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         Clinical intelligence for supply chain leadership


hpnonline Daily Update


April 8-12, 2013
April 8 April 9 April 10 April 11 April 12


April 12, 2013   Download print version

Checks find unsafe practices at compounding pharmacies

First H7N9 patient discharged from hospital, more recovering

Beijing Brambling, Zhejiang Duck spawn deadly flu, study finds

UM researchers help identify new gene associated with Alzheimer’s disease in African Americans

Lancaster General Hospital adds Xenex’s robot to fight superbugs

Study hints of links between HPV and lung cancer

HIMSS Analytics recognizes three-state group of ambulatory clinics with Stage 7 Award

SuccessEHS and Welch Allyn announce integration of SuccessEHS 6.1 EHR with Welch Allyn Devices

Covering up: Detroit hospital debuts patient gown to offer more style, comfort, rear coverage

Checks find unsafe practices at compounding pharmacies

After a crash inspection program, federal regulators said Thursday that they had found numerous unsafe practices at about 30 compounding pharmacies, the same type of facility responsible for the tainted drug that caused a deadly meningitis outbreak last year.

Among the problems found were unidentified black particles floating in vials of supposedly sterile medicines, rust and mold in clean rooms where such drugs are made, improper air flow, and clothing that left workers’ skin exposed.

Howard Sklamberg, director of the office of compliance for the drug division of the Food and Drug Administration, said such unsafe practices could cause contamination of drugs. He said the number of problems found at the compounding pharmacies, which were in 18 states, was higher than what is typically seen at conventional pharmaceutical manufacturers.

FDA officials also said the agency had to get a warrant from federal court to inspect one of the 30 compounding pharmacies. Four other operations resisted being inspected but gave in without a court order, agency officials said.

“It may surprise some people to know that, even in light of the recent tragic events, some of the firms we inspect still challenge our authority to conduct full inspections of their facilities,” Dr. Margaret A. Hamburg, the FDA commissioner, wrote in a post on the agency’s blog on Thursday.

Sklamberg said the FDA was exploring actions it might take against the pharmacies if the problems were not corrected.

A House subcommittee will hold a hearing on Tuesday at which Dr. Hamburg is expected to be questioned as to whether the FDA could have prevented the meningitis outbreak by better policing the compounding pharmacies. The agency maintains that it has limited legal authority to oversee compounders, which are regulated by state boards of pharmacy even though many ship drugs across state lines.

“Because they don’t register with us, we don’t know who they are, we don’t have a list of what products they produce,” Sklamberg said in an interview Thursday.

The FDA’s disclosure of the inspection reports and of the resistance its inspectors faced could bolster its case for legislation, already under development in the Senate, to give it more authority over compounding pharmacies.

It could also backfire. Some Republicans who have expressed skepticism about the need for legislation are likely to point to the recent inspections as evidence that the FDA already has the authority it needs, and that it could have done similar inspections in the past.

The FDA had inspected specific compounding pharmacies only when a problem was reported or suspected. Sklamberg said that regularly inspecting compounding pharmacies in the past would have strained the agency’s resources, given the extra effort required.

Some compounding pharmacies might brush off the FDA findings as being part of a push to win legislation.

“It behooves them to make sure they find observations or violations or deficiencies,” said Scott A. Livingston, a lawyer representing Olympia Compounding Pharmacy in Orlando, FL, for which the FDA said it required a warrant.

Livingston said the pharmacy allowed the inspection and access to documents. He said the warrant was required only because the pharmacy, concerned about patient privacy, did not want to provide the FDA with copies of those documents to take with them.

Perhaps seeking to take some heat off the FDA, four Democrats on the House Energy and Commerce Committee on Thursday said the head of the compounding industry’s trade group, the International Academy of Compounding Pharmacists, should also testify at Tuesday’s hearing. Visit the New York Times for the article.


First H7N9 patient discharged from hospital, more recovering

SHANGHAI --A four-year-old boy, one of China's 38 patients hospitalized with the H7N9 bird flu infection, has fully recovered and was discharged from a Shanghai hospital on Wednesday. The boy is the first H7N9 patient to be cured and discharged from hospital.

Lu Hongzhou, a professor with the Shanghai Public Health Clinic Center, said clinical observations have found that if a H7N9 patient can be given treatment no later than five days after he or she shows flu symptoms, China's current therapeutic methods can be effective in treating the disease.

"Over five days, the patient's visceral organs can be damaged, and the medicines like oseltamivir will have little effect on the patient," Lu said.

Doctors with the Pediatric Hospital affiliated to Fudan University, one of Shanghai's designated hospitals for taking H7N9 patients, said they did not use a large dose of antiviral drugs on the boy in order to minimize the side effects.

The boy was diagnosed as infected with the bird flu virus on April 4, three days after he started suffering from a fever and was admitted into a small hospital. The Pediatric Hospital certified the boy's discharge.

Apart from the boy, two more patients confirmed to have caught H7N9 bird flu in east China's Zhejiang Province have also shown signs of recovery.

Latest tests on the 51-year-old female patient surnamed Jia, who was diagnosed with H7N9 avian influenza on Tuesday, came back H7N9 viral nucleic acid negative, indicating she had recovered from the disease, said Fang Qiang, director with the intensive care unit at the No.1 Affiliated Hospital of the Medical College of Zhejiang University.

Another patient surnamed Yang, a 67-year-old man who was diagnosed with H7N9 on April 3, has also been recovering after falling into a critical condition for days. He regained consciousness and followed doctors' words on Wednesday.

"Comparatively speaking, his lung functions have improved a lot," according to Li Lanjuan, an academic with the National Key Laboratory for Epidemic Diagnosis and Treatment.

However, Li added that Yang's condition was still serious as he still needs a respirator to breathe.

Doctors said the hospital would give H7N9 virus tests to all patients with a fever higher than 38.5 degrees Celsius free of charge.

On Wednesday, health authorities in Shanghai Municipality, Jiangsu and Zhejiang provinces reported five new H7N9 avian influenza infections, updating Tuesday's tally of H7N9 infections to 33 nationwide.

The World Health Organization has said there is no evidence H7N9 is passing from person to person.

So far, all cases of the new strain of avian influenza have been detected in Shanghai and the east China provinces of Zhejiang, Jiangsu and Anhui. Visit XINHUANET for the story.


Beijing Brambling, Zhejiang Duck spawn deadly flu, study finds

A brambling from Beijing, a wild bird from Korea and a duck from China’s Zhejiang province probably helped spawn the new flu variant that’s killed 10 people, a study in the New England Journal of Medicine found.

The birds were infected with avian flu strains that most resemble the H7N9 virus circulating in eastern China, according to yesterday’s study by researchers at the Chinese Center for Disease Control and Prevention in Beijing and Fudan University in Shanghai.

Thirty-eight people have been sickened with H7N9 flu, which the authors said causes brain damage, muscles to break down and vital organs to fail in its most extreme form. Different mutations in samples taken from patients suggest the virus entered human populations at least twice, the study found.

“We are concerned by the sudden emergence of these infections and the potential threat to the human population,” Rongbao Gao and colleagues wrote. “An understanding of the source and mode of transmission of these infections, further surveillance, and appropriate counter measures are urgently required.”

The new strain, which hasn’t been detected in humans or animals before, raises “many urgent questions and global public health concerns,” Timothy Uyeki and Nancy Cox, flu scientists at the Centers for Disease Control and Prevention in Atlanta, said in an accompanying editorial in the journal.

There’s no evidence that the virus is spreading among people, though a previous avian flu outbreak caused by a related variant in the Netherlands showed limited human-to-human transmission is possible, the Chinese researchers said.

In 2009, a novel swine flu virus, known as H1N1, touched off the first influenza pandemic in 41 years. The H5N1 bird flu strain, which killed at least 371 people over the past decade, hasn’t acquired the ability to spread easily among people.

H7N9 infections are of concern because most patients observed so far have been severely ill, the World Health Organization said on its website, adding that both animal-to-human and human-to-human routes of transmission are being “actively investigated.”

It’s possible the severe cases that have been reported over the past five weeks represent a fraction of the total number of infections that have occurred, with some going undetected because they had mild or no symptoms, Uyeki and Cox said.

Detailed analysis of the genetic makeup of the H7N9 virus showed its six internal genes came from an avian H9N2 strain, resembling one collected from a brambling, a type of finch, isolated in Beijing last year, the Chinese researchers said.

The gene coding for a surface protein called hemagglutinin, which allows the virus to grip onto host cells, resembles an H7N3 virus collected from a duck in Zhejiang in 2011. The gene coding for neuraminidase, a protein on the surface of the virus that enables it to escape from infected cells, resembles an H7N9 virus isolated from a wild bird in Korea in 2011, they said.

The gene sequences indicate these viruses may be better adapted than other strains of bird flu to infecting mammals, Uyeki and Cox said. For example, a mutation in the hemagglutinin of H7N9 gene has been shown to aid its infiltration of the upper respiratory tract of mammals, and to increase transmissibility.

The coming weeks will reveal whether the disease pattern reflects a widespread outbreak in birds, whether an H7N9 pandemic is beginning, or something in between, Uyeki and Cox said.

“The key is intensified surveillance for H7N9 virus in humans and animals to help answer important questions,” they said. “We cannot rest our guard.” Visit Business Week for the article.


UM researchers help identify new gene associated with Alzheimer’s disease in African Americans

Researchers at the University of Miami Miller School of Medicine collaborated with a team to identify a new gene associated with Alzheimer’s disease in African Americans. Published April 10 in the Journal of the American Medical Association, their study, “Variants in the ATP-binding cassette transporter, ABCA7, and the apolipoprotein E ε4 allele substantially and equally influence risk of late-onset Alzheimer’s disease in African Americans,” provides new directions for biological, genetic and therapeutic studies of Alzheimer’s disease.

Margaret A. Pericak-Vance, Ph.D., director of the John P. Hussman Institute for Human Genomics and one of the senior authors, leads the analysis group for the Alzheimer’s Disease Genetics Consortium, which is responsible for the paper.

The research is believed to be the largest genome-wide association study conducted on late-onset Alzheimer’s disease in African Americans, and includes 1,968 cases of African American individuals with Alzheimer’s disease and 3,928 individuals without collected at multiple sites between 1989 and 2011. 

“It is critical to identify and assess genetic contributions to Alzheimer’s disease in all populations,” said Pericak-Vance, who has researched the genetics of Alzheimer’s for decades. “Health disparities have had an especially profound effect on the overall health of African Americans in the United States and, although Alzheimer’s occurs as frequently in African Americans as other populations, there have been significantly fewer studies that include this population. This research will enable African Americans to take full advantage of the benefits of genomic medicine research findings are translated into clinical practice.”

Pericak-Vance’s 1993 Science paper was the first to identify a form of the apolipoprotein E gene (APOE ε4), a gene involved in lipid metabolism, as a risk variant in Alzheimer’s disease. It accounts for more than 40 percent of all cases of Alzheimer’s, and remains the largest overall predictor for the disease. The paper continues to be one of the most-cited in all biomedical research.

While the latest paper confirms that APOE ε4 is the strongest risk factor for Alzheimer’s in African Americans, it also found that ABCA7, a gene likewise involved in lipid metabolism, is the second highest contributing risk factor in late-onset Alzheimer’s disease in African Americans. ABCA7 had previously been found to contribute to Alzheimer’s disease risk in non-Hispanic whites, but with a small effect. The paper showed that ABCA7 is associated almost as strongly in African Americans as APOE ε4 is in non-Hispanic whites.

These findings suggest that lipid metabolism is an important pathway of late-onset Alzheimer’s disease in African Americans. Understanding the etiology of Alzheimer’s disease will have a significant impact on future disease management. Visit the University of Miami for the study.


