it took years for the FDA to warn about infections tied to medical scopes
An outbreak at a Pennsylvania hospital in late 2012 should have been an
early warning that a reusable medical scope was spreading deadly infections
and nearly impossible to disinfect. But staff at the federal Food and Drug
Administration lost the report, one of multiple missteps that allowed
doctors and hospitals to continue using the scope for three more years even
as dozens of patients were sickened.
The missing paperwork, revealed in a recent Senate inquiry, underscores the
serious shortcomings in the antiquated national database used to monitor the
safety of medical devices, which even the FDA has long admitted is flawed.
But the fix called for by the Senate investigators — the speedy
implementation of a new system already a decade in the making — has hit a
roadblock put up by two powerful opponents who say an essential part of the
safety upgrade will cost too much.
Patients may now have to wait another decade for the new system, a delay
that could lead to more patient deaths.
"We need to build a better system to find these problems more quickly," said
Dr. Josh Rising, director of healthcare programs at the Pew Charitable
Trusts. Further postponement, he said, "could compromise the safety of
millions of Americans."
The device known as a duodenoscope is only the most recent example of a
risky medical device that was used in tens of thousands of patients before
regulators finally pinpointed a deadly problem in its design. Regulators did
not warn hospitals about its risks until after the Los Angeles Times
reported an outbreak at UCLA that killed three patients.
Two days after the Senate report was released last month, Olympus Corp., the
scope's leading maker, said it would recall and redesign the device.
Other devices recalled in recent years include metal-on-metal hip
replacements, vaginal mesh used in surgeries and lead wires in heart
To more quickly find the problems, Congress passed a law in 2007 requiring
that each device get a unique number, like a bar code, that would correspond
to the specific brand and model. The number would be recorded in patient
records and medical claims.
Experts say the new system will enable regulators or doctors to quickly
check large insurance databases to discover how frequently a device is
But the law included no deadlines. And it took the FDA until 2012 to
finalize rules requiring manufacturers to stamp the "unique device
identifiers" on their products.
Manufacturers began putting numbers on some devices — those considered most
critical — in 2014. Duodenoscope manufacturers must begin printing the
numbers on their products in September.
But with the system moving closer to completion, a trade group of the
nation's hospitals and the Obama administration's Medicare directors raised
objections to a key part of the plan: adding a line to the standard
insurance claim form so that the device numbers can be recorded. They say
reprogramming computers to process the device numbers would be an expensive
"Hospital internal billing systems do not currently exist to accommodate"
the device number, George Arges of the American Hospital Assn. testified at
a hearing in 2014. "Who will pay providers for undertaking such changes?"
Without device identifiers on claim forms, there would be few ways to track
the devices and their impact on patients, greatly limiting the system's
Supporters of the new system — including AARP and the insurer Aetna —
estimate that the nation's health system would eventually save money overall
by more quickly removing devices that cause injuries.
Hospital association officials said in an interview that they support the
use of the device identifiers. But they said adding the numbers to insurance
claims would not be practical.
"It's just not going to be possible to track every device used in the care
of the patient," said Chantal Worzala, the association's policy director.
CMS spokesman said that the agency was working with the FDA to "to explore
options that would improve surveillance in a timely and effective manner."
Not only is the FDA's existing database of device injuries and deaths
difficult to use, but it relies on hospitals and manufacturers to report
problems they are often reluctant to disclose because of the possibility of
In their Jan. 13 report, Senate investigators found that not one of 16 or
more American hospitals with outbreaks linked to scopes properly filed the
federal report required when a medical device kills or injures a patient.
Some of the hospitals eventually reported the outbreaks to the manufacturer.
But manufacturers are allowed to rewrite those injury reports before sending
them to the FDA's database.
By the time the FDA began looking into whether the $40,000 reusable scope
was transferring bacteria among patients in September 2013, Olympus and
another scope manufacturer had sent five reports of outbreaks to the agency.
