February 10, 2010
FDA unveils initiative to reduce unnecessary radiation exposure from medical imaging
The U.S. Food and D...
Cardiac Science Corporation and FDA notified healthcare professionals and consumers of a recall because the automated exte...
Schlotterbeck said the company picked up key orders during the second quarter from hospital operators that include Tenet H...
With the ranks of the uninsured growing, hospitals will most likely treat even more patients who cannot afford care. For o...
Paul Levy, the medical center’s president and chief executive, was looking at the prospect of laying off 600 of the hospit...
Paul Levy, the medical center’s president and chief executive, was looking at the prospect of laying off 600 of the hospit...
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February 10, 2010

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February 10, 2010

  1. 1. February 10, 2010 FDA unveils initiative to reduce unnecessary radiation exposure from medical imaging The U.S. Food and Drug Administration (FDA) announced Tuesday, an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: computed tomography (CT), nuclear medicine studies, and fluoroscopy. These procedures are the greatest contributors to total radiation exposure within the U.S. population and use much higher radiation doses than other radiographic procedures, such as standard X-rays, dental X-rays, and mammography. CT, nuclear medicine, and fluoroscopic imaging have led to early diagnosis of disease, improved treatment planning, and image-guided therapies that help save lives every day. The FDA continues to support a strong dialogue between patients and physicians over the medical necessity and risk associated with these types of imaging studies. However, like all medical procedures, CT, nuclear medicine, and fluoroscopy pose risks. These types of imaging exams expose patients to ionizing radiation, a type of radiation that can increase a person’s lifetime cancer risk. Accidental exposure to very high amounts of radiation also can cause injuries, such as skin burns, hair loss and cataracts. Healthcare decisions made by patients and their physicians should include discussions of the medical need and associated risks for each procedure. While there is some disagreement over the extent of the cancer risk associated with exposure to radiation from medical imaging, there is broad agreement that steps can and should be taken to reduce unnecessary radiation exposure. For example, the radiation dose associated with a CT abdomen scan is the same as the dose from approximately 400 chest X-rays. In comparison, a dental X-ray calls for approximately one-half the radiation dose of a chest X-ray. Both diagnostics serve important, sometimes critical, public health needs. Through the FDA’s regulatory oversight of medical imaging devices, such as CT scanners, and through collaboration with other federal agencies and healthcare professional groups, the FDA is advocating the adoption of two principles of radiation protection: appropriate justification of the radiation procedure and optimization of the radiation dose used during each procedure. The three-pronged initiative the FDA is announcing will promote the safe use of medical imaging devices, support informed clinical decision-making, and increase patient awareness of their own exposure. The FDA intends to issue targeted requirements for manufacturers of CT and fluoroscopic devices to incorporate important safeguards into the design of their machines to develop safer technologies and to provide appropriate training to support safe use by practitioners. The agency intends to hold a public meeting on March 30-31, 2010, to solicit input on what requirements to establish. Examples could include a requirement that these devices display, record, and report equipment settings and radiation dose, an alert for users when the dose exceeds a diagnostic reference level (the optimal dose for most patients), training for users, and a requirement that devices be able to capture and transmit radiation dose information to a patient’s electronic medical record and to national dose registries. In addition, the FDA and the Centers for Medicare and Medicaid Services are collaborating to incorporate key quality assurance practices into the mandatory accreditation and conditions of participation survey processes for imaging facilities and hospitals. These quality assurance practices will improve the quality of oversight and promote the safe use of advanced imaging technologies in those facilities. Additional information on this initiative may be found here. FDA Recall: BD Q-Syte Luer Access Devices, BD Nexiva Closed IV Catheter Systems, Acacia IV Extension Sets with BD Q-Syte Luer Access Device BD, Acacia Inc. (known as MPS Acacia), and FDA notified healthcare professionals of the recall of certain lots of these devices. The BD Q- Syte Luer Access Device is a needleless valve manufactured by BD, intended for use with other infusion therapy products in the administration of fluids into the intravenous system. Use of the recalled devices may cause an air embolism or leakage of blood or therapeutic product which may result in serious injury or death. The REF/catalog and lot numbers which were sold in the US are noted in the firm's press release. The affected lots were distributed from November 2008 through November 2009. Read the complete MedWatch 2010 Safety summary, including links to both firm's press releases. Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall
