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DAILY UPDATE

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January 30, 2015   Download print version

FDA takes steps to improve reliability of automated external defibrillators

Hygienically Clean Advisory Board introduces new, stringent testing protocols for healthcare laundries

Medline to bring supply chain expertise and savings to Blood Centers of America as new supply partner

CDC installing cameras in labs in agency-wide safety push

Patients respond to 'expensive' drug better than 'cheap' one

Up to six million households facing penalty for skipping health insurance

How (and why) chemists figured out how to unboil an egg

Marketer who promoted a green coffee bean weight-loss supplement agrees to settle FTC charges

 

Daily Update Archives

 

 

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February 2015

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FDA takes steps to improve reliability of automated external defibrillators

The U.S. Food and Drug Administration announced that it will strengthen its review of automated external defibrillators (AEDs) to help improve the quality and reliability of these devices.

The FDA issued a final order that will require AED manufacturers to submit premarket approval applications (PMAs), which undergo a more rigorous review than what was required to market these devices in the past. The agency’s strengthened review will focus on the critical requirements needed to ensure the safety and reliability of AEDs and their necessary accessories, including batteries, pad electrodes, adapters and hardware keys for pediatric use.

Automated external defibrillators are portable, electronic medical devices that automatically sense potentially life-threatening cardiac arrhythmias and either automatically deliver or advise the user to deliver electrical stimulation to re-establish normal heart rhythms. They are often stored in public locations for use in an emergency and, while they can be lifesaving, there has been a history of malfunction issues.

From January 2005 through September 2014, the FDA received approximately 72,000 medical device reports associated with the failure of these devices. Since 2005, manufacturers have conducted 111 recalls, affecting more than two million AEDs. The problems associated with many of these recalls and reports included design and manufacturing issues, such as inadequate control of components purchased from other suppliers.

By requiring premarket approval for these devices, the FDA will receive important information about an AED manufacturer’s quality systems information. The FDA will also conduct inspections of manufacturers’ facilities prior to approval. After approval, manufacturers will be required to submit to the FDA any changes made to the devices that affect safety or effectiveness, and annual reports on device performance.

Given the importance of these devices in emergency situations, AEDs currently on the market will remain available while manufacturers work to meet the new PMA requirements. The FDA does not intend to enforce the PMA requirement for AEDs until July 29, 2016, as long as manufacturers notify the FDA of their intent to file a PMA by April 29, 2015. The FDA does not intend to enforce the PMA requirement for currently marketed, necessary AED accessories until January 29, 2020. Visit the FDA for the release.

 

 

Hygienically Clean Advisory Board introduces new, stringent testing protocols for healthcare laundries

The Hygienically Clean Advisory Board announced new, more stringent testing protocols for its Hygienically Clean Certification for commercial laundry facilities processing healthcare related goods.

Reviewed by a third party, independent epidemiologist, the new protocols are designed to better ensure quantifiable hygienic outcomes for healthcare linens as well as recommendations for best practices for improved hygienic transportation and storage of clean linens and other textiles by commercial laundry services.

The independent certification program was developed by the Advisory Board in partnership with TRSA, the leading global textile services trade association.

In order to clear the initial thresholds of the Hygienically Clean Certification, facilities must submit two random textiles to an independent, TRSA-approved laboratory for bacteriological testing. The samples must pass testing on three consecutive rounds and the facility must pass an inspection prior to qualification.

At the conclusion of the qualification process, facilities must then pass new regularly scheduled testing protocols to maintain the Hygienically Clean Certification. These protocols include instituting the Replicate Organism Detection and Counting (RODAC) microbiological test. Modeled on European standards, facilities pursuing the Hygienically Clean Certification must now submit to RODAC testing four times per year rather than the previous protocol of twice per year.

