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politikimx@yahoo.gr

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REAL NEWS PRESIDENT TRUMP DOESN'T WANT YOU TO MISS Border Patrol union: Morale was 'low as it could get' under Obama, but Trump's support has 'helped' - Washington Examiner This week on Capitol Hill, Jon Anfinson, President of Local 2366 of the National Border Patrol Council, testified to lawmakers that under President Obama, “morale was probably about as low as it could get” among border patrol agents. “I think part of the improvement has been that we have an administration that clearly supports what we do.” ------------------------- Toyota, Mazda announce $1.6 billion plant for Huntsville, Alabama - Reuters This week, Toyota Motor Corp and Mazda Motor Corp announced that they will build a $1.6 billion joint assembly plant in Alabama. This plant will employ up to 4,000 workers and will produce 300,000 vehicles a year. The President tweeted about the news, congratulating Alabama and saying “companies are coming back to the U.S. in a very big way.” ------------------------- Holiday retail sales increased 5.5 percent in 2017, exceeding NRF forecast and showing strongest gain since Great Recession - National Retail Federation Yesterday, the National Retail Federation released new data showing that holiday retail sales the final two months of 2017 exceeded forecasts, showing the strongest gain since the Great Recession. The Federation credited this increase to growing wages, stronger employment, and higher consumer confidence. ------------------------- Tax cuts hit home - The Washington Times An editorial in The Washington Times slams those who claimed that President Donald J. Trump’s tax reform efforts would end in doom and gloom, citing myriad ways that tax cuts have already hit home for American workers, including raises, bonuses, and improved family policies. “’Are you better off than you were two years ago?’ For many [workers], the answer is obvious.” ------------------------- Americans' optimism about job market hit record high in 2017 - Gallup News The latest polling shows that Americans’ optimism about the U.S. job market hit record highs in 2017—“a sharp increase” from 2016. “Coinciding with rising optimism, the U.S. unemployment rate fell from an average 4.9% in 2016 to 4.4% in 2017, the lowest rate since 2000,” Gallup News reports. ------------------------- Trump looks to slash government red tape on overseas sale of U.S. made weapons - The Washington Times As part of the President’s “Buy American” initiatives, the Trump Administration is looking to “streamline the weapons export process and speed up the pace of deals” for overseas sales of weapons. American arms manufacturers believe these changes will “even the playing field with their less regulated foreign competitors and result in billions of dollars in new deals.” White House Drug Policy Office Releases Funding Opportunity Announcement for Drug-Free Communities (DFC) Support Program HEALTHCARE Issued on: January 12, 2018 Office of National Drug Control Policy Today, the Office of National Drug Control Policy, in collaboration with the Department of Health and Human Services’ Substance Abuse and Mental Health Services Administration, has started accepting applications for Drug-Free Communities Support Program grants, for Fiscal Year 2018. The Drug-Free Communities Support Program strengthens collaboration with community coalitions working to prevent youth substance use. Federal contributions to community coalitions play a vital role in preventing drug use in the United States. In New Jersey, Hunterdon County Safe Communities has been able to decrease the use of alcohol and marijuana in a 30-day period among high school students due to increased community mobilization directly correlated to funding granted by these support programs. There are an estimated 120 grant awards to be distributed for Fiscal Year 2018, totaling approximately $15,000,000. All applicants applying to the Drug-Free Communities Support Program are encouraged to attend one of the following pre-application workshops: January 23, 2018 – Amarillo, Texas January 25, 2018 – Henderson, Nevada January 31, 2018 – Jackson, Mississippi February 9, 2018 – National Harbor, MD To register for a workshop, please visit: https://cmpinc.net/dfc. To apply for a Drug-Free Communities Support Program Grant, please visit https://www.whitehouse.gov/ondcp/grants-programs/. Take Time to Volunteer on January 15 Thousands of people come together to celebrate the life and work of MLK every year in January. This Monday is also an opportunity to volunteer with organizations across the country. Pay your respects to MLK's legacy by taking time out of your day to help someone in need.   MedWatch - The FDA Safety Information and Adverse Event Reporting ProgramCORRECTION - Feeding Tube Placement Systems: Letter to Health Care Providers - Reports of Pneumothorax Events This letter corrects the previously issued Dear Health Care Provider Letter from January 11, 2018 AUDIENCE: Surgery, Critical Care Medicine ISSUE: The FDA is providing information about reports of pneumothorax events associated with feeding tube placement procedures using the Cortrak 2 Enteral Access System (EAS) by Corpak Medsystems. Most reports indicate these pulmonary events required urgent intervention, including needle decompression or chest tube placement. Several of these events were associated with cardiopulmonary arrest and patient death. Although pneumothorax is a known rare complication of “blind insertion” of feeding tubes, typically < 0.5%, we are alerting clinicians that the use of this device does not eliminate this risk and reminding health care providers of important use information for EAS systems. From January, 2012, to July, 2017, the FDA received 51 Medical Device Reports (MDRs) about pneumothorax events related to the use of the Cortrak device. These included 11 reports of patient death. The relationship between the pulmonary events and the death however, cannot be concluded definitively in all cases. In addition, because the MDR system is based on passive surveillance, we cannot determine how the rate of these complications compares to that estimated for blind insertion. During that same period of time, FDA received one report of a non-fatal pneumothorax event associated with the Kangaroo Feeding Tube with IRIS Technology. (The previous letter issued on January 11, 2018 attributed an inaccurate number of adverse events and deaths to the Kangaroo Feeding Tube with IRIS Technology). That event occurred following blind placement of the tube, without use of the video console. The smARTrack