  2. 2. Cardiac Science Corporation and FDA notified healthcare professionals and consumers of a recall because the automated external defibrillator (AED) may not be able to deliver therapy during a cardiac resuscitation attempt, which may lead to serious adverse events or death. These AEDs were manufactured in a way that makes them potentially susceptible to failure under certain conditions. Each of the approximately 12,200 devices affected in this recall can be confirmed at the Cardiac Science Web site, www.cardiacscience.com/AED195. The affected AEDs were manufactured or serviced between October 19, 2009 and January 15, 2010 and include the following models - Powerheart 9300A, 9300E, 9300P, 9390A, 9390E, CardioVive 92532 and CardioLife 9200G and 9231. Each affected AED should immediately be removed from service since it may not deliver the expected therapy. Read the complete MedWatch 2010 Safety summary. Can you donate oxygen supplies for Haiti Relief? Healthcare providers in Haiti are in desperate need of oxygen sources for patients recovering from injuries after the January 12, 2010 earthquake. ECRI Institute is assisting relief agencies and government organizations in identifying healthcare product suppliers who may be in a position to donate oxygen generating systems like oxygen concentrators and portable oxygen plants for this effort. Please contact ECRI Institute at communcations@ecri.org if you are in a position to donate equipment. Study: Health costs higher where hospital competition is lower Spending by private insurers tends to be higher when the hospital market is less competitive, a new study finds. The study, published in the American Journal of Managed Care, compared geographic patterns of Medicare spending, using the Dartmouth Atlas data, with spending by big employers that cover their workers. The upshot was that the two didn’t correlate. The reason didn’t seem to be that insurers (in this case, acting on behalf of big employers) are better than Medicare at saying no to paying for unneeded care since utilization patterns were somewhat parallel. Instead, the researchers suggest that when a small market has just one or a few big hospital systems, employers spend more than they do in large cities where there’s more competition, an issue that doesn’t generally affect government health payers like Medicare. “We found that for commercial insurers, the higher-spending markets were those that were the least competitive on the provider side,” said Michael Chernew, the lead author and a professor at Harvard Medical School. The finding, he argues, signals that as policymakers push for integrated systems bringing together all kinds of healthcare under one umbrella, they should keep antitrust concerns in mind. The new study’s suggestion comes with a bucket of caveats. For one thing, there are other reasons why private insurers’ payments wouldn’t match up with Medicare’s. Most obviously, the under-65 population has different medical needs than older folks. Some hospital executives have long argued that they are forced to rely on payments from private insurers to make up for the money they lose on government-covered patients, another reason why the two types of payment wouldn’t correlate. he database used in the study also had fewer than 60 large companies, a limited sample that could create distortions. Visit the Wall Street Journal for the article. CareFusion sees a ‘gradual thaw’ Medical device maker CareFusion said yesterday that it continues to see gradual improvement from a recessionary slump in hospital spending. The San Diego company, which makes a variety of hospital devices, said net income for its fiscal second quarter dropped 32 percent to $73 million, or 33 cents a share. But the company said revenue grew 5 percent to $1 billion. And net income excluding one-time items came in at $88 million, or 39 cents a share, one cent ahead of the Wall Street consensus as compiled by Bloomberg. It was CareFusion’s second quarter as an independent company after a spinoff from drug-distribution giant Cardinal Health. The company, whose more than 15,000 global employees place it among the largest San Diego-based companies, pointed to “modest improvements” in hospital capital spending and said it also picked up business related to flu preparedness. “We’re seeing a gradual thaw in hospital spending,” Chief Executive David Schlotterbeck said on a conference call with analysts. “I’ve characterized orders as improving 10 (percent) to 15 percent.” Still, Schlotterbeck said orders in the company’s key drug infusion business are roughly 65 percent to 70 percent what they were in the first half of 2008. He added that hospitals in the United States have $250 million in potential capital equipment orders that are on hold. The company, made up of components Cardinal acquired over the years that included one-time San Diego companies Alaris Medical and Pyxis — makes intravenous pumps, computerized drug dispensers and other hospital gear.
