December 11, 2009 Download print version

There's still time to save $300 for the 4th Annual Leadership Summit on Health Care Supply Chain Management

CDC’s fourth national report on Human Exposure to Environmental Chemicals

Most hospital patients don't know what meds they're taking

Additional information on the STERIS SYSTEM 1 Sterile Processing System after FDA teleconference

Healthcare loophole would allow coverage limits

Bone drugs taken by some women may lower breast cancer risk, studies say

Osteoarthritis increases aggregate healthcare expenditures by $186 billion annually

There's still time to save $300 for the 4th Annual Leadership Summit on Health Care Supply Chain Management

Leveraging on the success of the event's three year history, Healthcare Purchasing News as an event co-sponsor, is delighted to invite you to the 4th Annual Leadership Summit on Health Care Supply Chain Management, where you'll have the opportunity to attend a variety of sessions designed to maximize your learning experience and provide you with the necessary tools to increase the efficacy and efficiency of your supply chain. From thought-provoking case studies and in-depth presentations, to industry-specific breakout sessions and hands-on workshops, healthcare executives address a myriad of supply chain management topics as they relate to improving efficiencies, controlling costs and facilitating change in the healthcare industry. The dates are January 25-27, 2010 in Dallas.

• Align your organization's strategic vision to include supply chain management

• Learn from key industry stakeholders through thought-provoking case studies and in-depth presentations

• Maximize your learning experience and bring home the tools necessary to increase the efficiency and efficacy of your supply chain

• Attend industry-specific breakout sessions and hands-on workshops

• Peer to peer learning: Healthcare executives address best practices for improving efficiency, controlling costs and facilitating change in the industry

The General Session: Taking the Leap into Standardization: Breaking the Electronic Barrier between Suppliers and Patients

Closing Keynote Panel: Product Recalls and Supply Chain Interconnectivity: The Industry-Wide Challenge

Join the major industry expert professionals presenting and HPN for this important conference. Visit World Congress and save $300 by December 31, on your registration (use promo code: DHH953) (not valid for gov’t/RFID only)

CDC’s fourth national report on Human Exposure to Environmental Chemicals

The Centers for Disease Control and Prevention (CDC) released its Fourth National Report on Human Exposure to Environmental Chemicals, an ongoing assessment of the U.S. population’s exposure to environmental chemicals by measuring chemicals in people’s blood and urine, also called biomonitoring. The Fourth Report presents exposure data from the National Health and Nutrition Examination Survey for the civilian, noninstitutionalized U.S. population over a two-year survey period of 2003–2004. In addition to presenting data from 2003–2004, this Fourth Report will also include the data from 1999–2000 and 2001–2002 as reported in the Second and Third National Report on Human Exposure to Environmental Chemicals. The Fourth Report is the most extensive assessment to date of the U.S. population’s exposure to environmental chemicals. The full report and an executive summary can be downloaded at CDC’s website. 

Most hospital patients don't know what meds they're taking

A small study finds that even adults who know what medicines they take at home can't accurately name the drugs they're getting in the hospital. Forty-four percent of patients believed they were receiving a medication in the hospital that was not actually prescribed. A patient who normally receives a blood pressure medicine, for example, may have thought the medicine was continued when, in fact, it was not. Ninety-six percent of patients failed to recall one or more of the medicines that they had been prescribed during their stay, according to the study, which is published Dec. 10 in the Journal of Hospital Medicine.

"I don't think that's surprising at all. I think that that's the natural consequence of the way in which hospital culture is designed. Patients are given their medicines and they take their medicines," said study author Dr. Ethan Cumbler, an assistant professor of medicine at the University of Colorado Denver and director of the University of Colorado Hospital Acute Care for the Elderly Service.

"If the patient knows what medicines they're supposed to be getting and when, then they're sort of one extra layer of protection to make sure that things go well," he said. "If they don't know what medicines they're supposed to be getting or when, then they are dependent on hospital systems to work flawlessly, and the sad fact is that hospital systems in any hospital don't work flawlessly."

Kevin Colgan, corporate director of pharmacy at Rush University Medical Center in Chicago and immediate past president of the American Society of Health-System Pharmacists, was surprised that so many patients did not know what drugs their doctor has prescribed. "It means that evidently it was not well-communicated with them what their plan of care was," he said.

To catch medication errors, patients first have to know something about the medicines they're taking. So for this study, Cumbler and colleagues surveyed 50 adults between the ages of 21 and 89 at the University of Colorado Hospital. All were knowledgeable about the medicines they were taking before admission.

Patients were then asked to write down all the medicines they thought doctors were prescribing for them while they were in the hospital. Researchers compared that list to the actual medication administration record -- the list of medications that were being given to them in the hospital.

Medicines prescribed but not listed by the patient counted as errors of omission, while medicines listed by the patient but not actually prescribed counted as errors of commission. On average, patients omitted 6.8 medications, most commonly antibiotics (17 percent), cardiovascular medications (16 percent) and antithrombotics (15 percent), the researchers found. Only 28 percent of patients said they'd seen their hospital medication list, although 78 percent would like to have been given such a list, and 81 percent said it would improve their satisfaction with their care, the study authors noted.

"There are a group of patients that want to be more involved," Cumbler noted, "and I think this raises the question, 'How can we help them be more involved?'" What's more, for some patients, especially those who are older and cognitively impaired, more involvement may not be desirable and, in fact, may have disadvantages, he noted. Visit US News & World Report for the article.

Additional information on the STERIS SYSTEM 1 Sterile Processing System after FDA teleconference

There was an additional FDA teleconference yesterday to answer questions about the STERIS SYSTEM 1 Sterile Processing System usage. The first teleconference was held last Friday. After yesterday’s teleconference, STERIS issued another Dear Customer letter to update their SYSTEM 1 customers. In the letter they reiterate that the FDA recommends that healthcare facilities transition from SYSTEM 1 to an acceptable alternative. If an acceptable alternative is not readily available, FDA stated that healthcare facilities should not cancel surgical procedures and may continue using SYSTEM 1. The FDA has requested that healthcare facilities prepare a transition plan, which the Agency believes could be implemented within three to six months.

Further, the FDA requested input from SYSTEM 1 users on obstacles they may encounter in developing and executing a transition to an acceptable alternative. The Agency said that it may grant exceptions to healthcare facilities who are unable to complete the transition within the three to six month timeframe. SYSTEM 1 users who need more time to complete the transition should seek guidance directly from the FDA.

STERIS will continue to work with the FDA to help SYSTEM 1 users make a smooth transition to an acceptable alternative. They will continue to provide SYSTEM 1 Customers with S-20 sterilant and accessories, parts and service.

STERIS also stated that SYSTEM 1 has been used by more than 5,000 hospitals and other healthcare facilities for the last 20 years. In that time, there haven’t been any reports of a single patient infection caused by SYSTEM 1, when used as directed. STERIS will continue to provide further updates as soon as new information is available to us. If you have any questions, please contact STERIS at 1-800-548-4873 or visit www.steris.com/ss1.

During the teleconference, the FDA said they knew that their action regarding the STERIS SYSTEM 1, had generated questions from many facilities. They stated that they had been receiving many emails from individual facilities. More than a thousand people registered for the telephone conference yesterday.

As a reminder, the FDA has posted three major documents related to the STERIS SYSTEM 1 processor. The first is a notice about the concerns of the processor. Second, is the May 15th 2008 warning letter that summarizes FDA observations, deeming the STERIS SYSTEM 1 processor as adulterated and misbranded. The third is a Q&A document specifically addressing the December 3, 2009 FDA safety concerns that summarize what facilities should do, alternative products, notifying patients, and where additional information may be found for alternatives.

At the beginning of the teleconference, Tim Ulatowski, director of the FDA’s office of compliance and the center of devices and radiological health, gave an overview of the situation stating, “ It has now been a week since the FDA issued its notice to healthcare facility administrators and infection control practitioners that we posted on our website, entitled ‘Concerns about the STERIS SYSTEM 1 Processor Components and Accessories’. FDA recommended in the notice that if you have an acceptable alternative to the STERIS SYSTEM 1 to meet your sterilization and disinfection needs, you should transition to this alternative as soon as possible to ensure continued patient safety. If you do not have an acceptable alternative to the SYSTEM 1, you should promptly assess your facility and patient care needs and sterilization and disinfection requirements, and take steps to obtain legally marketed substitutes for the SYSTEM 1.”

