some medical equipment. Overall Equipment Effectiveness (OEE) and utilization coefficient is the metric measurement of Total Productive Maintenance (TPM) which specifies effective functioning of devices.  The results of the effectiveness of the devices are found to be below the standard of 85%. The cause of low effectiveness value was due to poor performance and availability. Equipment utilization is also needed for the evaluation of medical equipment necessity, appropriateness and efficiency of the use in diagnosis and treating a patient. The proposed methodology may be able to increase the amount of working medical equipment by implementing preventive maintenance schedule. The methodology is also validated by failure probability and reliability of the machines

An optimal approach for the joint problem of level of repair analysis and spare parts stocking

We propose a method that can be used when deciding on how to maintain capital goods, given a product design and the layout of a repair network. Capital goods are physical systems that are used to produce products or services. They are expensive and technically complex and have high downtime costs. Examples are manufacturing equipment, defense systems, and medical devices

Smart RFID application in health care: Using RFID technology for smart inventory and logistic systems in hospitals

In today\u27s hospital environments, many medical devices and tools are used. While some of these will be stationary due to size and bulk, many devices can also be moved from room to room. To facilitate an efficiently running hospital environment and protect expensive devices from being lost, it is important to keep track of the whereabouts of every medical device or utensil. We propose an RFID based system with a smartphone application based frontend for tracking the locations of medical devices and utensils in a hospital environment, both enabling medical professionals to quickly locate required devices as well as allowing hospital administration to keep track of when and where devices leave hospital premises, optionally alerting security after a configurable grace period. In addition to this, our proposed application allows doctors and other medical personnal to reserve equipment and rooms such as examination or operating rooms and to easily find which rooms or pieces of equipment are available at a given time. This reduces administrative overhead and allows a smoother operation of the hospital, where efficiency is needed not only for the sake of profits but also to ensure the continued well-being of patients

Wide-Range Optical CMOS-Based Diagnostics

Colorimetric, chemiluminescence and refractive index based diagnostics are some of the most important sensing techniques in biomedical science and clinical medicine. Conventionally laboratories and medical clinics rely on bulky and dedicated equipment for each diagnostic technique independently. In this paper, we present CMOS sensor based solutions, comprising a single photon avalanche detector array and photodiode array. The CMOS platform offers low cost integration and wide range of light-based diagnostic techniques, leading to development of point-of-care devices

A case study of technology transfer: Rehabilitative engineering at Rancho Los Amigos Hospital

The transfer of NASA technolgy to rehabilitative applications of artificial limbs is studied. Human factors engineering activities range from orthotic manipulators to tiny dc motors and transducers to detect and transmit voluntary control signals. It is found that bicarbon implant devices are suitable for medical equipment and artificial limbs because of their biological compatibility with human body fluids and tissues

Review of "Handbook of Human Factors in Medical Device Design", edited by Matthew B. Weinger, Michael E. Wiklund and Daryle J. Gardner-Bonneau, Assistant Editor Loir M. Kelly

Human factors is the study of the relationship between people and devices or systems. The goal of considering human factors in the design of medical devices is to create devices that take into consideration the way people use technology and process information to create a man-machine interface that leads to the best possible performance. This text describes the significant aspects of human factors issues related to medical device design. It is well written and is useful for medical device designers and for others who use or evaluate medical equipment