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August 25, 2016   Download print version

Zika images show 'worst brain infections that doctors will ever see'

Intalere inflationary update for healthcare supplies released

CDC continues to support Florida in response to Zika outbreak

Tru-D SmartUVC to exhibit at annual HealthTrust University Conference

HSCA statement on new pharmaceutical pricing report from JAMA/Harvard Medical School researchers

FDA, medical device industry strike deal over user fees

Obamacare subsidies preserve access as premiums climb, U.S. says

Doctors, hospitals prepare for difficult talks surrounding medical mistakes


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September 2016

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by Sandra Beauclair, BSN, RN, CNOR

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Zika images show 'worst brain infections that doctors will ever see'

A series of medical images published Tuesday offer the most complete picture, so far, of how the Zika virus can damage the brain of a fetus.

"The images show the worst brain infections that doctors will ever see," says Dr. Deborah Levine, at Beth Israel Deaconess Medical Center in Boston, who contributed to the study. "Zika is such a severe infection [in fetuses]. Most doctors will have never seen brains like this before."

The images — published in the journal Radiology — are part of a special report put together by neurologists in Boston and doctors in northeastern Brazil who care for babies with Zika infections.

"Our goal is to illustrate for heathcare professionals around the world what they could expect to see with a Zika infection during pregnancy," Levine says.

Many research studies and news stories have focused on microcephaly — a condition in which babies are born with very small heads, Levine says. But that defect is just the tip of iceberg of what Zika does to a fetus's brain.

For example, one baby in the study was born with a normal-size head. "But when you look inside the brain," Levine says, "there's very little brain tissue present."

MRI scans at 36 weeks of pregnancy showed the fetus's brain was filled with fluid, which had puffed up the size of the skull. And the baby was missing parts of the nervous system, including sections of the brain stem, the spinal cord and the midbrain, which controls eye movements and processes information from the eyes and ears.

The baby also had a flattened skull and extra skin around the head — which is likely caused by the skull collapsing in on itself after the brain stopped growing early in development, the researchers write.

For the study, Levine and colleagues analyzed medical images of 46 fetuses and babies born to mothers who had Zika during pregnancy. In almost all cases, the babies had damage in the cortex, the outer layer of the brain that controls a huge number of high-level functions like problem-solving, emotion and language. The cortex contains many folds and gives our brains its characteristic shape. But in these babies, oftentimes, the cortex was smooth, Levine says.

All the babies had scars in their brains, called calcifications. These are a telltale sign of an infection, Levine says, and show where the virus has injured the brain — or stopped its development.

The babies also had damage in the brain stem, which controls involuntary actions, like breathing and heartbeat, as well as injuries in the cerebellum, which coordinates muscle activity and voluntary movements.

Visit NPR for the report.


Intalere inflationary update for healthcare supplies released

Intalere recently released its updated Inflationary Indices to members. The update contains company and industry projections for inflation rates across contract portfolio categories for the coming year.

The Intalere Inflationary Indices is published biannually with updates to reflect any market trends or changes. The projections represent industry inflationary performance, actual pricing through Intalere contracts and programs, and the expected impact of upcoming contract bids.

The report offers estimates in categories including diagnostic imaging, environmental services, executive resources, foodservice, laboratory, medical supplies, office solutions, pharmacy, plant engineering and surgical supplies.

Some particular items of note:

The price of gases, especially helium, should see some reductions over time, with the discovery of a major helium field in Tanzania Africa. While there will probably not be an immediate impact, it should provide relief over time in helium prices.

In the area of diagnostic imaging, barium will be volatile with an industry projection of nearly 40 percent, but Intalere members should be protected based on a previously negotiated long-term contract.

In the information services portfolio, telecommunications (voice and data) and wireless communication should see slight declines based on increased market competition. For computer hardware, changes may occur due to extreme volatility in the memory market for RAM and solid-state drives coming from China.

Pharmacy will see significant increases in Albumin (approx. 20 percent) due to increased Asian demand, which has impacted U.S. supply through disruptions with two manufacturers. Biotech products should also see a double-digit rise. Although availability of biosimilars is growing, manufacturers appear to be increasing prices up to the time of competitor launches to maximize return.

Intalere’s members benefit from price protection controls and pricing being locked in for a majority of their contracts.

Visit Intalere for the report.


CDC continues to support Florida in response to Zika outbreak

CDC has and will continue to provide support to Florida to address the Zika outbreak. CDC experts in epidemiology, surveillance, and vector control have been on the ground for weeks supporting the state of Florida’s response.

CDC has provided $35 million in federal funds for Zika and emergency response, including public health and emergency preparedness funds for both FY 2015 and 2016 that can be used to purchase items for Zika prevention kits. CDC also has provided 10,000 bottles of DEET for the kits. 

