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Implications of Health Literacy for Public Health: Workshop Summary (2014)

October 1, 2014 Comments off

Implications of Health Literacy for Public Health: Workshop Summary (2014)
Source: Institute of Medicine

Health literacy is the degree to which individuals can obtain, process, and understand the basic health information and services they need to make appropriate health decisions. Nearly half of all American adults – 90 million people – have inadequate health literacy to navigate the health care system. Implications of Health Literacy for Public Health is the summary of a workshop convened by the Institute of Medicine Roundtable on Health Literacy in November 2013 that focused on the implications of health literacy for the mission and essential services of public health. The workshop featured the presentation of a commissioned paper on health literacy activities under way in public health organizations. Other presentations examined the implications of health literacy for the mission and essential services of public health, for example, community health and safety, disease prevention, disaster management, or health communication. This report includes the commissioned paper and summaries of the workshop presentations.

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Passenger Travel Facts and Figures 2014

September 30, 2014 Comments off

Passenger Travel Facts and Figures 2014
Source: Bureau of Transportation Statistics

The U.S. Department of Transportation’s Bureau of Transportation Statistics (BTS) today released Passenger Travel Facts and Figures 2014, a snapshot of the characteristics and trends of personal travel in the United States; the network over which passenger travel takes place; and the related economic, safety, and environmental implications. The 77-page report summarizes the basic demographic and economic characteristics of the United States that contribute to the demand for passenger travel; examines travel patterns by trip purpose, transportation mode, and household characteristics; provides a picture of the passenger transportation system in 2005 and 2011 and summarizes movement on the system by transportation mode and congestion impacts; discusses the economic characteristics of passenger travel and tourism and discusses the safety, energy, and environmental impacts of passenger travel. It is intended as a companion to Freight Facts and Figures, which is produced jointly by BTS and the Federal Highway Administration (FHWA)

Lack of Publicly Available Scientific Evidence on the Safety and Effectiveness of Implanted Medical Devices

September 30, 2014 Comments off

Lack of Publicly Available Scientific Evidence on the Safety and Effectiveness of Implanted Medical Devices
Source: Journal of the American Medical Association

Importance
Under the 510(k) process, the US Food and Drug Administration (FDA) clears about 400 implanted medical devices that are considered moderate to high risk for market each year without requiring clinical testing. Instead, the FDA requires the applicant to provide scientific evidence that the new device is “substantially equivalent” to a device or devices already on the market (predicate devices). Companies are legally required to submit the evidence to the FDA and to make publicly available at least a summary of the evidence.

Objective
To assess the types of scientific evidence used to determine substantial equivalence, safety, or effectiveness for a representative sample of implanted medical devices; the number of predicates for each implant; and whether this evidence was publicly available.

Design
Using FDA databases, we determined the device categories of the first 5 implanted medical devices cleared through the 510(k) process in 2008: cardiovascular, dental, general and plastic surgery, neurological, and orthopedic. We then identified the first 2 implanted medical devices approved in each of the 5 categories for each year from 2008 through 2012. The sample of 50 devices included, for example, total hip implants, vascular embolization devices, and surgical mesh. We also identified the 1105 predicates the manufacturers listed for these devices.

Main Outcomes and Measures
For each implanted medical device and its predicates, we determined whether clinical or nonclinical scientific evidence was provided to the FDA to support the claim of substantial equivalence and whether this evidence was publicly available. We also determined if safety or effectiveness data were provided.

Results
Scientific data to support the claim of substantial equivalence were publicly available for 8 of the 50 newly cleared implants (16%) and 31 of their 1105 listed predicates (3%). Most of the evidence was nonclinical data; some of the data also evaluated safety or effectiveness.

Conclusions and Relevance
Despite the legal requirement that scientific evidence of substantial equivalence be publicly available for medical devices cleared by the FDA through the 501(k) process, such information is lacking for most implanted medical devices cleared between 2008 and 2012, as well as for their predicates.

The Impacts of the Affordable Care Act on Preparedness Resources and Programs: Workshop Summary (2014)

September 26, 2014 Comments off

The Impacts of the Affordable Care Act on Preparedness Resources and Programs: Workshop Summary (2014)
Source: Institute of Medicine

Many of the elements of the Affordable Care Act (ACA) went into effect in 2014, and with the establishment of many new rules and regulations, there will continue to be significant changes to the United States health care system. It is not clear what impact these changes will have on medical and public health preparedness programs around the country. Although there has been tremendous progress since 2005 and Hurricane Katrina, there is still a long way to go to ensure the health security of the Country. There is a commonly held notion that preparedness is separate and distinct from everyday operations, and that it only affects emergency departments. But time and time again, catastrophic events challenge the entire health care system, from acute care and emergency medical services down to the public health and community clinic level, and the lack of preparedness of one part of the system places preventable stress on other components. The implementation of the ACA provides the opportunity to consider how to incorporate preparedness into all aspects of the health care system.

