Tag: Health Medical

The course covered the regulatory framework in the U.S. for medical device development throughout the product lifecycle. We reviewed the different routes to market, quality testing and quality design, device classification, FDA actions, and post-market surveillance.

Reflection paper 500 words max

APA Format

Learning Objectives:

• Summarize the history of US medical device regulations
• Identify the FDA regulations and guidance’s applicable to the development of medical devices
• Identify medical devices in the three classifications.
• Apply the device controls to determine device classification.
• Identify various materials used in the design of medical devices and concerns/issues with the materials.
  • Device Classification
  • Medical Device Definition
  • Classification by Risk

• Class I – General Controls
• Cass II – General Controls + Special Controls
• Class III – General Controls + Special Controls + Proof of Safety & Efficacy
• Panels and device subsets by medical specialties http://www.fda.gov/medicaldevices/deviceregulation…
• Format of device classification
• Examples of Class I, II & III devices
• Enforcement of CFRs
• Define predicate devices and substantial equivalence.
• Describe the use of predicate devices and substantial equivalence in medical device development and submission of 510(k) applications to the FDA.
• Summarize the 510(k) route to market.
• Summarize the PMA application process for marketing approval of a device
• Define IDEs and the requirements of clinical trials to prove safety and efficacy
• Describe the required contents of the PMA.
• Define and describe the actions the FDA can take when reviewing and approving PMAs.
• Discuss the importance of communication and meetings with the FDA during the PMA submission process.
• Define combination medical devices and explain Primary Mode of Action
• Identify and explain the importance of meetings and communication with the FDA during the submission process.
• Analyze safety issues with medical devices and identify tests, assessments, and steps to prevent the safety issue.
• Discuss the need for and types of postmarket surveillance of medical products.
• Describe and discuss CAPAs.
• Identify and describe the contents of the sections of a 510(k) application

I’m working on a health & medical question and need an explanation and answer to help me learn.

In Chapters 8 and 3, we learned some
concepts and methods for assuring that the CQI improvements that have
been identified will be fully implemented.

What do you think was the most meaningful implementation concept that you have learned?

Give an example of how you might use this concept in your role as a leader.

I’m studying and need help with a Nursing question to help me learn.

Patient-centered care is paramount to a successful nurse-patient relationship. Present an article, from a peer-reviewed journal, that discusses culturally competent care for diverse populations.

Develop a 4-6 page position about a specific health care issue as it relates to a target vulnerable population. Include an analysis of existing evidence and position papers to help support your position. Your analysis should also present and respond to one or more opposing viewpoints.

Introduction

Note: Each assessment in this course builds on the work you completed in the previous assessment. Therefore, you must complete the assessments in this course in the order in which they are presented.

Position papers are a method to evaluate the most current evidence and policies related to health care issues. They offer a way for researchers to explore the views of any number of organizations around a topic. This can help you to develop your own position and approach to care around a topic or issue.

This assessment will focus on analyzing position papers about an issue related to addiction, chronicity, emotional and mental health, genetics and genomics, or immunity. Many of these topics are quickly evolving as technology advances, or as we attempt to push past stigmas. For example, technology advances and DNA sequencing provide comprehensive information to allow treatment to become more targeted and effective for the individual. However as a result, nurses must be able to understand and teach patients about the impact of this information. With this great power comes concerns that patient conditions are protected in an ethical and compassionate manner.

Position papers are a way for individuals, groups, and organizations to express their views and intentions toward a specific issue. In health care, many position papers address specific policies, regulations, or other approaches to care. As a master’s-prepared nurse, you should feel empowered to express and advocate for your own views on policy and care matters. This is especially important when it comes to populations you or your organization cares for that are not receiving the quality, type, or amount of care that they require.

An important skill in creating a position paper or policy proposal is the ability to analyze and synthesize others’ views about the population or issue of interest to you. By synthesizing the positive and negative views of an issue, you can become better equipped to strengthen your own arguments and to respond to opposing views in an informed and convincing way.

Preparation

As you prepare to complete this assessment, you may want to think about other related issues to deepen your understanding or broaden your viewpoint. You are encouraged to consider the questions below and discuss them with a fellow learner, a work associate, an interested friend, or a member of your professional community. Note that these questions are for your own development and exploration and do not need to be completed or submitted as part of your assessment.

