The American Hospital Association (AHA) has established new guidelines for managing patients who are suspected of haviong suffered a stroke.  Eligible patients presenting to the hospital with ischemic stroke should receive recombinant tissue plasminogen activator (rTPA) within 60 minutes of arrival, according to the new ischemic stroke guidelines.
Published in Stroke, the guidelines include the following new or revised recommendations:
• Patients with suspected stroke should be quickly taken to the closest certified primary stroke center or comprehensive stroke center. If no such centers exist, they should be taken to the most appropriate institution that provides emergency stroke care.
• In community hospitals without onsite stroke expertise, telestroke consultation together with stroke education and training for clinicians could help increase use of rTPA.
• Intravenous fibrinolysis may be considered in patients with mild stroke deficits, rapidly improving stroke symptoms, major surgery in the prior 3 months, and recent myocardial infarction.
• Efforts should be made to reduce the time from symptom onset to reperfusion with intra-arterial therapies.


Stroke victims, their families and attorneys should be aware that Post-Traumatic Stress Disorder (PTSD) is a common disorder found after stroke or major traumas, and may play a significant role in impeding recovery. Frequently a consequence of acute life-threatening events, including acute coronary syndrome (ACS), cancer, and stroke, PTSD is estimated to affect up to 18% of stroke survivors.   PTSD has been shown to impair stoke victims’ reliable adherence to medication regimens, according to new research.

Investigators at Columbia University Medical Center in New York found that 65% of stroke survivors with PTSD failed to adhere to treatment vs 33% of their counterparts without PTSD. They also found that concerns about medications were a primary barrier to treatment adherence.
Stroke survivors should be assessed for concerns about medications and PTSD symptoms, so that interventions may be introduced as early as possible to get patients back on track to avoid future stroke events. The study was published online on January 7th in the British Journal of Health Psychology.

In survivors of strokes and transient ischaemic attacks…adherence to risk-reducing medications, including antiplatelet agents, antihypertensive agents, and statins, is especially important for preventing subsequent strokes.

Veterans and Medicare beneficiaries can now enjoy new access to their own medical information and other data. In August, President Obama announced the creation of the “Blue Button”—a web-based feature through which patients may easily download their health information and share it with health care providers, caregivers, and others they trust. Since then, the Department of Veterans Affairs (VA) and the Centers for Medicare & Medicaid Services (CMS) in the Department of Health and Human Services (HHS) have beta-tested their respective systems—with great success. The Blue Button was formally launched today.

Veterans should log onto My HealtheVet at and click the Blue Button can save or print information from their own health records. Medicare beneficiaries who are registered users of can log onto a secure site where they can save or print their Medicare claims and self-entered personal information with the Blue Button there. Data from of each site can be used to create portable medical histories that will facilitate dialog with Veterans’ and beneficiaries’ health care providers, caregivers, and other trusted individuals or entities.

The Blue Button option should help Veterans and Medicare beneficiaries save their information on individual computers and portable storage devices or print that information in hard copy. Having this ready access to personal health information from Medicare claims can help beneficiaries understand their medical history and work more easily and effectively with providers, as well as provide valuable assistance to their attorneys. The Blue Button feature will allow Medicare beneficiaries to view their claims and self-entered information—and be able to export that data onto their own computer. The information is downloaded as an “ASCII text file,” the easiest and simplest electronic text format. The files are easy to read by the individual, and helps organize a lot of information.

The My HealtheVet personal health record includes self-entered health data (including blood pressure, weight, and heart rate), emergency contact information, test results, family health history, military health history, and other health-related information. The ASCII text file that Veterans can download will include this information. As additional personal health information becomes available to VA patients through the My HealtheVet personal health record, this will also be added to the VA Blue Button download. In pre-launch testings, the VA’s Blue Button system has generated an overwhelmingly positive response, and many veterans have already used it to access their records.

