approval and the role of a catheter in health care services
Order ID 53563633773 Type Essay Writer Level Masters Style APA Sources/References 4 Perfect Number of Pages to Order 5-10 Pages Description/Paper Instructions
The research will be focused on the approval and the role of a catheter in health care services. A catheter is normally a thin tube that is made from a variety of medical grade materials and is used in different surgical procedures but alongside other medical devices. Among the functions include but not limited to correcting abnormal heart rhythms.
The research will focus on catheters used in surgical procedure with a recently approved complete catheter medical device set. The specific medical device product is The Arctic Front Advance and Arctic Front Advance Pro and The Freezor Max Cardiac Cryoablation Catheters – P100010/S098. The catheter was officially approved by the Food and Drug Authority (FDA) on 23rd June 2020. There are certain unique features of the device in both the available customizations and functions. The medical equipment is used as a whole set which comprises of various devices but used together as a complete catheter. Each of the devices has a distinct function but is used in a single procedure and all the devices in the set are interdependentThe medical device set was developed to treat the atrial fibrillation (AF) set where the patient experiences abnormal heart rhythms characterized by fast and irregular heartbeats. The Artic Front Advance Pro Cardiac Cryoablation and the Arctic Front Advance catheters are used in inserting balloon tubing through the veins to the heart which is then inflated at the opening of the vein draining blood from the lungs to the heart. The doctor sends cold air to the balloon to freeze the heart tissue thus blocking abnormal electric signals responsible f abnormal heart rhythm. The cold air comes from the CryoConsole which was part of the device set that was approved together with the catheter product. In cases where the two Arctic Front catheters do not reach the targeted part of the body, the Freezor Max Cardiac Cryoablation Catheter is used. This is the reason the three catheters are classified as a single medical device product and was approved as a single product (Food and Drug Authority, 2021).
The medical use of the catheters is when treating patients with persistent AF or paroxysmal AF of less than duration of six months. The procedure is to be used if the medical condition does not respond to medicine. However, the device should not be used in patients with clots or tumors inside the heart, blood thickening disorder or infections in the bloodstreams (Food and Drug Authority, 2021).
In the report, different aspects of the medical device will be explained in detail. First, an overview of the history of catheters and their role in improvement of health care services will be provided. This will provide a foundation to the discussion on why the approval of this specific catheter is necessary. Also, a brief summary of atrial fibrillation (AF) will be provided as a problem that the approved medical device seeks to solve. The expected impact of the new medical device will be explained at length and possible advance events that may be contributed by the use of the device along the safety measures put in place to mitigate such risks. In addition, the safety and quality features of the device will be outlined in the report and an analysis of the relationship between the device and improvement of patient outcome.References
Food and Drug Authority (2021). 2020 Device Approvals. https://www.fda.gov/medical-devices/recently-approved-devices/2020-device-approvals
Food and Drug Authority (2021). The Arctic Front Advance and Arctic Front Advance Pro and The Freezor Max Cardiac Cryoablation Catheters – P100010/. https://www.fda.gov/medical-devices/recently-approved-devices/arctic-front-advancetm-and-arctic-front-advance-protm-and-freezor-maxtm-cardiac-cryoablation
Freeman, J. V., Shrader, P., Pieper, K. S., Allen, L. A., Chan, P. S., Fonarow, G. C., … & Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) I & II Investigators and Patients. (2019). Outcomes and anticoagulation use after catheter ablation for atrial fibrillation. Circulation: Arrhythmia and Electrophysiology, 12(12), e007612.
Kalla, M., Sanders, P., Kalman, J. M., & Lee, G. (2017). Radiofrequency catheter ablation for atrial fibrillation: approaches and outcomes. Heart, Lung and Circulation, 26(9), 941-949.
Liang, J. J., Frankel, D. S., Parikh, V., Lakkireddy, D., Mohanty, S., Burkhardt, J. D., … & Nguyen, D. T. (2019). Safety and outcomes of catheter ablation for atrial fibrillation in adults with congenital heart disease: a multicenter registry study. Heart Rhythm, 16(6), 846-852.1. Analysis of the medical device of your choice (see Topic Proposal). The document should be 10 pages long and address the topics put forward in your proposal. Include images of the device and cite them. Include at least 5 citations.
