Deadly bacteria on medical scopes trigger infections

The deadly pattern of illnesses began to emerge in 2012 at hospitals in Seattle, Pittsburgh, and Chicago. In each case, the culprit was a bacteria known as CRE, perhaps the most feared of superbugs, because it resists even "last defense" antibiotics — and kills up to 40% of the people it infects.

And in each case, investigators identified the same source of transmission: a specialized endoscope, threaded down the throat of a half-million patients a year to treat gallstones, cancers and other disorders of the digestive system. They found that the devices, often called duodenoscopes, accumulate bacteria that are not always removed by conventional cleaning, so infections can pass from patient to patient.

Yet neither the scopes' manufacturers nor the Food and Drug Administration, which regulates them, have publicized or offered guidance on the problem. So, many doctors who use the scopes — and most of the patients they treat — don't know the risks. Nor do they know that steps can be taken to cut those risks dramatically.

"Most hospitals that do these procedures are not even looking for this problem, or they may not be aware, and that's got to change," says Jeffrey Duchin, a physician who heads communicable disease control at the Seattle and King County Public Health Department.

Many of the resulting infections may go unnoticed, says Duchin, who directed the investigation of the CRE outbreak in Seattle. In that case, seven patients died with infections that were associated with contaminated duodenoscopes; five of them with CRE.

When contaminated scopes transmit CRE, it's likely to get attention, because the infections involve especially perilous, "red-flag" bacteria, Duchin says. But more common bugs may elicit little more than a quick prescription for antibiotics — and no investigation. "There's a likelihood that we're just seeing a very small subset of the universe of infections from these types of scopes," Duchin says.

The FDA says in a written statement to USA TODAY that it is "aware of and closely monitoring" the infection risks associated with the scopes. "Some parts of the scopes may be extremely difficult to access and clean thoroughly," the agency adds, "and effective cleaning of all areas of the duodenoscope may not be possible."

The agency is studying the problem and working with manufacturers to determine whether new cleaning protocols should be mandated or the scopes should be redesigned entirely. Meanwhile, the scopes' "lifesaving" ability to detect and treat potentially fatal digestive disorders outweighs their infection risks, the statement adds. "It (is) important for these devices to remain available."

Few dispute the scopes' importance. But public health officials and endoscopy experts who have studied the problem believe the FDA and scope manufacturers have been slow to bring attention to the infection risks and publicize steps hospitals can take to reduce them dramatically.

Most of the patients involved had undergone a procedure known as ERCP, or endoscopic retrograde cholangiopancreatography. In the procedure, the duodenoscope is used to inject a contrast dye into the bile and pancreatic ducts, of which X-rays are taken to reveal blockages, tumors, gallstones and other problems. The scope also can be used to gather material for biopsies, remove stones or other obstructions, or install stents to open the ducts.

Last year, after linking the CRE outbreak in Chicago to ERCP scopes, the Centers for Disease Control and Prevention issued a warning about the risks of spreading infections among patients who undergo the procedure. The problem, investigators found, is that biological material can collect in the "elevator" mechanisms that control tiny devices that extend from the tip of the duodenoscope.

Even when the devices are cleaned strictly in accordance with manufacturers' FDA-approved guidelines, "they have a lot of intricate mechanisms and pieces that are very difficult to disinfect," says Alex Kallen, an infectious-disease physician at the CDC who helped direct the investigation. "There definitely is a risk of (disease) transmission with these scopes."

Several hospitals that have linked CRE outbreaks to their duodenoscopes have not waited for guidance from the FDA and scope manufacturers; they've developed new safety procedures on their own that are showing great promise.

At Virginia Mason Medical Center in Seattle, officials adopted new scope-cleaning protocols and now require that all scopes be quarantined after cleaning, then tested for any residual bacteria before they can be reused.

The hospital had to purchase additional scopes, and more staff were needed for cleaning and testing, according to Duchin, the county health official. He says the changes cost the hospital an estimated $1 million, but the investment paid off: No infections have been linked to the scopes since the new procedures were put in place.