For a long time, registered users of have had the ability to view their Medicare claims information add their personal and health information, such as emergency contact information, names of pharmacies and providers, self-reported allergies, medical conditions, and prescription drugs. Now, with the Blue Button, CMS is making it convenient and safe for them to download and share this information in an easy-to-read and portable format. For people who are involved in personal injury or medical malpractice claims, the slow-moving administration of Medicare agencies has delayed their recoveries of settlement funds for months, and oftentimes, for more than a year!

The VA and CMS both stress the importance to users of protecting the electronic information on their personal computers with appropriate security measures. Once individuals download their data, they will need to ensure its safety—for example, by encryption or password protection.

The VA and CMS issued a challenge to software developers to develop apps to make the Blue Button even easier and more useful.  The winner of that challenge is Adobe’s Blue Button Health Assistant. This new “app” provides a comfortable and familiar user layout and eases the linkage of consumer information—including immunizations, allergies, medications, family health history, lab test results, and military service histories—among patients, providers, and caregivers using My HealtheVet, or claims data for those using the CMS Button.

Soon, Blue Button users may be able to augment the downloaded information that is housed on their computers—or that they transferred to a commercial personal health record or other health application—through automated connections to, and downloads from, major pharmacies including Walgreens and CVS; lab systems such as Quest and LabCorp; and an increasing number of inpatient and outpatient electronic medical records systems.




The FDA has issued a “Warning Letter”, dated January 10, 2013, to St. Jude Medical, a company that manufactures many medical devices used throughout the world, including implantable cardiac devices.  In the letter, St, Jude was advised that, during a 2012 inspection of St. Jude’s Sylmar, California facility, FDA investigators determined that St. Jude manufactured implantable cardiac leads which were “adulterated” under federal law, in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. While St. Jude has responded to some of the concerns addressed by the investigators,the FDA has concluded that the responses were inadequate.

The FDA has asked St. Jude to provide written notice within fifteen business days from the date they received the warning letter of the specific steps St. Judey has taken to correct the noted violations, as well as an explanation of how the firm plans to prevent these violations, or similar violations, from occurring again.  They asked that St. Jude include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that the firm has taken.  If St. Jude’s planned corrections and/or corrective actions will occur over time, they are to include a timetable for implementation of those activities.  If corrections and/or corrective actions cannot be completed within fifteen business days, St. Jude was asked to state the reason for the delay and the time within which these activities will be completed. Finally, the warning letter notes that St. Jude’s “response should be comprehensive and address all violations included in this Warning Letter.”  We’ll see…but it looks like the FDA is finally running out of patience with St. Jude.



Unredacted Reports of Nursing Home Inspections Now Available!

From good buddy-nurse-paralegal Janabeth Taylor….’Feds Release Nursing Home Inspections, Free of Censor’s Marks’ – the government has released unredacted write-ups of problems found during nursing home inspections around the country. ProPublica is making them available today for anyone who wants to download the complete versions. “The Silent Epidemic – Nursing Home Care Abuse ”

Cars and trucks that are too quiet? In fact, it appears that some vehicles are so quiet that they may be dangerous! The National Highway Transportation Safety Agency has proposed a new safety standard, as required by the Pedestrian Safety Enhancement Act (PSEA) of 2010, which proposes to establish a Federal motor vehicle safety standard (FMVSS) setting minimum sound requirements for hybrid and electric vehicles. This new standard would require hybrid and electric passenger cars, light trucks and vans (LTVs), medium and heavy duty, trucks, and buses, low speed vehicles (LSVs), and motorcycles to produce sounds meeting the requirements of this standard. This proposed standard applies to electric vehicles (EVs) and to those hybrid vehicles (HVs) which are capable of propulsion in any forward or reverse gear without the vehicle’s internal combustion engine (ICE) operating. This standard would ensure that blind, visually-impaired, and other pedestrians are able to detect and recognize nearby hybrid and electric vehicles, as required by the PSEA, by requiring that hybrid and electric vehicles emit sound that pedestrians would be able to hear in a range of ambient environments and contain acoustic signal content that pedestrians will recognize as being emitted from a vehicle.



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