He continued, “notice on the question and answer document we describe the chain of events that led us to publish our notice, and summary, and in as plain language as I can use…FDA warned STERIS that it made changes to the SYSTEM 1 that could significantly affect the safety or the effectiveness of the device. Those changes cause the modified device to be an unapproved device that violates federal law. Given the illegal status of the SYSTEM 1, STERIS needed to either submit a new application to FDA for the modified SYSTEM 1, and have the FDA clear the application for the modified SYSTEM 1, or STERIS needed to take their SYSTEM 1 off the market, including retrieving devices in use.

STERIS disagrees with our position on the need for a new application. They were afforded the opportunity to respond to our warnings, and did so. After careful review, we did not change our decision on the status of the SYSTEM 1. STERIS then took steps to respond to the updated warning. They stopped selling SYSTEM 1 units to new customers. They submitted an application for a new product. I cannot assure you when or if or for what scope of use their new product will be cleared.”

He continued, “The FDA must be fair and consistent in our enforcements, and cannot permit an illegal product to remain on the market. Too much time now has gone by that could have been spent on that transition—the transition to legally marketed products must occur.” Ulatowski stated several times that the current action by the FDA was not a recall.

The teleconference continued for well over an hour with the FDA taking questions from the audience. It was obvious to this HPN reporter that there are many hospital professionals still confused by the FDA directive and unsure of what direction they should take. Many of the callers noted budget constraints, apprehension over possible safety issues in having to train staff on new equipment and procedures, and concerns in finding new equipment compatible with decontamination guidelines provided by the manufacturers of their scopes and instruments. The FDA will have the official transcript in the next 10 days or so, but visit STERIS for an unofficial copy.

Healthcare loophole would allow coverage limits

A loophole in the Senate healthcare bill would let insurers place annual dollar limits on medical care for people struggling with costly illnesses such as cancer, prompting a rebuke from patient advocates. The legislation that originally passed the Senate health committee last summer would have banned such limits, but a tweak to that provision weakened it in the bill now moving toward a Senate vote.

As currently written, the Senate Democratic healthcare bill would permit insurance companies to place annual limits on the dollar value of medical care, as long as those limits are not "unreasonable." The bill does not define what level of limits would be allowable, delegating that task to administration officials. Adding to the puzzle, the new language was quietly tucked away in a clause in the bill still captioned "No lifetime or annual limits."

The 2,074-page bill would carry out President Barack Obama's plan to revamp the healthcare system, expanding coverage to millions now uninsured and trying to slow budget-busting cost increases. A tentative deal among Senate Democrats to back away from creating a new government program to compete with private insurers appears to have overcome a major obstacle to the bill's passage.

Officials of the American Cancer Society Cancer Action Network said they were taken by surprise when the earlier ban on annual coverage limits was undercut, adding that they have not been able to get a satisfactory explanation.

Democratic officials of the Senate Health, Education, Labor and Pensions Committee would not comment publicly but said the bill contains numerous provisions that will benefit patients with cancer and other life-threatening illnesses, not to mention improvements in preventive care. Advocates for patients say they're concerned the language will stay in the bill all the way to Obama's desk.

"The primary purpose of insurance is to protect people against catastrophic loss," said Stephen Finan, a policy expert with the cancer society's advocacy affiliate. "If you put a limit on benefits, by definition it's going to affect people who are dealing with catastrophic loss." The cost of cancer treatment can exceed $100,000 a year.

Under the healthcare bills in Congress, the major expansion of health insurance coverage won't take place until three to four years after enactment. Democrats have touted a series of consumer protections as immediate benefits Americans will secure through the legislation. Both the Senate and House bills, for example, ban lifetime limits on the dollar value of coverage.

But Finan said the change in the Senate bill essentially invalidates the legislation's ban on lifetime limits. "If you can have annual limits, saying there's no lifetime limits becomes meaningless," he said. A patient battling aggressive disease in its later stages could conceivably exhaust insurance benefits in the course of a year. Visit ABC News for the article.

Bone drugs taken by some women may lower breast cancer risk, studies say

Drugs already taken by millions of healthy older women to prevent bone loss and broken hips may also protect them from breast cancer, according to two observational studies that found that women taking oral bisphosphonates developed about a third fewer breast cancers than other women. The drugs are in the class of medications that includes the brand name drug Fosamax, now available generically as alendronate sodium.

The findings, presented Thursday at a scientific conference, are from a retrospective analysis of data from the Women’s Health Initiative, a federal study, and a separate Israeli observational study of several thousand postmenopausal women. Neither study was a randomized clinical trial, and several top cancer doctors expressed skepticism about the findings, saying they prove only an association and may reflect the fact that women with bone problems who are most likely to take the medications have a lower breast cancer risk to begin with.

The research generated excitement at the conference, the annual San Antonio Breast Cancer Symposium, even before the official presentations on Thursday, because unlike other drugs that can be used prophylactically to prevent breast cancer, oral bisphosphonates are already widely used and do not cause hot flashes. There was also a hint in the studies that the drugs might have a particular impact on curbing the kinds of tumors that are the most difficult to treat: those that are not fueled by estrogen.

“With tamoxifen and raloxifene, we have drugs that reduce estrogen receptor-positive tumors, but we’ve never had anything worth anything that prevented estrogen receptor-negative tumors,” said Dr. Gabriel N. Hortobagyi, who directs the breast cancer research program at the University of Texas M.D. Anderson Cancer Center.

Other breast cancer experts agreed. “If in fact you have osteoporosis and you’re taking these drugs, it’s possible there is an added benefit,” said Dr. Eric P. Winer, a breast cancer specialist at the Dana-Farber Cancer Institute in Boston. “But at the moment, I don’t think these studies should be used as a reason to take a bisphosphonate to prevent breast cancer. As with all drugs, there are side effects and risks.” Visit the New York Times for the article.

Osteoarthritis increases aggregate healthcare expenditures by $186 billion annually

Osteoarthritis (OA), a highly prevalent disease, raised aggregate annual medical care expenditures in the U.S. by $185.5 billion according to researchers from Stony Brook University. Insurers footed $149.4 billion of the total medical spend and out-of-pocket (OOP) expenditures were $36.1 billion (2007 dollars). Results of the cost analysis study are published in the December issue of Arthritis & Rheumatism, a journal of the American College of Rheumatology.

The Centers for Disease Control and Prevention (CDC) estimate 27 million Americans suffer from OA with more women than men affected by the disease. Forecasts indicate that by the year 2030, 25% of the adult U.S. population, or nearly 67 million people, will have physician-diagnosed arthritis. OA is a major debilitating disease causing gradual loss of cartilage, primarily affecting the knees, hips, hands, feet, and spine.

John Rizzo, Ph.D., and colleagues used data from the 1996-2005 Medical Expenditure Panel Survey (MEPS) to determine the overall annual expected medical care expenditures for OA in the U.S. The sample included 84,647 women and 70,590 men aged 18 years and older who had health insurance. Expenditures for physician, hospital, and outpatient services, as well expenditures for drugs, diagnostic testing, and related medical services were included. Healthcare expenses were expressed in 2007 dollars using the Medical Care Component of the Consumer Price Index.

Researchers, using multivariable regression models, determined annual insurer healthcare expenditures were $4,833 for women and $4,036 for men. Out-of-pocket expenses were also higher in women than men, at $1,379 and $694, respectively. "Understanding the economic costs of OA is important for payors, providers, patients, and other stakeholders," said Rizzo. "Our study clearly reflects the significant impact of OA on U.S. healthcare spending."

Further analysis provided aggregate data based upon arthritis prevalence rates reported in a study by Helmick et al., and also published in Arthritis and Rheumatism (2008). The current study determined that OA increased insurer costs by $149.4 billion and OOP expenditures by 36.1 billion annually, for an aggregate increase of $185.5 billion per year. According to the authors women accounted for more of the expenditures ($118 billion) than men ($67.5 billion), reflecting the higher occurrence of the disease among women.