But when the FDA staff searched the database, they found just one of those
reports, according to investigators.
It took another 17 months for the agency to warn hospitals the scope was
almost impossible to clean.
By then, at least 195 patients in 16 hospitals across the country had been
sickened with lethal bacteria — though the toll is probably far higher,
Deborah Kotz, an FDA spokeswoman, said the agency was already working on the
report's recommendations. "The FDA is committed to establishing a national
medical device evaluation system that leverages real-world evidence to help
us more quickly identify safety signals," Kotz said.
The agency now makes a disclaimer when it uses information from its database
to evaluate the safety of a device.
Visit the Los Angeles Times for the report.
Virus profilers race to figure out what makes Zika tick
While some scientists seek ways to stop the spread of Zika by mosquitoes,
others have received new funding from the National Institutes of Health to
track the genes and habits of the virus itself.
When Carolyn Coyne's lab at the University of Pittsburgh recently tried to
order a sample of Zika virus from a major laboratory supplier, they were
told it was out of stock.
She's just one of a growing number of lab researchers who are racing to
investigate Zika virus in the wake of reports that it may be linked to some
cases of microcephaly, the birth defect that leaves babies with small heads
Zika virus was discovered back in 1947, but until recently, almost no one
studied it. If you type "Zika" into a searchable database of grants from the
National Institutes of Health, just one name pops up: Scott Weaver of the
University of Texas Medical Branch in Galveston.
"I've been really working on Zika for a long time because in Africa it
circulates with three other viruses that, until recently, were considered a
lot more important," Weaver tells NPR.
He says really, though, those other viruses were his focus — his lab did
very little with Zika, which was thought to cause a mild illness, if any.
But everything changed last fall, when Weaver went to a conference and heard
the shocking news that Zika might be linked to microcephaly.
His university has a collection of mosquito-borne viruses that it provides
to other labs, on request — and he says requests for Zika are pouring in.
What's more, government officials have been reaching out to virologists who
study pathogens that are closely related to Zika, offering extra funding and
support for any work on Zika, says Dr. Anthony Fauci, director of the
National Institute of Allergy and Infectious Diseases.
Fauci explains they can do this by just supplementing researchers' existing
grants. "There's a limited amount of money that you can do on a supplement,"
says Fauci, "but enough to get people started quickly."
One of the scientists contacted by the NIH is Dr. Michael Diamond, an
infectious disease specialist at Washington University in St. Louis.
"We need vaccines, we need therapies, we need diagnostics," says Diamond.
"We need to know how this virus works."
In addition to trying to create Zika-specific antibodies that could be used
for better diagnostic tests or even potentially as a treatment, his lab has
been trying to find a way to recreate in a lab animal the same signs and
symptoms the virus produces in humans.
Scientists also have been looking at the Zika virus itself — to see if it
has mutated in any way that could explain this large, unusual outbreak among
"The thing about working with Zika virus is that almost everything is a big
unknown," says Helen Lazear, who studies Zika at the University of North
Carolina at Chapel Hill. Scientists in Brazil have sequenced the genes of
Zika viruses circulating there, she says, so that they can be compared to
Zika viruses collected earlier around the world.
"There are some differences in the sequence between the viruses," Lazear
says, "but we don't know if that's just a chance variation in the sequence,
or if this is something that impacts disease. We're working on having the
systems in place to test that."
And then, of course, there's the big scientific question everyone wants
answered: What exactly is the link between Zika and birth defects? After
all, that's the main driver of all this attention and concern.
"This is one of those situations that we feel intrigued by the science, of
course, but we really feel we have here a moral obligation to act as rapidly
as possible," says Dr. Yoel Sadovsky, a physician-researcher at the Magee-Womens
Research Institute in Pittsburgh.
Along with Coyne, he studies cells in the placenta that normally act as a
first line of defense to protect the fetus from viruses in the mother's
blood. The researchers want to study how those cells react to Zika.
