The literature search strategy focused on leadership barriers and organizational disconnections related to the marketing of potentially unsafe medical devices. Many qualitative studies were found in the NCU ProQuest, EBSCOhost databases, and Dissertation resources on organizational barriers and disconnection. The starting point of the literature review is the theory of quality management and the subsequent emergence of quality-related standards and regulations. Information sources for the proposed study included books on quality management theory obtained from the EBSCOHost database and peer-reviewed articles from the ProQuest database.
Also, the literature search included research articles, private and government websites, and
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The ProQuest keyword advance search for the key words was narrowed by requesting full text, peer reviewed and scholarly journal articles in the last three years. Furthermore, the search phrases included variations of the key problem statement words disconnection, misalignment and process management. The articles returned and chosen were those that included information about leadership process disconnections, misalignment, and disconnected processes related to quality and medical devices
The purpose of this qualitative, multiple-case study is to investigate leadership barriers and organizational process disconnections that have led to the marketing of potentially unsafe medical devices. Many qualitative studies (e.g., Iden, 2012, Oakland, 2011, Obeidat et al., 2014, Pater, 2013, Raeesi et, al., 2013, Rising et al. 2012, Seethamraju, 2012, Suckley et al., 2013; Storbacka, 2012, Talib et al., 2011; Tucker et al., 2013) have been conducted on organizational barriers and disconnection. However, no studies were located related to the marketing of potentially unsafe medical devices. In the proposed study, factors that influence or hinder the manufacture of safe and effective medical devices will be identified and explored.
Medical devices are used to mitigate health issues and to maintain an acceptable quality of life (Harrison et al. 2013). Because medical devices are expected to perform without failure,
The level of technology that concerns the health of people in the United States has grown dramatically in the last twenty years. With this new wave of advanced technology numerous controversies have risen up into the public eye. At the top of this list, in health technology is the materials and methods used in keeping humans alive. There are many different viewpoints on how far technology should be allowed to go. Technology cannot effect the patient’s way of life.
My paper from leadership learning experience task, supports my definition of safety and quality by demonstrating how I proposed project that would enhance the safety and quality of my clients who were at risk of developing pressure ulcers. On the other hand, my paper from the organizational systems and quality leadership task 2 support my definition of safety and quality by demonstrating my capacity to coordinate root cause analysis, and designing projects that would enhance safety and quality by correctly identified system failures.
Each product must go through a progression of approval, clinical trials, and post market observation protocols in order to ensure its safety and effectiveness. Stages in the development of medical technologies are scientific background and development of idea for a product, product development, approval, and distribution, diffusion, adoption and utilization of the product. Health care professional, patients, families, and policy makers all struggle to understand how health is affected by behavior, economic and social
Patient death or serious disability associated with the use or function of a device in patient care in which the device is used or functions other than as intended
Although the United States is said to offer poor health services among other developed countries, it still has some internal features that makes the system thrive over most healthcare system. One of the major strength in the healthcare system is the breakthrough of technology advances. “Some technologies may improve the efficiency of care delivery by reducing procedure time, length of stay, or number of hospitalizations, thereby increasing the capacity of the hospital to treat additional patients” (Sorenson et al 2013). In which, also favors many patients whom wished to receive their test results sooner or on the estimated arrival date.
One technological change that may have the largest effect on our lives today is the rapid growth of medical technology development. Three main effects that medical technology has impacted our modern society are prolonging lifespan, improving quality of health care and promoting nation’s economic growth. The three stages of medical technology are review by regulatory agencies, technology assessments by insurance carriers, and review by purchasers, clinicians, and consumers. Review by regulatory agencies is the most recognized of the three stages and is administered by the Food and Drug Administration (FDA). The FDA is responsible for protecting and promoting public health by regulating pharmaceutical products and medical devices. Each product must go through a series of approvals, clinical trials, and post market surveillance protocols in order to ensure its safety and effectiveness. www.nap.edu
In the critical analysis of this article, it is apparent that information technology influences today's modern society in the aspects of leadership. From there, it is indicated that the information has strengthen leadership of business due to the access for the internet. As this idea has been proven true, some companies have used this technology to their advantage. For example, research has discovered that this company recently decreased in profit and stock because the competition that had not been evident in the past has showed face. There are many ethical and moral decisions to be made with drugs are available in health care facility. As department manager, a set of procedures and protocols regarding the handling, storing and monitoring of drugs is necessary to ensure the safety of the patients and employees. Within this set of procedures, generic drugs, controlled drugs, and all charting is necessary so that all drugs can be documented in order to keep track of everything and to keep all employees honest (Pamela Anderson, 2010). This is because no medicine is without side effects and some are worse than others."In any situation where care-workers are responsible for the looking after and giving of medicines to other people, be they young or old, healthy or sick, it is important to follow a set of general principles to ensure that this is done safely. In some ways this is similar to the way in which we follow a set of principles or rules in connection with the use of
Going back hundreds of years, we can trace the history of health care. Although it has evolved over the years, it all has a common goal; to heal those who are ill. Technology is one of the major evolutions and now plays a big role in the health care system. It helps patients to be more involved with their healthcare. They can make appointments, follow up on test results, and contact their doctors. Back then, they didn’t even have all the medicine we have now, let alone the technology. We can only imagine what is in store for the future.