Lancaster General Hospital adds Xenex’s robot to fight superbugs

Lancaster General Hospital’s new Xenex room disinfecting system uses ultraviolet (UV-C) light that is 25,000 times more powerful than the sun to ‘zap’ nasty organisms that cause infections like the flu, norovirus, MRSA and Clostridium difficile (C. diff). In minutes, the device can disinfect a patient room, patient bathroom or operating room (OR) by pulsing the light, which washes over the surfaces where germs reside.

LGH is the fourth hospital in Pennsylvania to have the Xenex device. About 100 hospitals nationwide are using the system, aimed at reducing rates of infection and saving costs. And it’s safe. Because the light is extremely intense, the machine operates on its own once it’s set up in a room. A sign placed outside the door warns people not to enter, and a motion sensor automatically shuts off the machine if someone should enter.

According to Scott Garrety, director of Environmental Services for LGH, three Xenex machines are being used in the operating rooms, isolation rooms and Intensive Care and Trauma-Neuro Units after every discharge or transfer.

"This technology is used in high risk areas in conjunction with the extensive cleaning services already provided by our Environmental Services team," said Garrety. “As the public health crisis of the 2013 flu season demonstrates, the most critical step to ensure infection control begins with a clean environment. In the past three weeks Xenex has sanitized 711 of our patient rooms.”

After cleaning, housekeepers position the Xenex device on both sides of the bed and in the restroom to further disinfect 99.99 percent of dangerous contaminants. Each treatment takes about five minutes, or 15 minutes per room. 

"We already have a strong infection prevention program. The Xenex technology allows us to be even more proactive in protecting the health of our patients and staff," said Deb Hess, RN, CIC, Supervisor of Epidemiology, who first learned about Xenex Healthcare Services at a conference last year, and then shared with colleagues at LG Health. "In addition to offering better protection to patients, Xenex is also anticipated to save the hospital approximately $1 million a year as it reduces the incidence of hospital acquired infections (HAIs)," added Hess. For more information, visit www.xenex.com.


Study hints of links between HPV and lung cancer

Human papillomavirus (HPV), the virus that can cause cervical and head and neck cancers, may also trigger some cases of lung cancer, according to a small new study.

Researchers examined 36 tumor tissue samples from patients with non-small-cell lung cancer who had never smoked. Smoking is a major cause of lung cancer, but the causes of lung cancer in nonsmokers can be difficult to pinpoint.

The investigators found that about 6 percent of the tissue samples showed signs of infection from two strains of HPV known to cause cancer. The strains are called HPV 16 and HPV 18.

Further examination of the tissue samples infected with HPV 16 revealed that the virus had integrated into the tumor's DNA, which the researchers said provides stronger evidence that HPV infection caused the tumor.

The study was scheduled to be presented Wednesday at the annual meeting of the American Association for Cancer Research, in Washington, D.C. Study data and conclusions should be viewed as preliminary until published in a peer-reviewed journal.

If it is confirmed that HPV plays a role in some cases of lung cancer, the next step is to learn more about those tumors so they can be treated more effectively, said the researchers from the Fox Chase Cancer Center in Philadelphia. This study, however, did not prove a cause-and-effect link between the virus and lung cancer.

Lung cancer kills more than 1 million people a year. About 10 percent of lung cancer cases occur in nonsmokers. (HealthDay) Visit MSN for the article.


HIMSS Analytics recognizes three-state group of ambulatory clinics with Stage 7 Award

Since 2005, HIMSS Analytics has tracked progress of electronic medical record implementation with its EMR Adoption Model (EMRAM) for hospitals. Now, HIMSS Analytics announces that 54 Essentia Health ambulatory clinics, located in Minnesota, North Dakota and Wisconsin, have reached Stage 7 on The Ambulatory EMR Adoption Model (A-EMRAM). 

Developed in 2011, the EMR Ambulatory Adoption Model provides a methodology for evaluating the progress and impact of electronic medical record systems for ambulatory facilities owned by hospitals in the HIMSS Analytics Database. These facilities include physician practices, clinics, outpatient centers and specialty clinics. Tracking their progress in completing eight stages (0-7), ambulatory facilities can review the implementation and use of IT applications with the intent of reaching Stage 7, which represents an advanced electronic patient record environment.

Stage 7 ambulatory facilities: deliver patient care without the use of paper charts; Use their EMR and patient portal to drive patient engagement, and thus, improved health status through better health maintenance; use their vast database of clinical information and evidence based practice guidance to improve  outcomes using business intelligence solutions; and are able to share patient information through private and public health information exchanges (HIE), which improves communications, speeds up appropriate care delivery, and ultimately, reduces unnecessary consumption.

The validation process confirms ambulatory facilities have reached Stage 7 with a site visit conducted by an executive from HIMSS Analytics and a Chief Medical Information Officer with ambulatory deployment experience to ensure an unbiased evaluation of the Stage 7 environments. Visiting a representative ambulatory clinic or clinics that deployed the same EMR applications and software, the validation team conducts both a comprehensive system overview and an analytics review to ensure improved health status indicators and understanding of the effectiveness of their patient engagement strategy. 

As the current data on the A-EMRAM indicates, as of March 30, 2013, HIMSS Analytics has recognized only: 1.10 percent of 19,234 ambulatory facilities at Stage 6; and 0.9 percent of 19,234 ambulatory facilities at Stage 7.

An explanation of each stage appears on the HIMSS Analytics website. Visit the HIMSS Analytics website for more information on the A-EMRAM.


SuccessEHS and Welch Allyn announce integration of SuccessEHS 6.1 EHR with Welch Allyn Devices

SuccessEHS, a health IT vendor, and Welch Allyn, a medical diagnostic device company, announced the integration of four Welch Allyn devices with the SuccessEHS 6.1 EHR and Practice Management solution. These four devices include: the Connex ProBP 3400 digital blood pressure device, Connex Integrated Wall System (CIWS), Connex Vital Signs Monitor (CVSM) and Spot Vital Signs LXi.

The incorporation of these four Welch Allyn devices with SuccessEHS 6.1 enables seamless data collection by delivering patient data directly into the patient's electronic chart. This integration helps customers increase clinical workflow efficiency, reduce data transcription errors and enhance patient care.

"The introduction of this connectivity furthers our mission to help clients achieve more results," said Tiffani Collins, Director of Client Services at SuccessEHS. "Medical device integration allows our clients to improve performance by streamlining workflows, increasing productivity, reducing risk of error and eliminating manual documentation required to meet Meaningful Use."

"By teaming with a leading healthcare technology company like SuccessEHS, we are able to provide more EHR-connectible devices than any other medical device manufacturer in the ambulatory care space," said Garrison Gomez, director of Integrated Devices at Welch Allyn. "In doing so, we help reduce the constant pressures on providers' time, enabling providers to increase productivity and focus on their most important task—enhancing patient care." Visit Sacramento Bee for the release.


Covering up: Detroit hospital debuts patient gown to offer more style, comfort, rear coverage

A Detroit hospital has a new patient gown that aims to offer a little more style, comfort and — perhaps most importantly — rear coverage for patients.

Resembling a wrap-around robe, the gown closes in the back and front and is made of a thicker, cotton and polyester blend than a typical gown to keep patients warmer. It has three snaps, instead of ties, to close it, and it’s accessible for IVs and other medical lines.

“A simple change can have a large impact on the patients’ stay at a hospital,” said Michael Forbes, a product designer at the Henry Ford Innovation Institute and graduate of the College for Creative Studies in Detroit.

The new gown is being used on several inpatient floors at Henry Ford Hospital after about two years of work on its design, the hospital said.

The gown was developed by the Henry Ford Innovation Institute in collaboration with the College for Creative Studies. The “No. 1 goal was to close the backside of the gown,” Forbes said in a statement Monday, and officials hope to license the design to an existing manufacturer. (Associated Press) Visit the Washington Post for the article.


April 11, 2013   Download print version

Novation awards Innovative Technology agreements

Surgeons report value-based decision-making process using single best practice to prevent DVT reduces costs by more than $1.5 million annually

BCI Remote Alarm Cables by Smith's Medical ASD, Inc.: Class 1 Recall - cables are not transferring alarms

Seal Shield’s washable keyboards prevent infections and save lives

Compound in red meat, energy drinks may have heart disease link

Technique finds software bugs in surgical robots and helps developers fix flaws, ensure safety

Nearly half of breast cancer patients at risk of having BRCA mutations not sent for genetic testing

Study of babies did not disclose risks, U.S. finds

Novation awards Innovative Technology agreements

Novation, the healthcare supply chain expertise and contracting company for the members of VHA Inc., UHC, Children’s Hospital Association, and Provista LLC, announced that it has awarded four new medical & surgical agreements through its innovative technology evaluation process. The agreements were awarded to SteadMed, KCK Industries, Milliken, and Sundance Enterprises.

SteadMed’s Drawtex hydroconductive wound dressings have a unique combination of three actions that actively draw bacteria and other harmful matter out of the wound. The three actions are a capillary action, a hydroconductive action and an electrostatic action. Pricing for this agreement offers hospital members an average of 27 percent savings in the aggregate when compared to list price.

KCK’s mesh pants and fecal pads reduce the risk of cross contamination, improve containment for patient worker safety, provide greater patient comfort and prevent incontinence-associated dermatitis, secondary skin infections, and pressure ulcers. In addition, hospital members can realize an average of 20-25 percent savings as compared to list price.

Milliken’s Active Fluid Management & SelectSilver wound dressings are used to create the optimal moisture balance for wounds while also providing an antimicrobial barrier to protect wounds. The agreement also offers as much as 39 percent savings over list price.

Finally, Sundance Enterprises patient positioners offer a unique Z-Flo fluidized technology that helps reduce pressure ulcers.  Additionally, anecdotal clinical reports of benefits to individual NICU infants have included improved comfort, sleep, calming, physiologic stability, weight gain, skin protection and positional alignment.  The agreement offers a savings of up to 35 percent over list price.

Novation’s Innovative Technology Program allows Novation to work with member councils and task forces to identify and review new or innovative technology that provides an incremental clinical benefit over existing products. Please visit www.novationco.com.


Surgeons report value-based decision-making process using single best practice to prevent DVT reduces costs by more than $1.5 million annually

A new Journal of the American College of Surgeons study reports that using a best-practice approach could lead to big cost reductions in hospitals nationwide. A major challenge facing today’s healthcare community is to find ways to lower costs without compromising clinical quality. Taking that challenge to task, researchers at Medstar Health and Georgetown University School of Medicine, Washington, DC, report success in using a concept called “value-based analysis,” which simultaneously measures quality and cost and addresses inefficiencies in care. The researchers applied a value-based analysis approach to implementing a single best practice for preventing deep vein thrombosis (DVT) in surgical patients and were able to reduce hospital costs in excess of $1.5 million per year.

“We’ve all been looking at how to deal with escalating costs in healthcare and since about 85 percent of the decisions regarding costs in healthcare are physician driven, you must impact physician decision making if you are going to impact value in healthcare,” said lead study author John R. Kirkpatrick, MD, MBA, FACS, professor of surgery, Georgetown University School of Medicine and director of The Surgical Advisory Group. “Our goal was to create the appropriate methodology to improve value, which is really what the [Patient Protection and] Affordable Care Act of 2012 is all about: how to improve value and outcome without compromising level of care.”

Each year, as many as two million Americans develop DVT, a condition that occurs when the blood in a person’s veins pools—usually in the calf or thigh—and forms a clot. The Centers for Disease Control and Prevention estimates that at least 300,000 of those people die from a pulmonary embolism, a complication that occurs when a clot breaks loose and travels to an artery in the lungs.  Importantly, surgical patients are at even greater risk for these lethal blood clots.

