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Developments in the medical device industry are driven by a rapidly changing healthcare arena in combination with advances in technological fields such as materials science, bio-engineering and electronics. Subsequently, it is now estimated that over 500 000 different types of medical devices are produced globally. This article aims to give a simple explanation of device classification as it relates to vascular access devices. It aims to provide the reader with information to increase their knowledge and understanding of this topic.
This article was published in the following journal.
Name: British journal of nursing (Mark Allen Publishing)
Vascular access devices are widely used in healthcare settings worldwide. The insertion of a vascular access device creates a wound, vulnerable to irritation, injury and infection. Vascular access-ass...
The Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines recommend intra-access flow (Qa) measurement as the preferred vascular access surveillance method over static intra-access pressure ra...
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations governing classification and reclassification of medical devices to conform to the applicable...
Arteriovenous (AV) access dysfunction is a common complication in hemodialysis patients. Markers of vascular calcification are associated with cardiovascular outcomes and mortality in this population,...
Vascular access is a necessary prerequisite for REBOA placement in patients with severe hemorrhagic shock.
The purpose of this study is to compare the safety and effectiveness of the HeRO Vascular Access Device in access challenged (e.g., catheter-dependent) hemodialysis patients. It is hypothe...
In the REaCT-Vascular Access Her2 negative study, we will use a novel method to allow comparisons of established standard of care vascular access strategies using the "integrated consent m...
The study will test a hypothesis that the RIVS system will have a higher rate of successful first PIV placement compared to conventional catheter without a significant increase in complica...
This first-in-human pilot study seeks to evaluate the feasibility and safety of using a percutaneous ultrasound device with needle guide for vascular access. Eligible participants will und...
Ellipsys Vascular Access System Registry will enroll up to 100 patients to evaluate the use and performance of the Ellipsys Vascular Access System when it is used within its intended use i...
Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.
Removal of a MEDICAL DEVICE from the market due to a problem occurring in the manufacture or distribution of the product.
Unauthorized access to personal information to obtain medical care or drugs, or to submit fraudulent billing for services. (from https://oig.hhs.gov/fraud/medical-id-theft/index.asp)
The condition in which individuals are financially unable to access adequate medical care without depriving themselves and their dependents of food, clothing, shelter, and other essentials of living.
Devices to be inserted into veins or arteries for the purpose of carrying fluids into or from a peripheral or central vascular location. They may include component parts such as catheters, ports, reservoirs, and valves. They may be left in place temporarily for therapeutic or diagnostic purposes.
The role of medical devices in healthcare is essential. The diversity and innovativeness of this sector contribute significantly to enhance the quality and efficacy of healthcare. Covering a wide range of products, from simple bandages to the...
Vascular relates to blood vessels (Oxford Medical Dictionary) and can be used to describe the supply of blood, a disease affecting the blood vessels or molecules associated with these structures. For example, <!--LGfEGNT2Lhm-->atherosclerosis ...
Health care (or healthcare) is the diagnosis, treatment, and prevention of disease, illness, injury, and other physical and mental impairments in humans. Health care is delivered by practitioners in medicine, chiropractic, dentistry, nursing, pharmacy, a...