CDC is also providing support for Zika lab testing. To date, CDC has shipped enough material for about 2,000 Zika lab tests, the number of tests Florida said would allow them to be at full capacity for Zika testing. 

After learning this week that Florida needed more materials, CDC is sending another shipment expected to arrive on Thursday, August 25. This gives Florida the ability to conduct 6,300 Zika antibody tests.

CDC’s Fort Collins laboratory is also testing specimens from pregnant women for the Florida Department of Health and is working with Florida on other possible support for Zika lab testing.

Visit CDC for the announcement.


Tru-D SmartUVC to exhibit at annual HealthTrust University Conference

Tru-D SmartUVC will join members of HealthTrust at the organization’s upcoming University Conference & Vendor Fair in San Antonio, TX, August 29-31 in booth 613. They will showcase the company’s automated UV disinfection robot and discuss how it implements seamlessly into healthcare facilities’ comprehensive infection prevention programs.

Tru-D has been a contracted HealthTrust supplier since January 1, 2015, working with supply chain management professionals to help save hospitals precious dollars and lives. HealthTrust, which serves more than 1,400 acute care facilities and members in more than 15,000 locations offers one of the industry’s committed and aligned group purchasing models.

Once an EVS worker cleans a hospital room with traditional methods, Tru-D is brought in to complete the disinfection process. Operating from a single position and administering a single cycle of UV light, Tru-D provides total room disinfection, killing up to 99.9 percent of harmful pathogens that can remain behind such as C. diff, MRSA, MERS, VRE, Ebola and many more. Tru-D takes whatever time is necessary to disinfect the entire room including in direct and shadowed areas, leaving EVS staff free to complete other tasks while Tru-D is in use. Once the cycle is complete, Tru-D alerts the operator with an audio and/or text message that the room has been thoroughly disinfected.                       

Tru-D invites attendees to their booth number 613 to learn more about the gold standard in UV disinfection.

For more information, visit


HSCA statement on new pharmaceutical pricing report from JAMA/Harvard Medical School researchers

Healthcare Supply Chain Association (HSCA) President and CEO Todd Ebert, R.Ph., released the following statement on “The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform,” a new study on the drivers of drug costs from Harvard Medical School researchers published in the Journal of the American Medical Association (JAMA):

“Significant pharmaceutical price spikes are jeopardizing patient access to affordable and effective healthcare, and robust competition and timely availability of generic drugs are part of the solution. The new report from Harvard Medical School researchers about the drivers of high drug costs underscores the need for Congressional and FDA action to expand priority review of new generic drug applications, particularly in the sterile injectable market.

“As the report notes, the FDA’s backlog of abbreviated new drug applications (ANDAs) has, in some instances, led to delays of up to three or four years for product review and approval, which discourages manufacturers from trying to bring competitive products to market.

“HSCA and its member group purchasing organizations (GPOs) are committed to reducing costs and increasing competition and innovation in healthcare. HSCA supports the Increasing Competition in Pharmaceuticals Act (S.2615), bipartisan legislation that would mandate priority review of generic drug applications for drugs made by just one manufacturer. As future opportunities to consider enhancements or additions to S.2615 arise, HSCA urges Congress to mandate priority review for generic injectable drugs with two or fewer manufacturers.”

Visit HSCA for the letter.


FDA, medical device industry strike deal over user fees

The FDA and the medical device industry hammered out the principles for the user fees medtech companies pay to have the federal safety watchdog review their products.

The 4th iteration of the Medical Device User Fee & Modernization Act would allow the FDA to collect nearly $1 billion in user fees over 5 years, beginning in October 2017. The last MDUFMA bill, enacted in 2012, doubled user fees from $295 million over 5 years to $595 million, in exchange for performance goals set for the FDA.

 “MDUFA IV is the result of more than a year of public input and negotiations with industry, laboratory, patient, and consumer representatives,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health, said in prepared remarks. “This funding will also improve the collection of real-world evidence from different sources across the medical device lifecycle, such as registries, electronic health records, and other digital sources.”

Lobbying groups for the medical device industry said the new agreement is the 1st to include metrics aimed at reducing review times, increased interaction with FDA staff before and during reviews and a pair of independent analyses of how the FDA manages the medical device approval process.

The MDUFMA IV agreement also includes a quality system management approach and enhanced quarterly and annual reporting requirements, the groups said. If it goes through, it would also require FDA reviewers to give feedback 5 days before the pre-submission meeting and document the thinking behind rejected applications, among other provisions.

“This tentative agreement is good news for FDA and industry, and most importantly for patients worldwide,” added AdvaMed president & CEO Scott Whitaker. “This agreement will allow for continued progress in improving the efficiency and predictability of the agency’s review process, and that means doctors and patients will have more timely access to the innovative tests, treatments and cures they are depending on.”

