FDA issues update on UDI implementation for registered
Having passed the first Unique Device Identification System compliance
date of September 24, 2014 (for Class III devices and devices licensed under
the Public Health Service Act), the FDAâ€™s Center for Devices and
Radiological Health (CDRH) would like to take this opportunity to summarize
recent and upcoming UDI activities and deadlines.
The next two compliance dates for
UDI requirements are:
September 24, 2015 for
non-class III implantable, life-supporting, and life-sustaining
September 24, 2016 for
class II devices
Global Unique Device Identification
Database (GUDID) Data Submission:
In January 2015, FDA will begin
accepting GUDID account requests from labelers of I/LS/LS devices. Later in
2015, we plan to accept GUDID account requests from labelers of class II
devices. FDA strongly encourages all device labelers to take steps to ensure
their readiness to meet UDI requirements well before actual data submission
to GUDID. This will provide labelers with ample opportunity to assess their
ability to meet requirements, including data submission to the GUDID, by
their deadline and to work with us if they have any difficulties coming into
Suggested steps are included on the UDI website.
Also in January, FDA will host a
webinar to help Class II and I/LS/LS device labelers prepare to comply with
the UDI rule.
FDA will continue to work with
industry on UDI implementation issues that surfaced in 2014, including GUDID
data submission for contact lenses/IOLs and development of approaches to
ensure the UDI is available at the point of use for non-sterile implants.
FDA recognizes there are several other policy issues that are of significant
interest to industry; FDA hope to address a number them in 2015, such as UDI
direct marking requirements, convenience kits, posting of decisions on UDI
exceptions and alternatives, and issuance of additional Frequently Asked
The use of National Health Related
Items Code (NHRIC) and National Drug Code (NDC) numbers for devices is being
phased out over a time period that corresponds with the compliance dates for
UDI requirements. Device labelers that want to retain the use of FDA-issued
NHRIC or NDC labeler codes under a system for the issuance of UDIs were
required to request such continued use by September 24, 2014. If you intend
to retain the use of a previously issued FDA labeler code within your UDI
system but have not made such a request, we urge you to do so as soon as
FDA continues to collaborate with
stakeholders, such as the Pew Charitable Trusts, the Office of the National
Coordinator for Health IT (ONC), and the
Brookings Institution to promote and facilitate UDI adoption in
For additional information, please
Medical breakthroughs and discoveries in 2014 that prove
the future really is here
The best thing about medicine is
that itâ€™s always finding ways to reinvent itself. This year has been a great
year for health innovation, and humans are living longer and healthier lives
than ever before. Hereâ€™s a breakdown of some medical breakthroughs that we
at Medical Daily felt truly stood out this year.
Heart Transplant From A Cadaver: When it comes to
body transplants, itâ€™s pretty much a necessity that the donor is alive, but
this year all that changed. In October, a team of Australian scientists made
history when they revived dead hearts from cadavers and successfully
transplanted them into awaiting patients. About 20 minutes after the hearts
had stopped beating, doctors put them inside a machine, dubbed the â€śheart in
a box,â€ť which supplied the vital organ with oxygen. After removing the heart
from the box it was injected with a preservation solution, designed to keep
it fresh. This was done thanks to a perfusion-based machine, named
Measles Vaccine Makes Cancer Undetectable: 2014
has seen a lot of innovations in cancer treatment, but one of the most
remarkable was seen in May, when a measles vaccine overdose made one womanâ€™s
blood cancer go into complete remission. Stacy Erholz was injected with a
truly tremendous amount of the measles vaccine, a treatment which ended up
targeting and killing her blood cancer.
Itâ€™s a landmark. Weâ€™ve known for a
long time that we can give a virus intravenously and destroy metastic cancer
in mice. Nobodyâ€™s shown that you can do that in people before,â€ť said Dr.