Medical technology encompasses a wide range of healthcare products and is used to diagnose, monitor, and treat diseases or medical conditions that affect humans. This may included but not limited too, pharmaceuticals, vaccines, and medical equipment. Such technologies are intended to improve the quality of healthcare delivered through earlier diagnosis, less invasive treatment options and reductions in hospital stays and rehabilitation times. Recent advances in medical technology have also focused on cost reduction. Medical technology may include medical devices, information technology, biotech, and healthcare services. The impacts of medical technology may involve social and ethical issues. For example physicians may seek objective information from technology rather than listening to subjective patient reports. A major contributor of healthcare expenditure in America is the advancement of medical technology. According to several studies it is shown that there is a correlation between the nation’s gross domestic product (GDP) and money allocated to healthcare. One of the leading theories is that medical technology is growing faster than expected.
The Joint Commission has set forth standards for health care organizations to reduce the number of risks and amend the quality of care and the safety of the patient. Risk management and quality management focus on these attributes of the organization and the patient. Risks are impossible to avoid since it linked to everyday living and the workforce. Risk management must take the initiative to distinguish and oversee these risks. Due to the lack of consistency in the quality of care, health care organizations aim to reduce the negative outcomes of the patient safety through quality management methods. Internal and external factors may pose a risk that can have an impact on the organization and the consequence of the patient care and safety.
The leadership and management dynamics of a physician run organization are complex and challenging. The biggest challenge is managing the differing opinions and perspectives of multiple physician owners. Up until recently, I have viewed my role with the physician owners as passive. My approach was to provide guidance with operational and strategic decision making and essentially let this group lead themselves. By shifting the style of my interactions with the physicians to a more active leadership role, I hope to improve the relationships and interactions within the physician group. These improvements will lead to a more positive organizational culture, more engaged employees and improved patient satisfaction. My vision is that by starting at the top of the organization any positive strides gained in improving the dynamics of the physician group, will have a trickle-down effect on the organization. Finally, championing this process will involve honing and fine tuning my own leadership skills.
Accountability, responsibility, and risk are three key leadership concepts that should be properly understood and applied for successful management of resources. Each of these concepts plays essential roles in the development of sound leadership decisions. Conversely, accurate and prompt decision making significantly contributes to the performance of leaders in different organizational settings. As a result, it is important for leaders to examine the key elements and links existing between the three concepts. This is because different stakeholders look at leadership, which is supposed to apply different success concepts to take care of their interests. This paper discusses the role of the three important concepts for leadership in healthcare industry and how they may be employed by leaders to improve patient outcomes. To begin, it is essential to indicate the definition of the three leadership concepts as done in the following section.
The purpose of this paper is to identify a quality safety issue. I will summarize the impact that this issue has on health care delivery. In addition, I will identify quality improvement strategies. Finally, I will share a plan to effectively implement this quality improvement strategy.
In today’s world, as technology is advancing around us, some of the major effects that can be seen are medical technology advances, ease of communication with the growing technology, and the negative effect on our body.
Valerie Merz and the other members of the IntensCare Product Development Team faced several intrinsic issues that were impairing the success of the new remote monitoring system product launch. We diagnosed these issues through the lens of Patrick Lencioni’s leadership model as described in The Five Dysfunctions of a Team . Based on the options available to her at the time, Valerie’s response to the incident on February 13, 2009 should be to take a step back and take the weekend to craft a comprehensive strategy to address her team’s dysfunctions.