Use of Medical Devices in Hospice for Symptom Management

2016 ◽  
Vol 33 (10) ◽  
pp. 929-934 ◽  
Author(s):  
Nidhi Shah ◽  
Peter Homel ◽  
Jennifer Breznay
Keyword(s):  
End Of Life ◽  
Medical Device ◽  
Medical Devices ◽  
Symptom Management ◽  
Hospice Care ◽  
The United States ◽  
Patient Controlled Analgesia ◽  
Sampling Weights ◽  
Hospice Patients ◽  
Device Use

Background: Home health services in the United States(US) have been on a rise. Hospice patients cope with diverse physical and pain symptoms; medical devices are used for symptom management to improve their quality-of-care at end-of-life. Objective: Using the National Home and Hospice Care Survey (NHHCS), the study summarizes medical device use for symptom management and tracks various demographic variables for home hospice patients. Methods: A cross-sectional analysis of data using the 2007 NHHCS was conducted. There were 4733 hospice discharges which corresponded to 2,505,011 individuals in US with sampling weights. The data was analyzed using chi square tests and confounding factors adjusted with logistic regression. Results: Eighty-nine percent of hospice discharges were evaluated for pain at first assessment. The regression model for pain at first assessment was significantly associated with use of patient controlled analgesia (OR = 1.82, 95% CI = 1.28, 2.59) and urinary catheters (OR = 1.16, 95% CI = 1.02, 1.33). Patient with dyspnea were associated with significant use of oxygen (OR = 3.00, 95% CI = 2.64, 3.40) and metered dose inhaler (OR = 2.43, 95% CI = 1.92, 3.07). There was negligible use of total parenteral nutrition (TPN) noted in the study. Conclusion: In conclusion, the study highlights medical device use in home hospice care for end-of-life symptom management. It noted the significant use of IV infusion pumps and patient controlled analgesia. Conversely, there is little use of TPN or CPAP in patients with anorexia or dyspnea. While missing data on critical symptom evaluations regrettably raises questions about the validity of the study, the NHHCS serves as an important reservoir of data on the growing population of home hospice patients.

scholarly journals DIVERSITY IN HOSPICE AND END-OF-LIFE EXPERIENCES: THE INFLUENCE OF CHRONIC DISEASE AND SOCIOCULTURAL FACTORS

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S790-S790
Author(s):  
David Russell ◽  
Elizabeth A Luth ◽  
Ruth Masterson Creber
Keyword(s):  
Heart Failure ◽  
Chronic Disease ◽  
End Of Life ◽  
Hospice Care ◽  
The United States ◽  
Sociocultural Factors ◽  
Diverse Range ◽  
Non Profit ◽  
Demographic Transitions ◽  
Hospice Patients

Abstract Hospice provides supportive and palliative services to persons nearing the end-of-life. Use of the Medicare hospice benefit has grown to cover nearly half of all Medicare decedents. Even more notably, hospice agencies now serve patients with a diverse range of terminal conditions, including those not traditionally served by hospices, such as dementia and heart failure. In addition to expanded use of hospice care by patients with multiple types of chronic disease, demographic transitions in the United States over the last several decades have also led to increased use of hospice services among patients with diverse socio-cultural and linguistic backgrounds. Limited research has identified the unique experiences of patients enrolled in hospice who have diagnoses of dementia and heart failure, or explored how socio-cultural factors act to influence the course and outcomes of hospice care. This symposium features interdisciplinary collaborations between academic researchers and clinical practitioners at a large non-profit hospice agency in a multicultural urban environment. These collaborations, which draw on multiple theoretical perspectives and research methodologies, shed new light on patient experiences in hospice and identify opportunities for improving care and comfort at end-of-life. Presentations will include an exploration of the unique symptoms and experiences of hospice patients with heart failure, an evaluation of a clinical program for heart failure hospice patients, an exploration of collaborative goal setting between patients-providers, and an examination of cultural health capital as it relates to race/ethnic and socioeconomic disparities in hospitalization among hospice patients, and factors for disenrollment among hospice patients with dementia.