In recent years the prevalence of OA has risen rapidly and this trend is expected to continue. Increased awareness and better screening to identify patients with OA may help to delay disease progression and its debilitating effects which could mitigate costs to insurers and patients. "Our results suggest that patients with OA may benefit from greater efforts to promote exercise, proper medication use, and appropriate surgical treatments for the disease," concluded Dr. Rizzo. Visit Wiley InterScience for the article.

December 9, 2009 Download print version

Medicare expands list of covered preventive services to include HIV screening tests

GAO: FDA yet to make safety changes post-Vioxx

Stanley InnerSpace awarded sole vendor status for clinical storage under ASCEND Contract

Management Health Solutions, Inc. Joins GS1 Healthcare US

Type 2 diabetes gene predisposes children to obesity

Democrats temper public option, Reid suggests accord clears way to pass health bill

Study shows 'Name Game' hints at Alzheimer's

A silent epidemic of needle injuries

Medicare expands list of covered preventive services to include HIV screening tests

The Centers for Medicare & Medicaid Services (CMS) announced its final decision to cover Human Immunodeficiency Virus (HIV) infection screening for Medicare beneficiaries who are at increased risk for the infection, including women who are pregnant and Medicare beneficiaries of any age who voluntarily request the service. The decision is effective immediately.

Under the recently passed Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), CMS now has the flexibility of adding to Medicare’s list of covered preventive services, if certain requirements are met. Prior to this law, Medicare could only cover additional preventive screening tests when Congress authorized it to do so.

Under MIPPA, CMS can consider whether Medicare should cover preventive services that Congress has not already deemed as covered or non-covered by law. Among other requirements, the new services must have been “strongly recommended” or “recommended” by the U.S. Preventive Services Task Force. For instance, the Task Force graded HIV screening as “strongly recommended” for certain groups.

CMS uses the national coverage determination (NCD) process to make decisions on these types of preventive services. This process provides transparency about the evidence that CMS considers when making its decisions and allows opportunity for the public to comment on CMS’ proposals. More information about Medicare’s new HIV screening benefit is available here.

GAO: FDA yet to make safety changes post-Vioxx

The Food and Drug Administration still hasn't restructured its staff to better monitor drug safety, more than three years after experts recommended key changes in the wake of the Vioxx scandal. That's according to congressional investigators who found that the FDA has yet to follow through on changes suggested in 2006 to help the agency detect problems with drugs taken by millions of Americans. Those recommendations came after the embarrassing and dangerous episode with Vioxx, a blockbuster pain drug the FDA approved in 1999, only to pull from the market in 2004 after linking it to heart attack and stroke.

Agency officials have made some changes to drug oversight, according to a Government Accountability Office report, but the FDA continues to give the bulk of its decision-making power to scientists who approve new drugs, rather than those who monitor the side effects of drugs on the market.

"It is not yet clear if or when FDA's decision-making process will be substantially improved as a result of its efforts," according to the GAO report, a copy of which was obtained by The Associated Press.

Within the FDA bureaucracy, scientists tasked with reviewing new drug applications have traditionally had the most say over questions of safety, even after drugs are approved. But outside experts say leaving such key decisions to the scientists who first cleared the drugs could lead to inadequate safety actions, putting prescription drug users at risk.

The GAO, the Institute of Medicine and other experts have long recommended that the so-called Office of Surveillance and Epidemiology be given equal authority on drug safety with the agency's Office of New Drugs. But GAO investigators report that FDA leaders still have not transferred key responsibilities to surveillance officials.

The watchdog agency's report calls on the FDA to set a timetable for transferring new responsibilities to the surveillance office. Despite a formal memo between the offices designed to put them on equal footing, the new drug office still retains nearly all the power over regulatory decisions, according to the GAO report to be released Wednesday.

In its response to the report, the FDA said major decisions about drug safety are delegated to the new drugs division because that is "where staff with the broadest expertise and experience" on product safety issues reside.

The FDA said it intends to give the surveillance office more responsibilities, but only after its nearly 200 employees gain the experience and resources needed to take on those tasks. The Office of New Drugs has more than 900 employees.

According to the GAO, the number of surveillance staffers would have to double in coming years to accommodate the additional work being assigned to the unit. FDA officials on Tuesday declined to comment beyond the agency's response included in the report. (AP) Visit CBS News for the story.

Stanley InnerSpace awarded sole vendor status for clinical storage under ASCEND Contract

Stanley InnerSpace was awarded sole vendor status in the clinical storage product category under Premier's newly created ASCEND contract. The contract duration is from Aug. 15, 2009, through Aug. 14, 2012. Hospitals and health systems participating in Premier healthcare alliance's ASCEND (Accelerated Supply Chain Endeavor) program have reduced their supply expenses in recently launched categories by up to 24 percent since May 2009. More than 145 participants that represent approximately $3 billion in supply chain purchasing volume and close to 28,000 hospital beds are collaborating to share best practices in supply chain efficiency as part of the program.

InnerSpace specializes in healthcare storage products that deliver optimal storage solutions throughout every room in the hospital, saving space, time, and money. Visit www.StanleyInnerSpace.com for more information.

Management Health Solutions, Inc. Joins GS1 Healthcare US

Management Health Solutions, Inc. (MHS) has elected to join GS1 Healthcare US as a Healthcare Solution Provider, it was announced Tuesday by MHS’ President and CEO, Bill Zierolf. Established in 2005, GS1 Healthcare US is a voluntary, global and industry-led healthcare user group that directs the healthcare sector in the development and implementation of global standards. GS1 Healthcare US brings together experts in healthcare to enhance patient safety and increase supply chain efficiencies through the adoption and wide-scale implementation of GS1 global standards.

By choosing to enroll with GS1 Healthcare US, MHS joins a full range of healthcare stakeholders including healthcare providers, pharmacies, industry associations, group purchasing organizations, manufacturers, distributors, and technology solution providers. The group develops a variety of tools and resources for use by the healthcare industry, including standards implementation guidelines, standards-based solutions for healthcare’s specific needs, case studies of successful applications, as well as training and education.

As a provider of solutions for reducing the cost and streamlining the management of clinical inventory supplies, MHS helps its clients build a supply chain that is flexible, sustainable and technologically robust. The company’s Optimal Inventory Control solution (OPTIC) draws on extensive experience in supply chain management and detailed knowledge of the latest technologies, leading supply chain practices and implementation methodologies. MHS’ state-of-the-art tracking software and programs are in use among leading hospitals throughout the country, helping them to reduce costs and waste, as well as increase profits and efficiency. Joining GS1 Healthcare US is expected to further assist MHS on its mission to help hospitals better manage the flow of their clinical inventory supplies. Visit www.mhsinc.com for more information.

Type 2 diabetes gene predisposes children to obesity

Pediatric researchers have found that a gene already implicated in the development of type 2 diabetes in adults also raises the risk of being overweight during childhood. The finding sheds light on the genetic origins of diabetes and may present an avenue for developing drugs to counteract the disease, which has been on the upswing in childhood and adolescence.

Researchers from The Children's Hospital of Philadelphia and the University of Pennsylvania School of Medicine published the study Nov. 23 in the online version of the journal Diabetes.

"It has been a bit of a mystery to scientists how or even if these adult diabetes genes function during childhood," said study leader Struan F.A. Grant, Ph.D., a researcher and associate director of the Center for Applied Genomics of The Children's Hospital of Philadelphia. "This finding suggests that there may be genetic activity during childhood that lays the foundation for the later development of type 2 diabetes."

Type 2 diabetes occurs either when the pancreas produces too little insulin, or when the body cannot efficiently use the insulin that is produced because the cells have become resistant. Formerly called adult-onset diabetes and still most common in adults, type 2 diabetes has been increasing sharply among children and teenagers.