In addition, the Advisory Board has incorporated United States Pharmacopeia (USP) 62 as an additional layer of testing. USP 62 is a recognized testing methodology for seven different microorganisms most commonly found in healthcare environments. Under the new Hygienically Clean Certification protocols, facilities seeking certification will be required to submit to this new, additional layer of testing twice annually.

The transportation and storage best practices include standards for cleaning of transportation vehicles and their storage containers, as well as proper handling, separation and storage of textiles on delivery to healthcare facilities.

Currently, 50 commercial laundry facilities have earned the Hygienically Clean Certification. Complete information on the program and its newly revised protocols and best practices can be found on the program’s new website at hygienicallyclean.org.

All programs under the Hygienically Clean umbrella will benefit from these changes.

Visit Hygienically Clean for the protocols.

 

 

Medline to bring supply chain expertise and savings to Blood Centers of America as new supply partner

Blood Centers of America (BCA), the nation’s largest blood supply network, has selected Medline Industries, Inc., as its exclusive supply partner of phlebotomy and donor screening kits.

The three year agreement, beginning April 1, 2015, will strengthen BCA’s ability to make phlebotomy and donor screening kits accessible to more than 50 member centers, as well as its suppliers and clients, all of which serve hospitals and patients across the country. BCA provides more than 40 percent of the U.S. blood supply.

Medline’s vast logistics network of more than 40 strategically located distribution centers across the country will provide BCA with kits whenever and wherever needed, especially in critical emergencies. The medical supplier, distributor and manufacturer, with extensive supply chain expertise, is built on serving the healthcare industry at a moment’s notice, for crises like Hurricanes Katrina and Sandy, or Ebola preparedness, as well as every day needs across the continuum of care. Visit Businesswire for the release.

 

 

CDC installing cameras in labs in agency-wide safety push

The U.S. Centers for Disease Control and Prevention (CDC) has introduced camera monitoring of workers in its highest-level biosafety laboratories as it seeks to restore public faith in its procedures after a series of mishaps, agency officials tell Reuters.

One lab worker inadvertently risked contracting Ebola last month when they worked with the live virus that was supposed to have been inactivated, or killed. Since last June, the Atlanta-based agency has disclosed several incidents, one in which scientists unknowingly sent potentially live anthrax to a lower-security laboratory and another in which a deadly form of bird flu was sent to an external agency's lab.

The mishaps have raised major questions over safety practices at more than 1,000 laboratory and support facilities that make up the CDC, whose role is to monitor and prevent outbreaks of disease.

The move to monitor workers will allow lab directors and senior scientists to ensure they have followed safety protocols exactly, Leslie Dauphin, interim director of laboratory safety. Dauphin, who played a key role in the CDC's initial response to the incidents, would not comment directly on the contents of the Ebola report, but confirmed that no one had been harmed.

The unidentified scientist, who was working with Ebola specimens that were supposed to have been inactivated, wore gloves and a gown but not a protective face mask or other gear recommended for working with live Ebola, the CDC said.

The anthrax and bird flu accidents touched off a congressional inquiry and a pledge from CDC director Dr. Thomas Frieden to overhaul the agency's safety culture.

The selection process for a new permanent lab safety chief could take months, so Dauphin has introduced new safety measures in the interim.

A total of 67 cameras have been installed in key laboratories to help ensure technicians follow protocols, especially the techniques to render dangerous pathogens harmless before they can be transferred to lower-security labs.

The move follows a strict review late last summer of inactivation methods in each high-security lab. Each lab now has a checklist for performing those procedures and it is up to senior scientists and lab directors to make sure each step is performed correctly.

The camera system will enable supervisors outside of a containment laboratory to review the footage and verify that steps were performed correctly, Dauphin said.

The video is transmitted from the containment lab via a Wi-Fi network, she said. The videos can be viewed by a supervisor in real time or later.

So far, the CDC has spent around $84,000 on the camera system, according to CDC spokesman Tom Skinner.