Stephen Russell, lead researcher of the project, the Star Tribune Health
Surgeons Use 3D Printer To Perform Worldâ€™s First Skull Transplant:
The year 2014 has been great for 3D technology, as weâ€™ve learned that it can
not only help make our lives easier, but also help make them longer. In May,
a team of surgeons from the Netherlands performed the worldâ€™s first complete
skill transplant using a plastic tailor-made 3D-printed piece. The recipient
of the printed skull was a 22-year-old woman suffering from a condition that
thickened the bone structure on the skull. This increased the pressure on
her brain and seriously affected her ability to function normally. Following
the operation, the patient reported that she had regained her vision and was
able to return to work.
"We used to create an implant by
hand in the operating theater using a kind of cement, but those implants did
not have a very good fit," Dr. Bon Verweij, leader of the team at University
Medical Center in Utretch, said in a statement. "Now we can use 3D printing
to ensure that these components are an exact fit. This has major advantages,
not only cosmetically, but also because patients often have better brain
function compared with the old method."
Lab-Grown Vaginas: This year doctors revisited four
teenage girls who were fitted with the worldâ€™s first lab-grown vaginas, and
reported that they are still enjoying normal, pain-free function, Medical
Dailyreported. Eight years ago, the girls, who were born with a genetic
disease that prevented their reproductive organs from fully forming, were
fitted with vaginas constructed from samples of their own muscles and cells.
These samples were then expanded in the laboratory and engineered into the
shape of a vagina with the help of biodegradable scaffolding.
The follow-up study demonstrated
that vaginal organs can not only be constructed in a lab, but also
successfully implanted in humans, lead researcher Dr. Anthony Atala
explained in the press release. "This may represent a new option for
patients who require vaginal reconstructive surgeries.â€ť
Prosthesis Which Converts Muscle Signals Into Movement:
2014 saw the arrival of the most complex prosthesis technology to date. In
May, the Food and Drug Administration approved the marketing of the first
prosthetic arm that translates electrical signals from peopleâ€™s muscles to
help them perform tasks with the upmost accuracy. The arm, known as the DEKA
Arm System, controls movement via electromyogram electrose. This allows
people with certain types of amputations to have a new prosthesis option.
Subjects who used the arm were able to complete tasks such as stacking
cones, moving objects, shaking hands, and most importantly feed themselves.
Legally Blind Can See With Bionic Eye: The
bionic eye was dramatically improved in 2014, allowing the legally blind to
finally see, as they had long dreamed.The bionic eye, known as the Argus II
Retinal Prosthesis System, was approved by the FDA in 2013, but this year
engineers further improved its visual system. It is the worldâ€™s first
implanted device to treat people with retinitis pigmentosa, one of the
leading causes of blindness. The bionic eye consists of a device implanted
into the eye, a video camera in a pair of glasses, and a video processing
unit carried by the patient.
Longest-Ever Preservation of Lungs Outside The Body:
Transplant specialists at University Hospitals Leuven in Belgium were able
to preserve donor lungs outside of a human body for a full 11 hours, the
longest time in medical history. The feat was possible thanks to OCS LUNG, a
perfusion-based machine that supplies the quarantined lungs with a
continual, refreshing supply of oxygen. The machine is now commercially
available in Europe and Australia, clinical trials in the U.S. are expected
to start soon.
Visit Medical Daily for the article
Should we worry about low fertility?
The five-year decline in fertility
in the U.S. has ended, according to the latest statistics. Before we cheer
this development, we should ask whether low fertility rates are a problem.
In particular, if we want more upward mobility, perhaps low fertility is not
such a bad thing. With fewer children to support, parents and society can
both invest more in each child, helping them to climb the ladder and become
productive citizens in their adult years.
So why are so many rich countries
worried about population decline? The concern, of course, stems from fears
that there will be too few people to support us in our old age. The greying
of the population could be addressed by reforming immigration laws to allow
more immigrants to come to America: unfortunately, growing nativism may make
that a politically unacceptable solution.
Are pro-natalist policies a viable
option? Japan and Singapore offer instructive case studies. Like other Asian
societies, their fertility rates are very low. At 1.2 births per woman in
Singapore and 1.4 in Japan, they are well below a replacement rate of 2.1
and well below the current U.S. rate of 1.9.