Visit Mass Device for the story.


Obamacare subsidies preserve access as premiums climb, U.S. says

Most buyers of Obamacare plans won’t see their costs jump, even if premiums increase next year, because of government subsidies, the U.S. said in a study that pushes back on reports of challenges facing the health-coverage overhaul.

Government contributions to premiums will mask the rise in costs for most buyers on the program’s exchanges, according to the report from the U.S. Health and Human Services Department.

“Headline rate increases do not reflect what consumers actually pay,” Kathryn Martin, HHS’s acting assistant secretary for planning and evaluation, said in a statement. “Even in a scenario where all plans saw double-digit rate increases, the vast majority of consumers would continue to have affordable options.”

The U.S. report highlights a bright spot for the Affordable Care Act, where signs of trouble are mounting. Insurers including UnitedHealth Group Inc. and Aetna Inc. are halting their sales in some states, citing financial losses, while many remaining insurers are boosting premiums. The subsidies may help ensure that buyers stick with the markets even as insurers boost premiums, helping avoid a situation where the markets become unstable because too few buy coverage.

Even if premiums rise by 25 percent, about 78 percent of shoppers will be able to buy health plans for $100 or less a month in 2017, compared to 76 percent this year, according to the report. The ACA offers subsidies to individuals with incomes of as much as 400 percent of the poverty level. As of March 31, about 9.4 million of the 11.1 million people in Obamacare plans on the exchanges were getting subsidies.

Individuals who don’t get the government subsidies, as well as people who buy individual health insurance through Obamacare exchanges, will bear the full cost of rate increases, though they may have the option of switching to cheaper plans. About 9 million people buy individual plans outside the exchanges, the Congressional Budget Office has estimated.

The U.S. report simulates the effect of increasing all health insurance premiums by 25 percent in the 38 states the use the federal website. It doesn’t analyze actual 2017 premiums, which are still being evaluated by regulators in some states. The sign-up season for 2017 coverage begins Nov. 1.

Visit Bloomberg for the report.


Doctors, hospitals prepare for difficult talks surrounding medical mistakes

Hospitals have traditionally been reticent to disclose to patients or their family members the specifics of how a medical procedure didn’t go as planned for fear of malpractice lawsuits. In recent years, though, many are beginning to consider a change. Instead of the usual “deny-and-defend” approach, they are revamping their policies to be more open.

To help them move in this direction, the federal Agency for Healthcare Research and Quality released in May an online toolkit designed to expand the use of the agency’s “Communication and Optimal Resolution” process, which establishes guidelines for adopting more transparency in communicating adverse events.

Hospitals’ interest in this approach has been fueled by studies showing that patients want to know when an adverse event has occurred and doctors suffer from anxiety when there are restrictions and concerns about what they are allowed to discuss. Some studies have found that patients are more likely to sue when they perceive that there is a lack of honesty.

MedStar Health, which is among the largest health providers in Maryland and the Washington, DC region, has been one of the pioneers in setting up such programs at all of its 10 hospitals. In 2012, it launched standardized program based on AHRQ’s guidelines across the system that drew on similar initiatives that were already in place at its various facilities.

The initiative established a standardized approach for physicians when they have to communicate with patients and family members about adverse events. A team of physicians — called the “Go Team” — complete a four-hour initial training program and then annual booster courses every six to eight months to prepare them for these conversations and also to help other staff physicians who confront the problem. After that, Go Team members are on call 24/7 to provide guidance. Another program, “Care for the Caregiver,” provides psychological support to other physicians as needed.

One of central elements of the training program for the Go Team involves role-playing exercises with professional actors who simulated patient scenarios.

MedStar is not the only hospital system implementing the system. Since 2012, second-year medical students at Johns Hopkins University are required to learn how to disclose adverse events in their patient safety classes by participating role-playing exercises. Several Harvard teaching hospitals also have coaching models similar to MedStar’s.

Part of the motivation for David Mayer, vice president of quality and safety for MedStar Health, to establish open communication programs came from his personal experience about a decade ago when he was the co-executive director at the University of Illinois Institute for Patient Safety Excellence. Back then, he and his colleagues were frustrated with the tension between doctors, patients and the amount of lawsuits the hospital had to field from patients who wanted to know more.

Mayer said by emphasizing transparency and creating an open environment, the doctors have been able to learn from past events and improve their performance. At MedStar Health, he has seen a 60 percent reduction in serious safety events in the past four years.

But the openness also has a cost. The hospital might have to pay for remedies, such as waiving medical bills, if a patient believes the hospital was at fault.

Visit Kaiser Health for the article.