CDC has also formed for the first time an agency-wide group to offer standardized safety training for lab workers. Dauphin said CDC is exploring whether its scientific laboratories should adopt standards set by the Geneva-based International Organization for Standardization (ISO) or another external accrediting group. Visit Reuters for the article.  

 

 

Patients respond to 'expensive' drug better than 'cheap' one

The placebo effect is a phenomenon that occurs when giving a fake treatment such as a distilled water or sugar to a patient improves his condition simply because that person believes that the treatment will help him.

Now, a new study shows another instance when the placebo response can be very effective. Researchers have found that when people take a drug that they believe is more expensive than it really is, they are more likely to believe that the drug will work even if it is just a placebo.

For the new study published in the journal Neurology on Jan. 28, Alberto Espay, from the University of Cincinnati's Department of Neurology and Rehabilitation Medicine, and colleagues involved 12 patients with Parkinson's disease to examine the placebo effects of medication cost.

The researchers told the participants that they would be given two variations of the same drug but the other one was more expensive compared with the other. The participants were told that the cheaper drug costs $100 while the more expensive one was $1,500. The researchers also said that the purpose of the study was to determine if the two drugs are similar in efficacy regardless of the difference in price albeit all the participants were only given saline solutions.

The participants underwent several tests that would measure their motor skills as well as brain scans for measuring their brain activity before and after they were injected with the placebo.

The researchers found that although both placebos have improved the participants' motor functions, those who received the costlier drug first exhibited up to 28 percent improvements in their motor skill. In comparison, participants who received the cheaper drug only improved by 13 percent.

The researchers said that the participants experienced a great placebo response because placebo has been known to boost the release of dopamine in the brain which affects movement. Visit Tech Times for the study.

 

 

Up to six million households facing penalty for skipping health insurance

The U.S. government estimates as many as six million households may have to pay a penalty for not having had health-insurance coverage last year as required under the Affordable Care Act, officials said Wednesday.

About 150 million taxpayers are expected to file returns during the coming tax season, said Mark Mazur, assistant secretary for tax policy at the Treasury Department. The tax-filing process this year is expected to be trickier because Americans will, in some cases, have to pay a penalty or get smaller refunds because credits they received to offset insurance premiums were too large.

Up to 20% of tax filers—or about 30 million—who weren’t insured for most or any of last year likely will request and receive an exemption from the penalty, officials said. Many exemptions can be applied for during the tax-filing process.

The health law requires almost all Americans to have coverage or pay a penalty, with some exemptions. About 2% to 4% of tax filers are expected to have to pay the fine for not having carried insurance in 2014, which is $95 per adult, or 1% of family income, whichever is greater.

Federal officials began in early January mailing statements called 1095A forms to consumers with information they will need to file returns.

Government officials on Wednesday provided some of their first estimates on how Americans will be affected by the ACA at tax time. About three-quarters of tax filers who had coverage in 2014 simply will have to check a box on their federal tax forms indicating they had coverage last year.

About 9.5 million people selected or automatically were enrolled in health-insurance coverage through the second month of the continuing open-enrollment season, the federal government said Tuesday. That included 7.1 million consumers who used the federal HealthCare.gov exchange and 2.4 million people who relied on states using their own marketplaces.

The enrollment numbers cover through mid-January and indicate the Obama administration largely is on track to reach its earlier sign-up goals. The administration said in November that it was aiming for up to 9.9 million paid-up enrollees by the end of 2015. Visit the Wall Street Journal for the report.

 

 

How (and why) chemists figured out how to unboil an egg

You can't unscramble an egg. But you can unboil it.

That's what chemists with University of California, Irvine, and South Australia’s Flinders University managed to do, and their findings were published last week in the journal ChemBioChem. All it took was a chemical solution and a machine that spins at high speeds.

