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Copyright © 2016

         Clinical intelligence for supply chain leadership


hpnonline Daily Update


April 4-8, 2016
April 4 April 5 April 6 April 7 April 8


April 8, 2016   Download print version

Hospitals' digital drug ordering boosts safety but can lead to fatal errors

Banned chemical in hospital IVs linked to ADHD in critically ill children

Former UnitedHealth executive to launch new health plan

Stimulant, banned from sports, found in dietary supplements in U.S.

Patient secretly recorded doctors as they operated on her

IBM wants Watson to be more like humans

The Joint Commission and NQF recognize Premier, Inc. for improving healthcare safety and quality

Medtronic says new inversion rules won’t hurt finances

Hospitals' digital drug ordering boosts safety but can lead to fatal errors

Hospitals' use of digital medication orders have dramatically reduced the number of dangerous drug errors, but their computer systems still fail to flag 13% of potentially fatal mistakes, a report released Thursday shows.

Medication errors are by far the most common mistakes made in hospitals —and hospital errors are the third leading cause of death in the United States. Digital drug ordering is part of so-called "computerized physician order entry," or CPOE, which was designed to address the problem.

"These findings show the transition from pen and paper to electronic ordering and prescribing is making patients safer — with the systems flagging nearly 9 in 10 possible errors," said Andrew Gettinger, a physician and chief safety officer in the Office of the National Coordinator for Health IT in an email. "But the report also serves as an important reminder to clinicians and the health IT community broadly that there is more work to do when it comes to our top priority: the health and safety of our patients."

Research released in 1999 found CPOE reduced serious medication errors by 88%. Ninety-seven percent of hospitals use CPOE, thanks in large part to the stimulus bill of 2009. To receive the money, CPOE is required — and must alert about errors — in the electronic health records that the Affordable Care Act pushed doctors and hospitals to use. Many doctors have complained the records are too costly, time consuming and hard to use.

Other critics have long charged that the systems lack the safeguards needed, such as to keep doctors from copying information from one chart to another either by mistake or to commit fraud.

The new report by data analytics company Castlight Health and the hospital rating organization Leapfrog Group, suggests they're right. About 40% of the most common, serious errors overall weren’t caught.

Electronic health records aren't required to be accurate, notes Reed Gelzer, a physician and records expert who co-leads two international standards development work groups on records systems. Other studies have shown a substantial number of potentially harmful errors are caused by inaccurate or otherwise defective patient information in the records, notes Gelzer.

Visit USA Today for the report.



Banned chemical in hospital IVs linked to ADHD in critically ill children

A chemical that has been banned from use in children’s toys but is still used in medical devices, such as plastic IV tubes and catheters, has been linked to the development of attention deficit hyperactivity disorder in critically ill children.

The devices contain a high level of plastic-softening chemicals called phthalates which circulate in the blood and can seep into the bloodstream, according to EU funded researchers. Phthalates have long been banned in toys and other products, in both the US and EU, due to their potential toxic effects but there is no such prohibition for their use in medical devices.

Research carried out under Soren Verstraete, from Leuven, Belgium found a “clear match between previously hospitalized children’s long-term neurocognitive test results and their individual exposure to the phthalate DEHP during their stay in intensive care.” DEHP, is the most commonly used plastic softener in medical devices.

Four hundred forty-nine children, ranging from newborns to age 16, who were treated in pediatric intensive care units and whose care involved between one and 12 medical tubes were tested. One hundred healthy children were also tested for comparison.

The researchers measured blood levels of DEHP metabolites, or byproducts, and found that levels were not detectable in the blood samples of healthy children but were “sky high” in children admitted with catheters. These remained 18 times higher than levels in healthy children until they were discharged from the ICU.

Visit RT for the study.



Former UnitedHealth executive to launch new health plan

With a fresh infusion of $80 million in venture capital funding, a Minneapolis start-up is preparing to launch a health insurance plan it says will make life simpler for consumers and be a more effective partner for hospitals and clinics.

“There’s a better way to better health,” said Bob Sheehy, a retired UnitedHealthcare CEO and one of three health care heavy hitters behind Bright Health.

The upstart health plan aims to start selling policies directly to consumers who don’t get coverage at work in 2017, mostly through state healthcare exchanges and independent brokers. It plans to offer Medicare Advantage plans for those 65 and older starting in 2018.

Bright Health will create exclusive partnerships with a leading healthcare system in each market, providing billing and claims processing as well as mobile technology to help patients with wellness plans and to more easily communicate with their doctors and Bright Health.

Such narrow alignments with providers can give consumers fewer choices but, in theory, helps providers better monitor their patient’s health by being able to see if they’ve filled prescriptions or wound up in the emergency room after a visit to the family doctor.

Bright Health is jumping into a health insurance marketplace that is becoming both more cost-conscious and consumer-centric as a result of the Affordable Care Act. It is more common for providers and insurers to team up to try to keep patients healthier and costs down. Tuesday’s announcement that Fairview Health System will bring the UCare health plan under its corporate umbrella is the latest example locally.

Bright Health is among a host of new players hoping to find ways to make the healthcare system more effective, she said, including Oscar Health Insurance, a $1.5 billion New York-based start-up that launched last year.

Bright Health will offer consumers a range of options, from high-deductible plans with low premiums to low deductibles and higher cost-sharing. It will work with providers to offer such things as bundled payments, in which something like knee surgery is assigned a single cost that covers surgery and all the other doctors’ visits and physical therapy.

Based in the North Loop area of downtown Minneapolis, the company is in the process of hiring 25 full-time employees. It expects to have close to 50 by the end of the year, and plans to be selling insurance policies in three to five markets in the next several years. It expects to announce its first market in the next three months.

Visit the Star Tribune for the story.



Stimulant, banned from sports, found in dietary supplements in U.S.

A stimulant banned from competitive sports has been found in more than a dozen dietary supplements marketed for "burning" body fat.

Researchers found the stimulant -- called oxilofrine -- in 14 supplement brands sold in the United States. All of the products listed the substance on their labels, but under the alternative name of methylsynephrine.

Experts said the results raise more questions about the loose regulation of dietary supplements in the United States. Unlike drugs, supplements do not have to be proven effective, or even safe, before hitting the market.

Oxilofrine, a stimulant, raises blood pressure and heart rate, and in some countries it's used as a prescription drug for low blood pressure. The World Anti-Doping Agency considers oxilofrine a doping agent, and has banned it from sports, the researchers noted.

Since 2009, several athletes have been suspended after testing positive for the drug. But they've claimed they unknowingly ingested oxilofrine through supplements.

"So it's been known since at least 2009 that dietary supplements may contain oxilofrine," said Dr. Pieter Cohen, lead researcher on the new study and an assistant professor at Harvard Medical School in Boston. Now there's "definitive proof," said Cohen, who reported the findings in the journal Drug Testing and Analysis.

An FDA spokesperson said the agency is taking action. Last week, it sent warning letters to manufacturers of eight dietary supplements that list methylsynephrine on their labels.

The substance fails to meet the definition of a "dietary ingredient," the FDA said, so any supplement containing it is misbranded. The companies were given 15 days to report the "specific steps" they will take to bring their products into compliance with the law.

Cohen noted that no one knows what risks a healthy person could face from taking oxilofrine regularly. But, he said, it's essentially a synthetic version of ephedra -- which the FDA banned from dietary supplements more than a decade ago because of serious risks including heart attack and stroke.

The current study analyzed 27 supplement brands marketed for "fat burning" that listed methylsynephrine on the label. It turned out that 14 actually contained the ingredient in varying doses, but six brands served up prescription-level doses or higher, the researchers found. (HealthDay) Visit UPI for the article.   



Patient secretly recorded doctors as they operated on her

Last summer, Ethel Easter wanted nothing more than to see a doctor. A hiatal hernia had caused her to suffer more than a hundred abdominal attacks within 24 hours, her stomach was bruised, and she found urine in her blood. The pain was excruciating, so Easter prayed that a surgery could be scheduled as soon as possible.

The doctor who would be operating on her at Lyndon B. Johnson Hospital in Houston did not share her urgency. He told the 44-year-old Easter that she would have to wait two months, and Easter burst into tears.

Shaken, Easter later went to see her family doctor, who told her that the surgeon had taken notes on their meeting and raised “red flags” about her attitude — “as if I was the problem,” Easter said in a phone interview with The Washington Post on Wednesday.

From the start, Easter was troubled that she didn’t trust her own surgeon, but she was in too much pain to cancel the operation. Then she had an idea: She would go through with the surgery — it was ultimately scheduled about a month later, for August — but she would sneak a recorder into the operating room so that her family could know what happened to her in case things went wrong. She had a “bad feeling,” after all.

It began with the surgeon asking Easter about what happens to her when she takes penicillin. “When I was a baby, they said I swelled up,” Easter can be heard responding in the recording.

The surgeon also used the name “Precious” several times in a manner that Easter interpreted as racial. After the doctors concurred that there had been many “teaching moments” that day, the anesthesiologist asked, “Do you want me to touch her?”

While much of the exact dialogue is difficult to discern from the recording, Easter was distressed by what she believed to be its subject matter. She thought “Precious” might be an allusion to the 2009 movie of the same name, chronicling the life of an illiterate African American teenager who suffers childhood abuse.

What bothered Easter the most were moments in the recording when, in her view, the doctors acted flippant about her health and well-being. She was disturbed that the surgeon talked on his cellphone at one point during the surgery, and even more so that he seemed unbothered by her penicillin allergy.

He said in the recording that swelling and rashes were not severe enough reactions to preclude Easter from receiving Ancef, an antibiotic injection that causes side effects in a small percentage of penicillin-allergic patients. The surgeon suggested first giving Easter a small dose as a trial.

This would prove an unfortunate decision. At the end of the recording, a groggy Easter can be heard telling a doctor that she was “itchy.” Shortly after the surgery, Easter said, her arms swelled up and started getting rashes, though her hernia was successfully repaired. Her husband brought her back to the hospital — this time to the emergency room, where she was treated for an allergic reaction.

Last fall, Easter sent the hospital a letter with her complaints with the recording attached. Stacey Mitchell, the administrative director of risk management and patient safety for the Harris Health System, responded by thanking her for providing them a copy of the recording “to better analyze your concerns.”

Visit the Washington Post for the story.



IBM wants Watson to be more like humans

In the near future, IBM will be interested in working on technologies that could help Watson detect emotions in written human communications. The effort involves exploring that aspect of artificial intelligence that will stress more on ability of computer to address the needs of people. If such a breakthrough is possible, there will be two way communication: men to computers and vice versa.

“Computers will communicate with us on our terms. They will adapt to our needs, rather than us having to interpret and adapt to them”, said Rob High, chief technology officer at IBM’s Watson Solutions at the GPU Technology Conference in San Jose.

AI has already made many things possible such as services related to speech and image recognition, language translation and autonomous cars. IBM and many other companies are looking forward for something that would involve humans and computers working together.