For the study, investigators tested whether value-based analysis—which uses clinical best practices as a surrogate of quality—could serve as a useful tool to determine the cost and quality of the perioperative clinical initiative DVT prophylaxis. The researchers determined the usual practice within the eight hospitals that comprise MedStar Health, a Baltimore-Washington, DC-based healthcare system, and then developed a clinical best practice based upon a meta-analysis of the medical literature.

The best practice they adopted for this clinical initiative consisted of limiting the use of sequential compression devices (stockings used to prevent blood from pooling in the calf area of the lower leg) to outpatient and short-stay procedures, and changing the protocol for pharmacological management for DVT prophylaxis by using an unfractionated heparin rather than a low-molecular-weight heparin, which is more expensive. “At one time, there seemed to be a therapeutic advantage to using a low-molecular-weight heparin.  Studies now indicate that there is no advantage in using low-molecular-weight heparin for prophylaxis,” Dr. Kirkpatrick explained.

The researchers converted four hospitals within MedStar Health to the best practice and analyzed the change in cost in going from usual practice to best practice. The analysis revealed an estimated overall system-wide savings opportunity of $4 million after implementing this single best practice. In addition, the study found that influencing the choice of supplies and materials by physicians (16 percent of total expenditures) was the most effective way to decrease cost and increase value for the system.

Dr. Kirkpatrick explained that best practices are always evolving, and what was a best practice 10 years ago may not be the case today. Therefore, a major challenge for physicians is to stay current. Value-based analysis addresses this issue by exposing the differences in the use of best practices rather than usual practices; revealing how practices are being carried out (whether or not outdated ones are being used); and identifying when providers are not following best practices.

“Most people think best practices are very static, but they are not, they are very dynamic,” Dr. Kirkpatrick said. “A physician is doing what his memory is telling him is the right thing to do, however, this [course of action] may no longer be the right thing. To avoid this dilemma you need to have a mechanism within hospitals to always upgrade or modify your usual practice, recognizing that while it reflected a best practice at one time, that is no longer the case.” What makes this approach different is that it compares best practice and usual practice, and analyzes cost at the same time.

There are 27 other initiatives that Dr. Kirkpatrick and his colleagues have identified as having cost-saving potential. Some of the next areas the researchers will tackle include decision making within the intensive care unit, evaluating clinical decisions about ventilator management, and determining how to develop best practices for managing end-of-life decisions. “The impact on value by enhancing quality and reducing cost is enormous,” Dr. Kirkpatrick said. Visit ACS for the study.


BCI Remote Alarm Cables by Smith's Medical ASD, Inc.: Class 1 Recall - cables are not transferring alarms

Smiths Medical has become aware that, in rare instances, the BCI Remote Alarm Cables (BCI Cables) are not transferring alarms when used with some remote nurse alarm systems. These products may cause serious adverse health consequences, including death.

The BCI Remote Alarm Cables are designed for use with the 9004 Capnocheck Capnography (Plus or Sleep) System to transfer alarm signals from the Capnocheck Capnography System to a remote alarm system. The BCI Remote Alarm Cables and the 9004 Capnocheck Capnography System are intended for use in all critical environments including ventilator applications, patient transport, and anesthesia on patients ranging from pediatric to adult.

On Feb. 6, 2013, Smiths Medical sent its customers an "Urgent Medical Device Field Safety Notice-Recall" letter by UPS and customers were instructed to inspect their inventory and remove all affected devices from use. Visit FDA for the recall notice.


Seal Shield’s washable keyboards prevent infections and save lives

As a pioneer in the infection control industry, Seal Shield developed the world’s first washable-fully submersible keyboard with antimicrobial product protection back in 2007. Since that time, the dangers associated with computer keyboards and mice have become even more evident. Among “keyboard infection” research conducted, Dr. William Rutala reported “25% of hospital keyboards harbor the Super Bug MRSA, but daily disinfecting of the keyboards could reduce the risk of cross contamination” and Dr. Charles Gerba found “computer keyboards harbor up to 400 times more microbial bacteria than the average toilet seats.”

Just recently, the Association for Professionals in Infection Control and Epidemiology (APIC) released a Guide to Preventing Clostridium difficile Infections. The guide’s prevention strategies include “cleaning and disinfection of computers, including keyboards” and goes on to say “check the computer manufacturer’s recommendations for acceptable products. Exposure to an environment or patient with CDI can create a challenge especially when there is a highly virulent strain. The use of some of the bleach-containing disinfectants may not be possible due to potential damage.”

The SILVER SEAL medical grade keyboard has been developed to help prevent infections, including MRSA and C. Diff. The SILVER SEAL keyboard is 100% waterproof/dishwasher safe and can be fully disinfected with bleach, without damage to the unit. As an added safeguard, it includes antimicrobial product protection. Unlike other antibacterial products, the SILVER SEAL keyboard utilizes all natural, pure silver ions which are embedded in the plastic to create a safe and effective antimicrobial solution. The combination of washable technology and antimicrobial product protection achieves the highest level of protection available in a true type keyboard today. For more information please visit www.SealShield.com or call 877-325-7443 x119.


Compound in red meat, energy drinks may have heart disease link

A compound found in red meat and added as a supplement to popular energy drinks promotes hardening and clogging of the arteries, otherwise known as atherosclerosis, a new study suggests.

Researchers say that bacteria in the digestive tract convert the compound, called carnitine, into trimethylamine-N-oxide (TMAO). Previous research by the same team of Cleveland Clinic investigators found that TMAO promotes atherosclerosis in people.

And there was another twist: The study also found that a diet high in carnitine encourages the growth of the bacteria that metabolize the compound, leading to even higher TMAO production.

"The [type of] bacteria living in our digestive tracts are dictated by our long-term dietary patterns. A diet high in carnitine actually shifts our gut microbe composition to those that like carnitine, making meat eaters even more susceptible to forming TMAO and its artery-clogging effects," study leader Dr. Stanley Hazen, head of preventive cardiology and rehabilitation in Cleveland Clinic's Heart and Vascular Institute, said in a clinic news release.

Hazen's team looked at nearly 2,600 patients undergoing heart evaluations. The researchers found that consistently high carnitine levels were associated with a raised risk of heart disease, heart attack, stroke and heart-related death. They also found that TMAO levels were much lower among vegetarians and vegans than among people with unrestricted diets (omnivores). Vegetarians do not eat meat while vegans do not eat any animal products, including eggs and dairy.

Even after consuming a large amount of carnitine, vegans and vegetarians did not produce significant levels of TMAO, while omnivores did, according to the study in the current issue of the journal Nature Medicine.

Although the new study could not prove any cause-and-effect relationship between carnitine and heart damage, the findings may provide a new understanding of the benefits of vegan and vegetarian diets, the researchers said.

"Vegans and vegetarians have a significantly reduced capacity to synthesize TMAO from carnitine, which may explain the cardiovascular health benefits of these diets," said Hazen, who is also vice chair of translational research for the clinic's Lerner Research Institute.

Two heart disease experts said the study yields up important new insights.

According to Dr. Robert Rosenson, it appears that poor eating habits could raise TMAO levels and "increase the ability of the cholesterol to get into our arteries and interfere with the ability of our body to eliminate that excess cholesterol." Rosenson, director of cardiometabolic disorders at the Icahn School of Medicine at Mount Sinai, in New York City, said the study "sheds important new information on the association between diet, atherosclerosis and cardiovascular events."

Another expert pointed the finger specifically at red meat and energy drinks.

"Most Americans have heard the famous saying 'you are what you eat,'" said Dr. Tara Narula, associate director of the Cardiac Care Unit at Lenox Hill Hospital, New York City. "This phrase may be more true and different than we might have imagined."

The new study "brings awareness that many 'supplements' like energy drinks can have the same [vessel-damaging] compounds as red meat," she said. "Energy drinks may not be harmless and can have unseen side effects that consumers should recognize."

As for beef, pork and the like, Narula said that the "real take-away message is the reinforcement of the current recommendations that a heart-healthy diet should have little to no red meat consumption." Visit NIH for the study.


Technique finds software bugs in surgical robots and helps developers fix flaws, ensure safety

Surgical robots could make some types of surgery safer and more effective, but proving that the software controlling these machines works as intended is problematic. Researchers at Carnegie Mellon University and the Johns Hopkins University Applied Physics Laboratory have demonstrated that methods for reliably detecting software bugs and ultimately verifying software safety can be applied successfully to this breed of robot.

They used theorem-proving techniques to analyze a control algorithm for a research robot that would help a surgeon perform surgery at the base of the skull. Their method identified a safety flaw that could enable a scalpel or other surgical tool to go dangerously astray in this area, where the eye orbits, ear canals and major arteries and nerves are closely spaced and vulnerable to injury. It also guided development of a new algorithm and verified that the new controller was safe and reliable.

"These techniques are going to change how people build robotic surgery systems," predicted APL's Yanni Kouskoulas, who led the research study with André Platzer, assistant professor of computer science at Carnegie Mellon. Platzer and Kouskoulas say this formal verification technique also could change the way regulators evaluate new devices, providing more assurance of safety than is possible even with the most rigorous testing.

Surgical robots are an example of a hybrid, or cyber-physical system - complex, computer-controlled devices that are becoming increasingly common. Other examples are aircraft collision avoidance systems, high-speed train controls and cars that avoid collisions, maintain their lanes or otherwise drive themselves.

"Because the consequences of these systems malfunctioning are so great, finding a way to prove they are free of design errors has been one of the most important and pressing challenges in computer science," Platzer said. Testing alone is inadequate because no test regimen can check all of the possible circumstances that the system might encounter.

Platzer has developed an approach based on differential dynamic logic and an associated tool called KeYmaeraD that can be used to model a hybrid system and its properties and then symbolically pick it apart. This approach, which Platzer already has used successfully to identify errors in aircraft collision avoidance systems and to verify the design of distributed car control systems, can verify that a design is safe or else help generate counterexamples of how the system can fail.

Platzer and his colleagues applied this approach to evaluate the control algorithm for the skull-base surgery robot. This robot aids in intricate surgery in small recesses of the brain by minimizing tiny movements as a surgeon manipulates a tool and by restricting the tool to movement within the surgical site. As the tool approaches the surgical boundary, beyond which healthy and vital tissues can be harmed, it exerts force feedback to warn the surgeon. If the tool reaches the boundary, the robot is supposed to stop it from going farther. This functionality is helpful for the surgeon, because the robot knows the delicate boundaries that the surgeon cannot necessarily see during the surgery.

By using the formal verification method, the researchers showed that indeed something unexpected could occur in corners of the surgical site. They found that in some geometrical configurations, the safety feedback for one boundary would interfere with that of the adjoining boundary, canceling each other out and allowing the tool to be pushed beyond the limits set by the surgeon. Visit CMU for the study.


Nearly half of breast cancer patients at risk of having BRCA mutations not sent for genetic testing

Only 53 percent of newly diagnosed breast cancer patients who were at high risk of carrying a BRCA 1 or BRCA 2 mutation – based on age, diagnosis, and family history of breast or ovarian cancer – reported that their doctors urged them to be tested for the genes, according to a research team from the Perelman School of Medicine at the University of Pennsylvania.

The findings, which will be presented during the American Association for Cancer Research Annual Meeting 2013 (Presentation #1358), were drawn from surveys completed by 2,258 women between 18 and 64 who were diagnosed with breast cancer in Pennsylvanian in 2007. While physician recommendations for genetic testing appeared to be targeted at the proper group of patients – just 9 percent of women at low risk of having one of the mutated genes were advised to undergo testing – the finding that such a large portion of high-risk women did not receive a testing recommendation underscores the need to improve provider education about the utility and availability of testing. Among women at high risk of mutation, the analysis found that those who were older, had lower income, and were employed were less likely to have received a recommendation for testing. Visit the University of Pennsylvania for the article.


