Archive for May, 2010

Headlines: Phantom Recall Alleged in Defective Motrin

Friday, May 28th, 2010

FALLS CHURCH – Today’s top headlines in recall and patient safety for Friday, May 28:

  • Maker of children’s drugs accused of hiding Motrin recall from public: The company at the center of a massive recall of children’s Tylenol and other popular over-the-counter products tried to perform a “phantom recall” of defective Motrin by sending contractors around the country to buy up the medicine from stores without alerting regulators or the public, according to the chairman of a Congressional committee investigating the company.
  • FDA weighs penalties in drug recall: A Johnson & Johnson unit that recalled millions of children’s Tylenol bottles may face criminal penalties.
  • Scribblers go electronic at hospitals: Patient safety advocates such as Sorrel King say that while patients who “scribble” treatment details from physicians are still noticed, the culture will change as patients begin to collect this data electronically.

News: Novel Therapeutic Approach Shows Promise Against Pathogens

Friday, May 28th, 2010

BETHESDA, Md. - A team of scientists has developed a new approach to pathogens that has the potential to enhance the action of antibiotics and provide an alternative to them.

A team of scientists from government, academia and private industry has developed a novel treatment that protects mice from infection with the bacterium that causes tularemia, a highly infectious disease of rodents, sometimes transmitted to people, and also known as rabbit fever. In additional experiments with human immune cells, the treatment also demonstrated protection against three other types of disease-causing bacteria that can be highly virulent.

The experimental therapeutic works by stimulating the host immune system to destroy invading microbes. In contrast, antibiotics work by directly attacking invading bacteria, which often develop resistance to these medications.

“A therapeutic that protects against a wide array of bacterial pathogens would have enormous medical and public health implications for naturally occurring infections and potential agents of bioterrorism,” says Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health, in a release. Read the full press release here.

Other health safety headlines from Noblis Health Innovation include:

  • Senator questions Medicare agency’s use of Defense audit unit: Iowa Sen. Charles Grassley has raised concerns that CMS could be risking the reliability of its audits by contracting with DCAA, which has undergone nearly two years of turmoil since a federal watchdog questioned the agency’s management and auditor independence.
  • No clouds in future for health data: Health care data won’t be moving to the cloud any time soon despite an expected increase in the volume of information, according to health IT managers.
  • Health data exchange build starts this summer: By early July, the Office of the National Coordinator will announce the winners of 11 contracts for developing a health information exchange framework based on a model originated by federal homeland security agencies for sharing sensitive information over the Internet.
  • In E. Coli fight, some strains are largely ignored: As the food industry and government regulators have focused on one virulent strain of the bacteria E. Coli, six others are emerging as a serious threat to food safety.

Hospitalists Step In For Family Doctors

Thursday, May 27th, 2010

Health Safety_RecallFALLS CHURCH – Today’s top headlines in healthcare and patient safety for Thursday, May 27, compiled by the library research department of Noblis Health Innovation:

Learn more about RASMAS by visiting their website at www.info.rasmas.org. Or follow Bill Klein’s daily coverage of the recall scene by following him on Twitter at twitter.com/HealthRecall

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News: Boston Scientific Resumes Distribution of ICDs

Wednesday, May 26th, 2010

BOSTON – Boston Scientific Corp. resumed distribution of the remainder of its heart devices whose sales were halted for two months as US regulators reviewed manufacturing changes, The Boston Globe reports.

Other Health Safety and Recall news gathered by the Noblis Health Innovation library staff includes:

  • FDA unveils food safety reporting Web portal: The Food and Drug Administration and the National Institutes of Health this week unveiled a Web site for reporting food safety issues.
  • USDA estimates E coli, Salmonella costs at $3.1 billion: The US Department of Agriculture, using its recently released tool for calculating the cost of foodborne illnesses, estimates that Salmonella and Escherichia coli O157:H7 cases cost the nation about $3.13 billion a year.
  • CMS proposes easing telemedicine credentialing rules: The Centers for Medicare and Medicaid Services has proposed changes to ease the burdens of credentialing and privileging for hospitals that provide telemedicine.
  • VA issues draft RFP for $12B IT contract: The Veterans Affairs Department’s $12 billion solicitation for information technology services under its Transformation Twenty-One Total Technology acquisition vehicle has moved a step closer to fruition.
  • U.S. government stockpiles new, safer smallpox vaccine: The U.S. government has begun bolstering its smallpox vaccine stockpile with a new version designed to close a gap that left millions vulnerable to a bioterror attack.
  • NPR looks at mental health apps for cell phones: As the computing power of cell phones increases, more and more sophisticated mobile apps are being developed for the mental health field. They’re seen as a way to bridge periodic therapy sessions — a sort of 24-7 mobile therapist that can help with everything from quitting smoking to treating anxiety to detecting relapses in psychotic disorders.