At University of Pittsburgh Medical Center and Advocate Lutheran General Hospital outside Chicago, officials have begun using EtO gas sterilization to ensure that any bacteria lingering on scopes after manual cleaning are destroyed. The process requires special facilities and equipment because the gas is toxic, but the hospitals have reported seeing no infections since they began using it.

The FDA says it is working with all three major manufacturers of duodenoscopes — Olympus, FUJIFILM and Pentax — to assess potential design changes and determine whether new disinfection processes can ensure the scopes' safety in their current configuration. Visit USA Today for the report.

Data on payments from drugmakers to doctors is marred by error

You’d think drug and medical device makers would know how to spell the names of their own products. But when companies submitted data to the federal government last year on their payments to doctors, some got the product names wrong. Forest Laboratories misspelled its depression drug, Fetzima, as “Fetziima” 953 times, in more than one-third of all the reports on the drug. Medical device company Amedica Corp. sometimes called its Preference screw system “Preferance.”

Amid much anticipation and after a lengthy delay, the government in September unveiled its Open Payments database, saying it would bring transparency to relationships between physicians and the drug and medical device industries. But this openness has been clouded by numerous errors that detract from its usefulness.

The database mistakes surfaced as an app was developed and rolled out this month with The Upshot, to identify the drugs and medical devices that were most heavily promoted to doctors in the last five months of 2013, the period covered by the data. The New York Times found that many of the drugs with the highest spending weren’t cures or even medical breakthroughs, but rather “me-too" drugs that were little different than other drugs on the market.

It was learned that the Centers for Medicare and Medicaid Services, which administers the Open Payments database, doesn’t double-check what companies submit.

“We are very committed to not altering data,” said Shantanu Agrawal, director of the agency’s Center for Program Integrity. “Our role is not to spell-check for the industry. The act of transparency also will improve the data itself.” As companies’ errors are exposed, he explained, they will work to fix them.

While misspelling product names was an obvious, infrequent error, a variety of other problems were discovered. Companies, for instance, routinely recorded payments associated with a single drug under multiple names.

Take H.P. Acthar Gel, an expensive injectable drug used to treat multiple sclerosis, kidney disease, lupus and other conditions. The drug’s maker, Questcor Pharmaceuticals, logged payments related to the drug under eight names, including Acthar, Acthar-Pulm, Acthar-IS, Acthar-Rheum and Acthar-MS. The payments associated with each name didn’t stand out much. But when they were all added together, the drug ranked in the top 20 for spending on doctors. For our analysis, we grouped them together.

Sanofi and Genzyme US Companies reported more than 31,800 payments totaling $1.7 million associated with Lantus, its long-acting insulin, but listed the drug under a variety of names: Lantus Timely Insulin, Lantus-Vial, Lantus TML and Lantus Capture Insulin.

Another complication was that about 8.5 percent of the 4.3 million general payments companies reported to the government were not connected to specific products. More than 140 companies did not list products at all in their payment records.

Other companies didn’t leave product fields blank but, in some cases, might as well have. Gilead Sciences listed the product associated with eight payments as “unrecognized” and connected two dozen more to “Gilead Corporate.” Novo Nordisk and its subsidiaries attributed 90 payments totaling $133,000 to a product called “Disease State,” a phrase that is physician talk for a medical condition like diabetes, not a particular drug.

It was also learned that some companies listed products in the wrong category, or listed them as both drugs and devices in the same payment records. Luitpold Pharmaceuticals Inc., a drug maker, did this in more than 8,000 payment records.

Companies were able to associate each payment with up to five drugs and five devices, so summing up spending by drug and device was tricky. When a payment was connected to more than one product, companies did not break out how much was attributable to each. Rather than guessing how to apportion such payments, ProPublica applied the full payment amount to each product. Since some companies routinely listed multiple drugs for individual payments, excluding such spending would have substantially distorted their totals.

Janssen Pharmaceuticals, a division of Johnson & Johnson, did this hundreds of times with its arthritis drug Simponi, listing it as both drug No. 1 and as drug No. 2 in records for the same payments. A company spokeswoman said although Janssen submitted the same name twice, the second reference was to Simponi Aria, a distinct product. As a result, code had to be written to count these payments only once.

