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February 10, 2016   Download print version

Why it took years for the FDA to warn about infections tied to medical scopes

Virus profilers race to figure out what makes Zika tick

MercyRockford Health System inks tech-enabled supply chain partnership with Premier, Inc.

Obama seeks funds to fight Zika; sees no cause for panic

Blood test giving false sense of security about cancer risk?

Hawaii Island declares a dengue fever state of emergency

With lawsuit pending, fourth victim of UPMC mold outbreak dies

8th annual UDI Conference with FDA to be held April 18 & 19 in Baltimore


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Self Study Series:
February 2016

Measuring the efficacy of manual endoscope cleaning
by Grace Thornhill

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Why 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 defibrillators.

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 malfunctioning.

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 task.

"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 usefulness.

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.

A 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 litigation.

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, investigators found.

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 and brains.

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 people.

"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 dengue.

Visit NPR for the article.



MercyRockford Health System inks tech-enabled supply chain partnership with Premier, Inc.

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 hold there.

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 has cancer.

The idea holds great promise, but Klausner said proving it works will take time.

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.

"CancerIntercept 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.

A 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 vector-borne disease. 

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 position.

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.



8th 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 systems.

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 to get a discount code.

Register here today.

For additional conference details and the most up-to-date information, please visit

For information on the FDA UDI Rule & GUDID Guidance, visit