Noblis ICD-10 Conference; Healthcare Experts Detail Strategy for Changes

Tuesday, May 25th, 2010

ICD-10 Expertise and readinessFALLS CHURCH – To help bring attention to the upcoming transition to the medical coding system ICD-10, Noblis Health Innovation held a panel discussion on the issue at the Noblis Innovation & Collaboration Center.

At the forum, Todd Couts, Noblis’ ICD-10 Implementation Program Manager, called the issue a potential “perfect storm” that can be avoided through planning.

The Tuesday, May 18 forum was entitled “Risk or Opportunity? Healthcare Leaders on Preparing for ICD-10” and was developed to exchange information and ideas among public and private sector stakeholders. Set for broadcast  on Federal News Radio AM 1500 on Wednesday, May 26 at 11 a.m, the radio show discussed the risks and opportunities of the ICD-10 transition, and how it relates to other healthcare initiatives such as healthcare reform and HITECH

The panel’s moderator was Robert J. Clerman, Noblis’ Vice President of Corporate Mission Development. Along with Couts, the panelists were Jacqueline Gibbons, Assistant Dean Health Information Management, Northern Virginia Community College; Marcia Insley, Deputy Director, Office of Health Data and Informatics at the Veterans Health Administration ; and Sonja Racke, Provider Outreach and Education Lead for National Government Services.

Each panelist discussed how the issue would affect their segment of the industry; a common concern was the difficulty of the transition.

Gibbons said that in preparation for the switch, Northern Virginia Community College has already created new timelines and training curriculums. One of the biggest changes, Gibbons said, is the need for more anatomy training. The old ICD-9 codes required a limited amount of biology. But the new scheme requires that coders have a far better understanding of anatomy and physiology. ICD-10, however, is but one of many changes coming to healthcare. Gibbons said that these must all be addressed together, because they are all connected. “None of them work in a silo.” said Gibbons.

Even for a federal government agency such as the Department of Veterans Affairs that has information systems that were built in house, the changeover will still be substantial. The agency, for instance, has stored billions of vital signs that must be protected. In addition, within the agency’s I.T. system, over 50 different applications will need to be modified.

Racke called the challenges “monumental.” Many smaller providers, she said, still use paper claims. Even when they want to make the change, they do not have the resources. “Large groups are able to make the change because they have the cashflow,” said Racke.

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News: High Technology Alternatives to High Costs

Tuesday, May 25th, 2010

FALLS CHURCH – Today’s headlines from Noblis Health Innovation:

  • Two wars produce unique and puzzling brain injuries: What has been called the “signature wound” of the wars in Iraq and Afghanistan — the mild brain damage troops suffer from a roadside bomb — might be so unique in its destruction that it could be a newly discovered disease, scientists say. (more…)

Tips and Advice for AED Maintenance and Usage

Monday, May 24th, 2010
With CPR and AED training, the American Heart Association gives out wallet-sized pamphlets to help remind people what to do in the event of an emergency.
For CPR and AED training, the American Heart Association distributes wallet-sized pamphlets to help remind people what to do in the event of an emergency.

FALLS CHURCH – Each year, over one million Americans have heart attacks.

One of the greatest lifesavers for heart attack patients is an Automated External Defibrillator, or AED. An AED is a lunchbox-sized device used to evaluate the cardiac status of an individual suspected of suffering a cardiac arrest.

AED use by non-professsionals

The AED guides the user through the process of administering a defibrillation shock if it determines one is needed. AEDs are designed to be used by non-professionals with a minimal amount of training. Once turned on, most AEDs provide visual and voice prompts that instruct the user what to do and when to do it. Many public facilities including hospitals, nursing homes, and clinics have AEDs readily accessible for use by any passerby.

The increasing use of sophisticated medical devices by consumers poses challenges to manufacturers, distributors, regulators, and the organizations that make these devices available to users. One problem is maintenance.

AEDs are very sophisticated devices that need on-site maintenance.  Most have internal component testing functions that relieve the owner of much of the maintenance burden, but—like smoke alarms or fire extinguishers—these devices cannot be hung on a wall and left there. Each manufacturer has its own recommended maintenance and testing schedule.  Some schedules recommend maintenance checks as frequently as every day.