Like IBM, Google and other companies are trying to humanize AI to transform computing. The idea will change the way people work and communicate on computer. The idea of a computer with cognitive system will be seen coming true within ten years. This is what IBM aimed with Watson to bring a day when computer will guide people on various fronts.

Watson already has a tone analyzer API that can measure similar emotions in samples of text from a sentence to a single word. Such an analyzer could judge whether a text is written out of which emotional experience such as anger, joy or confusion. Thus, it would guide that certain texts need to be changed for better effect.

The Watson Developer Cloud has personality insights service as well. This could extract insights from a lengthy piece of text by a particular person and can measure characteristics such as introversion or extroversion and conscientiousness. Such a system could help recruiters hire the right candidate.

Visit PerfScience for the report.



The Joint Commission and NQF recognize Premier, Inc. for improving healthcare safety and quality

Premier, Inc. has been nationally recognized by The Joint Commission and National Quality Forum (NQF) for improving patient safety and healthcare quality through its national quality improvement initiative, QUEST.

Premier has received the national 2015 John M. Eisenberg Patient Safety and Quality Award. The Joint Commission, the nation’s largest standards-setting and accrediting body in healthcare, and NQF, a leader in improving healthcare quality through measurement, established the annual award to honor John M. Eisenberg, MD, former administrator of the Agency for Healthcare Research and Quality, and member of the founding board of directors for NQF. The award recognizes major national achievements to improve overall healthcare quality by making care patient-centered, reliable, accessible and safe.

QUEST was launched in 2008 to help health systems reliably deliver the most efficient, effective and caring experience for every patient, every single time. Approximately 350 health systems volunteered to transparently share data and define a common framework with consistent measures that would continually set a top performance goal for both participants and the nation. To date, QUEST participants have prevented more than 176,000 deaths, reduced healthcare spending by more than $15 billion and improved readmission rates by 32 percent.

Residing in almost every U.S. state, QUEST participants are large and small, teaching and non-teaching, urban and rural, and high and low disproportionate share hospitals.

Two years ahead of the Affordable Care Act, QUEST was designed to support health systems as they transitioned to a reforming care delivery and payment environment. What began as a test bed for performance improvement, the multidimensional initiative has set national standards of excellence based on increasingly automated measures for readmissions, harm, mortality, patient/family experience, cost and evidence-based care. To achieve these goals, QUEST leverages a proven methodology for performance improvement that enables providers to learn from top performers, share data and outcomes, and accelerate and sustain quality, efficiency and safety innovations across their organizations.

Visit Premier for the announcement.



Medtronic says new inversion rules won’t hurt finances

Medtronic Inc. on Wednesday said the Treasury Department’s new proposed tax regulations on inversion deals won't have a material financial impact on the medical supply company, which moved its corporate address abroad in a deal last year.

In January 2015, Medtronic closed a $43 billion acquisition of Ireland’s Covidien PLC, combining two of the world’s largest medical-supply companies. Medtronic, formerly based in Minneapolis, redomiciled in Ireland upon completion of the merger, part of a wave of controversial deals aimed at taking advantage of lower corporate-tax rates overseas.

Medtronic said Wednesday that the acquisition “was undertaken for strategic reasons and has created a company that is positively impacting the lives of more patients, in more ways and in more places around the world.”

On Monday, the Treasury Department imposed tough new curbs on corporate inversions, making it harder for companies to move their tax addresses out of the U.S. and then shift profits to low-tax countries using a maneuver known as earnings stripping.

The new rules—the government’s third wave of administrative action against inversions—shocked Wall Street and forced Pfizer Inc. and Allergan PLC to terminate their planned $150 billion merger, which was on track to be the biggest deal of its kind.

The Treasury’s regulations would limit what is known as earnings stripping, a practice that follows many inversions and other cross-border acquisitions that helps lower companies’ effective tax rates.

Inverted companies—in fact, all non-U.S.-based companies—can lend money to their U.S. subsidiaries.

Those moves create deductible interest in the U.S., reducing the income subject to the 35% U.S. corporate tax rate and shifting income to a lower-taxed jurisdiction. If a U.S.-based company tried the same technique by borrowing from its offshore subsidiaries, the government would tax that income at the U.S. rate.

Visit the Wall Street Journal for the story.



April 7, 2016   Download print version

Roche seeks to avoid cancer-drug drama with cost-effective U.K. price talks

More evidence that obesity is a global catastrophe in slow motion

Fentanyl, a prescription opioid deadlier than heroin, is now showing up on the streets

Antiarrhythmic drugs found beneficial when used by EMS treating cardiac arrest

Value-based insurance program raises compliance

White House to transfer Ebola funds to combat Zika virus

FDA approves first leadless pacemaker to treat heart rhythm disorders

US departments finalize new version of the summary of benefits and coverage helping consumers better understand their health coverage

Roche seeks to avoid cancer-drug drama with cost-effective U.K. price talks

Roche Holding AG said it’s open to discussing ways to set prices for tumor-fighting treatments in the U.K., signaling that the world’s biggest maker of cancer drugs will seek to avoid a repeat of last year’s heated dispute with authorities over the cost of two key medicines.

The U.K., where cancer survival rates lag those of other developed countries, is in a unique position because its state-run National Health Service covers 54 million people in England. Under the Cancer Drugs Fund, which pays for therapies that aren’t deemed cost-effective enough for routine NHS use, the government put technology in place that may have the ability to track how patients are doing on treatment and help guide payment policy.

Roche is open to giving some money back to the NHS if patients don’t respond well to a treatment, or to limit payments for those needing to take the drug long-term to keep the cancer at bay. The U.K. could follow the example of Italy, where Roche is testing money-back-guarantees and other cancer-drug pricing models with the Italian Medicines Agency.

The Basel, Switzerland-based drugmaker quarreled with the NHS last year over its decision to stop paying for some cancer medicines including Roche’s Kadcyla and Avastin. Roche Chief Executive Officer Severin Schwan called the choice “stupid” and “completely arbitrary” because it focuses on the price of medicines rather than potential savings to the overall health system. Kadcyla was later covered by the drug fund for a type of breast cancer, though it’s still not backed for routine NHS use.

The Cancer Drugs Fund in its existing form ended in March, and the new version begins in July with a 340 million-pound ($485 million) annual budget. That’s in addition to the 1.2 billion pounds the NHS spends on cancer drugs each year. NICE is set to review 37 medicines available through the fund and decide whether they offer the NHS value for money. Because of their high prices, new cancer therapies often fail to win NICE’s backing unless manufacturers offer discounts.

Avastin is still not available for NHS patients with bowel cancer, he said, though it’s routinely used for that disease in the rest of the developed world. The medicine brought in about $7 billion in global sales last year, making it Roche’s second-best selling therapy.

Visit Bloomberg for the article.



More evidence that obesity is a global catastrophe in slow motion

Sometimes it is harder to see things that move in slow motion. Perhaps if the global obesity epidemic moved any faster, it would garner an emergency response similar to Ebola, Zika, and other infectious disease epidemics that have gripped the world in recent years. As two recent studies published in The Lancet and authored by the Non-Communicable Disease (NCD) Risk Factor Collaboration have re-emphasized, the sheer magnitude of the global obesity epidemic dwarfs those of most other epidemics.

The impact may be much greater as well, accounting for many more deaths (over 3.4 million a year) and more costs (over $2 trillion a year).

Larry Cheskin, MD, Associate Director of our Global Obesity Prevention Center (GOPC) at Johns Hopkins University and Associate Professor at the Johns Hopkins Bloomberg School of Public Health, describes the global obesity epidemic as “a catastrophe happening in slow motion.”

One of the Lancet studies confirmed that obesity and overweight is a growing problem worldwide, even in countries that in the past have had problems with lack of food. The study analyzed the change in body mass index (BMI) from 1698 studies among 19.2 million adults in 200 countries from 1975 to 2014. The researchers found that during this time period the average BMI increased from 21.7 to 24.2 kg/m2 among men and from 22.1 to 24.4 kg/m2 among women.

By comparison, the prevalence of people who are underweight, presumably from lack of enough food, decreased from 13.8% to 8.8% among men and 14.6% to 9.7% among women.

The other Lancet study showed a substantial worldwide increase in diabetes since 1980 by analyzing 751 studies that included nearly 4.4 million people.

As the study’s senior author Professor Majid Ezzati form Imperial College explained, “obesity is the most important risk factor for type 2 diabetes and our attempts to control rising rates of obesity have so far not proved successful. Identifying people who are at high risk of diabetes should be a particular priority since the onset can be prevented or delayed through lifestyle changes, diet or medication.”

The study found that between 1980 and 2014, diabetes prevalence more than doubled from 4.3% to 9.0% among men and climbed by over 50% from 5.0% to 7.9% among women. This corresponded to the number of adults with diabetes worldwide nearly quadrupling from 108 million to 422 million.

While attention to the obesity epidemic has grown in recent years, has there been enough concern, energy, action, and urgency to match the true magnitude and severity of this epidemic? Over the past several decades many of the obesity-measures have focused on the individual person such as diets and exercise programs.

True, some larger efforts here and there around the world have emerged to prevent and control obesity. For example, the World Cancer Research Fund International (WCRF) NOURISHING framework catalogs efforts aimed at improving diets to reduce obesity such as sugar sweetened beverage taxes in Mexico and Berkeley, CA. Other initiatives have tried to increase physical activity such as the United States First Lady Michelle Obama’s Let’s Move Campaign and the Aspen Institute’s Project Play. However, the two recent Lancet studies suggest that no country so far has truly successfully curbed the obesity epidemic.

But the two Lancet studies also provide further evidence that obesity is resulting from forces beyond the individual. It is highly unlikely that laziness and poor choices can explain such large increases in obesity and diabetes in so many different countries, including low and middle income countries that do not have the luxuries and access to food that high countries do. Such broader trends imply that other wider societal forces are at play such as fundamental changes in food, environmental, cultural, economic, and social systems. Therefore, more global and systems approaches to the obesity epidemic may be necessary.

Visit Forbes for the article.



Fentanyl, a prescription opioid deadlier than heroin, is now showing up on the streets

Undercover Orlando police officers don't have much trouble finding dealers who claim to be selling heroin. Recently, though, lab tests are showing that what officers are buying on the street isn't heroin, but something even deadlier — a painkiller known as fentanyl, typically prescribed after surgery or for patients with a terminal illness. It is as much as 50 times stronger than heroin.

"Sometimes it's 100 percent fentanyl," said Lt. Rich Lane, who oversees OPD's Drug Enforcement Division. "But it's always sold to us as heroin and that's the scary part ... it's like heroin on steroids."

This is how so many addicts looking for their next hit end up as another number in the morgue. They think they are shooting up with the dope they know. They have no idea they were just sold a fatal dose.

