MedSun
Patton-Fuller Community Hospital

The need for reporting on adverse events related to medical device usage has never before been more salient. Medical technology has certainly been responsible for improving the quality of care, the quality of life, as well as health outcomes. However, at the same time, medical devices are being developed and released at a much faster rate than ever before. To monitor the progress and the safety of these devices, it requires a centralized monitoring system to evaluate outcomes; especially the adverse outcomes. This can allow the monitoring of devices that have issues associated with them in an efficient and effective manner and would give regulators a better opportunity to stop the usage of devices with questionable track records.

The Medical Product Safety Network (MedSun) is an adverse event reporting program launched in 2002 by the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH); the primary…...

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Works Cited

Engleman, D., Rish, S., Powell, T., & Flack, M. (2008). Medical Product Safety Network (MedSun) Collaborates with Medical Product Users to Create Specialty Subnetworks . Agency for Healthcare Research and Quality, Volume I.

FDA. (N.d.). MedSun: Medical Product Safety Network. Retrieved from U.S. Food and Drug Administration:  http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/default.htm 

FDA. (N.d.). MedSun: Subnetworks. Retrieved from U.S. Food and Drug Administration:  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/subnetworks.cfm 

MedSun. (2014, September). Highlighted Reports. Retrieved from MedSun: Newsletter #99, September 2014:  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=99#5

equirements and Design - This focuses on the areas of intricacies of turning functional specifications into technical specifications, and also creating a series of approaches to giving users a chance to see the development of applications and most importantly, giving them the chance to review evolving system functionality.

Approval and Gate Process - This is the critical step where ownership by users is tested, as the evolving functionality and direction of medical devices and hospital procedures is evaluated. The approval of specifications and concepts happens in this step.

Development - the phase where medical devices designers complete their initial models and plans. Built into this step are several review cycles to ensure the medical devices direction is aligning with the users' needs.

Launch - the formal introduction of the medical device or hospital procedures and the support of these development effort by users including those who championed their development during the development phase.

Future…...

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References

Matthew Anderson. "Just what the doctor ordered. " Canadian Healthcare Manager 1 Dec. 2004: 43,45. ABI/INFORM Trade & Industry. ProQuest. 12 Nov. 2008

Brynjolfsson, Erik, Renshaw, Amy Austin, Van Alstyne, Marshall. "The Matrix of Change." Sloan Management Review 38.2 (1997): 37-54. ABI/INFORM Global. ProQuest. 11 Nov. 2008

Maria do Carmo Caccia-Bava, Valerie CK Guimaraes, Tor Guimaraes. "Empirically testing determinants of hospital BPR success. " International Journal of Health Care Quality Assurance 18.6/7 (2005): 552-563. ABI/INFORM Global. ProQuest. 14 Nov. 2008

Patricia Hunt Dirlam. "Taking Charge of change. " Management Review 88.8 (1999): 61. ABI/INFORM Global. ProQuest 12 Nov. 2008

Selecting the best country to locate off-shore manufacturing operations can be a difficult decision owing to the complexities involved in global supply chain operations. The various available options must be carefully evaluated if the desired outcomes are to be successfully achieved. With manufacturing costs in New Zealand on the rise, Kiwi must select a country that offers more competitive costs combined with an acceptable level of risk. Of the four most preferable countries (China, Indonesia, Mexico, and Slovakia), Mexico offers the best location. An important priority for the company as far as reducing its supply chain costs is concerned with locating its manufacturing operations in proximity to its major markets. While headquartered in New Zealand and with strong presence in Asia and Europe, Kiwi's major markets are in North America, which comprises 46% of its overall sales (Fawcett, 2014). Being in North America, Mexico is better compared to the other…...

Medical Devices The Bleeding Edge is a Netflix film that examines the $400 billion medical device industry, which produces and markets highly complex apparatuses that are implanted into human bodies (Dick, 2018). The documentary was carried out on the premise that more than 70 million Americans have been outfitted with internal medical devices. While there are numerous medical devices that help uplift and save people’s lives such as corneal transplants and hip replacements, the film mostly focuses on some medical devices that have harmed people. Through this expose, the Netflix film provides shocking revelations regarding medical devices that are implanted in people’s bodies in attempts to enhance their health and wellbeing.
One of the medical devices discussed in this film is hip replacement, which has traditionally been a terrific medical device. This medical device is implanted in an individual’s body to help restore mobility and relieve pain brought by hip diseases or…...