Survey on Use of Palliative Radiotherapy in Hospice Care

2004 ◽  
Vol 22 (17) ◽  
pp. 3581-3586 ◽  
Author(s):  
Stephen Lutz ◽  
Carol Spence ◽  
Edward Chow ◽  
Nora Janjan ◽  
Stephen Connor
Keyword(s):  
End Of Life ◽  
End Of Life Care ◽  
Hospice Care ◽  
Palliative Radiotherapy ◽  
The United States ◽  
Care Organization ◽  
Life Care ◽  
Oncology Patients ◽  
Hospice Patients ◽  
American Society

Purpose Radiation oncologists and hospice professionals both provide end-of-life care for oncology patients, and little has been written about the interface between these two groups of specialists. Hospice professionals were surveyed to assess the perceived need for palliative radiotherapy in the hospice setting, to investigate factors that limit the access of hospice patients to radiotherapy, and to suggest areas of future collaboration on education, research, and patient advocacy. Patients and Methods Members of the National Hospice and Palliative Care Organization (NHPCO) and American Society for Therapeutic Radiology and Oncology jointly authored a questionnaire to investigate the beliefs of hospice professionals toward the use of radiotherapy for oncology patients in hospice. The questionnaire was distributed to all NHPCO member institutions, and the results were compiled and statistically analyzed. Results Four hundred eighty of more than 1,800 surveyed facilities responded to the questionnaire. The findings suggest that the majority of hospice professionals feel that radiotherapy is important in palliative oncology and that radiotherapy is widely available in the United States. Yet less than 3% on average of hospice patients served by hospices responding to the survey actually received radiotherapy in 2002. The most common barriers to radiotherapy in hospice care include radiotherapy expense, transportation difficulties, short life expectancy, and educational deficiencies between the specialties. Conclusion Multiple barriers act to limit the use of palliative radiotherapy in hospice care. Finding ways to surmount these obstacles will provide opportunity for improvement in the end-of-life care of cancer patients.

Regulating Medical Devices in the United States

2020 ◽  
Author(s):  
Patricia J. Zettler ◽  
Erika Lietzan
Keyword(s):  
United States ◽  
Medical Device ◽  
Medical Devices ◽  
Complete Information ◽  
The United States ◽  
Risk Level ◽  
Management Tools ◽  
Medical Technologies ◽  
The Us ◽  
Medical Device Regulation

This chapter assesses the regulation of medical devices in the United States. The goal of the US regulatory framework governing medical devices is the same as the goal of the framework governing medicines. US law aims to ensure that medical devices are safe and effective for their intended uses; that they become available for patients promptly; and that manufacturers provide truthful, non-misleading, and complete information about the products. US medical device law is different from US medicines law in many ways, however, perhaps most notably because most marketed devices do not require pre-market approval. The chapter explores how the US Food and Drug Administration (FDA) seeks to accomplish its mission with respect to medical devicecough its implementation of its medical device authorities. It starts by explaining what constitutes a medical device and how the FDA classifies medical devices by risk level. The chapter then discusses how medical devices reach the market, the FDA's risk management tools, and the rules and incentives for innovation and competition. It concludes by exploring case studies of innovative medical technologies that challenge the traditional US regulatory scheme to consider the future of medical device regulation.

scholarly journals Duodenoscope Medical Device Reports Associated with Patient Infection, Patient Exposure, or Device Contamination

2020 ◽  
Vol 41 (S1) ◽  
pp. s196-s197
Author(s):  
Jian Connell ◽  
Shanil Haugen ◽  
Ann Ferriter
Keyword(s):  
Medical Device ◽  
The United States ◽  
Risk Of Infection ◽  
Patient Exposure ◽  
Safety Issues ◽  
Device User ◽  
Infection Patient ◽  
Device Use ◽  
Serious Injuries ◽  
Patient Infection