Grant and study co-leader Hakon Hakonarson, M.D., Ph.D., director of the Center for Applied Genomics at Children's Hospital, investigated 20 gene variants, known as single nucleotide polymorphisms (SNPs), previously reported to be associated with type 2 diabetes. The researchers drew on a cohort of nearly 7,200 Caucasian children, aged 2 to 18 years, in an ongoing genome-wide association study of childhood obesity at Children's Hospital. Dividing the cohort randomly in half allowed the team to follow their discovery study with a replication study.

Researchers continue to unravel the complicated role of different diabetes-related genes in influencing body weight toward both lower and higher ends of the scale. The risk of developing type 2 diabetes in adulthood is often influenced by factors in the first year of life, including lower birth weight, as well as by higher body mass index (BMI) during childhood. Obesity is a well-known risk factor for type 2 diabetes.

A previous study earlier this year by the same study team found that another type 2 diabetes gene, CDKAL1, affects fetal growth and increases the likelihood that a baby will be underweight at birth.

The current study found that the gene HHEX-IDE does not affect birth weight, but makes it more likely that a child will become obese during childhood. The gene does not appear to predispose to obesity in adults, although by contributing to childhood obesity, it may set the stage for type 2 diabetes in adulthood.

Grant cautioned that HHEX-IDE accounts for only a small proportion of the genetic contribution to the risk of type 2 diabetes, so many other gene variants remain to be discovered. However, he adds, HHEX-IDE may represent an important underpinning of the disease. "Previously we thought that this gene affects insulin production during adulthood, but we now see that it may play an early role in influencing insulin resistance through its impact on body size during childhood," said Grant. "One implication is that if we can develop medicines to target specific biological pathways in childhood, we may be able to prevent diabetes from developing later in life." For more information, visit www.chop.edu.

Democrats temper public option, Reid suggests accord clears way to pass health bill

Senate negotiators reached a tentative deal last night to drop a full-fledged government-run insurance plan from the healthcare overhaul bill and replace it with a patchwork of new ideas to help people get coverage, according to a Democratic Senate staffer. The deal might remove one of the biggest stumbling blocks to passage.

Senate majority leader Harry Reid announced that a team of 10 liberal and moderate Democrats had reached “broad agreement’’ on a compromise that would allow Senate Democrats to move the bill forward. Reid did not provide details, saying he wants congressional budget analysts to determine its cost. But he implied it could garner the 60 votes required to clear the way for passage.

The agreement would replace the government-run insurance plan in the bill, which several crucial moderate Democrats had steadfastly opposed, with new provisions designed to provide a wider selection of insurance options, according to the staffer.

One new provision would require the US Office of Personnel Management, which oversees the Federal Employees Health Benefits Program, to negotiate with private insurers to offer national nonprofit plans in each state.

The plan would also let middle-aged people who cannot get affordable coverage through work buy into Medicare, the staffer said. Liberal senators said yesterday that they had pushed the Medicare buy-in as one way to achieve some of the goals the government run plan would have.

The House approved a healthcare bill with a government run health plan to compete with private insurers; the two versions would have to be reconciled by House and Senate negotiators. In other action on the bill yesterday, the Senate defeated an amendment that would prohibit the sale of insurance plans that cover elective abortions to women who receive premium subsidies, much like an amendment the House approved. One of its cosponsors, Senator Ben Nelson, Democrat of Nebraska, has said he would not support a bill without that language.

The Senate bill requires insurance plans to separate federal subsidies from individuals’ premiums and use only private money to pay for abortion procedures. Such funding separation is also used by states to cover abortion procedures for Medicaid enrollees, as well as by religious organizations that are required to keep US funding for social programs separate from religious activities. It is not clear how long it would take for the nonpartisan congressional budget office to analyze the bill, but aides have previously said it could take a week.

Earlier yesterday, Senator Jay Rockefeller, Democrat of West Virginia and one of the 10 senators negotiating on the public option, said he had proposed expanding Medicaid, the government insurance program for the poor. It would be, he said, another way to achieve some of the goals of a true public option. But he said he was having difficulty persuading others.

Several senators said they are concerned that opening Medicaid to too many people would place a heavy burden on states, which share some of the cost. Visit the Boston Globe for the article.

Study shows 'Name Game' hints at Alzheimer's

Some researchers call it the "Name Game." The way our brain responds to hearing the names of celebrities such as Britney Spears or Angelina Jolie may end up telling us whether we're at risk for developing Alzheimer's disease, say experts such as Michael Seidenberg.

Seidenberg, a psychology professor at the Rosalind Franklin University of Medicine and Science in North Chicago, has spent several years working on research that one day could serve as an early diagnostic tool for Alzheimer's.

Currently there is none. Nor is there a cure. By the time a patient complains about being confused or forgetting simple details such as knowing what day it is, the disease usually has been present for more than a decade, Seidenberg said . "If we were able to slow down Alzheimer's by five years ... we would cut in half" the number of people with the disease, he said.

Seidenberg collaborated with three other doctors in the research funded by the National Institutes of Health. They selected about a 100 seniors from Milwaukee ranging in age from 65 to 85 who showed no symptoms of memory loss. The second round of testing was conducted more than a year ago at the Medical College of Wisconsin, where researchers used a type of magnetic resonance imaging that allows them to see activity in parts of the brain associated with memory.

Volunteers were divided into groups that included those with no memory problems or risk factors for Alzheimer's and those who either had a family history associated with the disease or had tested positive for the gene that could increase the risk. While lying inside the scanner, participants watched the names flash in front of them. Using a button, they responded either yes or no to indicate whether they recognized them. The names included Albert Einstein, George Clooney and Marilyn Monroe as well as lesser-known individuals.

For volunteers considered at risk, the results showed a difference in how their brains worked when retrieving the information, Seidenberg said. "Somehow their brain is working in a different way. It's showing more activity," he said. "We've come to hypothesize that in order to do the task, the brain is working harder, and other regions of the brain have to come into play to compensate."

Seidenberg, who will repeat the test next year, hopes that by tracking the participants, researchers eventually can map a relationship that could serve as an early marker to indicate the disease's presence.

According to the Alzheimer's Association based in Chicago, as many as 5.3 million people in the U.S. have the disease, the sixth leading cause of death. Healthcare costs are three times higher for people with Alzheimer's than for others 65 and older. The number of Alzheimer's patients is expected to nearly double every 20 years, experts say. Visit the Chicago Tribune for the article.

A silent epidemic of needle injuries

Surgical students are frequently stuck by needles, but many students don’t bother reporting the injuries, a new study found. Researchers from Johns Hopkins University surveyed 699 recent medical school graduates who had trained to become surgeons at 17 medical centers in the United States. The survey found that 59 percent had been stuck by a needle at some point during medical school, according to the study, in the December issue of Academic Medicine.

Inadvertent needle sticks are a concern to both doctor and patient. A healthcare worker accidentally pierced by a needle is at risk for contracting hepatitis C or H.I.V. or developing an infection. And if the healthcare worker already has a blood borne illness, a needle stick injury could expose patients to a droplet of infected blood.

It is estimated that as many as 800,000 needle sticks and other injuries that pierce the skin are reported by healthcare workers each year, but doctors say a larger number of cases are not reported. Less is known about needle injury rates among medical students, who, because of a lack of experience and skill, are believed to be at particularly high risk. In the Johns Hopkins survey, about half the victims of a needle stick didn’t report the injury to hospital officials. The most common reason cited for not reporting a needle stick was the amount of time and paperwork required to make a report.

Dr. Martin A. Makary, associate professor of surgery and health policy at Johns Hopkins, said hospitals and medical schools put students at high risk of needle stick injuries while at the same time creating a culture that made it difficult to report the incident or pursue early treatments that could prevent them from developing H.I.V. or hepatitis.

Injections, intravenous lines, biopsies and the sewing up of incisions are mundane tasks often relegated to medical students, who typically have less experience and skill at handling needles. But when students do get pricked by a needle, they are often being graded on their overall performance, giving them less incentive to report the injury.

“Not only are we putting them at the front lines, but when they do sustain a needle stick we have a culture that does not encourage them to speak up and get the care they need,” Dr. Makary said. “They’re being evaluated for a grade which determines what job they get when they finish. It’s easy to say that if you get a needle stick injury, take care of it. It’s a different thing when you’ve got this system which puts undue pressure on them not to report.”