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References

Dick, K. (Director). (2018). The Bleeding Edge [Motion picture]. USA: Netflix.

Gleiberman, O. (2018, July 27). Film Review: ‘The Bleeding Edge.’ Retrieved February 11, 2019, from https://variety.com/2018/film/reviews/the-bleeding-edge-review-kirby-dick-1202887859/

Van Norman, G.A. (2016, June). Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices. JACC: Basic to Translational Science, 1(4), 277-287.

An advance in terms of speech synthesis aimed at patients with Cerebral Palsy and similar diseases has been developed by the University of Virginia. While in the past speech synthesis devices for the disabled have been somewhat erratic in operation and produced a harsh "metallic' voice, the research at the University of Virginia has improved on these. The new envisaged device is specifically designed "... To electronically reproduce sounds of the human voice and allow speech-impaired people to speak with fluidity and inflection" (Thomasson L.).
This device operates in relation to an individual's range of movement. These movements are 'tracked' on a computer by a programmer or a trained therapist and "...Once the movement, such as swinging the arm or wiggling the foot, is recorded, it is overlaid onto a sound grid. The vowel and consonant sounds are produced as the user moves a tracking device through the grid" (Thomasson…...

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References

Jones P.E. Computer-Assisted Remote Control for the User with Motor

Impairment. Retrieved June 4, 2007, at http://people.csse.uwa.edu.au/peterj/personal/PDFs/HCI97-paper.pdf.

Communication. Retrieved June 7, 2007, at http://www.computers-technology-cerebralpalsy.com/cerebral-palsy-communication.html

Thomasson L. Speech Device Could Assist Palsy Victims. Retrieved June 7, 2007 at  http://www.cs.virginia.edu/csnews/show.php?artID=217

egulation of Devices
There are 3 classes of medical devices. A Class I medical device is typically designed to perform simple operations and have almost zero or no risk involved in their application. These devices are required to meet regular FDA guidelines: that is, they must be registered, branded and labeled accordingly, made properly and the FDA has to be told of the devices' existence before it is sent to market. Three examples of this type of device are: elastic bandages, tongue depressors, and examination gloves.

A Class II medical device is a little more complex than a Class I device, and its application does include some risk -- but the risk is low. Like Class I, these devices also have to conform to regular FDA policy, including labeling guidelines; but they must also be monitored in order to make sure they meet specific standards when being utilized. This includes conducting after-market…...

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References

FDA Device Advice. (2015). FDA. Retrieved from  http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ 

Jefferys, D. (2001). The regulation of medical devices and the role of the Medical

Devices Agency. Br J Clin Pharamacol, 52(3): 229-235.

Litron. (2015). Classification of Medical Devices. Retrieved from  http://www.litron.com/wp/classification-of-medical-devices/

Porters Australia
Porters Five Forces Analysis of Medical Devices in Australia

Threat of New Competition -- Medium

The threat of new competition in the medical devices industry is believed to be at a medium level. This is primarily due to the fact that this industry is heavily regulated and must comply with legislation such as the Therapeutic Goods Act of 1989 (Department of Health and Ageing, 2011). The regulatory environment acts as a deterrent for many potential competitors. However, given the profitability potential in the industry, there is still a significant threat from new competitors as many firms will tackle the regulations.

Threat of Substitute Products -- High

It was identified that there is a significant threat to most medical devices in the Australian market. Australia is an advanced economy with a great deal of innovation that floods the market with quality products. Although not all medical devices can be substituted with competing products, most…...

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Works Cited

AusMedtech, 2011. Australian Medical Technology. [Online]

Available at:  http://www.ausbiotech.org/content.asp?pageid=109 

[Accessed 20 February 2012].

Consumers Health Forum of Australia, 2007. Information Paper. [Online]

The Use of Biomedical Devices to Improve Patient Outcomes Abstract
There have been tremendous advancements that have been made in the field of biomedical devices. All the advancements have been aimed at improving patient outcomes and preventing infections especially in orthopedic surgeries. Biomedical devices have offered an opportunity to doctors and researchers to improve upon their products with an aim of improving the patient’s quality of life. Infection reduction and readmission rates have also been reduced. Biomechanics in surgery keep improving every day, such as better products that help better ERAS for patients. Doctors and researchers keep improving their products to make risk factors minimal and to create better and longer lasting products for patients of the present and future generations.
Introduction
There have been tremendous advances in biomedical devices and they keep improving with each passing day. These advances are aimed at improving patient outcomes and making more efficient products than in the…...