Background: Each year, the FDA receives more than a million reports of suspected device-associated deaths, serious injuries, and malfunctions. Medical device reports (MDRs) are submitted to the FDA by mandatory reporters (manufacturers, importers, and device user facilities) and voluntary reporters such as healthcare professionals, patients, and consumers. The FDA uses MDRs to monitor device performance, including monitoring reports of infection or device contamination to detect potential device-related safety issues and to share this information in public communications. In this analysis, the FDA presents MDRs for duodenoscopes, which are a type of flexible endoscope that have been associated with infections in patients. Methods: For this analysis, we searched the MDR database for duodenoscope reports submitted between January 2015 and July 1, 2019. MDRs were classified into clinical risk categories based on the MDR’s text narratives as patient infection (indicated the presence of infection in patients potentially transmitted by the device), patient exposure (indicated a contaminated device has been used in a patient, but the MDR lacks clear mention of patient infection), or device contamination (indicated that the device was contaminated, but no mention of device use in patients or patient infection). Results: Overall, 1,115 duodenoscope reports related to a patient infection, patient exposure, or device contamination for devices marketed inside and outside the United States were received from January 2015 to mid-2019. Among them, 79 MDRs were received for deaths in patient infection, patient exposure, or device contamination reports. The number of reported infections decreased from 247 MDRs in 2015 to 55 MDRs in the first half of 2019. Furthermore, the number of reported deaths decreased from 25 MDRs in 2015 to 2 MDRs reported in the first half of 2019. Conclusions: The MDR data indicate a decrease in the number of reported infections. The decrease in infections suggests that efforts to reduce the risk of infection from duodenoscopes have yielded improvements; however, additional improvements are necessary to further decrease the risk of infection.Funding: NoneDisclosures: None

scholarly journals An Analysis of FDA Adverse Event Reporting Data for Trends in Medical Device Use Error

2020 ◽  
Vol 9 (1) ◽  
pp. 130-134
Author(s):  
Benjamin M. Knisely ◽  
Camille Levine ◽  
Kush C. Kharod ◽  
Monifa Vaughn-Cooke
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Medical Device ◽  
Medical Devices ◽  
Product Life Cycle ◽  
Risk Mitigation ◽  
Adverse Event Reporting ◽  
Mitigation Strategies ◽  
Event Reporting ◽  
Device Use

Humans can contribute to error at all stages of the medical device product life-cycle. Use error associated with medical devices can result in catastrophic consequences for end users and inefficient use of healthcare system resources. Industry-wide statistics about medical device use error has the potential to aid in identifying opportunities for human factors intervention, however publicly available statistics are sparse. The Food and Drug Administration (FDA) requires medical device manufactures, importers, and device user facilities to track and report adverse events for post-market surveillance through medical device reports (MDRs). This data is available in an online database: Manufacturer and User Facility Experience (MAUDE). This study provides a comprehensive evaluation of use error adverse events in MAUDE (2010-2018) based on device class, device operator, and event outcome, to address the lack of industry-wide statistics on medical device use error. Results indicate that use error is significantly represented in adverse event reporting, constituting 28.1% of reports labeled with device problem codes. Events associated with patient device operators were predominately associated with diabetes-related medical devices, while provider operators were associated with a wider array of devices. Additionally, it was found that most use error reports were attributed to issues with device output; using the device in accordance with manufacturer expectations; and physically activating, positioning, or separating device components. This work demonstrates the viability of using MAUDE to attain industry wide statistics on medical device use error for later integration in industry-wide or device-specific risk mitigation strategies.