At 100 times more potent than morphine, it only takes a little fentanyl to kill. Joshua Stephany, interim medical examiner for Orange and Osceola counties, says more people are dying this way. Back in 2013, his office tallied just 18 deaths tied to fentanyl. In 2014, 34 people died after taking the synthetic opiate. The number of fentanyl deaths more than doubled in 2015 to 70. So far, in the first three months of this year, there have been five cases of fentanyl-related fatal overdoses. And that number is likely to go up because Stephany is still waiting on lab results to come back on some cases.

This is what police and addicts — and, yes, those two can be on the same team — are now up against: dealers who have no idea what they are really selling or just don't care.

When addicts hear about a rash of overdoses — such as the deaths that occurred last summer at the condemned condominium complex — dealers consider that good marketing. That isn't even the scariest part. This problem is spreading beyond heroin junkies.

In the Tampa Bay area, police have found overdose victims with counterfeit oxycodone and xanax pills laced with fentanyl.

"What we are now seeing are deaths of persons associated with fentanyl that are not known to use IV drugs, but rather pills obtained on the street or black market," said William Pellan, director of investigations at the medical examiner's office in Pinellas and Pasco counties. "These are pills that are being pressed out to appear to be authentic pharmaceutical xanax and/or oxycodone. ... This is particularly alarming and very dangerous, considering the potency of fentanyl."

A drug that doctors have long prescribed in patch form to control pain at the end of patients' lives is now being manufactured by drug cartels and used to increase the potency of other street drugs. Police want to get the word out.

Visit the Orlando Sentinel for the story.



Antiarrhythmic drugs found beneficial when used by EMS treating cardiac arrest

Researchers have confirmed that certain heart rhythm medications, when given by paramedics to patients with out-of-hospital cardiac arrest who had failed electrical shock treatment, improved likelihood of patients surviving transport to the hospital. The study was published online in the New England Journal of Medicine and helps answer a longstanding scientific question about the effectiveness of two widely-used antiarrhythmic drugs, amiodarone and lidocaine, for treating sudden cardiac arrest.

The study followed the patients from hospital admission to hospital discharge. Although neither drug significantly improved the overall rate of survival to hospital discharge, amiodarone showed a favorable trend in that direction. Survival to discharge is the point at which a patient is discharged from the hospital.

“This trial shows that amiodarone and lidocaine offer hope for bringing patients back to life and into the hospital after cardiac arrest,” said principal study author Peter Kudenchuk, M.D., a cardiac electrophysiologist at the University of Washington Medical Center in Seattle. “While the overall increase in survival to hospital discharge of about 3 percent with amiodarone was not statistically significant, it came very close. Importantly, there was a significant improvement in survival to hospital discharge with either drug when the cardiac arrest was bystander-witnessed.” A bystander-witnessed cardiac arrest is one that is witnessed by another person.

Sudden cardiac arrest is a condition in which the heart suddenly or unexpectedly stops beating, cutting off blood flow to the brain and other vital organs. More than 300,000 people are treated for out-of-hospital cardiac arrest each year, with the vast majority occurring at home, according to the American Heart Association. Studies show that nationally only about 10 percent of people who suffer cardiac arrest outside the hospital survive. Effective treatments, such as CPR and defibrillation, can greatly increase a victim’s chance of survival. This study adds the possibility of additional benefit from the use of the heart rhythm medications.

EMS (emergency medical services) providers commonly use antiarrhythmic drugs for out-of-hospital cardiac arrest that is not responsive to defibrillation shocks to the heart for restoring its normal rhythm. However, doctors remain unclear whether these drugs have proven survival benefit or if any benefit might be undone by possible drug side effects. As a result, use of these treatments by paramedics varies.

Adverse effects from the drugs were infrequent, and scientists are continuing to analyze findings from the trial to gain additional insight into its results.

Visit NIH for the study.



Value-based insurance program raises compliance

Giving patients economic incentives to participate in health screenings and take their prescribed medications resulted in decreased hospitalizations and increased medication adherence, a small study has found.

"The positive results in this case should encourage other payers to incorporate reduced cost sharing for high-value services across entire episodes of care in their benefit plans," wrote Richard Hirth, PhD, of the University of Michigan, in Ann Arbor, and colleagues in the April issue of Health Affairs.

The study involved 64,000 employees of the state of Connecticut who were enrolled in the state's health insurance plan; of those, about 98% enrolled in the state government's Health Enhancement Program. The program uses principles of value-based insurance design (VBID) -- incentivizing patients to receive care that's more clinically valuable by having them spend less for it.

Under the program, co-pays for office visits dealing with chronic conditions were eliminated (a savings of $15 per visit) and co-pays for medications associated with asthma, chronic obstructive pulmonary disease (COPD), diabetes heart disease, hypertension, and hyperlipidemia were reduced or eliminated.

However, program enrollees also had to do their part -- they were required to participate in health risk assessments, screenings, and physical exams -- such as mammograms or colorectal cancer screenings. Those with certain chronic conditions also had to obtain guideline-based clinical services and participate in disease management -- for example, eye exams for diabetes patients or blood pressure checks for hypertensive patients. In addition, patients had to pay a $35 co-pay for an emergency department (ED) visit that didn't result in a hospitalization.

Patients who participated in the program were exempt from a $100 monthly premium surcharge that nonparticipants paid, and those with chronic conditions who met all of the program's requirements received a $100 annual bonus, the authors explained. They compared outcomes from the Connecticut group over a 2-year period with those of a control group of 215,000 employees and their dependents enrolled in employer-sponsored plans in six states.

Preventive office visits and nearly all of the targeted preventive screenings showed significant gains from baseline in both the first and second program years, relative to the comparison group, the investigators found.

There were significant increases in physician office visits among patients with chronic conditions compared with the comparison group, the researchers found. The likelihood of having an office visit increased by 1.6 percentage points in year 1 and by 1.2 percentage points in year 2.

And for asthma or COPD, hyperlipidemia, diabetes, and hypertension, medication possession ratios for some drug classes -- a measure of medication adherence -- for enrollees in the Health Enhancement Program increased significantly relative to the comparison group between baseline and subsequent years, the authors noted.

In terms of ED visits, although there was no change in year 1, there was "a significant 1.0-percentage point decrease in the probability of an ED visit between baseline and the second year" compared with the control group, the researchers wrote. "In contrast, the total number of ED visits without a resulting hospital admission decreased significantly in both years."

Investigators also found that spending in year 1 of the Health Enhancement Program increased by about $730 per enrollee from baseline and in year 2 by about $961 per enrollee from baseline compared with the comparison group.

Michael Chernew, MD, of Harvard University in Cambridge, MA, said the study results "generally show that consumers respond to prices and so ... They are consistent with a whole range of other literature; when you lower prices for high-value services you can increase the use of those things and there seems to be some [cost] offset" such as in this case a reduction in ED use.

Visit MedPage Today for the report.



White House to transfer Ebola funds to combat Zika virus

Congressional officials say the Obama administration has decided to transfer leftover money from the largely successful fight against Ebola to combat the growing threat of the Zika virus. Most of the $600 million or so would be devoted to the Centers for Disease Control, which is focused on research and development of anti-Zika vaccines, treating those infected with the virus and combating the mosquitoes that spread it.

The officials spoke Tuesday on condition of anonymity because they were not authorized to publicly discuss the matter before an official announcement expected from the White House on Wednesday.

Researchers fear Zika causes microcephaly, a serious birth defect in which a baby's head is too small, as well as other threats to the children of pregnant women infected with it.

President Barack Obama has asked for about $1.9 billion in emergency money to fight Zika but the request has stalled in the GOP-controlled Congress. While the administration has acknowledged that substantial Ebola funding is left over, it has already committed much of it to helping at least 30 other countries prevent, detect and respond to future outbreaks and epidemics.

The upcoming move comes as there's greater urgency to battling the virus as summer weather leads to mosquito season and a broader spread of the virus.

Republicans on Capitol Hill had suggested the administration consider reshuffling existing funds and have said they are open to paying the money back in future legislation if it's needed for Ebola or some other purposes.

Wednesday's announcement would come as it's become plain that action on a stand-alone emergency spending bill is virtually impossible in the bitterly partisan atmosphere in Washington, though such funding could be attached to larger legislation later in the year. Congress approved about $5 billion in 2014 to combat Ebola.

Visit the Associated Press for the story.



FDA approves first leadless pacemaker to treat heart rhythm disorders

The U.S. Food and Drug Administration approved the first pacemaker that does not require the use of wired leads to provide an electrical connection between the pulse-generating device and the heart. While the Micra Transcatheter Pacing System works like other pacemakers to regulate heart rate, the self-contained, inch-long device is implanted directly in the right ventricle chamber of the heart.

Nearly 1 million people worldwide are implanted with pacemakers each year. The leads in a traditional single chamber pacemaker run from the pacemaker, implanted under the skin near the collarbone, through a vein directly into the heart’s right ventricle; the leads deliver electric pulses from the generator to the right ventricle and help coordinate timing of the chamber’s contractions. Micra eliminates these leads, which can sometimes malfunction or cause problems when infections develop in the surrounding tissue, requiring a surgical procedure to replace the device. 

“As the first leadless pacemaker, Micra offers a new option for patients considering a single chamber pacemaker device, which may help prevent problems associated with the wired leads,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. Micra is intended for patients with a heart arrhythmia called atrial fibrillation or those who have other dangerous arrhythmias, such as bradycardia-tachycardia syndrome.

Micra is contraindicated for patients who have implanted devices that would interfere with the pacemaker, who are severely obese, or who have an intolerance to materials in the device or the blood thinner heparin. It is also contraindicated for patients with veins that are unable to accommodate the 7.8 millimeter introducer sheath or pacemaker implant. The Micra device is manufactured by Medtronic.

Visit the FDA for the announcement.



US departments finalize new version of the summary of benefits and coverage helping consumers better understand their health coverage

The Department of Health and Human Services (HHS), the Department of Labor (DOL) and the Department of the Treasury announced key enhancements to the Summary of Benefits and Coverage (SBC) template and Uniform Glossary. The improvements include an additional coverage example and language and terms to improve consumers’ understanding of their health coverage.

Under the Affordable Care Act, issuers and health plans are required to provide a brief summary of what the plan covers and the cost sharing responsibility of the consumer, in order to help individuals make more informed choices among health plan options and better understand their coverage. Plans and issuers are also required to provide a comprehensive uniform glossary of commonly used health coverage and medical terms.

“Only when a consumer has a clear understanding of what their plan can do for them as well as what they are responsible for can they feel completely confident in their health plan choice,” says Marketplace CEO Kevin Counihan. “That is why we continue to improve upon the SBC requirements in order to provide that peace of mind to our consumers.”

The SBC includes coverage examples that demonstrate the cost sharing amounts an individual might be responsible for in three common medical situations. In addition to the current coverage examples that address diabetes care and childbirth, the updated template has a new coverage example that addresses coverage for a foot fracture so that a consumer understands what a plan covers in an emergency scenario.