What you should do if your organization has an AED:

  • Be aware of recalls and field corrections covering the devices you use.
  • Review your policy for suggested device maintenance.
  • Make sure your AED policies reflect the fact that AEDs are tracked devices by the FDA and understand your responsibilities related to the AED device.
  • Make sure inspection of the devices includes components with expiration dates, such as electrodes and pads.
  • Make sure the manufacturer of the devices you use has your correct contact information to ensure prompt communication of recalls and service bulletins.
  • Make sure that responding staff are trained to use these devices. The Red Cross and other organizations provide training classes for the use of AEDs.
  • Review the American Heart Association website that includes a page of tips on AED usage, as well as a page of AED manufacturers.

Your organization’s internal controls may be adequate, but because AEDs also are available over the counter, your patients who have these devices in their homes also need to be made aware that maintenance is required.

If your organization has patients with these devices in their homes, make sure they and their caregivers are aware of the need to perform the manufacturer recommended maintenance and the importance of keeping their contact information up to date with the manufacturer.

Note: For hospitals and healthcare organizations, check to see if you are a subscriber to the recall service RASMAS. RASMAS tracks AED recall notices and alerts, and routes them to the designated staff member. Consumers can follow RASMAS’ recall coverage on Twitter at @HealthRecall.

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News: VA Secures Networked Medical Devices

Monday, May 24th, 2010

US-DeptOfVeteransAffairs-SealWASHINGTON, D.C. - The Veterans Affairs Department has launched an initiative to isolate all 50,000 networked medical devices by December. Federal Computer Week ‘s Alice Lipowicz reports on the plan, which would secure 50,000 networked medical devices by isolating them from other computer networks.

The initiative was launched after computer virus and malware infections of 122 networked medical devices in the last 14 months that had the potential to harm patients, according to VA Chief Information Officer Roger Baker.

Other headlines for May 24, 2010 compiled by the library department of Noblis Health Innovation include:

  • VA’s Baker details improved data security regime: Roger Baker, CIO of the Veterans Affairs Department, believes he has the technical solution that will turn around many of the information security problems that have plagued VA for years and will help ensure the department does a better job of protecting its network and sensitive data.
  • VA sets the telehealth table: The Veterans Health Administration’s pioneering telehealth program is drawing the attention of health care reformers, but how soon and how much such approaches can help remains to be seen.
  • NIH proposes new funding rules to prevent conflicts of interest: The National Institutes of Health last week proposed new guidelines to prevent financial conflicts of interest among thousands of researchers who receive federal funding, a move long sought by watchdogs of scientific research concerned about the influence of the drug industry and others.
  • Defense bill aims to beef up health care for military personnel: The fiscal 2011 Defense authorization bill, which the House Armed Services Committee approved last week, would expand several military health programs, including TRICARE.

Learn more about RASMAS by visiting their website at www.info.rasmas.org. Or follow Bill Klein’s daily coverage of the recall scene by following him on Twitter at twitter.com/HealthRecall

Headlines: Gadget Knows You’re Sick Before You Do

Wednesday, May 19th, 2010

Health_Safety_Recall_NewsFALLS CHURCH -Dr. Geoffrey Ginsburg, director of Duke’s Institute for Genome Science & Policy, is collaborating with a team of colleagues to create a gadget that can detect viral infection hours before the faintest hint of a runny nose or a sore throat. Katie Drummond of Wired reports on the technology  in a story on the Pentagon’s virus detector.

Other headlines from Noblis Health Innovation’s library services department include:

Headlines: CMS Plans ‘Innovation’ Center, White House Appoints Varmus

Tuesday, May 18th, 2010

WASHINGTON, D.C. – The White House appointed Harold Varmus, a former Director of the National Institutes of Health and co-recipient of the 1989 Nobel Prize in Physiology or Medicine for studies of the genetic basis of cancer, as the new Director of the National Cancer Institute.

Varmus was co-chair of President Obama’s Council of Advisors on Science and Technology and has served as the President of Memorial Sloan-Kettering Cancer Center in New York City since January 2000. His research career began as a member of the U.S. Public Health Service at the NIH and as a post-doctoral fellow at the University of California, San Francisco.   He then served as a member of the UCSF medical faculty for over twenty years, conducting scientific work on cancer genes and retroviruses. (more…)