Happiness at the End of Life: A Qualitative Study

2020 ◽  
pp. 104990912093985
Author(s):  
Anne O’Callaghan ◽  
Ben Bickford ◽  
Conor Rea ◽  
Antonio Fernando ◽  
Phillipa Malpas
Keyword(s):  
Palliative Care ◽  
End Of Life ◽  
Hospice Care ◽  
Qualitative Interviews ◽  
Well Being ◽  
Natural World ◽  
The Internet ◽  
Present Moment ◽  
Hospice Patients ◽  
Health And Well Being

Background: Happiness is a core ingredient of health and well-being, yet relatively little is known about what happiness means for individuals near the end of life, and whether perceptions of happiness change as individuals approach the end of their lives. Aim: The aim of this study was to explore, through interviews, how individuals experiencing hospice care understood and conceptualized happiness. Design: Qualitative interviews with hospice patients were analyzed thematically. Setting/Participants: Adult patients (n = 20) in a New Zealand hospice who were receiving palliative care and who could give their informed consent were invited by hospice nurse coordinators to an interview. Results: Four themes emerged from analysis of the transcribed interviews. Participants defined happiness most frequently and in most depth in relation to connection with others. They identified being in the present moment, particularly in relation to nature, and that happiness had become less associated with money, status, or possessions. They had an attitude of determination to focus on what mattered now. Conclusion: Patients receiving palliative care were generally happy with their lives, appreciated the simpler aspects of life away from the material. There was a common exhortation to young people to avoid focusing too much on acquisition and the internet and to prioritize instead social connection and engagement with the natural world.

scholarly journals Innovation and Design: Pollution Prevention Opportunities in Medical Device Design

2009 ◽  
Vol 3 (2) ◽  
Author(s):  
J. Becker ◽  
C. Zimmer ◽  
K. Larson
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Chlorinated Solvents ◽  
Pollution Prevention ◽  
Cost Savings ◽  
The United States ◽  
Medical Device Industry ◽  
Potential Cost ◽  
Environmental Considerations ◽  
Device Industry

A wide variety of materials and chemicals are used in the development, production, cleaning, packaging, sterilization and shipment of medical devices. Some of these materials are used in large quantities and are often a source of waste. Some materials, such as poly vinyl chloride (PVC) plastics, have toxicity concerns. Additionally, many chemicals including chlorinated solvents and ethylene oxide are carcinogenic or highly toxic and can be detrimental to the environment and public health. While the medical device industry is highly regulated in the United States by the Food and Drug Administration, new green initiatives in the European Union are modifying the regulatory oversight of chemicals, materials, and their manufacture. In addition, hospitals are working to reduce waste and pollution as part of their operations and are increasingly asking vendors to assist them. Minimizing waste and pollution associated with medical devices can improve a company's environmental performance and save money. The primary focus in medical device manufacturing is patient safety and compatibility. Environmental considerations, which can include potential cost savings, are often overlooked in the design and process development phases. Numerous pollution prevention and energy efficiency options exist for medical device manufacturers. These options can be integrated into the development, design and process protocols, and engineering change orders when designing a new product or improving an existing part. By having a process design evaluation plan that includes environmental considerations, companies can effectively manage the creation of waste streams, toxicity of material inputs, and process efficiencies as a mechanism at both the front-end and the duration of the product line. These options often cut costs and can help reduce current and prospective regulatory burdens. The Minnesota Technical Assistance Program (MnTAP) at the University of Minnesota has been assisting businesses with pollution prevention and cost savings for 25 years. MnTAP's engineers and scientists have worked with the medical device industry to reduce the quantity of packaging and waste associated with cardiac catheters, reduce the use of toxic cleaning solvents, minimize the use of PVC, and research safer disinfection and sterilization methods. This poster includes case studies of the above mentioned projects, an overview of less toxic sterilization methods, and tools for medical device manufacturing that meet FDA requirements, but reduce waste and toxicity during production and use.