Changes have also been made to the SBC to improve readability for consumers. The new templates include more information about cost sharing, such as enhanced language to explain deductibles and a requirement that plans address individual and overall out-of-pocket limits in the SBC.

These improvements reflect input from consumer groups, the National Association of Insurance Commissioners, and other stakeholders. Health plans and issuers will use this final SBC template beginning on the first day of the first open enrollment period that begins on or after April 1, 2017.

The SBC is available for every Marketplace plan and most non-Marketplace plans.

Further information regarding the SBC and supporting materials can be found at CMS.



April 6, 2016   Download print version

What Yelp can tell you about a hospital that official ratings can’t

Medicare is often overbilled by hospices, and pays twice for some drugs

Never mind Zika and Ebola: It’s Yellow Fever we should be worried about

Zika mystery deepens with evidence of nerve cell infections

Concern over the rising cost of insulin

MEDICA Education Conference returns in 2016

symplr and Cactus Software merge in healthcare provider credentialing software

FDA drug safety communication: Diabetes medications containing Saxagliptin and Alogliptin have risk of heart failure

What Yelp can tell you about a hospital that official ratings can’t

If you've ever taken the time to give Yelp your two cents about a hospital, you'll be happy to know that someone's listening and that they've deemed the crowd sourced information not only useful — but unique.

In what is believed to be the first large-scale analysis of such data, researchers from the University of Pennsylvania looked at 17,000 Yelp reviews of 1,352 hospitals from consumers. They found that the online information provides a broader sense of a facility than the current gold standard — a U.S. government survey that costs millions of dollars to develop and implement each year.

The Hospital Consumer Assessment of Healthcare Providers and Systems Survey or HCAHPS has been used since 2006 and involves asking discharged patients questions about their stays. It covers 11 main categories including communication with nurses and doctors, responsiveness of staff, the cleanliness and quietness of the hospital environment, and pain management.

Yelp offers consumers the ability to rate hospitals on a scale of one to five stars and write a review to accompany that rating. The U-Penn researchers used natural language processing to take apart the narratives and put them into buckets that were similar to the categories used by the HCAHPS. They gave as an example a post that had words such as "pain," "nurse," "medication," "gave" and how that might be assigned to the pain category.

Their paper, published in the April issue of Health Affairs, found that Yelp reviews encompassed only about seven of the 11 categories covered by the HCAHPS. That was disappointing. But there was also a big surprise in the data. The Yelp reviews had information about 12 additional categories that weren't addressed in the government survey. Those include the cost of the hospital visit, insurance and billing, ancillary testing, facilities, amenities, scheduling, compassion of staff, family member care, quality of nursing, quality of staff, quality of technical aspects of care, and specific type of medical care.

For positive reviews they included caring doctors, nurses and staff; comforting; surgery/procedure and peri-op; and labor and delivery. And for negative reviews, they included insurance and billing and cost of hospital visits.

Read the article at the Washington Post.



Medicare is often overbilled by hospices, and pays twice for some drugs

Hospices often bill Medicare for a higher level of care than patients need, and Medicare often pays twice for the prescription drugs provided to people who are terminally ill, federal investigators say in a new report. The extra cost to Medicare was put at more than $260 million a year.

The investigators found that Medicare was paying hospices almost four times as much as it should have for some patients. The patients were receiving “inpatient care” when all they needed was less-expensive routine care in their homes, the report said.

Medicare now pays hospices an all-inclusive rate of $720 a day for inpatient care and no more than $187 a day for routine home care. Most hospice care is provided to Medicare beneficiaries in their homes. But if their pain or symptoms become too difficult to manage at home, they can be admitted to a hospital, nursing home or hospice inpatient unit.

The department’s inspector general, Daniel R. Levinson, found that hospices were billing Medicare for a higher, more expensive level of care than patients needed in about a third of such cases.

In response to the report, Andrew M. Slavitt, the top Medicare official, said he was stepping up supervision of hospices because he was concerned about “care being billed for but not provided, long lengths of stay and beneficiaries receiving unnecessary care.”

Medicare’s hospice benefit covers a combination of medical, social and counseling services, as well as prescription drugs, for people with a life expectancy of six months or less. It emphasizes the alleviation of pain and suffering rather than the cure of illness. Hospice patients generally forgo Medicare coverage for curative treatment of the terminal illness and related conditions.

In about 20 percent of hospice claims for inpatient care, Levinson said, the Medicare beneficiary did not need such care at all. In another 10 percent, he said, the patient needed the higher level care for only part of the inpatient stay.

And “in 1 percent of stays,” he said, “there was no evidence that the beneficiary elected hospice care or was even certified as having a terminal illness.”

Visit the New York Times for the full article.



Never mind Zika and Ebola: It’s Yellow Fever we should be worried about

Yellow Fever is a nasty way to die. Your muscles ache, your head hurts, and your skin starts turning yellow. You run a fever, and start vomiting. Eventually, if left untreated, you start having seizures and bleeding from your eyes and your mouth, until your organs pack up.

In Angola, at least 178 people have died this way since the beginning of a new Yellow Fever outbreak in December 2015. In total, an estimated 450 people have been infected with the disease, and that’s just the official statistics: experts estimate that the true figures could be as much as 10 times higher. That’s a lot of sick people, and a lot of dead bodies.

In contrast, the Zika virus, which has dominated health news in 2016, has claimed only a handful of lives, although it has caused nearly 1,000 cases of infants born with microcephaly in South America. If Zika is a public health emergency — and there’s no doubt that it is – then Angola’s Yellow Fever outbreak should be too.

To make matters even worse, Yellow Fever – unlike Ebola or Zika – is entirely preventable. A highly effective vaccine exists. Had the vaccine been administered in Angola, like it is as a matter of routine in many countries across the world, the current outbreak would not exist. Given Angola’s vast oil wealth, there is no doubt that the country could have afforded to implement a vaccination program that would have prevented these deaths.

Now, both Angolan and global authorities are scrambling to react. The World Health Organization has shipped its entire stock of six-million vaccinations to Luanda, where they are being rolled out as quickly as possible. But Luanda alone has a population of 7.2-million, so there are simply not enough vaccines to go round.

While efforts are under way to increase production, the Angolan outbreak underlines just how important it is to maintain sufficient vaccine stockpiles for emergency use. Without enough vaccines, virologists are concerned that Angolan Yellow Fever epidemic will spread quickly, both within Angola and the region. Already, people infected in Angola have been identified in Kenya, Mauritania, the Democratic Republic of Congo and China.

Alternatively, there’s another approach. In the wake of the Zika outbreak, several scientists advocated for a radical solution: the complete elimination of the Aedes aegypti mosquito, through which the Zika virus is spread. It just so happens that this same mosquito is also the primary vector for Yellow Fever. One biologist described this proposed specicide as “the ultimate swatting” – and said it could save up to a million human lives.

Visit the Daily Maverick for the story.



Zika mystery deepens with evidence of nerve cell infections

Top Zika investigators now believe that the birth defect microcephaly and the paralyzing Guillain-Barre syndrome may be just the most obvious maladies caused by the mosquito-borne virus. Fueling that suspicion are recent discoveries of serious brain and spinal cord infections - including encephalitis, meningitis and myelitis - in people exposed to Zika.

Evidence that Zika's damage may be more varied and widespread than initially believed adds pressure on affected countries to control mosquitoes and prepare to provide intensive - and, in some cases, lifelong - care to more patients. The newly suspected disorders can cause paralysis and permanent disability - a clinical outlook that adds urgency to vaccine development efforts.

Scientists are of two minds about why these new maladies have come into view. The first is that, as the virus is spreading through such large populations, it is revealing aspects of Zika that went unnoticed in earlier outbreaks in remote and sparsely populated areas. The second is that the newly detected disorders are more evidence that the virus has evolved.

"What we're seeing are the consequences of this virus turning from the African strain to a pandemic strain," said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine.

The suspicion that Zika acts directly on nerve cells began with autopsies on aborted and stillborn fetuses showing the virus replicating in brain tissues. In addition to microcephaly, researchers reported finding other abnormalities linked with Zika including fetal deaths, placental insufficiency, fetal growth retardation and injury to the central nervous system.

Doctors also are worried that Zika exposure in utero may have hidden effects, such as behavioral problems or learning disabilities, that are not apparent at birth.

"If you have a virus that is toxic enough to produce microcephaly in someone, you could be sure that it will produce a whole series of conditions that we haven't even begun to understand," said Dr. Alberto de la Vega, an obstetrician at San Juan's University Hospital in Puerto Rico.

First discovered in the Zika forest of Uganda in 1947, the virus circulated quietly in Africa and Asia, causing rare infections and producing mild symptoms. A 2013 outbreak in French Polynesia, the largest at that time, led researchers to make the Guillain-Barre link. Other neurological effects were noted but scientists made little of them at the time.

Other mosquito-borne viruses - including dengue, Japanese encephalitis and West Nile - are known to directly infect nerve cells in the brain and spinal cord. But such viruses are seldom associated with Guillain-Barre, and never with microcephaly, said Baylor's Hotez.

In a recent paper, WHO researcher Mary Kay Kindhauser wrote that Zika "appears to have changed in character," noting its transition from a mild infection to one causing "large outbreaks linked with neurological disorders."

Scientists studying Zika in Brazil now are reporting the same neurological disorders seen in French Polynesia. From April through July 2015, doctors in Brazil identified a spike in Guillain-Barre cases.

Zika exposed patients have had other neurological problems as well, including acute disseminated encephalomyelitis, which causes inflammation of the myelin, the protective sheath covering nerve fibers in the brain and spinal cord. Other patients experienced tingling, prickling or burning sensations, which are often markers of peripheral nerve damage.

In addition to Brazil and French Polynesia, at least 11 more countries and territories have reported hundreds of cases of Guillain-Barre syndrome linked to Zika. In Brazil, Guillain-Barre cases jumped 19 percent to 1,708 last year.

El Salvador, a country that has an annual average of 196 cases of Guillain-Barre, reported 118 cases in six weeks in December and January.

Dr. Carlos Pardo-Villamizar, a neurologist at Johns Hopkins University School of Medicine, is studying Zika complications with colleagues in five Colombian research centers. They have seen cases of encephalitis, myelitis and facial paralysis associated with Zika and want to understand what is triggering these complications.

They also want to study whether prior infection with dengue or chikungunya - two related viruses - are contributing to neurological disorders seen in patients with Zika.

Visit Reuters for the report.



Concern over the rising cost of insulin

The average price of insulin tripled between 2002 and 2013, according to a research letter published in JAMA, and that has led to higher costs for diabetics. Meanwhile, the cost of noninsulin therapies has trended downward, the researchers found.

A major driver of the increasing cost is analog insulin, a man-made insulin developed in the 1990s, according to the study. Analog insulin is considered superior to the other man-made insulin, known as human insulin, which was first engineered in the 1980s to be genetically identical to the body's naturally-produced insulin. 