Women are delaying marriage because
of their careers, having children at older ages, and having fewer of them.
Because unwed births are still stigmatized in these Asian cultures, births
among young singles are almost nonexistent.
Singaporean parents receive paid
maternity leave for 4 months, 6 days of paid child care leave per year per
parent, large baby bonuses (cash and matched savings) of between $10,000 and
$24,000 per child, tax savings, and many other benefits. But none of these
benefits appear to have had much effect on the fertility rate.
First, a fertility rate of 1.9 is
nothing to worry about. It is still high by international standards and
likely to tick back up as the economy recovers.
Second, young people cannot be
â€śbribedâ€ť into having children through lower taxes or large baby bonuses.
(Organizing work and school schedules to suit modern family life is likely
to be more effective.)
Third, with fewer children, more
public funds could be devoted to investments in education â€“ expenditures
that are badly needed if we want to remain economically competitive
Fourth, drops in fertility mean a
smaller youth cohort 15 to 20 years later â€“ a development that in the past
has been associated with less crime and more jobs for new entrants.
Fifth, a comprehensive immigration
bill could quell anxieties about financing our retirement costs, by allowing
skilled workers from other countries to join our labor force.
Sixth, and most important of all,
parents do a better job when they delay childbearing until they are ready to
commit to both parenthood and marriage. If we could reduce early, unwed (and
typically unplanned) parenting to Asian levels, lower fertility wouldnâ€™t be
a bad thing. Children would be better cared for and more upwardly mobile.
Visit Brookings for the study.
A flip flop? CME payments to doc must be reported to
In what appears to be an about face,
the Centers for Medicare & Medicaid Services has revised a controversial
provision of the Open Payments program and will now require companies to
report payments to physicians who speak at, or attend, continuing medical
The change comes less than two
months after the agency declared there are circumstances in which such
payments would not have to be disclosed. In fact, this marks the fifth time
that CMS has offered yet another interpretation of its final rule on
disclosing CME payments.
â€śThis appears to be one of the
biggest flip flops I have ever seen,â€ť says John Kamp, who heads the
Coalition for Healthcare Communication, a trade group for ad agencies and
medical publishers that supported an exemption for disclosing CME payments
In a phone conversation, Shantanu
Agrawal, director of Center for Program Integrity at CMS, tells us that the
agency has not actually changed its position and believes â€śweâ€™ve been
entirely consistentâ€ť in attempting to craft a final rule. â€śWe embarked on
the rule-making process specifically to remove the exemptionâ€ť that would
have blocked disclosure of payments for CME.
At issue is the extent to which CME
payments should be included in the Open Payments system, which maintains a
federal database of payments made by drug and device makers to physicians.
The program was created as part of the Affordable Care Act in response to
concerns that financial ties may unduly influence medical practice and
These CME payments are made by drug
and device makers, as well as group purchasing organizations, to CME
providers, which are either commercial firms or non-profits that organize
courses for physicians. From there, payments may be made to physicians who
speak at or attend CME events.
As a result, these are referred to
as indirect payments, but increased scrutiny of financial ties between
companies and physicians has caused a shift â€“ 83% of all CME courses are now
funded by non-commercial providers, according to the Accreditation Council
for Continuing Medical Education.
As noted previously, consumers
groups argue that indirect payments for speaking at and attending CME
courses should be included in the Open Payments database and fought against
industry efforts to exclude such payments from reporting requirements.
â€śThis new clarification is in line
with the intent of the Sunshine Act which is to disclose financial
relationships between companies and doctors,â€ť says Danny Carlat, who until
recently headed the Prescription Project at The Pew Charitable Trusts, which
argued for including CME payments.
There may be loopholes, though. For
instance, the latest rule includes examples of reporting requirements and
one indicates that a drug or device maker does not have to report payments
made to physicians if the funds given to the CME provider were part of an
The language suggests that companies
could avoid reporting payments, depending upon how they dole out funds. But
this is causing confusion, because it also appears to contradict reporting
requirements stipulated elsewhere in the CME rule change.