In a number of cases, multiple subsidiaries of a company reported payments related to the same drugs. Five subsidiaries of Johnson & Johnson reported payments associated with the diabetes drug Invokana: Janssen Research & Development LLC; Johnson & Johnson Health Care Systems Inc.; Animas Corp.; Janssen Pharmaceuticals Inc. and LifeScan Inc.

There’s no indication that companies were being deliberately evasive — indeed, payments could have come from different subsidiaries. But the complexity shows how difficult it would be for the general public to get a true sense of payments from the publicly released data sets.

The Pharmaceutical Research and Manufacturers of America, the industry trade group, said mistakes were understandable since this had been the first year companies reported this information publicly and the government repeatedly changed its guidance for companies. Officials hope the coming year goes more smoothly. Data covering the full year 2014 is expected to be released this June. Visit the New York Times for the article.

HBI China 2015 promotes Sino-foreign business and academic exchange

The healthcare reform has brought about development opportunities for the Chinese healthcare market, and new challenges for the domestic and international hospital construction industry.

The Hospital Build & Infrastructure China (HBI China) Exhibition & Congress that will be held from May 23 – 25 at the Dalian World Expo Center once again reinforces its commitment towards promoting sino-foreign business and academic exchange, by presenting more comprehensive exhibition segments as well as diversified learning and networking platforms.

Since its inception in 2011, HBI China has been committed to the healthy and orderly development of the industry. Regarded as Asia’s flagship event for the hospital build and infrastructure industry, the integrated trade show provides industry players with the best platform for mutual exchange and cooperation between the government, and decision makers from hospitals and enterprises.

According to China’s State Council, the total scale of China's health service industry will exceed RMB 8 trillion by 2020, and over RMB 4 trillion will be invested in infrastructure. China’s healthcare industry is on its way to becoming the world's largest emerging market.

To address the market demand of China's health service industry, HBI China aims to promote the development and upgrade of China's medical and health service system. Centered on the theme of “Reform, Innovation, Development and Guidance”, HBI China 2015 will present a bigger and better show, with improvements in terms of size, service, effect, and overall quality. 

The 2015 edition is expected to attract close to 300 exhibitors and more than 15,000 professional visitors over three days.

The 16th China Hospital Construction Forum will also be held concurrently with HBI China 2015. As the most authoritative national academic conference in China's hospital construction industry, the forum will attract over 500 hospital construction project owners, bringing with them procurement requirements of over RMB 80 billion. At the forum, more than 2,600 core decision makers will be present, 85 percent of whom are involved in making procurement decision, including presidents and vice-presidents of hospitals, as well as chiefs of infrastructure divisions.

With over 200 distinguished industrial experts and over 100 top global hospital architects invited to speak at the forum, the 16th China Hospital Construction Forum will provide delegates with a quality academic exchange platform with the world’s top academic experts.

To learn more about the HBI China Exhibition and Congress 2015, visit www.hospitalbuildchina.cn/en/. 

Study rates migraine medications

The best medications to use if you suffer migraine headaches are listed in a new study. Researchers reviewed recent scientific literature and concluded that a number of classes of drugs were effective for treating acute migraine.

These include triptans, dihydroergotamine (DHE) and many NSAIDS (nonsteroidal anti-inflammatory drugs that include aspirin, ibuprofen and naproxen). Also on the list: butorphanol nasal spray, and the combination medications sumatriptan/naproxen and acetaminophen/aspirin/caffeine.

Several other medications are "probably effective" or "possibly effective," according to the study in the January issue of the journal Headache.

While powerful opioid pain drugs such as butorphanol, codeine/acetaminophen and tramadol/acetaminophen are likely effective migraine treatments, they are not recommended for regular use, the researchers said.

The study will form the basis of new American Headache Society guidelines for the treatment of migraine.

"We hope that this assessment of the efficacy of currently available migraine therapies helps patients and their physicians utilize treatments that are the most appropriate for them," said study co-author Dr. Stephen Silberstein in a society news release. He is a professor of neurology and director of the Jefferson Headache Center of Thomas Jefferson University in Philadelphia.