The Impacts of the Affordable Care Act on Preparedness Resources and Programs is the summary of a workshop convened by the Institute of Medicine’s Forum on Medical and Public Health Preparedness for Catastrophic Events in November 2013 to discuss how changes to the health system as a result of the ACA might impact medical and public health preparedness programs across the nation. This report discusses challenges and benefits of the Affordable Care Act to disaster preparedness and response efforts around the country and considers how changes to payment and reimbursement models will present opportunities and challenges to strengthen disaster preparedness and response capacities.

FBI Releases Study on Active Shooter Incidents – Covers 2000-2013 Time Frame

September 26, 2014 Comments off

FBI Releases Study on Active Shooter Incidents – Covers 2000-2013 Time Frame
Source: Federal Bureau of Investigation

Today the FBI is releasing a study of 160 active shooter incidents that occurred between 2000 and 2013 throughout the U.S. The primary purpose of the study? To provide our law enforcement partners—normally the first responders on the scene of these dangerous and fast-moving events—with data that will help them to better prepare for and respond to these incidents, saving more lives and keeping themselves safer in the process.

But we believe the information contained in this study can benefit anyone who could potentially be in an active shooter situation—like emergency personnel, employees of retail corporations and other businesses, educators and students, government and military personnel, members of the general public, etc.—by giving them a better understanding of how these incidents play out.

Analysis of Recent Mass Shootings, 2014

September 22, 2014 Comments off

Analysis of Recent Mass Shootings, 2014
Source: Everytown for Gun Safety

Using FBI data and media reports, Everytown for Gun Safety developed an analysis of mass shootings that took place between January 2009 and July 2014. The analysis found that there have been at least 110 mass shootings in this five and a half-year period.
The FBI defines a “mass shooting” as any incident where at least four people were murdered with a gun. Below are some of the report’s more surprising findings:

  • Mass shootings represent a small share of total US firearm homicides.
  • There is a strong connection between mass shooting incidents and domestic or family violence: at least 57% of mass shootings surveyed were related to domestic or family violence.
  • Perpetrators of mass shootings are generally older than perpetrators of gun violence in the US as a whole. While the median age of known overall gun murderers in the U.S. is 26, the median age of perpetrators of mass shootings was 34.

New From the GAO

September 22, 2014 Comments off

New GAO Reports
Source: Government Accountability Office

1. Identity Theft: Additional Actions Could Help IRS Combat the Large, Evolving Threat of Refund Fraud. GAO-14-633,August 20.
http://www.gao.gov/products/GAO-14-633
Highlights – http://www.gao.gov/assets/670/665367.pdf
Podcast – http://www.gao.gov/multimedia/podcasts/665529

2. Oil and Gas Transportation: Department of Transportation Is Taking Actions to Address Rail Safety, but Additional Actions Are Needed to Improve Pipeline Safety. GAO-14-667, August 21.
http://www.gao.gov/products/GAO-14-667
Highlights – http://www.gao.gov/assets/670/665403.pdf
Podcast – http://www.gao.gov/multimedia/podcasts/665350

3. Patient Protection and Affordable Care Act: Procedures for Reporting Certain Financial Management Information Should Be Improved. GAO-14-697, September 22.
http://www.gao.gov/products/GAO-14-697
Highlights – http://www.gao.gov/assets/670/665984.pdf

4. Consumer Financial Protection Bureau: Some Privacy and Security Procedures for Data Collections Should Continue Being Enhanced. GAO-14-758, September 22.
http://www.gao.gov/products/GAO-14-758
Highlights – http://www.gao.gov/assets/670/666001.pdf

5. Bureau of Prisons: Management of New Prison Activations Can Be Improved. GAO-14-709, August 22.
http://www.gao.gov/products/GAO-14-709
Highlights – http://www.gao.gov/assets/670/665416.pdf

6. Army Corps of Engineers: The Corps Needs to Take Steps to Identify All Projects and Studies Eligible for Deauthorization. GAO-14-699, August 21.
http://www.gao.gov/products/GAO-14-699
Highlights – http://www.gao.gov/assets/670/665394.pdf

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