Analog insulin is faster-acting than human insulin, is considered more convenient to use and may lead to fewer low blood sugar reactions, says Dr. Bill Herman, a University of Michigan professor of medicine and epidemiology and co-author of the research letter.

But analog insulin is also more expensive, he says. A vial can cost $300 and diabetics generally need two to three vials a month, adds Herman, which he says can be hard to afford for those who have to pay out-of-pocket for their drugs.

Analog insulin now accounts for about 90 percent of the insulin market, says Herman, who adds that for many people with Type 2 diabetes, human insulin is safe and effective, in addition to being more affordable. 

The cost of insulin is increasing at a time of growing national anger over the skyrocketing costs of various prescription drugs.

Today's insulin products required significant research and development and are expensive to manufacture, says Herman. Still, "you have to balance that with the fact ...  that the cost of the medications, even since the time that they were launched, has continued to go up each year," he says.

"There's just not a lot of transparency in terms of what is actually research and development and manufacturing costs, versus what is profit," he says.

Noninsulin therapies, which are less expensive than analog or human insulin, are also an option for some patients.

Herman and his co-authors say the increases in the cost of insulin "suggest a need to reassess the effectiveness and cost-effectiveness" of the noninsulin treatments. 

Visit SCPR for the report.



MEDICA Education Conference returns in 2016

The German Association for Internal Medicine and Messe Düsseldorf will organize the MEDICA Education Conference again this year during the MEDICA trade fair. This conference offers participants a unique opportunity to exchange information about new medical technologies. MEDICA will take place from November 14 – 17, 2016 at the fairgrounds in Düsseldorf, Germany.

“Science meets Medical Technology”, is this year’s educational theme. Sessions will be geared towards professionals from all medical segments – from clinics and practices to anyone interested in medicine and medical technology in science, research, development and manufacturing. Scientific lectures will offer overviews or in-depth information while practical sessions will educate physicians about daily patient care.

In addition to the interdisciplinary offerings, the conference also provides an international information and networking platform with the majority of the events held in English.

Each of the four MEDICA education conference days will have a specific thematic focus.

On Monday November 14, the topics will be “New Operative Techniques in Surgery”. In addition to innovative techniques and future visions, current standards of surgical methods will be presented in a diverse and compact form.

The sessions on November 15 will address “Imaging and Interventional Procedures” such as magnetic resonance tomography and sonography. These procedures find application throughout medicine in diagnosis and therapy and are important elements of daily outpatient and inpatient clinical patient care.

The third conference day (November 16) will focus on “Internal Medicine: Future Technologies and Remote Patient Management”. Experts will discuss questions such as “What does telemedicine mean for chronic diseases such as diabetes” and “To what extent can digital solutions such as remote monitoring in case of heart failure help to avoid a hospital stay?”

The program on the final day (November 17) will look at “Diagnostics in Internal Medicine, Laboratory Medicine, Toxicology and Hygiene”. Determination of laboratory parameters, correct interpretation and connection to individual clinical symptoms will be the discussion topics.

Conference day passes can be purchased online in advance and include the MEDICA trade fair on the same day. The conference is structured to end at 3:30 pm daily to give participants the opportunity to walk to the neighboring exhibition halls and see new the technologies at MEDICA 2016 (the show closes at 6:30 pm).

More information about the conference is available online at www.medica-tradefair.com/mec2.

For further information on visiting or exhibiting at MEDICA 2016, visit www.mdna.com.


symplr and Cactus Software merge in healthcare provider credentialing software

symplr, a provider of Software as a Service (SaaS) based healthcare compliance and credentialing solutions, announced a merger with Cactus Software. Cactus Software provides management software for hospitals, managed care organizations, CVOs, and physician groups.

For more information or to contact symplr, visit www.symplr.com.



FDA drug safety communication: Diabetes medications containing Saxagliptin and Alogliptin have risk of heart failure

An FDA safety review has found that type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. As a result, FDA is adding new warnings to the drug labels about this safety issue.

Saxagliptin and alogliptin are part of the class of dipeptidyl peptidase-4 (DPP-4) inhibitor drugs, which are used with diet and exercise to lower blood sugar in adults with type 2 diabetes.

FDA evaluated two large clinical trials conducted in patients with heart disease. Each trial showed that more patients who received saxagliptin- or alogliptin-containing medicines were hospitalized for heart failure compared to patients who received an inactive treatment called a placebo.

In the saxagliptin trial, 3.5% of patients who received the drug were hospitalized for heart failure versus 2.8% of patients who received a placebo. This is the same as 35 out of every 1,000 patients compared to 28 out of every 1,000 patients. Risk factors included a history of heart failure or kidney impairment. In the alogliptin trial, 3.9% of alogliptin-treated patients were hospitalized for heart failure versus 3.3% in the placebo group. This is the same as 39 out of every 1,000 patients compared to 33 out of every 1,000 patients.

Healthcare professionals should consider discontinuing medications containing saxagliptin and alogliptin in patients who develop heart failure and monitor their diabetes control. If a patient’s blood sugar level is not well-controlled with their current treatment, other diabetes medicines may be required.

Patients taking these medicines should contact their healthcare professionals right away if they develop signs and symptoms of heart failure such as: Unusual shortness of breath during daily activities; Trouble breathing when lying down; Tiredness, weakness, or fatigue; Weight gain with swelling in the ankles, feet, legs, or stomach; Patients should not stop taking their medicine without first talking to their healthcare professionals.

Read the FDA MedWatch safety alert FDA Drug Safety Communication.



April 5, 2016   Download print version

Interference between CT and electronic medical devices

House Committee on Ways and Means pushes back on PAMA Laboratory payment reform timeline

Bypass boosts survival in heart failure, 10-year study says

Statin intolerance is real, researchers find. Another (more costly) drug may get around the problem

Why didn't Flint treat its water? An answer, at last

Medicare spends billions on chronic kidney disease, study finds

AORN 2016 Coverage:

Olympus introduces light & boom portfolio to support big screen surgery

Buffalo Filter celebrates 25th anniversary

UMF Corporation's PerfectCLEAN OR System receives AORN Seal of Recognition for 4th year

Encompass Group offers continuing educations courses at AORN

Mölnlycke Health Care doubles up on Biogel PI Micro Surgical Double-Gloving System

Interference between CT and electronic medical devices

CT is a valuable type of diagnostic imaging. Most patients undergo CT scans without any adverse consequences. However, the FDA has received a small number of reports of adverse events that they believe to be associated with CT imaging of some implantable and wearable electronic devices (eg. insulin pumps, cardiac implantable electronic devices and neurostimulators).

The current understanding is that when a CT scanner directly irradiates the circuitry of certain implantable or wearable electronic medical devices (i.e. when the device is visible in the resulting CT image), it can cause sufficient electronic interference to affect the function and operation of the medical device. The probability that this interference can cause clinically significant adverse events is extremely low. Furthermore, the probability of x-ray electronic interference is lower when the radiation dose and the radiation dose rate are reduced.

Interference is completely avoided when the medical device is outside of the primary x-ray beam of the CT scanner.

The electronic medical devices for which they have received reports of adverse effects and have updated our recommendations are: Insulin pumps, Cardiac implantable electronic devices (pacemakers and implantable cardioverter defibrillators), and Neurostimulators.

The presence of the devices mentioned above should NOT preclude the performance of an appropriate, medically indicated CT scan. The probability of an adverse event being caused by exposing these devices to CT irradiation is extremely low, and it is greatly outweighed by the clinical benefit of a medically indicated CT examination.

CT continues to be the preferred tomographic imaging technology for patients with implantable or wearable medical devices. CT is safer for patients with devices of unknown magnetic resonance imaging (MRI) safety status. You should be aware that an MR Conditional device is only safe within the MR environment that matches its conditions of safe use. Any device with an unknown MRI safety status should be assumed to be MR Unsafe.

Medical device manufacturers, distributors, importers, and device user facilities (which include many healthcare facilities) must comply with the Medical Device Reporting (MDR) Regulations of 21 CFR Part 803.

Adverse events included: seizures, dizziness, fainting, injuries related to falls, heart failure, hypertension, and one death.

Although the adverse effects listed above were reported to occur during CT scanning, there is no evidence of direct causation from the CT irradiation. The number of adverse event reports received is very small compared to the number of patients with insulin pumps who were scanned without adverse effects. Although there is literature to document the rare effects on implantable cardioverter defibrillators (ICDs) and pacemakers, there is no equivalent evaluation of insulin pumps.

Visit the FDA For the warning.



House Committee on Ways and Means pushes back on PAMA Laboratory payment reform timeline

The National Independent Laboratory Association (NILA), representing community and regional independent clinical laboratories across the country, applauds the Chairman and members of the House Ways and Means Committee Subcommittee on Health for raising concern about the implementation of new regulations by the Centers for Medicare and Medicaid Services (CMS) to reform Medicare laboratory test reimbursement.

A bipartisan majority of the Ways and Means Subcommittee on Health, under the leadership of Subcommittee Chairman Pat Tiberi (R-OH) and committee members Congressman Patrick Meehan (R-PA) and Bill Pascrell (D-NJ) sent a letter to CMS Acting Administrator Andy Slavitt, that strongly advises CMS not to rush the reconfiguration of the Part B Clinical Laboratory Fee Schedule (CLFS) under the Protecting Access to Medicare Act (PAMA) of 2014.

The Ways and Means committee members join the chorus of many other House Representatives, the Senate Finance Committee Chairman and Ranking Member, and other Senators who have asked for a delay in the regulations and expressed significant concern with rushing the implementation of a complex payment reform system.

The release of the CMS PAMA regulations on October 1, 2015, came over 17 months after Congress passed the law that requires laboratories on January 1, 2016, to begin reporting all non-capitated privately-contracted insurance rates for every laboratory test they provide and the associated test volumes for each rate. NILA is extremely concerned about the impact this law and corresponding regulations will have on regional and community laboratories and the Medicare beneficiaries they serve.

With the release of a late proposed rule and no feedback since comments on the rule closed in November, NILA fears that CMS might rush the finalization of these complex regulations such that NILA members will not have the time or ability to prepare for reporting and to make business adjustments to handle the requirements. At this point, CMS has never pilot tested the new first-time reporting system or provided any understanding of how it will operate.

Under the CMS proposed regulation, reporting requirements would have commenced between January 2016-March 2016. CMS would have then quickly evaluated the anticipated billions of reported data sets to issue new proposed rates by November 2016, issuing new Clinical Laboratory Fee Schedule rates by January 1, 2017 – providing just two months for laboratories to comprehend the impact these adjustments will have on their business and their ability to provide services.