Study of babies did not disclose risks, U.S. finds

A federal agency has found that a number of prestigious universities failed to tell more than a thousand families in a government-financed study of oxygen levels for extremely premature babies that the risks could include increased chances of blindness or death.

None of the families have yet been notified of the findings from the Office for Human Research Protections, which safeguards people who participate in government-financed research. But the agency’s conclusions were listed in great detail in a letter last month to the University of Alabama at Birmingham, the lead site in the study. In all, 23 academic institutions took part, including Stanford, Duke, and Yale.

The letter stated that the study did have an effect on which infants died and which developed blindness, and that those risks were not properly communicated to the parents, depriving them of information needed to decide whether to participate.

The 1,300 infants who participated in the study, which took place between 2004 and 2009, and whose results were published in The New England Journal of Medicine in 2010, were born at just 24 to 27 weeks of gestation, a very high-risk category that is already prone to death and eye disease.

Babies assigned to a high-oxygen group were more likely to develop eye disease and blindness, the letter said, and babies assigned to a low-oxygen group were more likely to die. Ultimately, 130 babies out of 654 in the low-oxygen group died, and 91 babies out of 509 in the high-oxygen group developed an eye ailment that in serious cases can lead to blindness.

The letter said that “the researchers had sufficient available information to know, before conducting the study, that participation might lead to differences in whether an infant survived, or developed blindness, in comparison to what might have happened to a child had that child not been enrolled in the study.”

The risk the consent form did mention was far less significant: abrasion of the infants’ skin by an oxygen monitoring device. It also said there was a possible benefit to participating — a decreased need for eye surgery depending on the group the infant was assigned to.

Richard B. Marchase, vice president for research at the University of Alabama at Birmingham, said in a telephone interview that the study kept the infants within the standard band of treatment for oxygen levels — 85 to 95 percent — and that its findings would help inform a discussion by the American Academy of Pediatrics this year about standards for oxygen levels.

But the federal office critical of the consent process said in its letter that the risks of participating in the trial “were not the same as those receiving standard care.” The office stated that the consent form should have explained that “there is significant evidence from past research indicating that the oxygen provided to an infant can have an important effect on many outcomes including whether the infant becomes blind, develops a serious brain injury or even possibly whether the infant dies.”

The consent forms were written by researchers at the University of California, San Diego, a spokesman for the University of Alabama at Birmingham said, and were approved by the review boards of all 23 institutions in the study. It was financed by the National Institutes of Health.

Dr. Marchase said he had assured the office that in the future, “we will to the best of our ability let the subjects or their parents know as thoroughly as possible what previous studies suggest in terms of risk.” He added, “We are going to be very sensitive to that going forward as we look at these consent forms.”

He said that a similar group of infants born around the same time in the same hospitals who did not participate in the study, but were eligible, died at higher rates than those in the low-oxygen group. Those infants were not a control group in the study, but were similar to those in the study group, he said; they had a 24 percent mortality rate, compared with a 20 percent mortality rate for the infants in the low-oxygen group.

But Michael Carome, a physician who is the deputy director of the health research group at Public Citizen, a consumer advocacy organization, which brought the letter to the attention of the news media on Wednesday, pointed out that a study in Pediatrics in 2012 that looked closely at the two groups determined that the infants who did not participate, or were not chosen, were in worse health, and therefore more prone to die.

Omitting risks from a consent form these days is relatively rare, experts said, as institutions often want to reduce the chances that they will be sued. The result is voluminous forms that do more to protect the institution than to empower the potential subject.

Clinical treatment of premature infants has a troubled history. Attempts to treat them with higher oxygen levels that were thought to improve their odds of survival led to many cases of blindness. Premature babies need oxygen because their lungs are underdeveloped and they often need help breathing.

A spokesman for the University of Alabama at Birmingham said that the treatment for the babies in the study was flexible, based on decisions by doctors, and that the infants were not held in rigid bands of oxygen levels. Visit the New York Times for the article.


April 10, 2013   Download print version

Olympus introduces the world’s only articulating HD 3D Laparoscopic Surgical Video System

As Walgreen plays doctor, family physicians bristle

Central Texas hospital marred by lab deficiencies

New genetic link found between normal fetal growth and cancer

Bloodless pressure: More surgery without transfusions

New drugs better value than Warfarin

AHA re-launches sustainability roadmap website

Study finds copper reduces 58% of healthcare-acquired infections

Olympus introduces the world’s only articulating HD 3D Laparoscopic Surgical Video System

Olympus, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Articulating HD 3D Laparoscopic Surgical Video System.

The Olympus Articulating HD 3D Laparoscopic Surgical Video System delivers value to surgeons and patients by reducing surgical errors and improving the speed, accuracy and precision of surgical tasks such as dissection, grasping and suturing when compared with traditional 2D surgical systems, based on internal Olympus testing conducted using a simulated surgical model. This is accomplished by restoring natural 3D vision and depth
perception when performing laparoscopic procedures and is independent of a
surgeon’s skill level.

 Another advantage of the new Olympus HD 3D video platform is its availability as a module that can be easily added to an existing Olympus EVIS EXERA III Universal Imaging System. The modular design reduces the investment necessary to add 3D capability, and allows the surgeon to choose either 2D or 3D visualization from the surgical field. This helps to reduce capital investments and simplify asset management and training.

The Olympus Articulating HD 3D Laparoscopic Surgical Video System will be showcased at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) 2013 Annual Meeting to be held April 17-20 in Baltimore, MD. Surgeons are invited to visit booth #111 and experience the benefits of the HD 3D technology. For more information visit Olympus at www.olympusamerica.com.


As Walgreen plays doctor, family physicians bristle

Walgreen’s latest push into primary care has one major doctor group taking issue with the retailer’s expansion into “management for chronic conditions” such as high cholesterol, diabetes and hypertension.

The nation’s largest drugstore chain earlier this week announced that its more than 330 Take Care clinics staffed by advanced degree nurses known as nurse practitioners were expanding the scope of the healthcare services beyond routine maladies like treating strep throat or pink eye.

Walgreen is now providing new services that include “assessment, treatment and management for chronic conditions such as hypertension, diabetes, high cholesterol, asthma and others, as well as additional preventive health services.” Walgreen said it was moving further along than clinics run by rivals like CVS/Caremark or Wal-Mart Stores. But some physicians are upset by the expansion, saying it will further splinter an already fragmented healthcare system and therefore harm quality and patient safety.

“It is more difficult to comprehensively manage a patient’s care if they are treated in multiple settings,” said Dr. Jeffrey Cain, president of the American Academy of Family Physicians in a statement to Forbes. “Our healthcare system is already fragmented, and our concern is that the expansion of retail clinics into chronic care will lower quality, increase costs, and pose a risk to patients’ long-term health outcomes,” Cain added. “Retail clinics may not have some specialty services needed to treat those with complex diseases. In addition, family physicians establish relationships and get to know their patients, which better enables them to help someone with diabetes learn how to eat better, start exercising and stick with their treatment plan.”

But Walgreen says the services offered at its Take Care clinics meet the company’s “objective to help address the need for greater access to care by working collaboratively with physicians to support and complement their care plans for chronic patients.”

Walgreen, for example, has formed various affiliations with large hospital systems and doctor-led clinics across the country to create patient-care protocols and other programs. Walgreen has also formed and is joining with larger providers to create accountable care organizations, which organize a collection of medical-care providers to care for a group of patients.

ACOs work to keep patients healthy and out of the more expensive hospital setting. If ACOs are successful and reduce costs, the providers in the organization divvy up the savings with the health plans that are paying them.

The American Medical Association, for example, and the retailer have discussed the new service expansions but the nation’s largest group said it had no comment on the retailer’s latest move.  A source close to the AMA said the doctor group was evaluating the expansion into chronic care services.

Still, the AMA and Walgreen have had various meetings over the years in regard to retail clinic expansion, which led to the AMA’s House of Delegates adopting policy in 2006 that was updated in 2007 on retail clinics. And Walgreen said it has been abiding by AMA policies. Visit Forbes for the article.


Central Texas hospital marred by lab deficiencies

AUSTIN, Texas (AP) — At least a dozen deficiencies in lab testing procedures at a new Central Texas hospital resulted in several patients undergoing unnecessary procedures and emergency room patients having to wait up to five hours for test results.

A report made by inspectors with the Texas Department of State Health Services at the request of the U.S. Centers for Medicare and Medicaid Services found deficiencies at the 100-bed, $210 million Lakeway Regional Medical Center, inaugurated last year, including poorly trained lab staff and a lack of policies and procedures.

The report also said the emergency room and nursing were affected by similar problems, according to a story in the Austin American-Statesman. For instance, the emergency room did not have policies and procedures regarding the treatment of stroke and heart attack patients.

The hospital voluntarily closed the blood bank and the microbiology lab at Medicare's request. It also has replaced some personnel, brought in an experienced lab director and outsourced work to other facilities in Austin. Lakeway is about 20 miles northwest of Austin.

Hospital CEO David Kreye said a review of cases found procedures were done "exactly right," just not properly documented.

Twelve of the thirteen deficiencies found had to do with the lab, and four of them remain under Medicare's review. There is one other infraction related to the hospital's use of restraints. At least one patient was restrained longer than the four hours set by standards and two more were restrained while they slept.

The hospital was built with a $167 million government-insured mortgage loan, the largest ever given to a for-profit hospital. This meant Lakeway Regional Medical Center will save $91.2 million in interest and that it would be able to care for population that has been medically underserved.

It opened its doors in April. Five months later, a complaint about the lab prompted Medicare to request the investigation. It revealed that a patient had received a surgical implant that had expired four months earlier to repair a broken arm and that same patient was anesthetized and waited six hours for surgery. The procedure was postponed by the surgeon because of the "the late hour" — after 6 p.m.

Medicare fined the hospital $10,000 and demanded a plan to correct the infractions.

Kreye said the problems have been corrected but declined to discuss individual cases with the newspaper. He said that most of the infractions had to do with lack of documentation, a view not shared by Medicare. Visit the Houston Chronicle for the story.


New genetic link found between normal fetal growth and cancer

Two researchers at the National Institutes of Health discovered a new genetic link between the rapid growth of healthy fetuses and the uncontrolled cell division in cancer. The findings shed light on normal development and on the genetic underpinnings of common cancers.

The work, conducted using mouse and human tissue, appears in the Proceedings of the National Academy of Sciences. The authors, Julian C. Lui, Ph.D., and Jeffrey Baron, M.D., work at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

“We’ve long known that some of the genes that promote rapid growth in prenatal and early postnatal life become reactivated in cancer cells,” said Dr. Baron. “Now we’ve identified a molecular switch that appears to turn on some of these genes, taking us a step forward in understanding normal body growth and the abnormal growth in some types of cancer.”

Before birth, a team of more than 200 growth-promoting genes is highly active, fueling the fetus’ explosive growth. After birth, these genes are gradually switched off, apparently to slow body growth as we age and approach adult size. In cancer cells, some of these genes can be switched back on.

One of the major growth-promoting genes is called IGF2. This gene is critical for normal prenatal body growth and is reactivated in many types of cancer, showing remarkably high activity in bladder and prostate cancer and some childhood cancers.

For years, scientists did not know what turned IGF2 on and off. Now, using a variety of techniques and tissue types, Drs. Lui and Baron found evidence that a protein known as E2F3 activates the IGF2 gene in normal development and in cancer — in particular, in bladder and metastatic prostate cancers.