The eggs were used as a proxy for a serious endeavor: making cancer research more time and cost efficient. University of California, Irvine, chemistry and molecular biology professor Gregory Weiss wanted to figure out how to refold lab-created proteins associated with cancer. "The problem is when we tried to produce cancer-associated proteins... often times the proteins come out as a jumbled mess," Weiss said. "It kind of looks like boiled eggs... When that happens, we sigh deeply."

It can take days, even weeks, for scientists to tease out those gunked-up proteins that are stuck to the edges of test tubes. Until recently, those proteins were unpacked using dialysis, a method that's been around for more than a century.

So when Weiss visited Colin Raston’s South Australia’s Flinders University laboratory and saw his high-powered, vortex-fluid device that essentially pulls things apart, Weiss thought: why not pull proteins apart?

The saying "you can't unscramble an egg" came to mind; Weiss thought he'd set about proving that wrong. So they took an egg and separated the yolk from the white. The whites boiled for 20 minutes at 90 degrees Celsius until they were rock hard.

The egg whites' proteins had changed shape, but the proteins themselves remained intact -- much like misshapen cancer-associated proteins. So Weiss set about unfolding those egg white proteins back into shape, by first dissolving the boiled egg whites overnight in a urea chemical solution.

Then, he took the mixture, put it into the vortex fluid device, and the whites went for a high-speed, five-minute spin. As the proteins brush up against the test tube walls, the high shear force generated is enough to pull the proteins.

The result was a clear solution that looked just like diluted egg whites. At a molecular level, researchers looked at the protein lysozyme (a pretty important protein in giving eggs their antibacterial property). The process of diluting the egg whites and sticking them in the machine restored lysozyme back to about 85 percent of pre-boiled activity, Weiss said.

"The fundamental principle that we demonstrated was this idea that the proteins have changed their shape but they haven't changed their bonding patterns, their connectivity," Weiss said.

Visit the Washington Post for the story.

 

 

Marketer who promoted a green coffee bean weight-loss supplement agrees to settle FTC charges

Lindsey Duncan and the companies he controlled have agreed to settle Federal Trade Commission charges that they deceptively touted the supposed weight-loss benefits of green coffee bean extract through a campaign that included appearances on The Dr. Oz Show, The View, and other television programs.

Under the FTC settlement, the defendants are barred from making deceptive claims about the health benefits or efficacy of any dietary supplement or drug product, and will pay $9 million for consumer redress.

The FTC charged that Duncan and his companies, Pure Health LLC and Genesis Today, Inc., deceptively claimed that the supplement could cause consumers to lose 17 pounds and 16 percent of their body fat in just 12 weeks without diet or exercise, and that the claim was backed up by a clinical study. In September 2014, the FTC settled charges against the company that sponsored the severely flawed study that Duncan discussed on Dr. Oz.

According to the FTC’s complaint, shortly after Duncan agreed to appear on Dr. Oz but before the show aired, he began selling the extract and tailored a marketing campaign around his appearance on the show to capitalize on the “Oz effect” – a phenomenon in which discussion of a product on the program causes an increase in consumer demand.

The defendants continued to use Duncan’s Dr. Oz appearance in their marketing campaign after the show aired, the complaint states, posting links to the episode on websites and using retail point-of-sale displays showing messages such as “New Health Discovery! As Seen on TV, ‘The Dieter’s Secret Weapon.’” After appearing on Dr. Oz, Duncan and his companies sold tens of millions of dollars’ worth of the extract, according to the FTC.

The FTC also alleged that Duncan and several of the companies’ paid spokespeople portrayed themselves on television shows as independent sources of information about green coffee bean extract and other natural remedies, while failing to disclose their financial ties to the companies.

The proposed stipulated court order requires the defendants to substantiate any future weight-loss claims with at least two well-controlled human clinical tests. Any claims the defendants make about the health benefits and efficacy of any dietary supplement or drug cannot be misleading and must be substantiated by competent and reliable scientific evidence. Further, the order prohibits false claims that the benefits of any such product are scientifically proven. Visit the FTC for the full news release.