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 agencyâs
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
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 manufacturerâs quality
systems information. The FDA will also conduct inspections of manufacturersâ
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.
Clean Advisory Board introduces new, stringent testing protocols for
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
The independent certification program was developed by the Advisory Board in
partnership with TRSA, the leading global textile services trade
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
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 programâs new
website at hygienicallyclean.org.
All programs under the Hygienically Clean umbrella will benefit from these
Visit Hygienically Clean for the protocols.
Medline to bring
supply chain expertise and savings to Blood Centers of America as new supply
Blood Centers of America (BCA), the nationâs 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 BCAâs
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.
Medlineâs 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 momentâs 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.
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
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.
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 filersâor about 30 millionâwho werenât 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
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
Australiaâs 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 Rastonâs South Australiaâs 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.
promoted a green coffee bean weight-loss supplement agrees to settle FTC
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
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 FTCâs 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
âOz effectâ â a phenomenon in which discussion of a product on the program
causes an increase in consumer demand.
The defendants continued to use Duncanâs 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 âNew Health Discovery! As Seen on TV, âThe Dieterâs Secret
Weapon.ââ After appearing on Dr. Oz, Duncan and his companies sold tens of
millions of dollarsâ worth of the extract, according to the FTC.
The FTC also alleged that Duncan and several of the companiesâ 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
Visit the FTC for the full news release.