When selecting a medication for migraine patients, doctors must consider the medicine's effectiveness and possible side effects, the researchers said.

Migraines affect about 36 million Americans, according to the American Migraine Foundation. (HealthDay) Visit NIH for the study.

Unhealthiness of sitting not offset by exercise: meta-analysis

Greater sedentary time was associated with increased risk of adverse health outcomes including early death, even in those who otherwise exercised regularly, a meta-analysis indicated.

With data pooled from 41 primary research studies, researchers found that long periods of sitting time were positively correlated with all-cause mortality and other outcomes, after adjustment for levels of physical activity, compared with study participants reporting relatively little sitting time.

The risk was generally greater at lower levels of physical activity, according to David A. Alter, MD, PhD, at University Health Network in Toronto, and colleagues, writing in the Jan. 20 issue of Annals of Internal Medicine.

In an accompanying editorial, Brigid M. Lynch, PhD, and Neville Owen, PhD, both of the Baker IDI Heart and Diabetes Institute in Melbourne, Australia, wrote, "The implications of these findings are far-reaching. Sedentary behavior is ubiquitous. Society is engineered, physically and socially, to be sitting-centric."

Governments and professional organizations around the world are now warning that too much sitting can be hazardous to health, noted Lynch and Owen. But they also wrote that our understanding of how sitting affects cardiovascular disease is rudimentary.

"Understanding the mechanisms by which sedentary behavior increases risk for disease and the precise amounts of sitting that generate risk may enable us to more effectively characterize the most at-risk groups within the population," they said.

To help fill the research gap, they proposed three areas of research. Isotemporal substitution modeling, which looks at the difference in associations when time spent doing one behavior is altered by another activity while time is constant, could be used to look at the relative advantages of doing activities other than sitting.

In addition, future research should have objective activity monitoring, Lynch and Owen wrote. Most of the research done has been self-reported and looks at only one measure, like overall hours of sitting or total television viewing time. Researchers could use devices like inclinometers or accelerometers to track activity to reduce measurement error.

The meta-analysis included studies in which the sedentary time of adult participants was correlated to at least one health outcome independent of physical exercise. Sedentary behavior was defined as sitting, watching television, or lying down. Alter and colleagues excluded studies that reported indirect surrogate outcomes with unclear end points, like quality of life, metabolic biomarkers, and weight gain. Visit MedPage Today for the study.

Tide turning in Ebola fight after hard lessons

A top U.N. official in the fight against Ebola greeted just three patients at one treatment center he visited this week in Sierra Leone. Families in Liberia are no longer required to cremate the remains of loved ones to halt the spread of the virulent disease. And in the streets of Guinea's capital, it is rare to see the formerly ubiquitous plastic buckets of bleach and water for hand washing.

Ten months after it dawned on health officials that they were facing an unprecedented Ebola outbreak in West Africa, experts and officials agree the tide is turning, although previous lulls have proved short-lived.

There is still no vaccine or licensed treatment, nor is it clear whether the international community has actually learned any lessons from an epidemic that killed at least 8,675 people.

Previous disease outbreaks, including SARS and bird flu, prompted calls to build strong health surveillance systems and to reinforce agencies like the World Health Organization. But little has changed.

After the 2009 swine flu pandemic, WHO commissioned an independent review, which recommended creating a $100 million emergency fund for health crises and beefing up rapid-response health experts. Neither has been done.

The human toll of Ebola can be starkly seen in one plot of land in Liberia's capital where only Ebola victims are buried now. Cards placed on sticks and stuck into the ground carry the names of those who died. One day, families hope they will be replaced with concrete gravestones marking the years of birth and death as sunrise and sunset.