Dr. Makary said hospitals needed to simplify the process by which healthcare workers reported such injuries and received treatment. In many hospitals today, victims of needle stick accidents are required to submit extensive paperwork and seek signatures from a supervisor before being treated. But these injuries often happen during a busy shift or in the evening, making it difficult or impossible to file a report.

Some hospitals, including Johns Hopkins, have pioneered “sharpless surgery” practices that virtually eliminate the need for handling sharp objects during surgical procedures. Surgeons use lasers for cutting, glue for closing skin, minimally invasive ports for laparoscopic procedures and blunt tip needles that lower the risk of an accidental skin prick. “We have these new techniques and devices, but very few people use them,” Dr. Makary said. Visit the New York Times for the article.

December 8, 2009 Download print version

Millions in U.S. drink dirty water, records show

Grow your own body parts

Groups try simple steps to avoid hospital rebound

CT Brain Perfusion scans safety investigation - Additional cases of excess radiation exposure discovered

McKesson unveils new pharmacy automation system that leverages drug manufacturer packaging

Versus Technology to demonstrate hand hygiene compliance at IHI National Forum

Hospital noise initiative reduces average peak decibel levels by 20 percent

Millions in U.S. drink dirty water, records show

More than 20 percent of the nation’s water treatment systems have violated key provisions of the Safe Drinking Water Act over the last five years, according to a New York Times analysis of federal data. That law requires communities to deliver safe tap water to local residents. But since 2004, the water provided to more than 49 million people has contained illegal concentrations of chemicals like arsenic or radioactive substances like uranium, as well as dangerous bacteria often found in sewage.

Regulators were informed of each of those violations as they occurred. But regulatory records show that fewer than 6 percent of the water systems that broke the law were ever fined or punished by state or federal officials, including those at the Environmental Protection Agency, which has ultimate responsibility for enforcing standards.

Studies indicate that drinking water contaminants are linked to millions of instances of illness within the United States each year. In some instances, drinking water violations were one-time events, and probably posed little risk. But for hundreds of other systems, illegal contamination persisted for years, records show.

On Tuesday, the Senate Environment and Public Works committee will question a high-ranking E.P.A. official about the agency’s enforcement of drinking-water safety laws. The E.P.A. is expected to announce a new policy for how it polices the nation’s 54,700 water systems.

The New York Times has compiled and analyzed millions of records from water systems and regulators around the nation, as part of a series of articles about worsening pollution in American waters, and regulators’ response. An analysis of E.P.A. data shows that Safe Drinking Water Act violations have occurred in parts of every state.

The problem, say current and former government officials, is that enforcing the Safe Drinking Water Act has not been a federal priority. A half-dozen current and former E.P.A. officials said in interviews that they tried to prod the agency to enforce the drinking-water law, but found little support.

The majority of drinking water violations since 2004 have occurred at water systems serving fewer than 20,000 residents, where resources and managerial expertise are often in short supply.

It is unclear precisely how many American illnesses are linked to contaminated drinking water. Many of the most dangerous contaminants regulated by the Safe Drinking Water Act have been tied to diseases like cancer that can take years to develop. But scientific research indicates that as many as 19 million Americans may become ill each year due to just the parasites, viruses and bacteria in drinking water. Certain types of cancer — such as breast and prostate cancer — have risen over the past 30 years, and research indicates they are likely tied to pollutants like those found in drinking water.

The violations counted by the Times analysis include only situations where residents were exposed to dangerous contaminants, and exclude violations that involved paperwork or other minor problems.

In response to inquiries submitted by Senator Barbara Boxer, Democrat of California, the E.P.A. has reported that more than three million Americans have been exposed since 2005 to drinking water with illegal concentrations of arsenic and radioactive elements, both of which have been linked to cancer at small doses. In some areas, the amount of radium detected in drinking water was 2,000 percent higher than the legal limit, according to E.P.A. data.

Those figures are particularly worrisome, say researchers, because the Safe Drinking Water Act’s limits on arsenic are so weak to begin with. A system could deliver tap water that puts residents at a 1-in-600 risk of developing bladder cancer from arsenic, and still comply with the law. Visit the New York Times for the article.

Grow your own body parts

Amid all the noise of healthcare reform, a real revolution is happening. Medical advancements that sound like science fiction; growing your own organs, being cared for by robotic nurses, popping anti-aging pills, are either at or near reality already. No matter what is decided about how we deliver and pay for healthcare in the future, the manner in which bodies and diseases are treated is about to change dramatically.

At least that's the opinion of the innovators in medicine and technology - scientists, doctors, engineers and philosophers, who gathered last month at a TEDMED, (that's Technology, Entertainment, Design Medicine) conference in San Diego to unveil solutions to some stubborn healthcare problems. These innovations are likely to be embraced not only because they could save money, but also because a large, vocal group is going to want them - the baby boomers.

Don't wait for an organ donation -- grow your own. Here's how. Cells from an organ to be replaced are put into nutrients, where they multiply and create a "soup," explained Dr. Anthony Atala, director of the Wake Forest Institute for Regenerative Medicine in North Carolina. The "soup" of cells is "painted" on a form or scaffolding in the shape of the organ, say a bladder, and placed into an incubator. A new bladder grows in about six weeks. Ears, arteries, heart valves, fingers and toes are being grown in this manner. Atala's group is experimenting with the ink-jet technology of a printer/scanner that will be able to "print out" a copy of skin, or even a heart, for replacement. This could spell the end of transplant organ shortages and, because they use the patient's own tissue, make organ rejection a thing of the past. Lab-grown bladders have already been transplanted into patients in the United States, a precursor to FDA approval, said a Wake Forest Institute spokeswoman.

Look for more medical home-monitoring products and services to hit the market soon. 70 million aging boomers could mean bulging nursing homes and depleted resources. It doesn't have to be that way, said Eric Dishman, director of Health Innovation at Intel's Digital Health Group. Put smart phone technology to work in medicine and people stay independent longer, he said. Intel's Health Guide, a laptop-like device already in use in some parts of the country, monitors patients' health from home.

With a touch screen and side ports for attachments, the device uses a friendly female voice to prompt users to measure blood pressure, blood sugar, lung function and more. Results go directly to a healthcare provider. If a follow-up call is necessary, a camera allows the patient and care provider to see each other as they talk. Closer supervision means better results for the patient, who can avoid trips to the doctor, hospitalizations and nursing home stays.

How about an in-home helper who never gets tired? The iRobot company, the one that put robotic vacuum cleaners into homes, is working on creating Grandma's little helper -- a robot nurse. Just getting underway, the idea is a helper strong enough to carry Grandma up a flight of stairs, but gentle enough to hand her the proper medicine at the right time. If Grandma doesn't answer the phone, the robot could roam the house, looking for her. Robotic help in the home could add years to independent living. Development of the robot nurse might come in stages, with a robotic arm or other devices debuting before the full-fledged robot.

It may well be that the boomer generation will be the last generation with a "natural" life span. It's the children and grandchildren of boomers who are likely to reap the most benefits. Visit the Chicago Tribune for the article.

Groups try simple steps to avoid hospital rebound

WASHINGTON (AP) -- Talk about unnecessary misery: One in five Medicare patients winds up back in the hospital within a month - even worse, one in four patients with heart failure. A major push is under way around the country to cut rehospitalizations, in part by arming patients with simple steps to keep their recovery on track - like getting past harried receptionists for quicker follow-up doctor visits, and reducing medication confusion.

Less than a year into a Medicare-sponsored ''Care Transitions'' project in 14 states, participating hospitals already are seeing readmissions start to inch down, says Dr. Barry Straube, chief medical officer of the Centers for Medicare & Medicaid Services. One of those projects, in Baton Rouge, LA, sends health coaches to five area hospitals to guide high-risk patients through discharge and check how they're faring through that critical first month. Of the first 145 patients coached so far, only seven had to be rehospitalized.

The key: Support, so that weakened seniors don't backslide merely because they couldn't get a timely doctor's appointment or had no ride to the drugstore to pick up a prescription, says coach DeeAnn Broussard with Louisiana Health Care Review, a quality-improvement company leading the project.