“While NILA has never supported the approach of this law, we want to ensure that a new process for determining Medicare reimbursement rates does not ultimately force smaller laboratories out of Medicare or perhaps out of business altogether-negatively affecting market competition and access to Medicare laboratory services,” says Mark Birenbaum, Ph.D., NILA Administrator. “The law itself is fundamentally flawed, as it requires CMS to determine a weighted median of all the test rates/volumes reported in order to set new payment rates. Clearly, the largest players in the laboratory market - the two national publicly traded laboratories - will drive the test volumes, and their rates will dominate CMS’s evaluation. The law does nothing to consider variances in the market and the impact that adjustments will ultimately have on community and regional laboratories, particularly those that offer significantly smaller test menus in comparison to their national competitors.”

The laboratory market is derived of independent clinical laboratories – national, regional, and community laboratories, and hospital and physician-owned laboratories. In addition to fast-tracking implementation in the absence of final regulations, the proposed rule seeks to exclude a majority of clinical laboratories, including all hospital and nearly all physician-owned laboratories, from the reporting requirements, which many in the laboratory community believe will inappropriately reduce the new Medicare reimbursement rates.

Visit NILA for the request.



Bypass boosts survival in heart failure, 10-year study says

Heart failure patients with clogged arteries have a better chance of surviving 10 years if they get bypass surgery plus medicine rather than just drugs alone, according to an international study.

Earlier results from the same research raised questions about the benefits of bypass versus medicine alone, but researchers say the long-term evidence clearly favors the surgery.

The lead author of the study, Duke University cardiologist Dr. Eric Velazquez, said the results "are so definitive and so robust" that they would likely to lead to stronger recommendations favoring bypass surgery for these patients.

Nearly 6 million Americans and 23 million people worldwide have heart failure, and many of them also have artery disease similar to those studied. In recent years, bypass surgery has increasingly been recommended for such patients, along with medicines to ease heart failure symptoms.

Concerns were raised when results after nearly five years of research showed about equal number of deaths in bypass patients and in those who got only medicine, despite fewer heart-related deaths in the bypass group. Those findings were published in 2011.

The 10-year results were published in the New England Journal of Medicine and presented at an American College of Cardiology meeting in Chicago. The study involved 1,200 heart failure patients in 22 countries, including the United States. Most were men around age 60 when the study began. All were taking heart medicines, and about half were assigned to also get bypass surgery.

More than half the patients in each group lived beyond the study's first phase. The 10-year results are a look back at all patients studied.

A total of 359 bypass patients died from any cause, or about 59 percent, compared with 398 medicine-only patients who died, or 66 percent. Deaths from heart disease-related causes totaled 247 in the bypass group, or 41 percent, versus 297 medicine-only patients, or 49 percent.

Visit Tampa Bay Times for the story.



Statin intolerance is real, researchers find. Another (more costly) drug may get around the problem

Statins such as Lipitor and its generics have revolutionized cardiovascular care for nearly two decades as an effective, inexpensive way to reduce LDL cholesterol, the so-called bad cholesterol in the bloodstream.

Not everyone can take them, though; a significant number of people complain of muscle pain, weakness and cramping so severe that they discontinue the therapy even at the risk of a heart attack or stroke. Their resistance to the medication has been controversial, because in most cases there are no biomarkers for the muscle problems individuals describe. Some researchers have speculated that the problem is psychological, the “nocebo” effect of blaming the medication for the pain.

But a study released Sunday shows for the first time that statin intolerance is very real and that a newer, different kind of drug can have a strong impact on these patients’ high cholesterol.

Researchers found that 42.6 percent of people who had complained of muscle pain while taking at least two different statins experienced the same symptoms when given a statin during the study but had no ill effects when administered a placebo. They were then able to reduce their LDL cholesterol levels by more than half when given a PCSK9 inhibitor, evolocumab, for 24 weeks, compared with just a 16.7 percent reduction on ezetimibe, another medication.

The Food and Drug Administration approved PCSK9 inhibitors last year, but only for small groups of people, including those with an inherited disease that dramatically elevates their LDL cholesterol levels.

“This problem of statin intolerance is one of the most vexing problems for both patients and physicians in cardiovascular medicine,” Steven E. Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, said in an interview. He said the new study, which he led, offers hope for people who have not been able to take statins because of side effects.

Mary Norine Walsh, vice president of the American College of Cardiology and medical director of Heart Failure and Cardiac Transplantation at St. Vincent Heart Center in Indianapolis, called the study “encouraging.” PCSK9 inhibitors, she added, are “going to be, possibly, an option for patients who are statin-intolerant.”

But that may not happen for a while. In addition to requiring FDA approval, the drugs are much more expensive — from $10,000 to $15,000 a year. And because evidence of statin intolerance is largely subjective, insurance companies may balk until there are ways to more conclusively prove that patients are unable to take the cheaper drugs.

In another study released Sunday morning, researchers showed that a drug that raises HDL cholesterol, often called good cholesterol, and lowers LDL cholesterol does not help high-risk heart patients. In fact, the study of more than 12,000 people was cut short after the results revealed that the drug, evacetrapib, did not prolong the time until death, heart attack, stroke, coronary artery bypass surgery or hospitalization for chest pain due to restricted cardiac blood flow.

It was the third failure for drugs in a class known as cholesteryl ester transferprotein (CETP) inhibitors, which disrupt the process by which HDL cholesterol is converted to LDL cholesterol, the ACC said in a release.

Visit the Washington Post for the report.



Why didn't Flint treat its water? An answer, at last

Back in 2014, Flint water treatment workers expected they'd add corrosion control to the city's drinking water -- chemicals that would that would have prevented a public health crisis -- after the city switched its water supply. But the Michigan Department of Environmental Quality said they didn't have to.

Up to this point, it's been hard to understand why the state didn't require Flint to use corrosion control, chemicals that stop lead from leaching into the city's water supply. And the state's rationale, that it misunderstood federal guidelines, has mystified water treatment experts interviewed by the Free Press. It also drew scorn from the Flint Water Advisory Task Force, appointed by Gov. Rick Snyder himself to investigate the crisis -- the task force called MDEQ's interpretation of the rule "egregious" and "lax," saying it bypassed important and obvious questions about water safety.

But testimony at a legislative hearing from the city's utilities chief may help explain why: When Flint began to pump drinking water from the Flint River, the city's water treatment plant wasn't capable of adding corrosion control treatment, not without equipment upgrades the broke city couldn't afford.

In fact, Flint didn't start to install the required equipment until November 2015, when MDEQ signed off on an October permit application for a temporary phosphate feed system while a permanent feed was under construction, according to state records.

That's the same month Snyder finally acknowledged that there was a problem in Flint, that the abundant evidence amassed by independent researchers was accurate, and that the city's drinking water was not safe.

It's critical context for understanding the state's disastrous decision-making in Flint.

Michael Glasgow, then a lab supervisor and now the city's utilities administrator, testified at a legislative hearing about the Flint water crisis.

The state has said, for months, that MDEQ misinterpreted the federal Lead and Copper Rule, a guideline for treating water to prevent the kind of public health crisis that happened in Flint -- because water pumped from the Flint River hadn't been dosed with corrosion control chemicals, the city's residents were exposed to lead-contaminated water, for almost two years, including nearly 9,000 children younger than 6.

And even after the U.S. Environmental Protection Agency told the state last spring that Flint must begin corrosion control immediately, the state didn't act -- in official emails, claiming it was appropriate to continue monitoring the city's water before changing its treatment, even as two rounds of state testing showed lead levels in the city's drinking water climbing.

The decision to skip corrosion control certainly didn't save money. Corrosion-control chemicals, which keep lead contained by coating the inside of plumbing pipes, are cheap; some reports estimate the cost of treating Flint River water at less than $150 a day.

Plant upgrades, however, are expensive. A 2014 engineering report, performed in conjunction with a bond offering for a new regional water authority the state OK'd Flint to join in 2013, said the local treatment plant would require $8 million in upgrades to process the Lake Huron water the new system would pump.

Flint was broke by the time it joined the new regional water authority, and under the oversight of a state-appointed emergency manager hired to cut costs. And it was still broke the next year, when a different emergency manager opted to pull drinking water from the Flint River while the new system was under construction, instead of purchasing water from the Detroit system Flint had patronized for years.

Both choices were billed as cost-saving measures, justified because of Flint's financial situation.

That 2009 report didn't specify how much of that $8 million total installation of corrosion control equipment would account for, but the idea that Flint's plant needed a corrosion control upgrade wasn't new. A 2009 engineering analysis associated with the same water system detailed equipment necessary to add corrosion control at Flint's plant: a 6,000-gallon bulk storage tank, a transfer pump and a 120-gallon day tank and chemical metering pumps.

According to MDEQ, no upgrades to corrosion-control equipment were made at the plant before it began to pump and treat Flint River water, more corrosive than the Lake Huron water it expected to use when the new system was complete.

Visit the Detroit Free Press for the story.



Medicare spends billions on chronic kidney disease, study finds

Chronic kidney disease affects nearly 14 percent of Americans and costs Medicare billions of dollars a year, a new study reveals. In 2013, Medicare spent $50 billion on chronic kidney disease among people 65 and older, and $31 billion on those with kidney failure, the researchers found.

"This report is a one-stop shop to try to understand the prevalence of kidney disease, how it's being treated and how the burden affects various populations," researcher Rajesh Balkrishnan, a professor of public health sciences at the University of Virginia School of Medicine, said in a university news release.

"If we can identify which treatment modalities are working and how they're used and link these treatments to outcomes, we can inform the government of the most cost-effective ways to manage and treat the growing burden of kidney disease in the U.S.," he added.

The study was published online in March as a special report by the American Journal of Kidney Diseases.

Balkrishnan led the analysis of prescription drug use and found that in 2013, spending on prescriptions for Medicare Part D patients with chronic kidney disease was 46 percent higher than for general Medicare patients -- $3,675 per patient versus $2,509.

Spending for prescriptions for Part D patients with kidney failure was $6,673 a year per patient, 2.6 times higher than for general Medicare patients. Dialysis patients had the highest cost at $7,142 per person per year, the findings showed.

Spending for Part D-covered medications was more than two times higher for chronic kidney disease patients who received Medicare's low-income subsidy than for those who did not -- $6,088 versus $2,873. Out-of-pocket costs were 1 percent to 2 percent for patients who got the subsidy, and between 28 percent and 32 percent for those who did not, according to the report. (HealthDay) Visit NIH for the report.




Association for Perioperative Registered Nurses' Surgical Conference and Expo 2016 in Anaheim, California April 3-5, 2016

Olympus introduces light & boom portfolio to support big screen surgery

Olympus has announced it now sells surgical lighting, equipment booms and infrastructure products through a distribution agreement with AMICO. The agreement brings with it several innovative and differentiated technologies, two of which will be featured this week at AORN 2016.

There will be a presentation on ergonomic positioning of large monitors in the operative field and a live demonstration of the Patient Lift Pendant (PLP) system. The PLP is a patented, safe, and ergonomic method of transferring patients into the surgical field directly from a ceiling mounted boom.  Other applications include elevating and holding appendages during long surgical cases.  