Meanwhile, the final rule on CME
payment disclosure does not go into effect until 2016, which means there is
time for still more changes. The CME Coalition, in fact, hopes to meet with
CMS officials to sort out the latest change and persuade the agency to
Visit the Wall Street Journal for the story.
How prepared are states for infectious disease outbreaks?
Arkansas is the state least prepared
for an infectious disease outbreak, according to a new analysis. But no
state is perfect: none scored higher than an eight on the 10-point scale
used in â€śOutbreaks: Protecting Americans from Infectious Disease,â€ť a new
report assessing readiness for infectious threats and conducted by the Trust
for Americaâ€™s Health and the Robert Wood Johnson Foundation.
â€śIt is not a comprehensive review;
but collectively, it provides a snapshot of efforts to prevent and control
infectious diseases in states and within the healthcare system,â€ť the
reportâ€™s authors write of their scoring system, based on 10 indicators of
preparedness. The states that scored highestâ€”8 points eachâ€”were Maryland,
Massachusetts, Tennessee, Vermont and Virginia. Half the states scored a
six, seven or eight. Arkansas alone scored two. D.C. earned a score of five.
The scores were determined by how
states ranked along 10 indicators chosen by consulting with leading public
health officials. Together, they â€śoffer a composite snapshot of strengths
and vulnerabilities across the health system,â€ť the authors write. But the
scores should not be taken as a reflection on state health departments or
systems. Some are attributable to broader factors, such as resources,
policies, community health status and attitudes.
The indicators evaluated such things
as public health funding, information management, childhood and flu
vaccination rates, preparedness for the public health impacts of climate
change and food safety.
The indicator on which states were
most successful measured the capabilities of public health laboratories
during emergencies or drills. Between July 2013 and July 2014, 47 states and
D.C. conducted an exercise or used a real event to test how long it took for
urgent information to travel between labs.
The indicator on which the fewest
states succeeded measured efforts to minimize health care-associated
infections, in which patients contract an infection while receiving medical
treatment. The study evaluated two such types, but the one on which states
scored worst evaluated those in which infections were spread by the
insertion of a central line, a tube often placed in a large vein, often in
the neck, chest, arm or groin, to provide medical treatment. Only 10 states
saw such infections fall from 2011 to 2012.
Thirty-five states and D.C. have
already met a federally-set child vaccination goal as part of the Healthy
People 2020 initiative to improve the nationâ€™s health by that year. The goal
is to ensure that at least 90 percent of children aged 19 months to 35
months get at least three doses of the Hepatitus B vaccine.
The CDC estimates that anywhere from
700,000 to 1.4 million people are infected with Hepatitus B and nearly two
in three of them donâ€™t know it. It is typically transferred from mother to
child during birth and the vaccine has been available since 1982.
Just 14 states vaccinated at least
half their population aged six months or older for the seasonal flu during
last yearâ€™s flu season, according to the study. South Dakota had the highest
vaccination rate, of 57.4 percent. Wyomingâ€™s was lowest, at 37.6 percent.
Historically, children and seniors have been encouraged to get vaccinated
but there are benefits to everyone getting the vaccination.
The majority of states scored well
on food safety, with 38 meeting national goals of testing reported cases of
the common food-borne illness E. coli (Escherichia coli O157, to be
precise). The national goal is to test 90 percent of reported cases within
four days. Sixteen states achieved that goal 100 percent of the time.
Visit the Washington Post for the article.
Doctors prescribing most potent painkillers face scrutiny
Doctors who are the most prolific
prescribers of powerful narcotic painkillers and stimulants often have
worrisome records, a ProPublica analysis of Medicare data shows.