Rehospitalizations ought to be handled with the same urgency as an epidemic, says Dr. Harlan Krumholz of Yale University. He helped the American College of Cardiology begin a ''Hospital to Home'' program this fall, signing up hundreds of hospitals to share solutions with the goal of cutting heart patients' readmissions by 20 percent within three years.

The top risks: Medication problems. Patients on a dozen or more drugs forget which ones they're supposed to toss when given new ones in the hospital, or can't afford the new ones, or have no way to pick them up; Not getting a follow-up doctor's visit within a week of discharge. Waiting longer is proven to increase rehospitalization. Yet even if patients have a primary care doctor, getting a rapid appointment can be tough; Not realizing early signs of trouble and knowing what to do about them.

Rehospitalizations aren't just bad for patients, but for taxpayers, too. They're costing Medicare $17 billion a year, a recent study estimated. Hospitals make more money when patients have to return. Visit NJ.com for the article.

Senator Grassley seeks financial details from medical groups

Republican senator, Charles E. Grassley, has sent letters to the American Medical Association, the American Cancer Society and 31 other disease and medical advocacy organizations asking them to provide details about the amount of money that they and their directors receive from drug and device makers. Such funding amounts are often considered proprietary by the organizations and their directors, but critics contend that the industry’s sway over such groups leads them to lobby on industry’s behalf.

Mike Lynch, a spokesman for the A.M.A., said the organization had received the senator’s letter and would respond. He said industry funding comprised less than 2 percent of the organization’s budget. Steve Weiss, a spokesman for the American Cancer Society, sent an e-mail stating that the society “holds itself to the highest standards of transparency and public accountability, and we look forward to working with Senator Grassley to provide the information he requested." Kate Meyer, a spokeswoman for the Alzheimer’s Association, which also received a letter from the senator, said the organization “was going to answer all of his questions,” but she would not immediately say what share of the organization’s funding comes from drug or device makers.

The letter from the Iowa Republican is part of his long-running investigation into the pervasive influence of drug and device makers on the practice of medicine. Grassley has also long been interested in how charities get and spend their tax-deductible contributions.

Earlier this year, Grassley sent a similar letter to the National Alliance on Mental Illness. In response, the group told the senator that more than two-thirds of its donations come from the pharmaceutical industry. In response to the disclosure, Dr. H. Richard Lamb, a board member for the alliance, resigned. In an interview, Dr. Lamb said that NAMI’s dependence on the drug industry made some actions impossible. For instance, Dr. Lamb said that NAMI should consider warning against the use of some mental health drugs with life-threatening side effects. But the organization could not consider such a move since doing so could threaten much of its funding, Dr. Lamb said.

Michael J. Fitzpatrick, the organization’s executive director, promised that the industry’s share of the group’s fundraising would drop significantly next year.

Grassley’s request that organizations provide details about the outside income of directors may cause some consternation. While a few large patient advocacy groups have provided general guidance about their reliance on industry, almost none has given such details about their leaders. Visit the Gadsden Times for the article.

CT Brain Perfusion scans safety investigation - Additional cases of excess radiation exposure discovered

The FDA, working with state and local health authorities, has identified at least 50 additional patients who were exposed to excess radiation of up to eight times the expected level during their CT perfusion scans. These cases so far involve more than one manufacturer of CT scanners. Some of these patients reported hair loss or skin redness following their scans. High doses of radiation can cause cataracts and increase the risk of some forms of cancer.

On the basis of its investigation to date, the FDA is providing interim recommendations for imaging facilities, radiologists, and radiologic technologists to help prevent additional cases of excess exposure. These recommendations include: Facilities assess whether patients who underwent CT perfusion scans received excess radiation; Facilities review their radiation dosing protocols for all CT perfusion studies to ensure that the correct dosing is planned for each study; Facilities implement quality control procedures to ensure that dosing protocols are followed every time and the planned amount of radiation is administered; Radiologic technologists check the CT scanner display panel before performing a study to make sure the amount of radiation to be delivered is at the appropriate level for the individual patient.

If more than one study is performed on a patient during one imaging session, practitioners should adjust the dose of radiation so it is appropriate for each study. Read the MedWatch safety summary.

McKesson unveils new pharmacy automation system that leverages drug manufacturer packaging

McKesson introduced the PROmanager-Rx system that enables hospitals for the first time to fully automate the dispensing of tablets, capsules, and other oral solid medications that come pre-packaged from drug manufacturers in unit-dose, barcoded form. By retaining the original manufacturer packaging—widely recognized as the safest type—the new PROmanager-Rx system helps hospital pharmacies increase accuracy. In addition, pharmacists are freed from packaging and dispensing activities so they can play more integral roles on the clinical care team.

PROmanager-Rx was unveiled at the 44th Midyear Clinical Meeting and Exhibition of the American Society of Health-System Pharmacists (ASHP) in Las Vegas. The system currently is installed at Riverside Methodist Hospital in Columbus, Ohio, part of the OhioHealth system.

PROmanager-Rx is ideal for patient-centric filing, and directly supports barcode medication administration operations. Barcode driven robotics scan every dose for the greatest possible safety and accuracy. It features order processing and inventory management software to increase inventory turns, manage expired and returned medications, and streamline wholesale ordering. It accommodates more than 90 percent of the oral solid medications that are in use and available from U.S. drug manufacturers today, including a wide variety of shapes and sizes.

Unit-dose packages produced by SKY Packaging, a McKesson company, are certified for use in PROmanager-Rx. The SKY product line includes the most widely prescribed dosages and strengths in generic oral solid medications used by acute care, long-term care and institutional pharmacies.

Through Fulfill-RxSM software, PROmanager-Rx interfaces with McKesson’s pharmaceutical distribution system. Fulfill-Rx helps reduce drug inventory costs and associated labor with a two-way electronic data interchange between McKesson’s pharmaceutical distribution centers and hospital automation solutions.

McKesson will also debut the CytoCare Robot. Through automation, CytoCare improves the safety, accuracy, and cost-effectiveness of oncology IV admixtures in hospital pharmacies. Visit McKesson for more information.

Versus Technology to demonstrate hand hygiene compliance at IHI National Forum

Versus Technology, Inc. will be demonstrating its real-time Hand Hygiene Compliance solution at the IHI Forum in Orlando this week. This solution allows hospitals to automatically capture hand-washing events and relate them to patient care events. A tool for safer patient care, this system helps hospitals understand individual and unit compliance to hospital hand-washing policies. Versus is currently working with accreditation organizations to document failure points and how improved hand-washing processes impact patient care.

For after-the-fact discovery, the Hand Hygiene Report helps Infection Control and Patient Safety Managers direct additional education and training to areas where compliance rates are not in-line with patient care episodes. Advanced users will actually prevent non-compliant patient care events by alerting caregivers to their compliance state before attempting patient care.

The Versus Hand Hygiene Compliance solution utilizes soap/gel dispensers equipped with sensors that, when activated, “read” the participant’s active ID badge, noting when and where the event is taking place. Participants and on-lookers will experience the ease of capturing hand-washing events

For nearly 20 years, has been dedicated to making healthcare safer and more efficient utilizing its Real-time Locating System (RTLS) to provide caregivers and administrators with the situational awareness that clinical environments lack. To see Versus’ Hand Hygiene Compliance solution in action, visit IHI booth #1015 or visit www.versustech.com.

Hospital noise initiative reduces average peak decibel levels by 20 percent

Patients often complain that getting a good night's sleep or a bit of peace and quiet in hospital can be difficult. But a study published in the December issue of the Journal of Clinical Nursing has shown that adopting some simple measures can reduce peak noise levels on hospital wards by just under 20 per cent.

UK researchers from Newcastle upon Tyne audited average decibel levels before and after a noise reduction intervention programme on three wards with a total of 92 beds - a surgical ward, medical ward and orthopaedic ward.