More broadly, E2F3 appears to regulate not just IGF2, but also many other genes on the body-growth team. When E2F3 levels are high, these genes are active. When E2F3 takes a dive, so do these genes. The upshot is that E2F3 may function as one of the master switches that limit body growth. As such, it is of great interest as researchers seek to understand the complex genetic choreography responsible for normal growth and the diseases that result when it goes awry. Visit NIH for the study.


Bloodless pressure: More surgery without transfusions

Bloodless surgery—operations performed without the use of donated blood—has been done for years on patients with religious objections to transfusions. Now, hospitals are embracing the practice more widely, saying it is cheaper and better for patients to avoid transfusions whenever possible.

Surgeons who champion bloodless surgery say that in addition to reducing costs related to buying, storing, processing, testing and transfusing blood, the technique reduces the risk of transfusion-related infections and complications that keep patients in the hospital longer.

“I think that everyone now feels that blood utilization should be minimized,” says Frank Sellke, a professor of cardiothoracic surgery at Brown Medical School. “Blood transfusion can certainly be lifesaving, but you’d like to avoid it if at all possible.”

A few hospitals pioneered bloodless surgery decades ago in response to requests from patients who were Jehovah’s Witnesses, as well as fears about the safety of donated blood during the early days of the AIDS epidemic. The practice became more widespread in recent years as an increase in the cost of blood (partly due to stricter screening procedures) and research suggesting there are downsides to nonessential transfusions prompted hospitals to try to cut back on blood use in the operating room.

The Cleveland Clinic, one of the biggest blood users in the U.S., is using new protocols designed to make doctors think twice before ordering transfusions. The initiative helped lower costs for external blood purchases to $26.4 million in 2012 from $35.5 million in 2009, and led to savings elsewhere in the hospital system as blood storage and processing costs and transfusion-related complications declined.

Robert Lorenz, medical director of blood management for the Cleveland Clinic, says the new guidelines encourage physicians to give some patients iron before surgery to boost the oxygen-carrying capacity of red blood cells, and to accept some level of anemia and a higher heartbeat before resorting to transfusions.

To reduce blood loss in patients both before and after surgery, Cleveland Clinic uses lower-volume test tubes when samples are collected and uses computer programs to minimize the number of blood draws performed on patients. Meanwhile, physicians have to answer a series of questions before ordering blood, and managers in the hospital system regularly review data on blood use.

Still, doctors are quick to point out that they need to have the freedom to use their judgment when it comes to avoiding transfusions.

“I think there’s no risk as long as it’s not proscriptive,” says Harvey Klein, chief of the department of transfusion medicine at the National Institutes of Health Clinical Center. What you don’t want is to “become so fixated on the dollar bottom line that you don’t do what’s in the patient’s best benefit,” he says. Visit the Wall Street Journal for the article.


New drugs better value than Warfarin

The three newest anticoagulants -- dabigatran (Pradaxa), apixaban (Eliquis), and rivaroxaban (Xarelto) -- are cost-effective relative to warfarin for preventing stroke in patients with nonvalvular atrial fibrillation, researchers found.

In a decision-analysis model, apixaban, dabigatran, rivaroxaban, and warfarin were cost-effective in 45.1%, 40%, 14.9%, and 0% of the simulations, respectively, using the generally accepted cost-effectiveness threshold of $50,000 per QALY, Daniel Malone, PhD, of the University of Arizona in Tucson, and colleagues reported.

Compared with warfarin, the cost per quality-adjusted life year (QALY) gained came in under $50,000 for each of the new drugs -- $15,026 for apixaban, $11,150 for dabigatran, and $3,190 for rivaroxaban, they wrote online in Stroke: Journal of the American Heart Association.

"Healthcare providers already encounter choices between novel oral anticoagulants and warfarin in clinical practice for this high-risk population," they wrote. "The findings provided from this study, in combination with results of previously conducted analyses, provide an estimation of the implications of clinician decisions."

The researchers used a Markov decision-analysis model constructed with data from pivotal clinical trials to explore the cost-effectiveness of using apixaban 5 mg twice daily, dabigatran 150 mg twice daily, rivaroxaban 20 mg once daily, and warfarin adjusted to a target international normalized ratio (INR) of 2.0 to 3.0. They accounted for costs related to clinical events, prescription drugs, INR testing, physician visits, and side effects.

Estimated lifetime costs of treatment were lowest with warfarin ($77,813), followed by rivaroxaban ($78,738), dabigatran ($82,719), and apixaban ($85,326).

The ranking for estimated quality-adjusted life expectancy ran in the reverse order, with apixaban at the top (8.47 years), followed by dabigatran (8.41), rivaroxaban (8.26), and warfarin (7.97).

The researchers noted that two previous analyses looking a dabigatran showed the drug to be cost-effective compared with warfarin, with one -- published last year in Stroke -- establishing a cost per QALY of $25,000.

Another study published the year before, however, calculated a cost per QALY of $86,000.

Fewer studies have evaluated the cost-effectiveness of apixaban and rivaroxaban, but both have been shown to be cost-effective compared with warfarin. Visit MedPageToday for the study.


AHA re-launches sustainability roadmap website

The American Hospital Association (AHA) has launched a revamped website that provides free, practical tools to help health care facilities reduce their environmental footprints. The Sustainability Roadmap—www.sustainabilityroadmap.org—shows hospitals how to implement real-world sustainability projects, enhance existing efforts, and share their environmental successes with other facilities.

“Hospitals are committed to creating healthy communities, and part of that mission involves being good environmental stewards,” said Rich Umbdenstock, AHA president and CEO. “The expanded Sustainability Roadmap website provides easy-to-use resources that can help hospitals achieve their sustainability goals and provide economic, health, and environmental benefits. Our members can contribute resources and share experiences to build on the progress we have already made.”

Three AHA personal membership groups—the American Society for Healthcare Engineering (ASHE), the Association for the Healthcare Environment (AHE), and the Association for Healthcare Resource & Materials Management (AHRMM)—have collaborated to produce this expanded set of resources developed by healthcare professionals for healthcare professionals.

The Sustainability Roadmap website features search functions, how-to guides, and other resources. It also provides users the opportunity to share resources and tools, letting other facilities know what’s working well and what’s not. This sharing of experiences can help focus sustainability efforts on efficient and cost effective projects. Users can also contribute suggestions, sample documents, and case studies to add to the library of practical information on the site.

The Sustainability Roadmap is useful for hospital managers, hospital staff, and those who design health care facilities. It also provides health care leaders with strategic planning resources to help get sustainability efforts on the radar of complex healthcare organizations.

The Sustainability Roadmap will continue to grow as more information is developed by users and ASHE, AHE, and AHRMM.


Study finds copper reduces 58% of healthcare-acquired infections

New research has revealed that the use of Antimicrobial Copper surfaces in hospital rooms can reduce the number of healthcare-acquired infections (HAIs) by 58% as compared to patients treated in Intensive Care Units with non-copper touch surfaces. Although numerous strategies have been developed to decrease these infections, Antimicrobial Copper is the only strategy that works continuously, has been scientifically proven to be effective and doesn’t depend on human behavior, according to a recently published study in the SHEA Journal of Infection Control and Hospital Epidemiology.

The study, funded by the U.S. Department of Defense, was conducted in the Intensive Care Units (ICUs) of three major hospitals: The Medical University of South Carolina, Memorial Sloan-Kettering Cancer Center in New York City and the Ralph H. Johnson Veterans Affairs Medical Center in Charleston, SC. To determine the impact of copper alloy surfaces on the rate of HAIs, copper-surfaced objects were placed in each ICU, where patients are at higher risk due to the severity of their illnesses, invasive procedures and frequent interaction with healthcare workers. Patients were randomly placed in available rooms with or without copper alloy surfaces, and the rates of HAIs were compared. A total of 650 patients and 16 rooms (8 copper and 8 standard) were studied between July 12, 2010 and June 14, 2011.

Results of this study, that appeared last July in the Journal of Clinical Microbiology, found that Antimicrobial Copper can continuously kill 83% of bacteria that cause HAIs within two hours, including strands resistant to antibiotics.  The study compared copper to equivalent non-copper touch surfaces during active patient care between routine cleaning and sanitizing.

In study results, 46 patients developed an HAI, while 26 patients became colonized with MRSA or VRE. Overall, the proportion of patients who developed an HAI was significantly lower among those assigned to intensive care rooms with objects fabricated using copper alloys. There are currently hundreds of Antimicrobial Copper healthcare-related products available today, including IV poles, stretchers, tray tables and door hardware.

This study was so successful that an interdisciplinary team from UCLA began replicating this research in July 2012. The team is testing ICUs with Antimicrobial Copper at Ronald Reagan UCLA Medical Center. For more information about Antimicrobial Copper, visit www.antimicrobialcopper.com.


April 9, 2013   Download print version

Joint Commission Alert: Medical device alarm safety in hospitals to be sure alarms are not ignored

AHRMM releases new resource to advance supply chain CQO movement

MedAssets enters into strategic partnership with Ariba

Putting an end to chickenpox

Experts triple estimate of world dengue fever infections

Chinese told to change eating habits as H7N9 fatalities rise

Sanford, Fairview, University of Minnesota talk merger

Johnston County hospital system partnering with UNC Health Care

Joint Commission Alert: Medical device alarm safety in hospitals to be sure alarms are not ignored

The constant beeping of alarms and an overabundance of information transmitted by medical devices such as ventilators, blood pressure monitors and ECG (electrocardiogram) machines is creating “alarm fatigue” that puts hospital patients at serious risk, according to a Sentinel Event Alert issued today by The Joint Commission.

The Joint Commission Alert urges leaders at hospitals to take a focused look at this serious patient safety issue. Over a recent four-year period, a U.S. Food and Drug Administration (FDA) database shows that there were more than 560 alarm-related deaths and The Joint Commission’s sentinel event database includes reports of 80 alarm-related deaths and 13 serious alarm-related injuries during a similar period. Patient deaths related to alarms on monitoring devices have also been the focus of national media attention and special reports by the Association for the Advancement of Medical Instrumentation (AAMI) and ECRI Institute. The Joint Commission, AAMI, ECRI Institute and American College of Clinical Engineering also brought together patient safety and health care experts at a 2011 summit to seek solutions to problems with medical device alarms.

Alarms are intended to alert caregivers of potential problems, but can compromise patient safety if they are not properly managed. Many patient care areas have numerous alarms and the barrage of warning noises tend to desensitize caregivers and cause them to ignore alarms or even disable them. Other issues associated with effective alarm management include too many medical devices with alarms or individual alarms that are difficult to hear.  Pre-set or default settings also may cause problems because the device sounds a warning even when no action or decision by a caregiver is required. Rather than calling attention to a patient’s needs, these settings may distract caregivers.

These issues vary greatly among hospitals and even within different units in a single hospital. Although there are many variables, the Alert makes it clear that in order to reduce risks related to alarms on medical devices, a series of actions still needs to occur related to people, processes and technology.

The Joint Commission Alert recommends that healthcare organizations take the following actions, which correspond with recommendations made by both AAMI and ECRI Institute:

·         Ensure that there is a process for safe alarm management and response in areas identified by the organization as high risk.

·         Prepare an inventory of alarm-equipped medical devices used in high-risk areas and for high-risk clinical conditions, and identify the default alarm settings and the limits appropriate for each care area.

·         Establish guidelines for alarm settings on alarm-equipped medical devices used in high-risk areas and for high-risk clinical conditions; include identification of situations when alarm signals are not clinically necessary.

·         Establish guidelines for tailoring alarm settings and limits for individual patients. The guidelines should address situations when limits can be modified to minimize alarm signals and the extent to which alarms can be modified to minimize alarm signals.

