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

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.

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 Effects of body protection vests and experience levels in prevention of equestrian injuries

2018 ◽  
Vol 4 (1) ◽  
pp. e000426 ◽  
Author(s):  
Sarah A Andres ◽  
Adrienne M Bushau-Sprinkle ◽  
Michael E Brier ◽  
Yvette R Seger
Keyword(s):  
The United States ◽  
Safety Equipment ◽  
Contributing Factors ◽  
Experience Levels ◽  
Equestrian Sports ◽  
Risk Of Injury ◽  
Report Data ◽  
Cross Country ◽  
Serious Injuries ◽  
Show Jumping

ObjectivesTo investigate the risk reduction and benefit of wearing body protection/safety vests in equestrian sports.MethodsA comparison of equestrians wearing body protective vests and those not wearing vests was performed using incident report data of 718 participants in the United States Pony Clubs during 2011–2017. Data obtained included age, gender, certification level of member, type of activity, description of incident, description of injuries, what protective equipment was worn and other possible contributing factors.ResultsWhile wearing body protective vests when riding on the flat or for show jumping was not correlated with a decrease in injuries, wearing vests for cross country was correlated with decrease in reported injuries (p=0.036) and showed a trend towards a lower incident severity level (p=0.062). Wearing body protection during cross country reduced the relative risk of injury by 56%. While the volume of incidents varied with a rider’s experience level, the number of serious injuries did not appear to correlate with lesser equestrian experience.ConclusionsWhile equestrian sports are considered to have a certain degree of risk associated with them, there are ways to make them safer. Wearing safety equipment, such as helmets and body protection, and obtaining education and experience can lessen the chance of incurring serious injuries.

scholarly journals Suggested Research Agenda for the Railroad Industry

2006 ◽  
Vol 17 (2) ◽  
pp. 38-45
Author(s):  
Barton Jennings
Keyword(s):  
Research Agenda ◽  
Academic Research ◽  
The United States ◽  
Regulatory Agencies ◽  
Degree Programs ◽  
Safety Issues ◽  
Railroad Industry ◽  
Transportation Infrastructures ◽  
Research Initiatives ◽  
Service Standards

The railroad industry is experiencing a worldwide resurgence. International trade is booming as populations continue to grow and transportation infrastructures are nearing capacity. In the United States, the industry is being pressured to provide more services, while at the same time traffic levels are skyrocketing on a network that is much smaller than it was just fifty years ago. Additionally, security and safety issues are challenging the industry, as well as the regulatory agencies associated with railroading. To help with these problems, the industry is calling for more academic involvement through new degree programs and research initiatives. This paper reviews five major areas where academic research could assist the railroad industry in these challenges: capacity expansion, service standards, safety, security, and data management and analysis.

scholarly journals Preventing School Shootings: The Interprofessional and Community Approach to Prevention

2020 ◽  
Vol 12 (1) ◽  
Author(s):  
Heather C Alonge ◽  
Constant P Craig
Keyword(s):  
Law Enforcement ◽  
School Safety ◽  
National Level ◽  
The United States ◽  
School Shootings ◽  
School Level ◽  
Current Status ◽  
School Design ◽  
Safety Issues ◽  
Community Approach

This essay examined the issue of school shootings within the United States, to include a literature review and analysis of the current status of the issue on a national level. From the review and analysis, the essay provides the multidisciplines engaged in school safety issues with viable, workable, and quickly implementable solutions to address this serious national issue at the local school district and even school level of implementation. This analysis examined a multidiscipline and multiprofessional community approach using existing federal guidelines that address actionable intelligence (social media and human information/informants), school design and incorporation of safety and protective features, involvement of law enforcement on campuses, and engagement of law enforcement with administrators and educators. Most importantly, it provides awareness to educators, administrators, and law enforcement along with the general public that the attitude of “It can’t happen here” can indeed and way too many times it has “happened here.”

Evaluation of Seizures and Seizurelike Events

2021 ◽  
pp. 722-730
Author(s):  
Angela M. Parsons ◽  
Joseph F. Drazkowski
Keyword(s):  
Diagnostic Tests ◽  
Diagnostic Testing ◽  
The United States ◽  
Social Consequences ◽  
Altered Level ◽  
Safety Issues ◽  
The People ◽  
Level Of Consciousness ◽  
Self Reports ◽  
Proper Diagnosis

Correctly diagnosing seizures and seizurelike events is important for numerous reasons, including safety issues, social consequences, and therapy. Patients with transient neurologic events of unknown cause are commonly admitted to hospitals, and an estimated 10% of the people in the United States have a seizure in their lifetime. These facts highlight the importance of diagnostic accuracy. History taking is imperfect, but it is still a cornerstone in making the proper diagnosis of transient neurologic events. Focused, supporting diagnostic tests may add accuracy in arriving at the proper diagnosis, but even with a good history, diagnostic testing, and physical examination findings, the diagnosis may be inaccurate. Self-reports of seizure frequency are notoriously inaccurate and often miss more than 50% of focal-onset seizures, especially if the seizures begin in the dominant hemisphere (largely because the effects of the event cause an altered level of consciousness).

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