In 2012, 12 of Medicare's top 20
prescribers of drugs such as oxycodone, fentanyl, morphine and Ritalin have
faced disciplinary actions by their state medical boards or criminal charges
related to their medical practices, and another had documents seized from
his office by federal agents. These drugs have a high potential for abuse
and are classified as Schedule 2 controlled substances by the Drug
The No. 1 prescriber Shelinder
Aggarwal of Huntsville, AL, with more than 14,000 Schedule 2 prescriptions
in 2012 â€” had his controlled-substances certificate suspended by the state
medical board in March 2013. He surrendered his medical license four months
Prescribing high volumes of Schedule
2 drugs can indicate a doctor is running a pill mill, said Andrew Kolodny,
chief medical officer of Phoenix House, a New York-based drug treatment
provider. "We wait 'till these doctors kill people â€¦ It doesn't make any
sense," said Kolodny, founder of Physicians for Responsible Opioid
Prescribing, which advocates for tighter regulation of painkillers.
Medicare's drug program, known as
Part D, now covers about 38 million seniors and disabled people and pays for
more than one of every four prescriptions dispensed in this country.
Concerns about oversight of controlled substances date back to at least
2011, when the Government Accountability Office highlighted abuse of opioids
in Part D and called on Medicare to take action.
Within the past year, Medicare has
started to use prescribing data to identify potentially problematic doctors,
as have some state medical boards. Beginning in mid-2015, Medicare will have
the authority to kick doctors out of the program if they prescribe in
The 2012 data shows the upward trend
line for prescriptions of controlled substances before these initiatives
took hold as USA TODAY reported in Peter Eisler's June 2014 story,
Aggarwal's Medicare prescribing
history had plenty of red flags. The pain-medicine specialist has
consistently shown up in Medicare's data as a top prescriber of narcotics.
By 2012, the year before he stopped practicing, more than 80% of his
Medicare patients received at least one prescription for a Schedule 2 drug,
in many cases oxycodone.
It took a complaint from pharmacies
near Aggarwal's office to alert the Alabama Board of Medical Examiners to
his unusual prescribing habits, said Larry Dixon, the board's executive
director. Board investigators subsequently made undercover visits to the
doctor's office and videotaped him prescribing drugs without an exam.
"If you paid $1,200 in cash, they
would put a VIP stamp on your medical records and you didn't ever have to
have an appointment," Dixon said.
Medicare's Part D data draws a
roadmap to the doctors who prescribe controlled substances most frequently.
In 2012, 269 providers wrote at
least 3,000 prescriptions for Schedule 2 drugs, ProPublica's analysis shows.
They were concentrated in a handful of states. Florida led the country with
52 providers, followed by Tennessee with 25.
About one in five doctors who wrote
at least 3,000 prescriptions for Schedule 2 drugs have faced some kind of
sanction or investigation, ProPublica found. Because of their risk of abuse
and dependence, these drugs require written prescriptions and cannot be
In September, Medicare sent 760
letters to doctors who prescribed far more Schedule 2 drugs than others in
their medical specialty and state. Officials hope the initiative will cause
doctors to examine their prescribing and make changes.
Some medical licensing boards are
also expanding their efforts to use data to spot problematic prescribing.
North Carolina's medical board has proposed new regulations allowing the
agency that runs the state's prescription drug monitoring program to share
data with the board. The board currently can only access the data when it is
pursuing an active investigation into a particular physician.
Similarly, Alabama's Legislature
recently authorized its medical board to regulate pain medicine clinics and
proactively access data from its prescription monitoring database.
Visit USA Today for the story.
Public easily swayed on attitudes about health law, poll
Just days before the requirement for
most large employers to provide health insurance takes effect, a new poll
finds the public easily swayed over arguments for and against the policy.
Six in 10 respondents to the monthly
tracking poll from the Kaiser Family Foundation (Kaiser Health News is an
editorially independent program of the foundation) said they generally favor
the requirement that firms with more than 100 workers pay a fine if they do
not offer workers coverage.
But minimal follow-up information
can have a major effect on their viewpoint, the poll found.
For example, when people who support
the â€śemployer mandateâ€ť were told that employers might respond to the
requirement by moving workers from full-time to part time, support dropped
from 60 percent to 27 percent. And when people who disapprove of the policy
were told that most large employers will not be affected because they
already provide insurance, support surged to 76 percent.