"Hospitals can be very noisy places" explains lead author Annette Richardson, a nurse consultant in critical care at Newcastle upon Tyne Hospitals NHS Foundation Trust. "Dropping a stainless steel bowl creates 108 decibels, which is more than the 100 decibels from a nearby car horn or chainsaw. Even opening a packet of rubber gloves creates 86 decibels, which is louder than heavy traffic at 80 decibels. Our study found that peak decibel levels at the start of the study were 96.48 decibels over 24 hours and at the end of the study they had gone down to 77.52 decibels, an overall reduction of just under a fifth."

After the initial noise levels were monitored, key parts of the ward environment were reviewed against clinical guidelines put together by a working group led by a nurse consultant and involving ward sisters, staff nurses and modern matrons from the different specialist areas. These included the door entry system, the position, number and volume of telephones, the patientline system, the nurse call system and the physical make-up of the ward, including floors, drawers and rubbish bins.

"A number of practical steps were taken to reduce noise" says Richardson who won a prestigious Nursing Times award for her clinical work in promoting sleep for critical care patients. Telephones were turned down at night or switched to vibrate and carried by a member of staff, staff wore soft soled shoes and changes were made to the night call systems. We also displayed posters at nursing stations highlighting the noise created by certain activities, the impact on patients and sleep promotion guidelines."

UK legislation expects employers to carry out a risk assessment if employees are exposed to peak levels higher than 80 decibels, but no patient focused standards are set for the National Health Service. However, the United States Environmental Protection Agency recommends levels of 45 decibels for day-time noise in hospital settings and 35 decibels for night-time noise. Meanwhile, the World Health Organization has recommended that noise levels should not exceed 35 decibels in rooms where patients are treated or observed.

"The main significant finding of our study was the reduction in average peak noise levels on all wards" says Richardson. "Previous studies have shown how patients can become accustomed to low-level white noise, but they can be more aware of high pitched, irregular sounds.”

"Sleep deprivation is detrimental to patients with acute illness, so any developments to improve patients' sleep are important.” Visit Wiley Interscience for the abstract.

December 7, 2009 Download print version

Transplant infectious disease experts provide pandemic guidance

PBS home video explores a medical mystery from the past that could potentionally save lives today with new DVD Killer Flu

Missing gene linked to childhood obesity

STERIS statement in response to December 3, 2009 FDA Notice and Developments on SYSTEM 1 warning letter

Is money tainting the plasma supply?

Musical surgeon examines the OR soundtrack

Nurse Assist launches global distribution for its Saline Wound Flush

Transplant infectious disease experts provide pandemic guidance

Surgeons and other healthcare professionals specializing in solid organ transplants have been issued with expert advice to guide them through the complex clinical issues posed by the global H1N1 (swine flu) pandemic. The paper, published online by the American Journal of Transplantation, also urges them to stay alert to the significant concerns that swine flu could combine with seasonal flu, and possibly even bird flu (H5N1), to develop into a strain with unpredictable virulence.

"The current virus pandemic can cause severe disease in transplant patients and could be transmitted from donors" explains assistant professor Dr. Deepali Kumar, an expert in transplant-related infectious diseases from the University of Alberta, Canada. "This has major implications for donor selection and transplant management and care."

Dr. Kumar has teamed up with infectious disease experts from across Canada and the USA to discuss the solid organ transplant guidance issued as part of the wider H1N1 guidelines produced by the American Society of Transplantation (AST) and The Transplantation Society (TTS), which are updated online as new information emerges.

The article has been produced on behalf of both societies and carries the additional endorsement of the Canadian Society of Transplantation. It includes discussions about clinical presentation, diagnosis, therapy and prevention, specifically addressing areas such as chemoprophylaxis, immunization and donor-derived infection.

The International Society for Heart and Lung Transplantation has already developed guidelines for heart and lung transplant recipients in the pandemic setting, raising concerns about transmission from donors to recipients. However, autopsy studies suggest that other organs, such as the brain, kidney, pancreas, spleen, liver and heart, can also become infected. This pandemic has important clinical implications for all stages of the solid organ transplant process.

Key points raised by the discussion document include: All patients with influenza-like illnesses, and milder symptoms such as a persistent runny nose, should be tested for the virus and empiric antiviral therapy considered; Some experts recommend continuing antiviral therapy until viral replication has ceased and clinicians should base their therapy decisions on current advice from the Centers for Disease Control (CDC) and individual patient assessments; Some experts also recommend that the oseltamivir (Tamiflu) dose may be doubled in critically ill patients and a significant reduction of immunosuppression is recommended in patients with significant disease; Transplant patients and donors should receive at least one dose of H1N1 vaccine; People who receive a Live Attenuated Influenza Vaccine may shed the virus for up to 21 days after immunization.

There is currently no data on the duration of antiviral therapy that donors with H1N1 must undergo before organs can be safely used. If the donor has not completed a course of treatment, the current recommendation is to give the recipient five to ten days of antiviral therapy, at therapeutic not prophylaxis doses. The paper is available free at Wiley InterScience..

PBS home video explores a medical mystery from the past that could potentionally save lives today with new DVD Killer Flu

In the midst of today’s H1N1 virus, swine flu, and bird flu, PBS Home Video looks back at the mysterious 1918 flu pandemic that swept through the country and killed more people than WWI to better understand the causes for modern day flu viruses. PBS Home Video follows medical detectives in its riveting new title, Killer Flu, as they work tirelessly to uncover the secrets of the 1918 pandemic in order to save lives today. Set for release on December 8, Killer Flu explores the most important health issues as they relate to modern times.

In 1918, at the end of the World War I, a flu pandemic ripped through the world with such speed and virulence that by the end of the following year an estimated 40 million people died, four times more than those claimed by the war. Where did this particular flu strain come from and what made it so deadly? "Killer Flu" will show how 85 years later, virologists and epidemiologists are still hunting down the answers to those two critical questions. To order a copy of Killer Flu ($24.99), please call (800) PLAY-PBS or visit www.shopPBS.org.

Missing gene linked to childhood obesity

Some children get severely obese because they lack particular chunks of DNA, which kicks their hunger into overdrive, researchers report. The British scientists checked the DNA of 300 children who became very fat, on the order of 220 pounds by age 10. The researchers looked for deletions or extra copies of DNA segments. They found evidence that several rare deletions may promote obesity, including one kind found in less than 1 percent of about 1,200 severely obese children.

That deletion, on chromosome 16, causes trouble because it removes a gene that the brain needs to respond to the appetite-controlling hormone leptin, said Sadaf Farooqi of Cambridge University.

In her study, children with a chromosome-16 DNA deletion "have a very strong drive to eat," said Farooqi, who co-led the study. "They're very, very hungry; they always want to eat." The work, reported on Sunday by the journal Nature, has already produced a real-world payoff. Farooqi said four children with chromosome-16 deletion drew the attention of British child-welfare authorities, who blamed the parents' overfeeding.

"We were able to intervene" and get the parents of two children off the hook, and the other two cases are under discussion, she said. Visit the Washington Post for the article.

STERIS statement in response to December 3, 2009 FDA Notice and Developments on SYSTEM 1 warning letter

STERIS Corporation was notified on December 3, 2009 that the U.S. Food and Drug Administration (FDA) had issued a notice to healthcare facility administrators regarding the regulatory status of the STERIS SYSTEM 1 Sterile Processing System, as well as actions healthcare facilities should take if they use this device.

“We disagree with the FDA’s recent notice and are working to engage in further dialogue with the Agency about this matter. Since its introduction in 1988, we estimate that the SYSTEM 1 Sterile Processing System has safely and effectively sterilized more than 300 million devices when used as directed,” said STERIS President and Chief Executive Officer, Walt Rosebrough. “We understand our customers’ concerns and apologize for the inconvenience the FDA notice will cause to their sterilization and decontamination processes.”

The FDA has stated that healthcare administrators should transition to acceptable alternatives to meet their sterilization and decontamination requirements. If they do not have an acceptable alternative, FDA has stated that customers may continue to use SYSTEM 1 while they assess their sterilization requirements. FDA has also stated it is not aware of any confirmed cases of infection directly attributable to inadequate reprocessing by SYSTEM 1.