"Recriminations are counterproductive, but it will be necessary to understand whether this outbreak could have been responded to quicker with less cost and less suffering," U.N. Ebola chief, Dr. David Nabarro, told the U.N. General Assembly earlier this week

"The epidemic has turned," Ismael Ould Cheikh Ahmed, the new head of the U.N. Mission for Ebola Emergency Response known as UNMEER, recently declared. The number of cases in Guinea and Sierra Leone is at its lowest since August, and in Liberia it's the lowest since June. Still, he and other officials caution that they lack critical information about the cases that do remain. Only about half of new cases in Guinea and Liberia are from known contacts, meaning that the remainder is getting infected from unknown sources.

No such statistics even exist for Sierra Leone, where deaths are still being underreported because families want to carry out burials in accordance with tradition, which involves touching bodies — one of the quickest ways to spread Ebola

The outbreak has not killed as many people as some predictions. At its height, one estimate warned that as many as 1.4 million people could become infected by mid-January if there were no additional interventions. Instead, the probable, suspected and confirmed case toll is 21,797 with 8,675 deaths.

Nearly every agency and government stumbled in its response to Ebola, now expected to cost the three most-affected countries at least $1.6 billion in lost economic growth in 2015.

In an internal draft document obtained by The Associated Press last year, WHO acknowledged there was "a failure to see that conditions for explosive spread were present right at the start." WHO blamed incompetent staff and said it let bureaucratic bungles delay people and money to fight the virus. The document said the agency was hampered by budget cuts and the need to battle other diseases flaring around the world.

Officials must also think about changing risky cultural practices in future epidemics, said Dr. Peter Piot, director of the London School of Hygiene and Tropical Medicine and co-discoverer of the Ebola virus. (Associated Press) Visit ABC News for the story.

FDA clears new medical app to track real-time glucose levels in diabetics

Doctors and other caregivers will soon be able to track the blood-sugar levels of diabetic patients by simply logging into a smartphone app, in the latest example of how mobile technologies are changing the health care landscape.

The Food and Drug Administration on Friday approved the first set of glucose-monitoring medical apps aimed at automatically and securely sharing data in real time. The system, produced by California-based Dexcom Inc., includes a small, wire-like sensor inserted just under the skin that continuously transmits data to a monitor that is worn externally.

Using the company's smartphone app, the patient can then designate "followers" with whom to share their information. The app then receives real-time data and transmits it to an Internet-based storage location, where the follower can also download and view the information via the app. While other similar app systems exist, Friday's approval marks the first of its kind since the FDA started regulating certain medical apps as devices in the fall of 2013.

The FDA's marketing approval for Dexcom's system could pave the way for similar technologies. Because the app was approved as a "low- to moderate-risk" medical device, other manufacturers that want to market a similar app in the future won't need to receive prior clearance from the agency. They will, however, have to register their product with the FDA.

The agency has made clear that it does not intend to crack down on the majority of health-related mobile apps -- of which there are thousands, because most pose little risk to consumers. But in its 2013 guidance, the FDA said it would regulate a subset of mobile apps "that present a greater risk to patients if they do not work as intended."

Visit the Washington Post for the announcement.

HPN wants your Infection Prevention Success Stories

Healthcare Purchasing News wants to share your Infection Prevention Success Stories. We will be selecting and including the most effective and innovative stories in our April 2015 feature. Below are some ideas that would tell our readers about your facility's success story:

·         What specific infection was your facility aiming to reduce or eliminate, and why was it chosen for the focus of the campaign?

·         When did your facility start this campaign to reduce or eliminate this specific infection?

·         What was the rate of this infection before your facility began their campaign to reduce or eliminate it?

·         What is the rate of infection currently, or at the end of the study?

·         Have they been able to sustain the reduced rate of infection?

·         Describe specific steps your facility took to reduce or eliminate this infection.

·         If a product(s) was part of the solution, identify it and explain how it contributed to reduction/elimination of this specific infection.

·         What department(s) was involved in formation and implementation of this campaign? Was teamwork involved?

·         Did those charged with the task meet with any resistance by administration or staff in implementing the changes? If so, how did they overcome it?

Please include how you quantified your successes with numbers and percentages, monetary savings, time savings, and patient safety enhancement figures. The deadline is February 5, 2015. Please send stories to editor@hpnonline.com.  

Visit here for the success stories from 2014.