Opinion also remains malleable about
the requirement for most people to have health insurance â€“ the so-called
It remains among the least popular
aspects of the law â€“ with just a 35 percent approval rating. But when people
are told that the mandate doesnâ€™t affect most Americans because they already
have coverage through an employer, support jumps to 62 percent. Conversely,
when supporters are told that the requirement means some people might have
to purchase insurance â€śthey find too expensive or donâ€™t want,â€ť opposition
grows from 64 percent to 79 percent.
The poll also found that a year into
full implementation, most Americans, and most of those without insurance,
remain unaware about many of the health lawâ€™s major features. Nearly four in
10 people say the law allows immigrants in the country illegally to get
financial help to purchase insurance (it does not), and more than 40 percent
say (incorrectly) that the law creates a government panel to make decisions
about end-of-life care for Medicare recipients.
At the same time, only about 3
percent were able to correctly say what the fine will be in 2015 for lacking
insurance (the greater of $325 or 2 percent of household income). Among
those without insurance, only 5 percent knew that the deadline for 2015
sign-ups is Feb. 15.
The poll was conducted between Dec.
2 and 9 among a nationally representative sample of 1,505 adults age 18 and
over. The margin of error is plus or minus three percentage points for the
Visit Kaiser for the report.
In Epilepsy, surgery tops drugs for most patients
Patients with seizure disorders who
have had surgical treatment tend to do better over time than otherwise
similar patients managed solely with drugs, according to two studies
presented at the recent American Epilepsy Society annual meeting. But
surgery is rarely a first-line option, and for patients who seem amenable to
drug therapies, a third AES study suggested that a new investigational agent
may be helpful.
For most patients with
drug-refractory epilepsy who are eligible for surgical treatment, their
outcomes end up better than continuing on medical therapy in most cases, two
new studies suggested.
In the first study, which was based
on published data from various sources, researchers led by Ivan Sanchez
Fernandez, MD, of Boston Children's Hospital calculated that the average
10-year-old undergoing surgery for drug-refractory temporal lobe epilepsy
has a life expectancy of 55.2 additional years -- versus 49.3 years for
those managed with drug therapy.
Results were similar for modeled
outcomes in patients with extratemporal lobe epilepsy, he reported, with a
nearly 6-year extension in life expectancy with surgical treatment.
A second study by researchers at the
Cleveland Clinic, reviewing outcomes of 36 children with Lennox-Gastaut
syndrome, found that 15 became seizure-free (shortly after surgery in most
cases) and another nine had reductions in seizure frequency in excess of
90%. An additional 10 patients showed reductions of 50% to 90%.
Although the study did not have a
medically managed control group, senior investigatorAhsan Moosa Naduvil, MD,
said at an AES press briefing that these outcomes could not have been
achieved solely with drug therapy. He said the findings were important
because it is only recently that children with Lennox-Gastaut syndrome have
not been considered candidates for surgical therapy.
Of the 36 patients included in the
study, 21 had undergone hemispherectomy while the other 15 had received
lobar or multilobar resections. Patients receiving vagal nerve stimulator
implants or corpus callosotomy were excluded from the analysis. Mean
follow-up was a little less than 2 years, ranging from 6 months to more than
The Boston Children's study was a
modeling effort using data on mortality in patients with and without
refractory epilepsy over their lifetimes, as well as on mortality associated
with the surgical procedures usually performed for epilepsy treatment. The
model also included data on the likelihood of achieving seizure freedom
after surgery and on recurrence of regular seizures after initially
successful surgery, all from previously published studies.
Computer simulations indicated that,
for a cohort of 10-year-olds with temporal lobe epilepsy, 92.8% would
benefit more from surgery than medical management in terms of overall life
expectancy. In other forms of epilepsy, surgery would be optimal for 88%.
Both studies reinforce what
epileptologists have been saying for some time, which is that surgery is a
curative option whereas medical management is not, and that surgery should
be considered - and discussed with patients (or their parents) - when drug
therapy is not providing seizure freedom.
Visit MedPage Today for the study.