device is not currently being sold within the United States and no MDRs have been received for this device. BACKGROUND: EAS are designed to aid in the placement of naso-enteric feeding tubes by transmitting real-time positional information to an external visible screen or console. The FDA has cleared three EAS devices for marketing in the United States, each of which uses a different technology to track the position of the feeding tube during the insertion procedure. The Cortrak 2 Enteral Access System by Corpak Medsystems uses electromagnetic sensors in a stylet to provide a visual representation of the tip of the tube relative to an external receiving unit placed over the patient’s xiphoid process. The Kangaroo Feeding Tube with IRIS Technology by Covidien employs a camera embedded in the distal end of the tube and provides a video stream of the gastrointestinal tract during placement. The smARTrack Feeding Tube by ART Healthcare uses impedance sensors embedded within the feeding tube to provide a visual representation of the tube relative to the lower esophageal sphincter. RECOMMENDATION: For Enteral Access Systems, the FDA recommends: The device only be used by clinical staff who have received the prerequisite training developed by the manufacturer and who are credentialed within their institution to place an enteral feeding tube. The device not be used in patients who have contraindications for naso-enteric feeding tubes in general. If any resistance is met during placement or the patient demonstrates any signs of respiratory distress, including cough or shortness of breath, the tube should be withdrawn and the patient re-assessed. Confirmation of the final tube position should be done per institution protocol, in particular if:◦Any difficulty occurred during insertion; The patient displayed any signs of respiratory distress during or after the procedure; The tube’s path during placement appeared to deviate from expected or the final location is uncertain; The patient has a variation in normal gastrointestinal anatomy; or The patient is intubated or has an altered level of consciousness. For the Cortrak device in particular, the FDA also recommends: The user ensures that the receiver is aligned properly throughout the procedure and does not move. The manufacturer instructions call for the top of the receiver to be positioned at the xipho-sternal junction, level, and parallel with spine and midline. The user observes and assesses the real-time tracing to ensure the proper path of the tube. The final location, including which quadrant the tip is located in, and the centimeter marking, should not be solely relied upon for assessment of whether the device is correctly placed or not. The device be used with caution in proximity to other electrical equipment (especially those emitting in the 20-300 kHz frequency band) as readings may be impacted. Prompt reporting of adverse events helps the FDA identify and better understand the risks associated with medical devices. Voluntary reports of adverse events related to EAS devices can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Device manufacturers and user facilities must comply with the applicable MDR regulations. Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Complete and submit the report Online: www.fda.gov/MedWatch/report Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 Read the MedWatch Safety Alert, including a link to the Healthcare Provider letter, at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm592051.htm Becton-Dickinson (BD) Syringes Used to Store Compounded or Repackaged Drugs: FDA Alert - Problematic Rubber Stoppers Replaced AUDIENCE: Pharmacy, Health Professionals, Risk Manager ISSUE: Becton-Dickinson (BD) informed FDA that it is no longer using the rubber stopper material associated with loss of drug potency in its general use syringes, and BD has instead returned to a rubber stopper it used previously in the syringes. In 2015, FDA initially alerted health care professionals not to administer compounded and repackaged drugs stored in certain sizes of general use BD syringes, based on reports of an interaction with the rubber stopper that caused some drugs stored in these syringes to lose potency when not used immediately. As stated previously, the general use BD syringes are cleared for immediate use in fluid aspiration and injection, but not for use as a closed container storage system for drug products, and FDA has not established the suitability of these syringes (with either rubber stopper) for that purpose. BACKGROUND: The FDA’s original alert in August 2015 applied to compounded or repackaged drugs that have been stored in 3 mL and 5mL BD syringes; FDA expanded its alert in September 2015 to include certain additional syringe sizes including 1mL, 10mL, 20mL and 30mL BD syringes, and BD oral syringes. RECOMMENDATION: Health care professionals may contact BD at (201) 847-6800 for more information and for confirmation that the specific lots of syringes used by a facility contain the new stoppers Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 Read the MedWatch Safety Alert, including a link to the FDA alert, at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm592437.htm Fieldbrook Foods Corporation Clarifies Scope of its Voluntary Recall. Products Include Orange Cream Fieldbrook Foods Corporation is clarifying that the previously announced voluntary recall of all orange cream bars and chocolate coated vanilla ice cream bars that were produced in 2017 on the company’s Hoyer 1 Line at its Dunkirk, NY plant (plant code 362677) also includes 28,751 cases of Raspberry Cream Bars that were included with Orange Cream Bars in ALDI seasonal split-case purchases. The split-cases were shipped between March and August 2017. These products are being recalled due to the possibility that they may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only shortterm symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Hom/Ade Foods, Inc. Voluntarily Recalls Frozen Biscuits Because of Possible Health Risk Hom/Ade Foods, Inc is voluntarily recalling Mary B’s® brand biscuits due to potential contamination with Listeria monocytogenes. The problem was discovered in a product sampling conducted by an outside co-packer, who manufactured the product. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. The Mary B’s products affected are frozen bagged biscuits with the UPC codes listed below. All “Best If Used By” dates BEFORE September 23, 2018 and with the letter “M” immediately after the date are included in the recall. The code may be found on the back of the bag, lower right corner. No other code dates are affected.