The partnership with AMICO solidifies a key addition to the Olympus Systems Integration business which will now include an OR design element. Combining a best-in-class imaging system, robust integration offering, and differentiated infrastructure product, Olympus has a highly competitive and complete solution for all surgical environments.

Three weeks ago, at the 2016 Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) in Boston, Olympus launched its Big Screen Surgery concept, featuring the new Olympus 4K Imaging platform, which highlights the visual elements – light, color and higher resolution – essential for laparoscopic and arthroscopic surgery. Given the recommended use of a larger screen with 4K imaging, appropriate infrastructure and ergonomics are recommended for managing screen placement to best accommodate the surgical team.

For more information about big screen surgery visit Olympus.



Buffalo Filter celebrates 25th anniversary

Buffalo Filter is pleased to announce that 2016 marks its 25th anniversary.  In 1991, Buffalo Filter was founded on the belief that there was a need to rid the world’s surgical environments of the hazards associated with surgical smoke plume exposure. Over the course of the last 25 years, Buffalo Filter has set the standard with state-of-the-art surgical smoke plume evacuation products and technologies; their world renowned education program has changed the way the global healthcare community sees surgical smoke.

Buffalo Filter’s 25th Anniversary will be commemorated with a variety of events and promotions to be kicked-off at AORN in Booth #509.

Visit www.buffalofilter.com.



UMF Corporation's PerfectCLEAN OR System receives AORN Seal of Recognition for 4th year

For the fourth consecutive year, the Association of periOperative Registered Nurses (AORN) has awarded its AORN Seal of Recognition to the PerfectCLEAN Operating Room Processing & Checklist System developed by UMF Corporation, a Chicago-based innovator of infection prevention products, systems and training for all healthcare markets.

For the PerfectCLEAN OR Processing & Checklist System, the AORN Seal of Recognition confirms that the content of the program has undergone thorough review by AORN and meets the guidelines of the "AORN Guidelines for Perioperative Practice." While not an endorsement, the Seal of Recognition is confirmation that the PerfectCLEAN Operating Room education materials meet AORN's guidelines for excellence in providing a safe patient environment.

UMF Corporation and its PerfectCLEAN OR System were recently brought in as part of a multimodal initiative at three Kentucky hospitals -- Bourbon Community Hospital of Paris, Georgetown Community Hospital of Georgetown and James B. Haggin Memorial Hospital of Harrodsburg -- to prevent transmission of infections in the operating room. The initiative aligns the efforts of the three hospitals' Environmental Services (ES) staffs responsible for OR processing, Logan's Healthcare Linen and Uniform Rental of Shelbyville (the hospitals' healthcare laundry); and UMF Corporation.

AORN's guidelines for safe patient care figure prominently in the hospital initiatives. Logan's is accredited by the Healthcare Laundry Accreditation Council (HLAC), which also is a recipient of the AORN Seal of Recognition. Last year, Logan's joined UMF Corporation's expanding PerfectCLEAN Infection Prevention Network (PC/Network) of specialized healthcare laundries serving acute care hospitals and extended care and ambulatory surgical centers.

Visit www.perfectclean.com.



Encompass Group offers continuing educations courses at AORN

Encompass is pleased to offer two Continuing Education courses at this year’s AORN conference in AORN Booth #1611: Mind the Gap: Utilizing Evidence-Based Outcome Evaluation to Simplify Patient Warming; and Back to the Future: New Innovations in Reusable OR Textiles.

Visit www.encompassgroup.net.



Mölnlycke Health Care doubles up on Biogel PI Micro Surgical Double-Gloving System

Mölnlycke Health Care is enhancing its Biogel PI Micro range to offer the Biogel PI Micro Indicator Underglove for use with the Biogel PI Micro surgical glove – creating the next-generation puncture indication system. The system offers a thinner, more comfortable, synthetic double-gloving solution, giving the best possible protection without sacrificing tactile sensitivity.

With Biogel PI Micro Indicator Underglove, Mölnlycke Health Care is building on the success of the 20-percent-thinner profile of Biogel PI Micro to provide continuous improvement for customers. A recent user evaluation showed that 85 percent of Operating Room staff preferred the new Biogel PI Micro Indicator Underglove to the existing Biogel PI Indicator Underglove.

With Biogel PI Micro, the company now offers a synthetic double-gloving solution that both protects against latex sensitivity and allergic reactions, and addresses the demand for tactile sensitivity and dexterity. Tactile sensitivity is cited as one of the main barriers to adopting double-gloving in the Operating Room.

While clinical evidence increasingly supports global recommendations for double-gloving in all cases, a survey with 107 surgical staff members found that fewer than one-third of surgeons report using double-gloving in > 75% of cases.

For more information, visit Mölnlycke.



April 4, 2016   Download print version

Researchers find 1400 software vulnerabilities in medical supply system

Ultrasounds missed her Zika infection—until one showed serious harm to her fetus

FDA Alert: Sterile drug products by Medaus Pharmacy

CMS invites Quality Innovation Network-Quality Improvement Organizations to submit special innovation projects to expand their reach in improving care delivery

AORN 2016 Coverage:

Clorox Healthcare introduces povidone-iodine alternative to antibiotics for nasal decolonization

Tru-D SmartUVC to showcase the gold standard in disinfection technology at AORN

Nurse appreciation and patient care focal points for Cardinal Health Showcase at AORN

TIDI Products to showcase Sterile-Z infection-prevention products at AORN 2016 in-booth presentations

Researchers find 1400 software vulnerabilities in medical supply system

Security researchers found vulnerabilities in end-of-life versions of CareFusion’s Pyxis SupplyStation system.

Collaborating with CareFusion, researchers Billy Rios and Mike Ahmadi identified the vulnerabilities in end-of-life versions of CareFusion’s Pyxis SupplyStation system, said the notice from the Industrial Control Systems Cyber Emergency Response Team (ICS-CERT).

“These vulnerabilities could be exploited remotely,” the advisory says. “Exploits that target these vulnerabilities are known to be publicly available.”

Pyxis SupplyStation systems are automated cabinets that dispense medical supplies and can document usage in real time. They typically include a network of workstations, located in patient care areas throughout a facility and managed by the Pyxis SupplyCenter server, which links to the facility’s existing information systems, according to ICS-CERT. The SupplyStation system is designed to provide access to supplies in “fail-safe mode” if the cabinet is rendered inoperable.

CareFusion will not provide a patch for these outdated systems, but has begun providing customers of end-of-life versions with an upgrade path. Those who choose not to upgrade can apply a series of compensating methods detailed in the advisory.

 “Vulnerabilities will always be discovered in connected devices,” John Smith, principal solution architect at Veracode, said. “The security of all IoT devices must be looked at holistically so that all devices, as well as their web and mobile applications, and back-end cloud services, are secure by default.”

Researcher Ahmadi specializes in critical systems security – in which system failures can cause disastrous events that can lead to death.

“A heart is a vital organ and if it needs a pacemaker in order to survive, the pacemaker itself becomes as vital as the heart,” Ahmadi said. “If you can find a vulnerability that can cause a failure, then it is actually a digital pathogen, the body doesn’t differentiate anymore between a carbon-based virus and a digital one.”

Visit QMED for the story



Ultrasounds missed her Zika infection—until one showed serious harm to her fetus

Zika successfully hid through nearly half of a District woman’s pregnancy, its damage to her fetus not showing despite a series of early ultrasounds. But suddenly at 19 weeks, another scan revealed significant abnormalities, and a more sophisticated test one week later identified even greater damage in her baby’s brain. In early February, the woman terminated the pregnancy.

The report, in the New England Journal of Medicine, provides troubling new information about the capacity of the virus to infect a fetus and cause serious harm. The case also indicates that Zika may remain in the blood for a long time: The 33-year-old woman still tested positive for Zika 10 weeks after she likely was infected during a trip to Guatemala – far beyond what scientists have thought is the case.

"This helps put more pieces together in the puzzle because we know so little about how this virus acts and when and how long it stays in your blood after you have symptoms," said Laura Riley, vice chair of obstetrics and gynecology at Massachusetts General Hospital in Boston, who was not part of the study. Even though the study only involves one patient, "it's very important because she was followed so closely and there is so much detailed information.”

While the case offers important details to researchers and obstetricians-gynecologists counseling pregnant women who may have been exposed to the virus, "we're going to need to study this with a large number of patients to provide guidance for women," said Catherine Spong, acting director for the National Institute of Child Health and Human Development.

The woman and her husband traveled on vacation to Mexico, Guatemala and Belize in late November when she was 11 weeks pregnant. The couple told researchers they had been bitten by mosquitoes during their trip, particularly in Guatemala. After returning home, the woman developed eye and muscle pain, fever and a rash.

A series of ultrasounds that began one week after her symptoms subsided -- at 13, 16 and 17 weeks of pregnancy -- showed none of the characteristic problems linked to Zika. The most prominent in utero are an abnormally small head and brain calcifications, bright, white spots that indicate something is amiss. Both are key to a diagnosis of a rare condition called microcephaly.

Yet on the ultrasound at 19 weeks, significant brain abnormalities appeared: The baby's brain was small and contained an unusual amount of fluid. The cerebral cortex, its outer layer, was very thin. By the 20th week, a fetal MRI showed severe atrophy, especially in the front and top brain areas that are involved in decision-making, learning, vision, hearing, touch and taste. The fetus did not meet the threshold to be diagnosed with microcephaly.

In the initial ultrasounds, "they only looked at the size of the head and looked for brain calcifications to make sure she didn't have microcephaly and reassured her that everything looks okay," said Rita Driggers, one of the study's lead authors and medical director of Sibley Memorial Hospital’s maternal-fetal medicine division. Driggers, an assistant professor of gynecology and obstetrics at Johns Hopkins University School of Medicine, was involved in the patient's care.

The takeaway for clinicians, she and others said, is to make sure during ultrasounds to look for other brain changes beyond microcephaly and intracranial calcifications. Adre du Plessis, director of Children's National Health System's Fetal Medicine Institute and another study author, said Wednesday that the lack of those markers in the earlier ultrasounds may have led to "false reassurances" for the mother. What's more, he said, such delayed diagnosis of brain infection in the fetus may put women who'd opt to terminate a pregnancy "outside the legal limits" of an abortion.

The study also provides new information about how long the virus persists in the blood of an infected person. The common thinking has been that the virus is only present for seven days to about two weeks at the outer limits. But this patient had virus in her blood from the time she became infected, when she was about 11 weeks pregnant, up until the time of her abortion, at 21 weeks.

Visit the Washington Post for the article.



FDA Alert: Sterile drug products by Medaus Pharmacy

FDA is alerting healthcare professionals and patients not to use unexpired drug products that are intended to be sterile that were produced by Medaus Pharmacy in Birmingham, AL, due to lack of sterility assurance. Medaus’ products were distributed nationwide and internationally.

During FDA’s recent inspection of Medaus’ facility, investigators observed insanitary conditions, including poor sterile production practices, which raise concerns about Medaus’ ability to assure the sterility of drug products that it produced.