They'll also explore the relationship between Zika and a closely related
virus, dengue, which is common in Brazil, says Coyne. "It's possible that
the pre-exposure to dengue virus in some way may alter the ability of Zika
virus to infect these women and/or cross the placenta," she says.
Coyne is not the only one wondering what role, if any, dengue may play in
these unusual manifestations of a Zika infection.
Doctors already know, Diamond says, that a person who has been infected with
one dengue strain can later have a much more severe form of the disease if
they get a second infection with a related, but not identical strain of
Visit NPR for the article.
MercyRockford Health System inks tech-enabled supply chain partnership with
MercyRockford Health System, a vertically-integrated regional health system
with five hospitals and 561 W-2 employed physician partners in northern
Illinois and southern Wisconsin, has partnered with Premier, Inc. (NASDAQ:
PINC), a leading healthcare improvement company, for group purchasing and
expense reduction services on a system-wide basis.
Formed in January 2015 through the merger of Mercy Health System and
Rockford Health System, MercyRockford also operates a wholly-owned health
insurance company, 80 outpatient clinics, and offers a host of complementary
services including retail pharmacy, DME, hospice, and home health services.
MercyRockford chose Premier to support its integration strategy through
technology-enabled supply chain and performance improvement data management
services. The new five-year agreement includes Premier’s group purchasing
services and sourcing, contract management and supply chain analytics
powered by Premier’s performance improvement platform PremierConnect.
Visit Premier for the release.
Obama seeks funds to fight Zika; sees no cause for panic
President Barack Obama will ask the U.S. Congress for more than $1.8 billion
in emergency funds to fight Zika at home and abroad and pursue a vaccine,
the White House said on Monday, but Obama also said there was no reason to
panic over the mosquito-borne virus.
Zika, spreading rapidly in South and Central America and the Caribbean, has
been linked to severe birth defects in Brazil and public health officials'
concern is focused on pregnant women and women who may become pregnant.
Obama's request to Congress includes $200 million for research, development
and commercialization of new vaccines and diagnostic tests for the virus.
In addition, the London-based European Medicines Agency (EMA), Europe's
drugs regulator, said it has formed a task force on Zika to advise companies
working on vaccines and medicines against the virus.
There are no vaccines or treatment for Zika and none even undergoing
clinical studies, as the disease had previously been viewed as relatively
benign. Most infected people either have no symptoms or develop mild ones
like a fever and skin rashes.
In a separate White House briefing on Monday, senior U.S. health official
Anthony Fauci said he was not expecting a large-scale Zika infection in the
continental United States. He said a widely available vaccine would not be
ready for a few years.
"We have already started to develop the vaccine in the early stages and we
can predict that we likely would be in phase 1 trial - just to determine if
it's safe and if it induces a good response - probably by the end of the
summer and get that going by the end of this year," Fauci, director of the
National Institute of Allergy and Infectious Diseases, told reporters.
Scientists are working to find out if there is a causal link between Zika
and babies born with microcephaly, meaning they have abnormally small heads
and can suffer developmental problems. The research began after a huge rise
in such birth defects last year in Brazil at the same time the virus took
Most of the money sought by Obama, who faces pressure from Republicans and
some fellow Democrats to act decisively on Zika, would be spent in the
United States on testing, surveillance and response in affected areas.
Visit Reuters for the story.
Blood test giving false sense of security about cancer risk?
Thanks to breakthroughs in technology, the market for genetic tests that
give patients information about their genes has surged over the past decade.
According to one recent estimate, there are now more than 60,000 on the
market. But in the race to profit from this exploding industry, CBS News
found some may be promising more than science can deliver.
In the fight against cancer, a test that could detect a tumor before a
patient shows symptoms would be a game-changer. Best case scenario: that's
still three to five years away, reports CBS News correspondent Jim Axelrod.
But a CBS News investigation found one test on the market now that could
give patients a false sense of security about their cancer risk.