2. A 5-minute presentation about the security and privacy of your selected medical device. Make a PPT for this.
RUBRIC
QUALITY OF RESPONSE NO RESPONSE POOR / UNSATISFACTORY SATISFACTORY GOOD EXCELLENT Content (worth a maximum of 50% of the total points) Zero points: Student failed to submit the final paper. 20 points out of 50: The essay illustrates poor understanding of the relevant material by failing to address or incorrectly addressing the relevant content; failing to identify or inaccurately explaining/defining key concepts/ideas; ignoring or incorrectly explaining key points/claims and the reasoning behind them; and/or incorrectly or inappropriately using terminology; and elements of the response are lacking. 30 points out of 50: The essay illustrates a rudimentary understanding of the relevant material by mentioning but not full explaining the relevant content; identifying some of the key concepts/ideas though failing to fully or accurately explain many of them; using terminology, though sometimes inaccurately or inappropriately; and/or incorporating some key claims/points but failing to explain the reasoning behind them or doing so inaccurately. Elements of the required response may also be lacking. 40 points out of 50: The essay illustrates solid understanding of the relevant material by correctly addressing most of the relevant content; identifying and explaining most of the key concepts/ideas; using correct terminology; explaining the reasoning behind most of the key points/claims; and/or where necessary or useful, substantiating some points with accurate examples. The answer is complete. 50 points: The essay illustrates exemplary understanding of the relevant material by thoroughly and correctly addressing the relevant content; identifying and explaining all of the key concepts/ideas; using correct terminology explaining the reasoning behind key points/claims and substantiating, as necessary/useful, points with several accurate and illuminating examples. No aspects of the required answer are missing. Use of Sources (worth a maximum of 20% of the total points). Zero points: Student failed to include citations and/or references. Or the student failed to submit a final paper. 5 out 20 points: Sources are seldom cited to support statements and/or format of citations are not recognizable as APA 6th Edition format. There are major errors in the formation of the references and citations. And/or there is a major reliance on highly questionable. The Student fails to provide an adequate synthesis of research collected for the paper. 10 out 20 points: References to scholarly sources are occasionally given; many statements seem unsubstantiated. Frequent errors in APA 6th Edition format, leaving the reader confused about the source of the information. There are significant errors of the formation in the references and citations. And/or there is a significant use of highly questionable sources. 15 out 20 points: Credible Scholarly sources are used effectively support claims and are, for the most part, clear and fairly represented. APA 6th Edition is used with only a few minor errors. There are minor errors in reference and/or citations. And/or there is some use of questionable sources. 20 points: Credible scholarly sources are used to give compelling evidence to support claims and are clearly and fairly represented. APA 6th Edition format is used accurately and consistently. The student uses above the maximum required references in the development of the assignment. Grammar (worth maximum of 20% of total points) Zero points: Student failed to submit the final paper. 5 points out of 20: The paper does not communicate ideas/points clearly due to inappropriate use of terminology and vague language; thoughts and sentences are disjointed or incomprehensible; organization lacking; and/or numerous grammatical, spelling/punctuation errors 10 points out 20: The paper is often unclear and difficult to follow due to some inappropriate terminology and/or vague language; ideas may be fragmented, wandering and/or repetitive; poor organization; and/or some grammatical, spelling, punctuation errors 15 points out of 20: The paper is mostly clear as a result of appropriate use of terminology and minimal vagueness; no tangents and no repetition; fairly good organization; almost perfect grammar, spelling, punctuation, and word usage. 20 points: The paper is clear, concise, and a pleasure to read as a result of appropriate and precise use of terminology; total coherence of thoughts and presentation and logical organization; and the essay is error free. Structure of the Paper (worth 10% of total points) Zero points: Student failed to submit the final paper. 3 points out of 10: Student needs to develop better formatting skills. The paper omits significant structural elements required for and APA 6th edition paper. Formatting of the paper has major flaws. The paper does not conform to APA 6th edition requirements whatsoever. 5 points out of 10: Appearance of final paper demonstrates the student’s limited ability to format the paper. There are significant errors in formatting and/or the total omission of major components of an APA 6th edition paper. They can include the omission of the cover page, abstract, and page numbers. Additionally the page has major formatting issues with spacing or paragraph formation. Font size might not conform to size requirements. The student also significantly writes too large or too short of and paper 7 points out of 10: Research paper presents an above-average use of formatting skills. The paper has slight errors within the paper. This can include small errors or omissions with the cover page, abstract, page number, and headers. There could be also slight formatting issues with the document spacing or the font Additionally the paper might slightly exceed or undershoot the specific number of required written pages for the assignment. 10 points: Student provides a high-caliber, formatted paper. This includes an APA 6th edition cover page, abstract, page number, headers and is double spaced in 12’ Times Roman Font. Additionally, the paper conforms to the specific number of required written pages and neither goes over or under the specified length of the paper. GET THIS PROJECT NOW BY CLICKING ON THIS LINK TO PLACE THE ORDER
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