·         Inspect, check and maintain alarm-equipped medical devices to provide for accurate and appropriate alarm settings, proper operation, and detectability. Base the frequency of these activities on criteria such as manufacturers’ recommendations, risk levels and current experience.

The Joint Commission Alert also recommends training and education for all clinical care team members on safe alarm management and response in high-risk areas. In addition, organizations should consider how to reduce nuisance alarm signals and to determine whether critical alarm signals can actually be heard in patient care areas. Seeking input from patient care providers, health care engineers, risk managers and information technology professionals, organizations should also establish policies and processes for alarm safety that include the regular review of trends and patterns that reveal improvement opportunities. Finally, the Alert urges organizations to share information about alarm-related incidents, prevention strategies and lessons learned with organizations such as AAMI, ECRI, the FDA and The Joint Commission.

Beyond the Alert, The Joint Commission is considering the possible creation of a National Patient Safety Goal to help health care organizations address this issue. A field review of the proposed Goal occurred in February and the public comments are now under review. The Joint Commission already has numerous accreditation standards in place related to alarm safety. The standards address issues such as leadership, the environment of care, provision of care and staff training and education. Visit Joint Commission for the alert.


AHRMM releases new resource to advance supply chain CQO movement

The Association for Healthcare Resource & Materials Management (AHRMM) of the American Hospital Association released an online education course that identifies the major impacts of healthcare reform – including implications for supply chain and recommendations for adapting to a new healthcare delivery model – and that will advance the industry-wide Cost-Quality-Outcomes (CQO) Movement the professional organization launched in January.

In the emerging environment of coordinated care, supply chain will play a strategic role across the continuum of care in implementing delivery system reforms and responding to new incentives to achieve positive patient outcomes. The online educational course entitled Supply Chain: Owning the Intersection of Cost, Quality and Outcomes will help supply chain professionals:

-Define cost, quality, and outcomes.
-Identify the major implications of the Affordable Care Act on supply chain operations.
-Recognize the importance of improving structure and accountability in the supply chain.
-Identify ways to integrate CQO into hospital operations, including making recommendations to stakeholders on key action items, and measuring success.
-Describe how to transform premium products into value products.

The new course is part of the Cost-Quality-Outcomes education and training framework. The first CQO course, Patient Protection and Affordable Care Act - Goals and Components, Provider Reimbursement, and Health System Changes, was released in January. Additional courses and training opportunities will be released throughout the year.

Supply Chain: Owning the Intersection of Cost, Quality and Outcomes is now available and being offered to AHRMM members and chapter members and for a nominal processing fee. The course is also available for purchase to the general public. For more information and to register for the course please visit www.ahrmm.org/CQO.


MedAssets enters into strategic partnership with Ariba

MedAssets, Inc. announced a multi-year strategic partnership with Ariba, an SAP company, that significantly expands MedAssets supply chain management and outsourced procurement capabilities. The partnership offers healthcare providers and suppliers a comprehensive electronic commerce platform, including requisition to purchase order (PO) transmission, shipment notification, invoice transmission and reconciliation workflow automation, expense posting, supplier payment and early-pay discount solutions.

Through this partnership, healthcare providers will be able to conduct fully automated e-commerce with the nearly one million companies connected to the Ariba Network through the MedAssets eCommerce Exchange. The combination of MedAssets’ technology-enabled services with Ariba’s cloud-based applications and business network will deliver unparalleled cost management and healthcare provider-supplier collaboration opportunities.

Providers, for instance, will be able to eliminate up to 100 percent of paper invoices received from suppliers using Ariba’s “smart invoicing” applications, which automatically validate supplier-initiated electronic invoices through a provider-managed rules engine and post them directly to their accounting system for true "touchless" processing. 

In addition, capturing all supplier invoice data electronically for both PO and non-PO based transactions will accelerate a provider’s ability to identify and execute upon cost reduction opportunities for all non-labor spend, including purchased services, a growing area of focus in all healthcare organizations. (BusinessWire) For more information, visit MedAssets.


Putting an end to chickenpox

A long-term study of the chickenpox vaccine has found it highly effective after one dose and even more effective after two. Before 1995, when the varicella vaccine came into widespread use, chickenpox affected about 90 percent of the population, leading to thousands of hospitalizations and about 100 deaths a year.

“Now a very safe vaccine will totally prevent it from happening,” said the lead author, Dr. Roger Baxter, co-director of the Kaiser Permanente Vaccine Study Center in Oakland, CA.

Between June and November 1995, researchers began studying 7,585 children vaccinated between the ages of 1 and 2. They interviewed their parents every six months, asking about the occurrence of both chickenpox and shingles, the painful rash that can occur after recovery from chickenpox. In June 2006, a second vaccine dose was recommended, and the researchers followed those cases through the end of the study in 2009.

The analysis, published online in Pediatrics, found 1,505 cases of chickenpox, all except 30 of which were mild or moderate, involving fewer than 300 lesions. There were no cases among children who received a second dose.

There were also fewer cases of shingles, which is very rare in children. The researchers found 40 percent fewer cases than would have been expected in this same age group following naturally acquired chickenpox. Visit the New York Times for the article.


Experts triple estimate of world dengue fever infections

LONDON (Reuters) - Around 390 million people are infected each year with dengue fever - the world's fastest-spreading tropical disease - more than triple the current estimate by the World Health Organization, experts said on Sunday.

The new finding, based on several years of analysis, underscores the growing burden of the mosquito-borne viral disease, which is also called "breakbone fever" because of the severe pain it can cause. There is as yet no approved vaccine or specific drug to treat dengue, which is not normally fatal but lands many victims in hospital.

Researchers from the University of Oxford and the Wellcome Trust presented their results, along with a detailed map of dengue distribution, in the journal Nature.

Their new figure includes 96 million severe cases and approximately 300 million mild or asymptomatic episodes. That compares with the WHO's most recent estimate for overall infections of 50-100 million a year,

The high number of relatively mild cases offers little cause for comfort, since it suggests the reservoir of disease is far larger than expected. What is more, dengue is a disease that hits more than once and people who get it mildly first time are more likely to have a serious episode if bitten again by an infected mosquito.

"The asymptomatic patients, in terms of the future burden of disease, are a very important contributor," said Jeremy Farrar, director of Oxford University's tropical disease research unit in Vietnam.

Spread by the Aedes aegypti mosquito, dengue has grown rapidly along with urbanization and globalization because it thrives in tropical mega-cities and is easily spread in goods containing small puddles of water, such as used tires. Climate change is also making more parts of the planet habitable for the dengue-spreading mosquito. As a result, half the world's population is now exposed to the disease, mostly in the developing world - but also in parts of southern Europe and the southern United States.

Last year Europe experienced its first sustained transmission of dengue fever since the 1920s with around 2,000 people infected in the Portuguese archipelago of Madeira.

Farrar said more such outbreaks were likely in future, since the mosquito was already present in southern Europe and there were increasing numbers of people travelling to and from dengue-infected areas.

The researchers estimated that 70 percent of the world's serious dengue cases were in Asia, with India alone accounting for 34 percent of the total. The Americas - mainly Brazil and Mexico - made up 14 percent, while Africa's dengue burden was nearly as large.

The prevalence of the disease in Africa is worrying, since dengue has not generally been seen as a major problem on the continent. The research team said the impact of disease in Africa was being masked by symptomatically similar illnesses, such as malaria.

Hopes for an effective dengue vaccine suffered a setback last year when an experimental shot from Sanofi proved far less effective than hoped in a mid-stage clinical trial in Thailand. Further large trials of the Sanofi vaccine - the most advanced in development - are still continuing and scientists have not given up hope that it may yet have a role of play. A number of other experimental vaccines are also in development, although at a much earlier stage. Visit NIH for the release.


Chinese told to change eating habits as H7N9 fatalities rise

China asked its citizens to avoid contact with live poultry as it tries to stem a H7N9 bird flu outbreak whose death toll rose to seven today, with a further 17 people infected in three eastern provinces and Shanghai.

Consumers should avoid markets where poultry are butchered as authorities increase monitoring for the new influenza strain, Feng Zijian, head of emergency response at the Chinese Center for Disease Control and Prevention, said in Beijing today. A vaccine is being prepared in case the virus starts spreading from human to human, health officials said.

“Consumers should no longer pursue the kind of eating habits where they buy fresh chickens that are butchered on the spot,” Feng told reporters at a briefing held jointly with the World Health Organization. “Stalls and markets in cities where live poultry is being butchered need to be closely monitored as possible venues of infection.”

Shares in Shanghai and Taiwan fell on concern that infections may become more widespread, with airlines leading the slump after trading resumed today following a two-day holiday. The H7N9 infections tally rose to 24 after Chinese authorities reported three more cases today. Asian makers of medical gloves rose, led by Supermax Corp., which said the outbreak in China will bolster earnings.

China “is confident” of controlling the virus, Ma Xiaowei, a vice minister at the National Health and Family Planning Commission, said in an interview in Beijing yesterday. The nation has adequate stocks of flu medication and is developing a vaccine for possible production, he said.

A new vaccine will take six to eight months to produce, said Liang Wannian, head of the H7N9 working group at China’s National Health and Family Planning Commission. The nation will share information about the latest cases in a timely manner and boost hospitals’ ability to handle them, he said.

“If the virus becomes transmissible between humans, and especially if it becomes a pandemic, then we will have to speed up the production of vaccines,” Liang told reporters today. “For now, we are still making preparations because there is no clear evidence this virus can be transmitted between humans.”

Supermax, Malaysia’s third-largest maker of medical gloves, gained 6.4 percent to close at the highest level since August. The H7N9 outbreak “augurs well” for the company’s growth plans and a surge in glove demand would lead to a profit increase, Group Managing Director Stanley Thai said in an e-mail. Top Glove Corp., Malaysia’s biggest rubber-glove maker, advanced as much as 4.7 percent.

Melbourne-based CSL Ltd. (CSL), the Southern Hemisphere’s biggest maker of flu vaccines, is ready to assist the Chinese government if needed, the Australian Financial Review quoted Chief Executive Officer Brian McNamee as saying.

H7N9 has some of the genetic hallmarks of an easily transmissible virus, Ron Fouchier, a professor of molecular virology from the Netherlands, who showed how H5N1 avian flu could become airborne, said April 5.

Health authorities are still investigating how individual patients in China were infected by H7N9, and the WHO isn’t recommending travel or trade restrictions be applied at this stage, said Michael O’Leary, China representative of the Geneva- based United Nations health agency.

There has been no human-to-human transmission of H7N9, and no connection has been established yet between human infections of the virus and dead pigs found floating in a Shanghai river, O’Leary said at the Beijing briefing.

All confirmed H7N9 infections have been in eastern China -- in Shanghai and in Zhejiang, Jiangsu and Anhui provinces. Shanghai, the financial capital, has been hit hardest, with 11 infections including five deaths.

Shanghai’s latest fatality was a 64-year-old man who fell ill on April 1 and died on April 7, the same day he was hospitalized, the city government press office said on its official microblog.

Two further infections were found in Jiangsu province, including an 85-year-old man in Nanjing city who fell ill on March 28 and was hospitalized on April 1, and a 25-year-old woman in Zhenjiang city who became sick on March 30 and hospitalized on the same day. Both patients are now in serious condition, the provincial government’s health department said in a statement posted on its website.

The cities of Shanghai, Nanjing and Hangzhou have ordered live poultry markets to close and have seized birds, according to reports in the state-run CCTV and Xinhua News Agency.