• What is the vulnerable population that most interests you?
  • What is the health issue that is most prevalent or severe in the population?
  • How does the health issue impact the daily lives of members of the population?
  • How does the care environment in your chosen context impact both the population and the level of care related to the health issue?
  • What are the biggest challenges that you would need to overcome to improve the outcomes for the population related to the health issue?
• What is your position on how to best work to improve the care and outcomes that the population is receiving?
  • What previously published position papers support your position, or the need to work to improve care and outcomes in general for the population?
    • How do these position papers support your assertions?
    • How could one or more of the position papers help you to form a treatment plan?
  • What previously published position papers contradict your position?
    • What, if any, of these differences would make your position stronger if you incorporated them?
    • How could you respond to any irreconcilable differences in such a way as to encourage buy-in for your position from those opposed?

Assessment 1 will be based on an analysis of position papers that are relevant to a health care issue related to a vulnerable population. Think about your experience working with vulnerable populations, and the issues related to health care you have observed for those populations. Refer to the resources listed below:

• Guiding Questions: Analysis of Position Papers for Vulnerable Populations [DOC].
• Finding Position Papers.
• Vila Health: Resources for Topical Research.
• Vila Health: Health Challenges in Different Populations .

Scenario

Pretend you are a member of an interprofessional team that is attempting to improve the quality of health care and the outcomes in a vulnerable population. For the first step in your team’s work, you have decided to conduct an analysis of current position papers that address the issue and population you are considering.

In your analysis you will note the team’s initial views on the issue in the population as well as the views across a variety of relevant position papers. You have been tasked with finding the most current standard of care or evidenced-based practice and evaluating both the pros and cons of the issue. For the opposing viewpoints, it is important to discuss how the team could respond to encourage support. This paper will be presented to a committee of relevant stakeholders from your care setting and the community. If it receives enough support, you will be asked to create a new policy that could be enacted to improve the outcomes related to your chosen issue and target population.

The care setting, population, and health care issue that you use for this assessment will be used in the other assessments in this course. Consider your choice carefully. There are two main approaches for you to take in selecting the scenario for this assessment:

1. You may use one of the issues and populations presented in the Vila Health: Health Challenges in Different Populations and Vila Health: Resources for Topical Research media pieces. For this approach, you may consider the population in the context of the Vila Health care setting, or translate it into the context in which you currently practice or have had recent experience.
2. You may select a population and issue that is of interest to you and set them in the context of your current or desired future care setting. While you are free to choose any population of interest, the issue you choose should fall within one of the following broad categories:
   • Genetics and genomics.
     • Sickle cell, asthma, multiple sclerosis, myasthenia gravis.
   • Immunity.
     • Type 1 diabetes, systemic lupus erythematosus (SLE), congenital neutropenia syndrome.
   • Chronicity.
     • Arthritis, any type of cancer or lung or heart disease, obesity.
   • Addiction.
     • Abuse of alcohol, prescription drugs, tobacco, illegal substances.
   • Emotion and mental health.
     • Post-traumatic stress disorder (PTSD), depression, eating disorders, psychosis.

Note: If you choose the second option, contact the FlexPath faculty for your section to make sure that your chosen issue and population will fit within the topic areas for this course.

Instructions

For this assessment you will develop a position summary and an analysis of relevant position papers on a health care issue in a chosen population. The bullet points below correspond to the grading criteria in the scoring guide. Be sure that your submission addresses all of them. You may also want to read the Analysis of Position Papers for Vulnerable Populations Scoring Guide and Guiding Questions: Analysis of Position Papers for Vulnerable Populations [DOC] to better understand how each grading criterion will be assessed.

• Explain a position with regard to health outcomes for a specific issue in a target population.
• Explain the role of the interprofessional team in facilitating improvements for a specific issue in a target population.
• Evaluate the evidence and positions of others that could support a team’s approach to improving the quality and outcomes of care for a specific issue in a target population.
• Evaluate the evidence and positions of others that are contrary to a team’s approach to improving the quality and outcomes of care for a specific issue in a target population.
• Communicate an initial viewpoint regarding a specific issue in a target population and a synthesis of existing positions in a logically structured and concise manner, writing content clearly with correct use of grammar, punctuation, and spelling.
• Integrate relevant sources to support assertions, correctly formatting citations and references using APA style.