When considering the availability of acceptable alternatives to meet sterilization and disinfection needs, STERIS suggests that healthcare administrators include these considerations: Consult the device manufacturer’s written instructions for reprocessing procedures; Be aware that not all devices can be reprocessed using the same sterilization technology; Note that the healthcare facility’s validation/verification requirements will need to be reviewed.

STERIS has established a dedicated hotline for more information - 440-392-7223 - if SYSTEM 1 users have immediate questions. STERIS will also continue to update Customers via the STERIS website as more information becomes available.

As a result of the December 3, 2009 FDA notice, the company is considering its available options and expects to have further discussions with the FDA. There is no assurance, however, that the FDA will not pursue an administrative or enforcement action or not seek other remedies, including the demand that STERIS stop further sales of the SYSTEM 1 device and any related services, accessories and sterilant. These actions by the FDA could possibly result in administrative orders or judgments requiring re-labeling or restriction on the manufacturing, sale, or distribution of products, or could require us to take other actions, including recalls, to pay significant monetary fines or civil damages, or to be subject to other governmental or third party claims or remedies, which could materially affect our business, performance, value, financial condition, and results of operations.

Additional information regarding the FDA investigation of SYSTEM 1 is described in our Form 10-K for the fiscal year ended March 31, 2009 and the Form 10-Q for the quarter ended September 30, 2009. Visit STERIS for more information.

Is money tainting the plasma supply?

Hundreds, probably thousands, of Mexicans come to the United States to trade their plasma for dollars. Eagle Pass, a town of 27,000 that bills itself as the place “where yee-hah meets olé,” has two such plasma collection centers. There are about 15 others in border cities from Brownsville, TX., to Yuma, AZ. The centers are run by pharmaceutical companies that transform the plasma into life-saving but expensive medicines for diseases like immune deficiencies and hemophilia.

Some border centers are new while others have been around for many years. They account for only a small percentage of the plasma collected by the industry, with the rest coming from collection centers throughout the United States. But they have stirred debate in recent years because they illustrate the workings of the $12 billion plasma products business, a fast-growing industry that has depended on the blood of people hard up for cash. Based on typical industry yields and prevailing prices, it appears that a single plasma donation, for which a donor might be paid $30, results in pharmaceutical products worth at least $300.

Away from the border as well, many plasma collection centers have historically been located in areas of extreme poverty, some with high drug abuse. That troubles some people, who say it might contaminate the plasma supply or the health of people who sell their plasma.

“Why in the United States do we have to depend on people who are down and out to donate?” says Dr. Roger Kobayashi, an immunologist in Omaha who uses plasma products to treat many patients. “You are taking advantage of economically disadvantaged individuals, and I don’t think you are that worried about their health.” Dr. Kobayashi, who also teaches at the University of California, Los Angeles, says the collections on the Mexican border skirt the policy aimed at keeping plasma products safe from pathogens by prohibiting imports of plasma. “If you can’t import the plasma,” he says, “why not import the donor?”

But the plasma companies and federal regulators say the practice is legal, ethical and safe. There have been no known cases of an infectious disease being transmitted through plasma products for more than a decade. And since the body quickly renews its plasma, the process is considered safe for donors if properly monitored.

The industry says the same precautions are taken at the border as everywhere else. “I don’t understand the difference between having a center in El Paso and having a center in Columbus, Ohio,” says Bruce Nogales, who runs plasma collection for Talecris BioTherapeutics. Nine of Talecris’s 71 collection centers, including four new ones, are on the border.

Still, the industry has made a lot of efforts in recent years to shed its skid row image by building some centers in middle-class areas and by promoting altruistic reasons for donating plasma. Companies say donors now come from various walks of life. The United States is one of the few countries that allows plasma donors to be paid. (And even here the plasma industry says it pays donors for their time, not for the plasma itself.)

But many of the countries that prohibit compensation do not collect enough plasma. So they rely on plasma or plasma products made from the blood of people who donate in the United States, which supplies more than half the world’s plasma.

For the plasma industry, times have been good. Growth has averaged 8 percent a year over the last two decades. Talecris, a leader in the business, just raised $1.1 billion in an initial public stock offering. The transaction represented a handsome return for Cerberus, the private equity fund. Cerberus acquired what is now Talecris from Bayer in 2005.

To satisfy demand for plasma-based medicines, the industry has increased the number of collection centers to 408, from 299 in 2005, according to the Plasma Protein Therapeutics Association, the industry trade group. Paid donations in the United States rose to 18.8 million in 2008 from 10.4 million in 2005.

The number of plasma product companies has declined from 13 in 1990 to 9 in 2003 to 5 now — Baxter International of Deerfield, IL; CSL of Australia; Talecris, of Research Triangle Park, NC; Grifols of Spain; and Octapharma of Switzerland. And the companies now own most of their own collection centers instead of buying plasma from independent collectors.

The industry “operates as a tight oligopoly, with a high level of information sharing,” the Federal Trade Commission said earlier this year in a lawsuit that broke up a planned $3.1 billion acquisition of Talecris by CSL. The lawsuit said that Baxter and CSL, the two biggest players, “even have explored means of punishing firms that dare to ‘break ranks’ and chase market share.” The F.T.C. dropped its suit when the deal was abandoned in June. But about a dozen hospitals have filed class-action suits charging that industry collusion has driven up prices of plasma products.

CSL said in a statement that the F.T.C. “did not claim that our company ever engaged in wrongdoing,” adding, “There is no question that the plasma industry is intensely competitive.” A spokeswoman for Baxter said the company had no idea what the F.T.C. was referring to and that the charge was not substantiated in the government’s complaint. Visit the New York Times for the article.

Musical surgeon examines the OR soundtrack

For performing a routine colorectal surgery, Dr. Claudius Conrad prefers the music of Bach, whose fugues and preludes mirror the methodical, structured steps of the procedure. But when operating on a patient with terrible burns, Conrad queues up techno or rap to set the right tone of tension and urgency.

Surgeons have long listened to music while they work - everything from classical to Celtic to rock. They say it helps them relax and concentrate. But now Conrad, an accomplished pianist and a senior surgical resident at Massachusetts General Hospital, is scientifically testing how music affects surgeons, their patients, and even relatives in the waiting room. The goal is to understand whether music can improve results of surgery, and whether it might be used as a medical treatment. Despite the prevalence of music in the operating theater, the topic has not been intensively studied.

Fifteen years ago, a study in the Journal of the American Medical Association found that surgeons’ speed and accuracy in performing a stressful math task were improved when they selected their music instead of a piece - Pachelbel’s Canon - chosen by the experimenter. A 2006 survey of 171 doctors and nurses at three hospitals found that the majority of respondents listened to music on a regular basis in the operating room and 58 percent preferred classical music.

The use of music in medicine is not new. As early as 4,000 BC, descriptions of music therapy appeared in cuneiform writings from Mesopotamia. Studies have shown music’s benefits in everything from dentistry to obstetrics.

Conrad’s research on music and medicine began when he investigated how music affects patients in the intensive care unit. In a study published in 2007, he tested the effects of music on a group of 10 critically ill patients. Half of them listened through headphones to the slow movements of Mozart piano sonatas for an hour, and half heard no music. Those who heard music needed less sedation, and had reduced stress hormone levels, and lower blood pressure and heart rate.

To systematically test the effects of music in the operating room, Conrad created tasks for surgeons to complete on a computer simulator of laparoscopic procedures - surgeries that involve operating through a small incision. He tested the speed and accuracy of eight expert surgeons under different conditions: Surgeons performed the tasks in silence; while listening to Mozart; and accompanied by the chaotic, stressful noise produced by hearing a different stream of music in each ear - one, German folk music; the other, death metal.

He found that the folk and death metal mix increased the time it took expert surgeons to do the procedures, but did not affect their accuracy compared with silence. It also negatively affected their ability to learn a task: their accuracy did not improve when doing the task a second time while listening to the same music. While listening to Mozart, surgeons’ speed varied, but their accuracy improved compared with silence.

Conrad is working with others at Mass. General to begin playing music in the emergency room waiting areas to see whether it has an effect on the relatives of patients, which will be measured by surveys. Visit the Boston Globe for the article.

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