The government in Nanjing, the capital of eastern Jiangsu province, banned non-farmers from raising fowl to help contain the outbreak, its city management bureau said. China’s Ministry of Agriculture also said today that visits to poultry farms nationwide would be strictly controlled to contain the virus. In Hangzhou, where two of three people diagnosed with the disease have died, trade at a farm-produce market was suspended after the virus was found in quail and a cull started on April 6, Xinhua said.

Hong Kong will implement rapid avian influenza tests from April 11 to ensure imported chickens are virus-free, the city’s Secretary for Food & Health Ko Wing-man announced, Xinhua reported today.

Minimizing the risk of human infections will hopefully help reduce the danger of the virus mutating to a form where it can spread between people, said Benjamin Cowling, an infectious disease epidemiologist at the University of Hong Kong’s School of Public Health, in a Bloomberg Television interview. China may have to adopt similar measures to Hong Kong, which kills unsold live chickens at the end of each day to prevent viruses from spreading in a poultry market, he said. Visit Bloomberg for the article.


Sanford, Fairview, University of Minnesota talk merger

A proposal for Fargo- and Sioux Falls, SD-based Sanford Health to take control of Minnesota’s Fairview Health Services faces opposition, but both companies’ officials say they want to continue talks if it could benefit patients.

“We think there’s merit in us exploring it,” Fairview interim CEO Chuck Mooty said. “Whether a relationship between Fairview and Sanford Health – or any other partner – would advance our clinical, research and educational goals is yet to be determined.”

Minnesota Attorney General Lori Swanson hosted the first of a series of public hearings on the issue Sunday in a packed Capitol hearing room. The next hearing is April 21.

“There should be significant public dialogue about any potential transfer of control of this century-old Minnesota charitable institution to Sanford Health of South Dakota,” Swanson said Sunday. She said the hearings will allow her office to determine the potential merger’s impact “on the Minnesota healthcare system, the Minnesota charitable community and on Minnesota patients.”

Mooty said healthcare organization mergers are becoming more common due to changes in the industry.

Mooty said Sanford and Fairview share similar missions, goals and histories. They also have “compatible, but not overlapping, geographies,” he said. Fairview’s facilities primarily are located in the Twin Cities and northeastern Minnesota, while Sanford’s are in western Minnesota, North Dakota and South Dakota.

Another organization affected by the potential takeover, the University of Minnesota, said the proposal raises serious questions.

“This possible merger carries very important implications for the university, for the University of Minnesota Medical Center and, most important, for the university’s medical training and medical research missions that are of vital importance to all Minnesotans,” university attorney Mark Rotenberg said.

The University of Minnesota Medical Center and clinics have been part of Fairview since 1997, though Fairview does not own the medical school or employ faculty. Swanson said the University of Minnesota Medical School trains about 70 percent of Minnesota doctors.

Mooty emphasized Sunday that if the university objects to the merger, Fairview would not continue to pursue it. The university has not ruled it out, Rotenberg said.

The university also has proposed a takeover of Fairview.

“Our discussion with Fairview about this is in a very preliminary phase,” Rotenberg said. He said the university had been in talks with Fairview before the Sanford merger was discussed about ways to improve their working relationship.

Swanson said she has concerns that control of Fairview, a nonprofit organization, could come from outside Minnesota, especially with Fairview’s current lack of a permanent CEO, if it merges with Sanford. Fairview has benefited from tax exemptions, land donations and other perks from the state, she added, and it employs about 22,000 Minnesotans. Visit the Grand Forks Herald for the story.


Johnston County hospital system partnering with UNC Health Care

NORTH CAROLINA - The Johnston County hospital system has became the latest community care provider to align itself with a much larger partner, selecting UNC Health Care to help it expand services and lower operating costs.

The decision by Johnston Health, which operates a hospital in Smithfield and an outpatient clinic in Clayton, represents a victory for UNC over its rival WakeMed, which was one of two other possible partners that Johnston had been considering. It is also another example of the type of hospital consolidation that some believe is driving up the cost of healthcare for patients and employers.

The two sides have not reached a formal agreement — which won’t happen until this summer — but Johnston Health chief executive Chuck Elliott said members of the local hospital board would retain majority control. UNC would have a minority presence on the board, but Elliott said the sides have not agreed on an exact board structure.

Johnston Health officials made the announcement Monday afternoon in Smithfield. Elliott said the system needed to find a partner to help it adjust to changes in Medicare and Medicaid reimbursements.

“Because of changes in how hospitals get paid for care, we’ll need to work more closely with physicians and other providers to bring quality and efficiency,” he said.

Elliott said patients will have access to more specialized services, like pediatric cardiology. UNC doctors and staffers will travel to Johnston County whenever possible to make it easier on patients, he said.

Hospital board chairman Ralph Stewart said that was a major advantage UNC offered over its competitors. “One of our main goals was to keep people in Johnston County so they wouldn’t have to make the drive,” he said.

Elliott also cited UNC’s experience with community clinics around the Triangle and its participation in clinical trials and research.

The new board will set patient costs, Elliott said, but he doesn’t expect the partnership to lead to higher costs. Officials are hoping the partnership could actually lower patient costs.

“UNC’s goal is not to be the biggest healthcare system in the state,” said David Strong, chief operating officer of system affiliations for UNC. “... The desire is to lower costs and then pass those along to patients.”

Nor does Elliott expect any layoffs because of redundancies in administrative staff. Johnston Health will basically function as a separate system, he said, with UNC as a managing partner.

That was particularly important to the Johnston County Board of Commissioners. Although the decisions wasn’t theirs, commissioners had been vocal about their desire to keep a measure of independence for the local hospital.

Commissioner Jeff Carver, the board’s chairman, said he thinks UNC is committed to “empowering our local board, preserving the culture of our healthcare system and keeping patient care in the community.”

But critics of the wave of hospital consolidation now occurring across the country say it has contributed to growing hospital bills and insurance premiums. To ease their burden, employers have shifted more of their health-care costs to employees, in the form of higher deductibles and co-pays.

Johnston Health is entering into exclusive negotiations with UNC a year after hospital commissioners decided to pursue a partnership with a larger hospital. UNC was among five healthcare groups that submitted proposals to merge with Johnston Health, a taxpayer-owned hospital system.

Last October, Johnston Health narrowed its list of potential partners to three – UNC, WakeMed and Vidant Health – after eliminating Duke LifePoint and Quorum Health Resources.

By partnering with Johnston Health, UNC gets a much firmer foothold in one of the state’s fastest-growing counties.

And Johnston Health recently received approval from the state to build a 50-bed hospital on its Clayton campus, where it has medical offices and an emergency department.

WakeMed, which launched an unsuccessful $750 million bid for Rex in 2011, also has a significant presence in Johnston County. Dale Armstrong, the hospital’s vice president of regional operations, said he doesn’t believe the partnership will result in a loss of patients to its rival. Visit the Smithfield Herald for the article.


April 8, 2013   Download print version

CMS surveyors assessing protocols to reduce tubing misconnections

Animas Corporation 2020 Insulin Infusion Pump: Class I recall - false alarm or warning sound

China confident it can control bird flu outbreak

CKD patients may be overexposed to PICC

New bird flu seen having some markers of airborne killer

NIH study sheds light on how to reset the addicted brain

Assessing disease surveillance and notification systems after a pandemic

Terumo announces U.S. distribution agreement for Nonin's EQUANOX 7600 Regional Oximetry System

CMS surveyors assessing protocols to reduce tubing misconnections

The Centers for Medicare and Medicaid Services (CMS) is advising its surveyors to determine what steps organizations are taking to prevent Luer or tubing misconnections while the long awaited international standards are being developed that will specify unique connectors for each system/application, such as, IV, enteral, or epidural. These designed incompatibilities would make it easy to make the correct connection and difficult or impossible to make the wrong connection.

Misconnections of tubing that link patients to medical devices continue to result in serious injury and death. Examples of misconnections that have resulted in death include: Enteral feeding tubes connected to trach tube or ventilator in-line suction catheter; Epidural tubing connected to IV tubing; Oxygen tubing connected to a needleless IV port; Blood pressure tubing connected to IV catheter; and Pulsatile anti-embolism stocking connected to IV heparin lock.

Medical devices must have the ability to connect to related tubing and accessories - the standard "Luer" connector makes this possible. However, because the Luer connector is a standard size and is used on such a broad range of medical devices and products, it allows functionally dissimilar tubes or catheters to be connected together. Depending on the acuity level, a patient may have as many as 40 different tubing lines connected to devices, with many of the fluids and tubings being similar colors, increasing risk for misconnections.

An international standards committee, led by ISO2 and AAMI3 with participation by FDA, suppliers and the healthcare community, is developing standards that limit the use of Luer fittings to specific devices and design other connectors that are incompatible with Luer connections for the remaining devices.

In January 2011, the ANSI/AAMI/ISO4 small bore connectors standard (80369-1 general requirements) was released, the first in a seven-standard series to give manufacturers guidance on preparing for remaining standards. Each standard will focus on connectors for a specific clinical application and the remaining six standards will be released as they are completed beginning in 2014 with a phase in period for product development and implementation guided by the FDA and existing state legislation, such as California.

Until international standards are finalized and new products with unique connectors are on the market, CMS is reviewing the steps that healthcare facilities have in place right now to reduce the risk of tubing misconnections. CMS notes that the FDA tubing and Luer misconnection website has been updated with tips, images, and information for healthcare providers and manufacturers of devices that use small bore connectors that can be used for educational programs and action plans to prevent misconnections. Examples of actions that can be taken by providers to reduce risk include:

Investigating and changing to devices recently developed with alternative connector designs that may reduce the likelihood of misconnections of incompatible lines; labeling all tubes and connections at the time they are established and re-checking as part of staff hand-off process; tracing all lines back to their origins before reconnecting devices; and educating non-clinical staff and visitors not to reconnect lines, but to seek clinical assistance instead.

CMS surveyors are asked to encourage healthcare facilities to report misconnections to the FDA as part of the FDA's user facility reporting requirements, even if an adverse event did not occur. Increased awareness and analysis of these errors by the FDA, including corrected errors, can lead to improvement in patient safety.

The Premier healthcare alliance has taken a leadership role in preventing tubing misconnections beginning in 2003 in collaboration with suppliers, regulatory and non-governmental organizations. Visit the Safety Institute's website for tools, resources and solutions. Resources:

CMS Memorandum 
Luer Misconnection Adverse Events

FDA website
Tubing and Luer Misconnections: Preventing Dangerous Medical Errors

Premier Safety Institute
Tubing Misconnections website


Animas Corporation 2020 Insulin Infusion Pump: Class I recall - false alarm or warning sound

Animas identified a component issue affecting Animas 2020 Infusion Insulin Pumps manufactured from March 1, 2012 to November 30, 2012. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following: “Loss of prime”, “Occlusion”, and “No Cartridge detected”.

If you receive any of these alarms, the pump may prompt you to complete the rewind, load and prime sequence to clear this alarm. Failure to follow the pump’s safety instructions and disconnect your infusion set from your body before the “rewind, load and prime” steps can lead to unintended delivery of insulin, placing you in danger of potential serious health risks, such as hypoglycemia.

The Animas 2020 Insulin Pump also has a software limitation that will impact the ability of the pump to function past December 31, 2015. After this date, the pump will no longer deliver insulin and will generate a “Call Service Alarm.”

Customers with the device should contact Animas’ Product Fulfillment Center at 877-280-2339 between the hours of 6 a.m. and 12 a.m. EST to schedule shipment of your free replacement pump. Customers with technical questions or who want to report a concern should contact Customer Technical Support Center at 866-793-5253.

Read the MedWatch safety alert, including a link to the Class I Recall Notice.