The Impact of Hospice on Mortality of Widowed Spouses (DRAFT)

2018 ◽  
Author(s):  
Kimberson Tanco ◽  
Regina Mackey
Keyword(s):  
Social Support ◽  
End Of Life ◽  
Mortality Risk ◽  
Symptom Management ◽  
End Of Life Care ◽  
Hospice Care ◽  
Family Satisfaction ◽  
Life Care ◽  
Advanced Illness ◽  
The Impact

Caring for a sick spouse can have adverse health consequences and may increase mortality for the surviving spouse. This can be associated to a caregiver and widow/er effect, which may be related to the loss of beneficial social support and impact of stress from the advanced illness and death of the spouse. This study explores if the nature of end-of-life care that the decedent spouse received might be associated with the mortality risk of the surviving spouse. This is preceded by the hypothesis that “good deaths” may result in less stress on the families. At the same time, it is presumed that hospice care facilitates “good deaths” by optimizing symptom management, enables home deaths, and may enhance patient and family satisfaction.

Informal Caregivers’ Perceptions of Needs From Hospice Providers: An Integrative Review

2019 ◽  
Vol 36 (12) ◽  
pp. 1114-1123
Author(s):  
Ruth Anne Engbers
Keyword(s):  
End Of Life ◽  
End Of Life Care ◽  
Interpersonal Skills ◽  
Hospice Care ◽  
Informal Caregivers ◽  
The United States ◽  
Easy Access ◽  
Life Care ◽  
The United Kingdom ◽  
Formal Services

Introduction: In the United States, informal caregivers (ICs) provide care to over 70% of patients at the end of life. Approximately 500 000 ICs contribute to the end-of-life care for patients in the United Kingdom. Hospice care is expanding worldwide to meet the needs of these ICs. Because ICs play an instrumental role in the provision of hospice services, and their perspective of their needs of formal services requires further clarity, the purpose of this review is to synthesize research that elucidates perceptions of ICs regarding their experiences with hospice providers. Methods: Twelve research studies regarding perceptions of informal hospice caregivers were obtained by searching CINAHL, PsycINFO, and MEDLINE databases. Results: Four primary themes emerged that describe what ICs perceive as beneficial contributions of hospice providers in aiding their caregiving: providing easy access to desired care, building up the caregiver, forming a relationship, and utilizing culturally relevant interpersonal skills. Conclusion: Particular attention must be paid to ensuring that the IC is acknowledged as an expert part of the team. Clearly explaining available services, creating better ways to ease the IC’s transition from caregiving to bereavement, and recruiting minority hospice providers are other important efforts that could improve the caregiving experience. The needs of ICs are complex, but by listening to their perspective, we can begin to clarify the best ways to aid them in their difficult job.

Premarket Review of Medical Devices in the United States

2000 ◽  
Vol 7 (3) ◽  
pp. 293-326
Author(s):  
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Regulatory System ◽  
The United States ◽  
The Public ◽  
The World ◽  
Contemporary Perspective ◽  
Premarket Approval ◽  
The U.S ◽  
Medical Device Regulation

AbstractIt has been sixty years since the Congress first authorized FDA to regulate medical devices. During this period, countless studies, reports, and investigations have been targeted at medical devices. The law has been significantly modified several times, and the regulations revised on numerous occasions. As for any other scheme of administration or management, revisions are necessary as demand arises for legislative attention to societal risks, the economy fluctuates, and when businesses expand and globalize. Studying the U.S. system of medical device regulation merely from a contemporary perspective fails to take into account the significance of decades of effort in maintaining the quality and integrity of the system in an ever-changing field of medical device regulation.The three-pronged medical device regulatory system that entails inspection of manufacturing facilities, premarket approval, and postmarket recall and reporting enables the public to benefit from medical devices without the fear of unreasonable risk with their use (Appendix 1). President Clinton proudly pronounced the following in a 1995 speech:Today, Americans don't have to worry about safety or effectiveness when they buy [drugs and medical devices] - from cough syrups to the latest antibiotics or pacemakers. The Food and Drug Administration has made American drugs and medical devices the envy of the world and in demand all over the world. And we are going to stick with the standards we have - the highest in the world.…^218

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