At a healthcare conference in Silicon Valley a few weeks ago, biotech
pioneers pitched the latest and greatest in personalized healthcare
"This has the potential to totally change not just cancer but all of
medicine," said Dr. Richard Klausner, former head of the National Cancer
Institute and a director of Grail, a company developing a liquid biopsy,
which is a blood test for cancer. According to Klausner, someone with no
symptoms could get his or her blood drawn and determine whether he or she
The idea holds great promise, but Klausner said proving it works will take
There is a lot of incentive: the liquid biopsy market is estimated to be
worth $22 billion by 2020. Another company after a piece of it is San
Diego-based Pathway Genomics.
Pathway's board members include the former chair of the Joint Chiefs of
Staff Peter Pace, former Secretary of Commerce Barbara Franklin and Newt
Gingrich. The company raised $40 million in its last round of fundraising.
But what caught our attention is the test Pathway launched in September
called the CancerIntercept Detect and Monitor. Available by physician order
for as little at $299, Pathway's marketing claimed it could do what others
say is years away.
can detect a growing tumor in the body, before the patient may notice
symptoms - it's like a cancer stethoscope for detecting and monitoring
cancer," a marketing video claimed.
few weeks ago, we visited Pathway to ask them about their claims. Before we
sat down with CEO Jim Plante, they played us that video.
"It says it may. We don't say-- we don't say will. We say may," Plante said.
Pathway has three clinical trials underway to study its liquid biopsy, but
they all started months after the test was put on the market. Following our
interview, Pathway removed that marketing video from its website, telling us
they had "proactively decided to limit some of our marketing activities
associated with CancerIntercept."
In September, the FDA sent Pathway Genomics a letter about CancerIntercept,
citing concerns the test did not have "adequate clinical validation and may
harm the public health."
The FDA told CBS News they consider tests like this one a "major health
risk," the main concern being that patients and physicians might make major
health decisions based on information we don't yet fully understand. The FDA
does not currently oversee tests like this, but are in the process of
drafting the framework to regulate them.
Visit CBS News for the story.
Hawaii Island declares a dengue fever state of emergency
The mayor of Hawaii's Big Island declared a state of emergency on Monday
amid the state's largest outbreak of dengue fever since the 1940s.
The move comes more than three months after the state Department of Health
confirmed the first cases of locally acquired dengue, and less than a week
after state and county officials defended the ongoing response against
criticism that they had been slow to act.
Much like Zika virus, dengue fever is a viral illness spread by mosquitoes.
While it is not endemic to Hawaii, the state does have the mosquito species
capable of transmitting the disease. As of Monday, the Hawaii Department of
Health had confirmed 251 cases of dengue on the Big Island, including 227
infected Hawaii Island residents and 24 visitors.
Symptoms include fever, rash, joint or muscle pain, headache, or pain behind
the eyes. Though often debilitating, the symptoms can be effectively
managed if recognized and treated. The virus, nicknamed "breakbone fever,"
can develop into a more severe form called dengue hemorrhagic fever that can
be fatal if left untreated.
Hawaii County's emergency proclamation, signed by Hawaii County Mayor Billy
Kenoi, does little by itself. It temporarily suspends a county law that
prohibits people from disposing of tires -- known breeding sites for
mosquitoes -- at county landfills.
As West Hawaii Today reports, the declaration opens the way for Hawaii
Gov. David Ige to make his own emergency declaration, which would provide
state funds for mosquito-control efforts.