Administration of a non-sterile product, intended to be sterile, may result in serious and potentially life-threatening infections or death. The Alabama Board of Pharmacy ordered Medaus to cease sterile compounding operations on March 22, 2016. On March 29, 2016, FDA recommended Medaus recall all unexpired drug products that are intended to be sterile. To date, Medaus has not voluntarily recalled any drug products intended to be sterile. Therefore, FDA alerts health care professionals and patients not to use drug products marketed as sterile from Medaus.

Healthcare professionals and patients should immediately check their medical supplies, quarantine any drug products marketed as sterile from Medaus, and not administer them.

Read the MedWatch Safety at FDA alert.



CMS invites Quality Innovation Network-Quality Improvement Organizations to submit special innovation projects to expand their reach in improving care delivery

The Centers for Medicare & Medicaid Services’ (CMS) Quality Improvement Organization (QIO) Program is constantly evolving to help ensure that Medicare beneficiaries receive better care, better health, and greater value. CMS is announcing the program’s next evolution: two projects focused on supporting and scaling quality improvement innovations.

With this announcement, Quality Innovation Network-Quality Improvement Organizations (QIN-QIOs) can collaborate with healthcare providers and/or partners to compete for 28 Special Innovation Project (SIP) awards that fall within two topic categories totaling $8 million. Statements of Objectives will be released in early April to the QIO community. Information regarding award dates will be included in the Statement of Objectives.

SIPs are two-year quality improvement projects that align with the goals of the CMS Quality Strategy and emphasize the power of partnerships. There are two categories of SIPs for QIN-QIOs to consider:

·         Innovations that Advance Local Efforts for Better Care and Smarter Spending,” which will address healthcare quality issues that occur within specific QIN-QIO regions.

·         Interventions that are Ripe for Spread and Scalability,” which will focus on expanding the scope and national impact of a quality improvement project that has experienced proven but limited success. The expectation is that similar benefits would be experienced on a large scale if spread throughout the greater health care community.

The scalability category aligns with the CMS Strategic Innovation Engine (SIE), a new endeavor launched in August of 2015. The SIE is working to rapidly move innovative, evidence-based quality practices from research to implementation through the QIO Program. In consultation with the SIE Executive Leadership Council, CMS is seeking projects that: Streamline patient flow in various healthcare settings, including hospital units, outpatient clinics, primary care offices, ambulatory surgical centers, and cancer centers resulting in efficiencies, improved satisfaction, decreased mortality, better care, healthier people, and smarter spending.

Work with health plans and/or care coordination providers to deploy an integrated approach to post-acute care that results in enhanced care management, safe transitions from one care setting to another, improved health outcomes, and reductions in harms.

Increase value, patient affordability, and appropriate use of specialty drugs by applying evidenced based criteria to prescribing practices and by monitoring effectiveness when providers have a choice(s) among equally effective drugs with differing costs.

Address acute pain management. For example, more is needed to assist sickle cell patients: from accurate identification of their illness to education of emergency department staff on sickle cell disease while addressing the cultural stigmas often associated with the disease.

Utilize big data analytics to reduce preventable harm in healthcare.

For more information about the CMS QIO Program and for a complete list of QIN-QIOs, please visit the QIO Program website at www.qioprogram.org/.




Association for Perioperative Registered Nurses' Surgical Conference and Expo 2016 in Anaheim, CA, April 3-5, 2016

Clorox Healthcare introduces povidone-iodine alternative to antibiotics for nasal decolonization

To help healthcare professionals in their ongoing efforts to protect patients from SSIs, Clorox Healthcare is introducing Clorox Healthcare Nasal Antiseptic Swabs, a povidone-iodine alternative to antibiotics, at AORN. Using an antiseptic, like Clorox Healthcare Nasal Antiseptic Swabs, instead of an antibiotic, like mupirocin, for preoperative nasal decolonization is a simple and effective way for any healthcare facility to reduce unnecessary antibiotic use.

The swabs offer several key benefits as part of preoperative and inpatient decolonization strategies:

They are clinically shown to be non-irritating and well tolerated in the nares after 10 applications. They are further shown to reduce 99.4% of S. aureus at 1 hour and maintain persistence through 12 hours in an in vitro study.

The pre-saturated, ready-to-use swabs that are applied to a patient’s nostrils by a healthcare provider one hour before surgery. This method shifts the responsibility for nasal decolonization from patients to trained healthcare professionals, increasing the likelihood of compliance.

Clorox Healthcare Nasal Antiseptic Swabs contain povidone-iodine, an antiseptic that has broad activity against gram-positive and gram-negative bacteria. This antiseptic has been in use for over 50 years and to date, studies have not shown that bacteria develop resistance to povidone-iodine.

Clorox Healthcare will bring attention to nasal decolonization as an important part of plans for SSI prevention and antibiotic stewardship through an immersive virtual reality experience. Clorox Healthcare booth #313 attendees will be able to view a 360° video that puts them in the shoes of a healthcare provider performing nasal decolonization in a real-world setting. For those unable to attend the conference, for an optimal 360° experience, watch the video from your virtual reality headset or smartphone by visiting Clorox Healthcare’s YouTube channel.

To further help AORN conference attendees understand the issue of nasal decolonization, Dr. Rosie D. Lyles will lead a continuing education (CE) presentation at the Clorox Healthcare booth #313 titled, “Nasal Decolonization: Alternatives to Antibiotics.”  The free CE credit presentation will discuss the causes and clinical and economic impact of HAIs and SSIs, problems associated with antibiotic therapy, antiseptic alternatives to antibiotics for nasal decolonization, and best practices.

For more information, including complimentary educational resources such as kits, training materials and sample products, visit www.CloroxHealthcare.com/NasalAntisepticSwabs.



Tru-D SmartUVC to showcase the gold standard in disinfection technology at AORN

The pioneer in UV disinfection robots, Tru-D SmartUVC will exhibit its state-of-the-art technology at AORN in booth #1719. The leader in advocating for excellence in perioperative practice and healthcare, AORN provides perioperative nurses with resources for safe clinical practice and professional development.

Tru-D is a germ-eliminating robot that is deployed in hospital rooms and operating rooms after an environmental services member has completed traditional cleaning methods. Operating from a single position and single placement, it is seamlessly implemented into a hospital's work flow and allows for operators to do other tasks while the disinfection cycle is completed. Using patented Sensor360 technology, Tru-D analyzes the space including size, shape and contents, to deliver a lethal dose of UV light, killing up to 99.9% of pathogens in the room. Administering a single, measured cycle of UV light, Tru-D removes the guesswork along with any chance of human error in the cleaning process.

For more information, visit Tru-D.com.



Nurse appreciation and patient care focal points for Cardinal Health Showcase at AORN

Perioperative nurses humbly serve as the patient advocate throughout every procedure. So, Cardinal Health will focus on being the nurses’ advocate by educating, encouraging and energizing the nearly 5,000 who will attend the AORN.

Cardinal Health will host four live continuing education (CE) activities, each approved for two CE credits, and provided by Pfiedler Enterprises with grant funds provided by Cardinal Health. These courses will be offered live in the Cardinal Health CE theater, booth #1139.

While supplies last, attendees can also visit their booth for two CE handouts from Pfiedler Enterprises, which are approved for two CE credits, “Surgical Fires: Keys to Awareness and Prevention,” and “Understanding Facial Protection: What to Know and What to Wear.”

Cardinal Health’s RNspire nurse appreciation program, which is dedicated to honoring and inspiring nurses, will encourage nurses to “#ShowYourLove” in the Cardinal Health photo booth. Nurses can get a photo strip of images sharing who – or what – inspires them. Cardinal Health will donate $5 to Heart to Heart International on behalf of every nurse that comes through the photo booth, up to $5,000. A deserving nurse will also be surprised with a special recognition in the Cardinal Health booth during the opening night session.

Cardinal Health will further support clinician education at its booth by highlighting cost-effective solutions that allow practitioners to focus on what matters most – their patients. Attendees can learn more about healthcare essentials, including:

·         Launch of tissue management module, the latest offering from Cardinal Health Inventory Management Solutions, which provides automated tissue and biological implant tracking that supports tissue management for ambient and non-ambient environments. The module utilizes real-time inventory data from RFID-enabled tools to help clinicians adhere to FDA and Joint Commission compliance requirements, including documentation for chain of custody, digital capture of tissue preparation, and identification if tissue has been compromised due to infection, recall or expiration.

·         Launch of Cardinal Health LiquiBand OCTYL Topical Skin Adhesive, which avoids premature drying or clogging and allows adhesive to be expressed for up to 90 minutes after activation. The adhesive sets within approximately one minute1,4 and the intuitive, dome tip applicator allows for ease of application.

·         Demonstration of new mobile app for the PackManager program, which provides on-the-go, real-time access to information such as procedure pack inventory, pricing and images. The app, currently available for Apple and Windows tablet devices, reduces time capturing changes and allows electronic signatures. A pack standardization feature helps standardize supplies and reduce cost across the hospital or IDN.

·         Introduction of enhanced Cardinal Health SMS Surgical Drape features, including a new royal blue color to help reduce glare from operating room lights and provide color contrast for visual definition of critical zone. Nurses can also learn about new drape designs, including Cardiovascular Universal Drape Sets, Heavy Duty Orthopedic drapes and Robotics drapes.

·         Launch of a new antiseptics line from Cardinal Health, including povidone-iodine products, chlorhexidine gluconate solutions, hydrogen peroxide and isopropyl alcohol, to offer hospitals the opportunity to standardize products and reduce costs.

Visit Cardinal Health for more information.



TIDI Products to showcase Sterile-Z infection-prevention products at AORN 2016 in-booth presentations

TIDI Products, LLC, announced they will showcase an array of solutions from their infection-prevention portfolio at AORN 2016. TIDI will feature the patented Sterile-Z product line, clinically designed to help protect the sterile field and reduce infection risk. To aid perioperative practitioners in meeting new AORN surgical-site infection (SSI) prevention recommendations, TIDI will conduct presentations demonstrating Sterile-Z back-table cover advantages at Booth #701.

Sterile-Z back-table covers can be applied and removed in seconds, and fit all standard-size back tables. Sterile-Z technology has earned the AORN Seal of Recognition and overwhelmingly positive clinical feedback since its introduction in 2014. In addition to Sterile-Z back-table covers, TIDI Products will also feature Sterile-Z patient drapes, C-Armor equipment drapes, and the TIDIShield Grab ‘n Go Eye Shields in a convenient, point-of-use dispenser.

TIDI will be located in Exhibit Hall Booth #701 through Tuesday, April 5th. Sterile-Z presentations will occur Monday, April 4th, on the hour, beginning at 10:00am, and Tuesday, April 5th, at 11:00am, 12:00pm, and 1:00pm.

More information about Sterile-Z, C-Armor, and TIDIShield eyewear dispensers is available at www.TIDIProducts.com.


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