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References

Auyong, David B, et al. \\"Reduced Length of Hospitalization in Primary Total Knee Arthroplasty Patients Using an Updated Enhanced Recovery after Orthopedic Surgery (Eras) Pathway.\\" The Journal of arthroplasty 30.10 (2015): 1705-09. Print.

Campoccia, Davide, Lucio Montanaro, and Carla Renata Arciola. \\"The Significance of Infection Related to Orthopedic Devices and Issues of Antibiotic Resistance.\\" Biomaterials 27.11 (2006): 2331-39. Print.

Christenson, Elizabeth M, et al. \\"Nanobiomaterial Applications in Orthopedics.\\" Journal of Orthopaedic Research 25.1 (2007): 11-22. Print.

Goodman, Stuart B, et al. \\"The Future of Biologic Coatings for Orthopaedic Implants.\\" Biomaterials 34.13 (2013): 3174-83. Print.

Hamed, Abbi, et al. \\"Advances in Haptics, Tactile Sensing, and Manipulation for Robot-Assisted Minimally Invasive Surgery, Noninvasive Surgery, and Diagnosis.\\" Journal of Robotics 2012 (2012). Print.

Hannan, Mahammad A, et al. \\"Energy Harvesting for the Implantable Biomedical Devices: Issues and Challenges.\\" Biomedical engineering online 13.1 (2014): 79. Print.

Hebl, James R, et al. \\"A Pre-Emptive Multimodal Pathway Featuring Peripheral Nerve Block Improves Perioperative Outcomes after Major Orthopedic Surgery.\\" Regional anesthesia and pain medicine 33.6 (2008): 510-17. Print.

Holzapfel, Boris Michael, et al. \\"How Smart Do Biomaterials Need to Be? A Translational Science and Clinical Point of View.\\" Advanced drug delivery reviews 65.4 (2013): 581-603. Print.

Background
In June, 2014, the world's #2 maker of medical devices, Medtronic, agreed to buy Covidien, a smaller company in the same industry.  The deal was valued at $42.9 billion, and it was a cash and stock deal.  The deal was done at a 29% premium over Covidien's June 13, 2014 closing price. The deal was described by Medtronic's CEO as a "strategic and operational alignment" and there were immediate benefits to be accrued by moving the company out of the country, to Covidien's headquarters in Dublin (Cortez & Welch, 2014).  The company disputes the tax argument, noting that it did not believe its 18% tax rate would change much with the move (Kelly & Roumeliotis, 2014).  Mostly, the value of the deal was the expected $850 million in annual savings that was expected to accrue from synergies in back office operations, supply chain, distribution and manufacturing (Cortez & Welch, 2014).

Medtronic…...

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References

Cha, M., Copp, J. & Pellumbi, G. (2014).  Value creation in medical device M&A. McKinsey & Company. Retrieved April 26, 2015 from

Cortez, M. & Welch. D. (2014). Medtronic to buy device maker Covidien for $42.9 billion .  Bloomberg. Retrieved April 26, 2015 from http://www.bloomberg.com/news/articles/2014-06-16/medtronic-to-buy-device-maker-covidien-for-42-9-billion

Covidien 2013 Annual Report.  

Coyle, D. (2014).  Medtronic becomes Ireland's biggest business.  The Irish Times. Retrieved April 26, 2015 from http://www.irishtimes.com/business/health-pharma/medtronic-becomes-ireland-s-largest-business-1.2081212

Kelly, S. & Roumeliotis, G. (2014).  Medtronic to buy Covidien for $42.9 billion, rebase in Ireland.  Reuters. Retrieved April 26, 2015 from http://www.reuters.com/article/2014/06/16/us-covidien-medtronic-inc-idUSKBN0ER03420140616

MDDI (2014). Top 40 medical device companies.  Medical Device and Diagnostic Industries. Retrieved April 26, 2015 from http://www.mddionline.com/article/top-40-medical-device-companies

Medtronic 2013 Annual Report.