China confident it can control bird flu outbreak

BEIJING (Reuters) - China can control the outbreak of an avian flu strain newly contracted by humans, a senior Chinese health official said on Sunday, a day after China reported its eighteenth case of the H7N9 virus that has so far killed six people.

China has said it is mobilizing resources nationwide to combat the new strain of bird flu, monitoring hundreds of close contacts of confirmed cases and culling tens of thousands of birds where traces of the virus were found.

"We are confident we can effectively control it (H7N9)," the head of China's National Health and Family Planning Commission Li Bin told Reuters on the sidelines of a World Health Organization-backed event in Beijing. Li did not elaborate, but she is the most senior Chinese health official yet to publicly comment on the subject.

The bird flu outbreak has caused global concern and some Chinese internet users and newspapers have questioned why it took so long for the government to announce the new cases, especially as two of the victims fell ill in February. The government has said it needed time to correctly identify the virus.

The WHO's representative to China, Dr. Michael O'Leary, repeated that no evidence of transmission between humans has been found and praised China for its efforts to determine the source of the virus.

In 2003, authorities initially tried to cover up an epidemic of Severe Acute Respiratory Syndrome (SARS), which emerged in China and killed about 10 percent of the 8,000 people it infected worldwide. Visit the Chicago Tribune for the article.


CKD patients may be overexposed to PICC

Patients with chronic kidney disease (CKD) received percutaneous inserted central catheters (PICC) in the acute care setting more often than other patients, despite professional guidelines that discourage PICC use in a CKD population, researchers said here.

In an observational study of 375 inpatients at a single institution, 86 PICC lines were placed and 21% of those were in CKD patients, reported Rita McGill, MD, from Allegheny General Hospital in Pittsburgh, and colleagues at the National Kidney Foundation meeting. In addition, more patients with higher-stage CKD received PICC compared with other patients, the authors stated.

However, guidelines from the American Society of Diagnostic and Interventional Nephrology (ASDIN) state that PICC lines should be avoided in CKD patients and those with end-stage renal disease (ESRD), "but this guideline appears to have relatively little traction outside of the nephrology community," they pointed out.

"PICCs, which seem to be a marker for a higher burden of illness, are [being used in] CKD patients even more commonly than other types of patients," McGill told MedPage Today. "Many of these patients with chronic kidney disease have diabetes – probably at least 30% -- which makes them at higher risk for ESRD, and also gives them fragile blood vessels, so these are exactly the type of patients who should not be getting PICC."

McGill's group spent a single morning at their hospital assessing every patient for PICC. They took note of age, gender, and service line. Monitoring level was used as a surrogate for clinical acuity and burden of illness. CKD was assessed on the day of the survey and compared with data from previous surveys. Finally, the ordering physician was contacted to determine the reason for PICC.

They found that CKD patients who received PICC did not differ from the general inpatient population in terms of age, gender, and service line. For monitoring level and acuity, the authors reported the following:

Regular floor: 19.7% PICC, 55.3% no PICC

Telemetry: 16.3% PICC, 33.6% no PICC

Stepdown: 16.3% PICC, 9.7% no PICC

Intensive care unit (ICU): 47.7% PICC, 1.4% no PICC

Convenience was reported by ordering physicians as the most common reason for PICC (34.8%) followed by the need for vancomycin intravenous therapy (17.4%), and poor access (14%). Other reasons included chemotherapy and parenteral nutrition.

The authors also found that 10% of patients who received PICC had had stages 5-6 CKD. "As PICC can reduce future arteriovenous fistula prospects, future hemodialysis patients may be at risk for negative consequences of the burgeoning PICC rate," the group concluded.

One issue may be that nephrologists are not routinely consulted in CKD patients, pointed out Allan Jhagroo, MD, from the University of Wisconsin in Madison.

Other physicians "call us when it is acute kidney disease," said Jhagroo, who was not part of the study. But "it is a nephrologist who is likely to recognize that the access point for dialysis fistulas may be compromised by the use of PICC. You would hope there would be less use of PICCs in patients with more severe illness, but while these numbers in this study are small, there are actually more PICCs in these more severely ill patients." Visit MedPageToday for the study.


New bird flu seen having some markers of airborne killer

The new bird influenza that’s killed six people in eastern China has some of the genetic hallmarks of an easily transmissible virus, according to the scientist who showed how H5N1 avian flu could become airborne.

The H7N9 strain, which is a new virus formed as a result of two others merging their genetic material, has features of viruses that are known to jump easily from birds to mammals, and a mutation that may help it attach to cells in the respiratory tract, said Ron Fouchier, a professor of molecular virology at Erasmus Medical Center in the Netherlands, in a telephone interview yesterday. “That’s certainly not good news,” said Fouchier, who reviewed a gene sequencing of H7N9 published by Chinese health authorities. “This virus really doesn’t look like a bird virus anymore; it looks like a mammalian virus.”

To curb the spread of H7N9, Shanghai, Hangzhou and Nanjing, cities with confirmed human cases of the virus, have halted trading in live poultry, closed bird markets and slaughtered more than 20,000 fowl. Shanghai today reported two new infections, taking China’s tally to 18, according to data compiled by Bloomberg News from reports released by the national and provincial governments.

The outbreak caused soybean futures and airline stocks to fall on concern the virus may spark a pandemic. While there’s no evidence yet of human-to-human transmission, scientists are scrutinizing the virus’s genetic makeup for clues to the threat it may pose.

Fouchier authored a study last year that showed five genetic tweaks to the deadly H5N1 virus, which has killed more than 600 people since 2003, made it airborne in ferrets, the mammals whose response to flu most closely resembles that of humans. One of the mutations he made is in an enzyme called polymerase; another was in a protein called hemagglutinin on the surface of the virus. H7N9 has both mutations, he said.

Whether those mutations alone are enough to make the virus easily transmissible isn’t clear, and should be “high on the research agenda,” Fouchier said. Still, there’s no evidence yet that the virus is more likely to become more dangerous than H5N1, he said.

Unlike H5N1, which is highly lethal for birds, H7N9 is a so-called low-pathogenic virus in birds, meaning it may be widespread without causing severe sickness, Fouchier said. That would make it difficult to eradicate, he said. It doesn’t necessarily follow that the virus will be mild in humans, he said. Visit Bloomberg for the article.


NIH study sheds light on how to reset the addicted brain

Could drug addiction treatment of the future be as simple as an on/off switch in the brain? A study in rats has found that stimulating a key part of the brain reduces compulsive cocaine-seeking and suggests the possibility of changing addictive behavior generally. The study, published in Nature, was conducted by scientists at the Intramural Research Program of the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, and the University of California, San Francisco.

“This exciting study offers a new direction of research for the treatment of cocaine and possibly other addictions,” said NIDA Director Dr. Nora D. Volkow. “We already knew, mainly from human brain imaging studies, that deficits in the prefrontal cortex are involved in drug addiction. Now that we have learned how fundamental these deficits are, we feel more confident than ever about the therapeutic promise of targeting that part of the brain.”

Compulsive drug-taking, despite negative health and social consequences, has been the most difficult challenge in human drug addiction. NIDA researchers used an animal model of cocaine addiction, in which some rats exhibited addictive behavior by pushing levers to get cocaine even when followed by a mild electric shock to the foot. Other rats did not exhibit addictive responses.

 “This is the first study to show a cause-and-effect relationship between cocaine-induced brain deficits in the prefrontal cortex and compulsive cocaine-seeking,” said NIDA’s Dr. Billy Chen, first author of the study. “These results provide evidence for a cocaine-induced deficit within a brain region that is involved in disorders characterized by poor impulse control, including addiction.”

“What I find to be an exceptional breakthrough is that our results can be immediately translated to clinical research settings with humans, and we are planning clinical trials to stimulate this brain region using non-invasive methods,” said Dr. Antonello Bonci, NIDA scientific director and senior author of the study. “By targeting a specific portion of the prefrontal cortex, our hope is to reduce compulsive cocaine-seeking and craving in patients.”

In 2011, there were an estimated 1.4 million Americans age 12 and older who were current (past-month) cocaine users, according to the National Survey on Drug Use and Health. However, there are currently no medications approved by the U.S. Food and Drug Administration for the treatment of cocaine addiction. Visit NIH for the release.


Assessing disease surveillance and notification systems after a pandemic

Significant investments over the past decade into disease surveillance and notification systems appear to have "paid off" and the systems "work remarkably well," says a Georgetown University Medical Center researcher who examined the public health response systems during the 2009 H1N1 influenza pandemic. The findings are published online in PLOS ONE.

After the Sept. 11 terrorist attacks in the U.S. and the potential threat of bioterrorism, many new advanced systems for disease surveillance and notification have been developed and implemented throughout the world. The goal of these systems is not only to detect a possible biological attack, but to characterize emerging pathogens so that a public health response can be implemented rapidly.

"You can't test these systems on a day-to-day basis," says the study's corresponding author, Michael A. Stoto, PhD, a professor in the department of health systems administration at Georgetown University School of Nursing & Health Studies, part of Georgetown University Medical Center. "The only way to test these systems is how they perform in a real public health emergency."

Stoto and his colleagues conducted a systematic and detailed review of the scientific literature, official documents, websites and news reports to construct a timeline of events for the 2009 H1N1 influenza pandemic, including the emergence and spread of the virus, local health officials' awareness and understanding of the outbreak, and notifications about the events and their implications.

Stoto's analysis focused on three critical events: the identification of a novel viral subtype in of two California children, the recognition that multiple disease outbreaks throughout Mexico were connected to the two cases California cases, and the additional connection of about 100 New York City school children who had been to Mexico for spring break.

"Enhanced laboratory capacity in the U.S. and Canada led to earlier identification and characterization of the novel H1N1 strain," says Stoto, an expert on population health and public health assessment. "That recognition triggered national and global pandemic plans." He says tests were quickly developed to aid in surveillance and clinical decision-making and a vaccine was developed in time for the second H1N1 pandemic wave in fall 2009.

He also credits enhanced global notification systems that led to an earlier detection and characterization of the outbreak by "connecting the dots" between the cases in California, Mexico and New York City.

"The systems worked remarkably well," Stoto says, estimating that it might have been possible for the detection to be made a week sooner, though he says it's not likely that earlier detection would have changed the outcome. "Had the pandemic occurred as recently as 10 years ago, the delay could have been much greater," Stoto adds. Visit Georgetown for the article.


Terumo announces U.S. distribution agreement for Nonin's EQUANOX 7600 Regional Oximetry System

Terumo Cardiovascular Systems announced that it has entered into a multi-year distribution agreement with Nonin Medical, Inc. Beginning May 1, 2013, Terumo CVS will distribute Nonin's EQUANOX Model 7600 Regional Oximetry System to adult and pediatric cardiovascular hospitals in the United States; Nonin's direct sales force will focus on certain non-cardiovascular applications in those hospitals, and applications in all other U.S. hospitals. Terumo CVS manufactures and markets medical devices for the global cardiac surgery market.

The Nonin EQUANOX Model 7600 Regional Oximetry System is a noninvasive medical monitoring system that continuously detects oxygen saturation status in the brain and tissue beneath the sensor during surgical procedures and in intensive care environments such as pediatric and neonatal intensive care units. The system allows anesthesiologists, perfusionists, cardiovascular surgeons, and other clinicians to quickly react to reverse tissue ischemia events before they become critical. 

About 500,000 cardiovascular surgical procedures are performed annually in the U.S. Regional oximetry-monitored procedures typically allow for early indication of oxygen desaturation that could lead to stroke, neurocognitive decline and other neurological or major organ injuries resulting from inadequate oxygen saturation. Regional oximetry solutions have been shown to reduce the cost of post-operative care and improve patient outcomes. For more information about the Nonin EQUANOX System, visit www.noninequanox.com/news.


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