Ige said late Monday he supported Hawaii Island's efforts to "break the
cycle of dengue fever infection and transmission." The state, he said in a
statement, would declare an emergency if the outbreak requires additional
resources, spreads to other islands or expands to include Zika or other
In a December assessment of Hawaii's response to the dengue outbreak, Lyle
Petersen, director of the Center for Disease Control and Prevention Division
of Vector-Borne Diseases, said there were "critical deficiencies" in the
state Health Department that should be "urgently addressed." The state said
it's working to release $250,000 to the state Health Department to fund
eight vector-control positions, one entomologist and one communications
Hawaii's tropical environment, which allows dengue-carrying mosquitoes to
thrive, makes it especially prone to outbreaks of the virus. The current
outbreak is the first locally acquired cluster in Hawaii since four people
contracted dengue on Oahu in 2011.
Visit the Huffington Post for the report.
With lawsuit pending, fourth victim of UPMC mold outbreak dies
The fourth person who became infected with mold last year while a patient at
UPMC died Saturday while still in hospital care. Che DuVall, who launched a
medical negligence lawsuit in January against UPMC, was a patient at UPMC
Presbyterian at the time of his death.
The death was reported by UPMC to the Allegheny County Medical Examiner.
DuVall, 70, died at 12:20 p.m. Saturday. The cause of death was listed as
multi-organ system failure due to sepsis, which is a systemic infection. The
manner of death was listed as natural. The death certificate was signed by
the attending UPMC physician. No autopsy will be conducted, according to the
medical examiner’s office.
DuVall, of Perryopolis, used a report released in December by the federal
Centers for Disease Control and Prevention as the foundation of his suit.
DuVall was an organ transplant patient at UPMC Presby when he contracted the
fungal-sourced mold infection along with three other transplant patients who
already had died. The CDC report, released Dec. 21, 2015, noted DuVall had
been a patient in a negative-pressure room at the hospital as had two of the
other infected patients. Negative-pressure rooms are designed to draw air
into the room from outside for patients who already have a potentially
airborne contagious disease, but prevent the air in the room from spreading
to other patients. The fourth patient who contracted the fungal infection
was a patient at UPMC Montefiore, located near UPMC Presby.
The Fayette County man and his wife, filed suit in Allegheny County Common
Pleas Court in January. The suit alleges a series of missteps that led to
DuVall contracting a fungal-sourced mold infection. In part, the suit reads:
“Defendant [UPMC] Presbyterian knew or should have known that placing Che
DuVall in a negative-pressure environment, given his state of immune
suppression, vastly increased his risk of contracting a myriad of
life-threatening infections, including that which befell him.”
DuVall remained a patient at UPMC Presby and, as recently as last month, was
able to speak, according to a previous statement from his attorney, Brendan
Lupetin. DuVall was a double-lung transplant patient. Lupetin characterized
the death as “unexpected.”
The hospital suspended its transplant program for six days in September
after identifying mold in four patients, three who had been at UPMC Presby
and one at UPMC Montefiore.
Visit the Pittsburgh Post-Gazette for the article.
annual UDI Conference with FDA to be held April 18 & 19 in Baltimore
As an educational authority on UDI, the 8th annual UDI Conference will once
again bring industry stakeholders together with the FDA UDI Team to ensure
accurate UDI implementation and continued adoption momentum.
This year's Conference will be geared to Class II Medical Device
Manufacturers and others facing compliance deadlines. The UDI Conference is
the annual industry gathering for medical device manufacturers,
distributors, and hospitals to convene to learn about, and understand, the
UDI Regulation and the Global UDI Database (GUDID).
The UDI Regulation requires new/improved systems and processes to
efficiently mark/tag equipment, scan device information at various points in
its life cycle, and transmit that data to the GUDID and other software
The UDI Conference allows you to interact directly with the FDA UDI team,
investigate UDI technology in the exhibit hall, plan your migration path,
and network with peers in the healthcare industry in one place, at one time.
To secure your seat at the best price, register by February 26th. Alumni
participants will have a $150 discount. Team registrations are encouraged.
If 2 or more from the same company are planning to attend, contact email@example.com
to get a discount code.
Register here today.
For additional conference details and the most up-to-date information,
For information on the FDA UDI Rule & GUDID Guidance, visit www.FDA.gov/UDI.