Rocha, E. & Ho,S. (2014). Investors cheer Burger King- Tim Horton's combo deal. Reuters. Retrieved April 26, 2015 from http://www.reuters.com/article/2014/08/25/us-burger-kg-wld-tim-hortons-mergers-idUSKBN0GP00R20140825http://www.mckinsey.com/~/media/McKinsey/dotcom/client_service/Pharma%20and%20Medical%20Products/PMP%20NEW/PDFs/Value_creation_in_medical_device_M_and_A.ashx

Essay Topic Examples 1. The Evolution and Impact of Class I Medical Devices on Healthcare
This essay will explore the simplest class of medical devices, Class I, which includes devices with the lowest risk to patients and users. The paper will trace the history of Class I devices, their regulatory requirements, and their role in modern healthcare. Case studies of ubiquitous Class I devices, such as stethoscopes and bandages, will be examined to illustrate their importance in preventative care, diagnosis, and patient management.

2. Navigating the Complexities of Class II Medical Devices: Regulation and Innovation
This essay topic will delve into Class II medical devices, which require stricter regulatory controls due to their higher risk relative to Class I devices. The paper will discuss the balance between innovation and safety, the premarket notification process (510(k)), and post-market surveillance. It will also highlight how Class II devices such as infusion pumps and surgical gloves have…...

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Primary Sources

International Medical Device Regulators Forum. \"IMDRF Medical Devices and IVD Medical Devices Classification.\" IMDRF, 2019,   Accessed 2 April 2023.

U.S. Food and Drug Administration. \"Product Classification.\" FDA,  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm . Accessed 2 April 2023.

European Commission. \"Classification rules for medical devices.\" Official Journal of the European Union, Annex VIII, Regulation (EU) 2017/745, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745. Accessed 2 April 2023.

World Health Organization. \"Medical device regulations: global overview and guiding principles.\" WHO,  http://www.who.int/medical_devices/publications/en/MD_Regulations.pdf . Accessed 2 April 2023.

Medicines and Healthcare products Regulatory Agency. \"Guidance on the classification of medical devices.\" GOV.UK, https://www.gov.uk/government/publications/medical-devices-guidance-on-classification. Accessed 2 April 2023.

http://www.imdrf.org/documents/documents.asp .

Admission EssayI am writing to express my interest in the program and how it fits my professional goals. I currently work in the field of cyber security and have been keeping abreast of the latest tools and concepts that can assist in the praxis, such as MyCyber, DVE, FortiRecon, and XDR Ingest. I am particularly interested in exploring the field of cybersecurity in medical devices, as I believe this is an area that has the potential to make a significant impact on the healthcare industry.My interest in the program aligns with my professional goals of continuing to develop my skills and knowledge in the field of cyber security. The program offers the opportunity to explore a specific and emerging area of the field that is relevant to my current work. By participating in the program, I believe I will be able to gain a deeper understanding of the unique challenges…...

The facts that you have provided indicate extremely troubling circumstances that could seriously jeopardize the welfare of your organization. It is well-settled law that entities contracting for the services of subsidiaries are legally responsible for legal and ethical improprieties committed by those subsidiaries irrespective of whether or not the contracting organization had any specific involvement in or knowledge of those actions. Accordingly, we would strongly advise that you take immediate action to rectify the situations described in the manner outlined in our recommendations below.

ecommendations

To avoid the potentially serious criminal, civil, and financial consequences arising under MWHC's respondeat superior responsibility to prevent fraud and abuse in connection with its association with subsidiaries, it is hereby recommended that MWHC immediately:

1. Instruct the subsidiary to cease and desist from offering its contracted home health agency employees compensation of any kind in connection with client durable medical equipment (DME) orders from the subsidiary.

2. Instruct…...

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References

Reid, T. (2009). The Healing of America: A Global Quest for Better, Cheaper, and Fairer Health Care. New York: Penguin Group.

USDHHS. (2004). U.S. Department of Health and Human Services-Office of Inspector

General-Statement of Organization, Functions -- and Delegations of Authority.

Federal Register. Vol. 69, No. 127; July 2, 2004. Retrieved November 14, 2010,

These examples highlight that technology is always a tool, a way of enhancing human judgment -- we must not mistake it as a replacement for good nursing practice.
After all, the use of a computer is no substitute for a medical education. Anyone who works in a hospital can see this -- the increased accessibility of information through the Internet also means that patients often come in, convinced that they are suffering from a serious illness, allergy, or condition, based more upon a diagnosis Googled on WebMD, rather than upon the fact that they saw a doctor! If a computer alone was required to diagnose, everyone would have a degree!

Don't get me wrong -- I use technology every day in my life, and thank my lucky stars, and my patient's lucky stars, that it is so ubiquitous. When health care providers wish to communicate, the use of cell phones is…...