Create an assignment on cigarette smoking at a young age that consists of creating a vision, mission, and conducting a needs assessment using health promotion theory. 

Precursors: Peer pressure, thinking as a stress reliever, working parents ( where teenagers don’t get enough supervision)

Initiatives: Raising awareness on social media platforms/ through organizing different organizations at college.

Understanding Community and Organizational Problems

Assignment Overview

In your work as a human services leader for an organization, you will often be called upon to make presentations to stakeholders, such as a board of directors, to secure funding or support, or propose partnerships. In any of those situations, you will want to be fully prepared with a well-researched statement of the problem, an analysis of the community affected, and identification of the key partners that can be engaged in finding a solution. Think about what you would be looking for as an audience member for this kind of presentation and what would make the message engaging and sticky.

Instructions

In the u01d1 discussion, you selected your topic for your course project: an event or situation requiring social justice intervention that demands collaborative relationships among business, government, religious, and nonprofit organizations in a community. This can be a real past event, current situation, or a hypothetical case (such as a natural disaster, a community crisis situation, or a significant need identified for a community).

For this assignment, create an engaging and professional 4–7 minute oral presentation, using PowerPoint (or similar software) and Kaltura (or similar software) for audio, that addresses the following:

• Present your chosen event (or situation, condition, problem, need, opportunity, or risk).
  • Define at least five key terms that describe the scope and essence of the problem.
• Explain the target population and its human service needs.
  • Describe the diversity and cultural considerations that will be important for serving this population.
  • Develop strategies for authentic engagement with this population.
• Assess the community capacity and assets, including patterns of influence, control, and relevant historical and contextual information.
• Present a macro environment for the problem by identifying at least three agencies or organizations involved in the social justice intervention.
  • Explain the role of each organization and describe patterns of influence, control, and service delivery.
• Identify collaboration, negotiation, and mediation needs in the macro environment.
• Identify potential plans for positive community impact through the collaboration of business, government, religious, and nonprofit sectors.

Submission Requirements

• Written communication: Written communication should be free of errors that detract from the overall message.
• APA style: Use APA style in citations and references. Include a References slide at the end of the presentation.
• References: Use 3–4 scholarly resources.
• Length: Narrated presentation should be no more than 4–7 minutes.
• Presentation deck: Presentation deck should include no more than 8–10 slides, with only key ideas or bullets on the slides and full elaboration in the detailed speaker’s notes.
• Font and font size: Times New Roman, of an appropriate size and weight for a presentation (generally 24–28 points for headings and no smaller than 18 points for bullet-point text).
• ADA compliance: As part of the Kaltura tool, closed captioning will be generated for your presentation within 24 hours after you submit it, to make your presentation ADA compliant. If you choose to use a different software than Kaltura for this presentation, you are responsible for creating and submitting a transcript for your presentation instead.

Refer to the Understanding Community and Organizational Problems Scoring Guide to ensure you meet the grading criteria for this assignment.

The purpose of this assignment is to examine essential leadership competencies to effectively lead individuals in an organization.

Complete the “Essential Leadership Competencies” worksheet.

While APA style is not required for the body of this assignment, solid academic writing is expected, and documentation of sources should be presented using APA formatting guidelines,

This assignment uses a rubric. Please review the rubric prior to beginning the assignment to become familiar with the expectations for successful completion.

Review your problem or issue and the cultural assessment. Consider how the findings connect to your topic and intervention for your capstone change project. Write a list of three to five objectives for your proposed intervention. Below each objective, provide a one or two sentence rationale.

After writing your objectives, provide a rationale for how your proposed project and objectives advocate for autonomy and social justice for individuals and diverse populations.

RN to BSN

1.5:  Advocate for autonomy and social justice for individuals and diverse populations.

• A description of your personal safety plan for your field education experience
• An explanation of how your personal safety plan might differ from your agency safety plan during your field education experience

I am doing my internship in a hospice