PESTEL Analysis of the Medical Devices Industry in Australia
Political

The medical devices industry in Australia has become the focus of political leaders in recent months. For instance, the Australian Senate launched an investigation into regulation of the medical device regulation in response to growing concerns about Poly Implant Prostheses breast implants. According to Murphy (2012), "The inquiry, which is being conducted by the Senate's Community Affairs Committee, follows a senate committee inquiry into Australia's medical device regulation that was completed late last year and that generated 18 recommendations on how to improve the regulations" (p. 1). Increased regulatory oversight, though, is complicated by the very nature of the medical devices industry. According to Breton and Stinson, "The medical device world is a shapeless blob" (2010, p. 27). This point is also made by Egan (2001) who emphasizes that while there have been a number of major pieces of legislation regulating medical…...

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References

Breton, T. & Stinson, C. (2010, January/February). 'The Medical Devices Industry.' Searcher, vol. 18, no. 1, pp. 26-27.

Egan, M.P. (2001). Constructing a European Market: Standards, Regulation, and Governance.

Oxford: Oxford University Press.

'Joint Industry Statement.' (2007). European Coordination Committee of the Radiological,

DDoSCISA Warns of Possible DDoS Risk in Contec Patient Monitor Medical deviceshttps://www.scmagazine.com/analysis/device-security/cisa-warns-of-possible-ddos-risk-in-contec-patient-monitor-medical-devicesIn September 2022, CISA reported that Contec Health patient monitor medical devicesnamely, the CME8000are vulnerable to possible threat actor attacks, such as mass DDoS attacks or malicious firmware updatesanywhere Contec Health patient monitor medical devices are used due to security bugs in the devices. One bug is that uncontrolled resource consumption causes failures in the parsing of malformed network data in the CMS800, for example. The bugs could be exploited by threat actors looking to gain control of health networks or sensitive data. This report is significant because it shows that the lack of security in the devices makes employees and patients vulnerable to a threat actor. One possible solution for addressing this issue is to improve authentication/controls that would prevent a threat actor from accessing the network through the devices; fix security bugs in the CME8000.Who, What, When,…...

I. Introduction
A. Explanation of artificial intelligence (AI)
B. Importance of AI in healthcare
C. Overview of the topic

II. History of AI in healthcare
A. Early developments
B. Progress over the years
C. Current use in the healthcare sector

III. Benefits of AI in healthcare
A. Improved diagnostics
B. Enhanced treatment planning
C. Personalized medicine
D. Efficient patient care

IV. Challenges of AI in healthcare
A. Data privacy concerns
B. Ethical implications
C. Integration with existing systems

V. Future of AI in healthcare
....

I. Introduction:
A. Define Artificial Intelligence (AI) and its relevance in healthcare.
B. Provide a brief overview of the history of AI in healthcare.
C. Thesis statement: The impact of AI on healthcare and its potential to revolutionize the industry.

II. AI in Healthcare Today:
A. Diagnosis and Medical Imaging:
1. Explain AI's role in analyzing medical images and assisting healthcare professionals in diagnosing various diseases and conditions.
2. Discuss specific examples of AI systems used in medical imaging, such as deep learning algorithms for cancer detection and image-based diagnosis tools.

B. Clinical Decision Support Systems:
1. Describe how AI-powered clinical....

1. The role of technology in improving medical equipment efficiency and accuracy
2. The impact of advancements in medical equipment on patient care and outcomes
3. Challenges and opportunities in the development and adoption of new medical equipment
4. The importance of proper maintenance and calibration of medical equipment in healthcare settings
5. The ethical implications of using advanced medical equipment in patient treatment
6. The cost-effectiveness of investing in new medical equipment for healthcare facilities
7. The role of medical equipment in improving the diagnosis and treatment of various medical conditions
8. The future trends and innovations in the field of medical equipment
9. The impact of....

Medical Equipment: Innovation, Advancements, and Impact on Healthcare

1. The Evolution of Medical Technology: A Historical Perspective
- Trace the historical evolution of medical equipment, from simple tools to sophisticated devices.
- Analyze the impact of technological advancements on medical practices and patient outcomes.

2. Innovation in Medical Equipment Design: From Concept to Commercialization
- Explore the design process of medical equipment, from initial idea to product launch.
- Discuss the challenges and considerations in designing safe, effective, and user-friendly devices.

3. The Regulatory Landscape of Medical Equipment: Balancing Innovation and Safety
- Analyze the regulatory frameworks governing the development and marketing of....