  3. 3. Schlotterbeck said the company picked up key orders during the second quarter from hospital operators that include Tenet Healthcare and the Cleveland Clinic. In coming months, he said it plans to invest $30 million in increased research, expanded sales coverage and new product launches. Visit the San Diego Union Tribune for the story. Lawmaker's death a reminder of surgery risks Gallbladder surgery is usually a very safe operation, but a powerful congressman's death is a reminder of the known risks. Well over half a million people have their gallbladders removed annually, most of them minimally invasively just as the late Rep. John Murtha, D-PA. Complications are rare. But they include nicking the intestine, liver or bile duct as doctors struggle to squeeze an inflamed gallbladder through a tiny opening in the abdomen. And if an intestine or bile duct is perforated, spotting it quickly can mean the difference between survival or death from massive infection. "Every hour we delay diagnosis, the chance of overwhelming sepsis goes up," said Dr. Kevin Olden, a gastroenterologist at Washington Hospital Center - who wasn't involved in the congressman's care at two nearby hospitals. Moreover, the risk of complications rises with age, and when doctors must remove what they call a "hot gallbladder," one already inflamed or diseased. In a younger person, a less diseased gallbladder is similar to a boiled egg, and can just slide out fairly easily, Olden said. But an older or sicker gallbladder more resembles a prune that has to be peeled off surrounding tissue, making removal a bigger challenge. Murtha, 77, was first hospitalized with gallbladder problems in mid-December at the National Naval Medical Center, and eventually had his gallbladder removed there. Then on Jan. 31, a few days later, he came to another hospital's emergency room with a fever and infection. The Virginia Hospital Center in Arlington, VA, said he died there Tuesday from "major complications from surgery" at the first hospital. His family is not revealing details, but a longtime friend, Rep. Bob Brady, D-PA, has said Murtha's large intestine was damaged during the gallbladder removal, triggering the infection. It's most common to nick the bile duct that connects the gallbladder and liver. That can often be repaired with minimally invasive surgery, resealing it to stop leakage of bile and treating any infection with antibiotics. Nicking the liver seldom is life-threatening; it's a solid organ. Nicking the intestine is an especially rare event. A small hole sometimes will reseal on its own, and the intestine's folds can hide a perforation, leading to delayed diagnosis. But a perforation means bacterial-laden intestinal contents start leaking into the abdomen, which is supposed to be sterile, and can require open surgery both to fix the leak and to literally cleanse the abdominal cavity, Olden said. Virginia Hospital Center has said only that Murtha received "aggressive critical care interventions." Visit the Washington Post for the article. Bills stalled, hospitals fear rising unpaid care President Obama says he aims to keep trying. But what happens if the healthcare legislation cannot be revived, and tens of millions of uninsured Americans continue without coverage? For the nation’s hospitals, at least, the cost of doing nothing in Washington translates into tens of billions of dollars each year in medical bills that go unpaid by patients with little or no insurance. Nationwide, the cost of unpaid care for hospitals, which includes charity care as well as money that could not be collected from patients, was around $36 billion in 2008. It is expected to spiral higher. The number of people without insurance in this country could increase to as high as 58 million by 2014, from about 49 million now, according to an estimate by the Urban Institute. No wonder hospital systems like Park Nicollet Health Services near Minneapolis worry about their futures if the healthcare legislation remains stalled. “Our business model will continue to falter,” said Dr. David Abelson, chief executive of Park Nicollet, a not-for-profit system that runs a 426-bed hospital and a chain of clinics. Park Nicollet has had to cut back services and lay off hundreds of employees as its level of uncompensated care rose — to $43 million last year, up from $29 million in 2007. And when the hospital provides care under state and federal programs like Medicaid and Medicare, it is already reimbursed below its costs, Dr. Abelson said. Park Nicollet, whose revenue was $1.2 billion last year, says it expects to lose $120 million on government programs in 2010. For hospitals, unpaid bills can stem from uninsured patients like a man who recently showed up at Park Nicollet’s emergency room in withdrawal from alcohol. Besides needing emergency heart surgery, the patient was treated for respiratory failure and alcoholic hepatitis, which involved a five-day stay in the intensive care unit. His care ended up costing $85,000, which the hospital has little hope of recovering.
  4. 4. With the ranks of the uninsured growing, hospitals will most likely treat even more patients who cannot afford care. For one thing, hospitals are legally obliged to medically stabilize anyone who shows up in the emergency room. But they also choose to provide charity care for many people who clearly cannot afford to pay their bills. Hospital executives hope Nancy Pelosi’s and the president’s perseverance pays off. “If nothing happens, it’s more of the same, and it will continue to be harder and harder in terms of financial viability,” said Nickolas A. Vitale, the senior vice president for financial operations for Beaumont Hospitals, a hospital system based in Royal Oak, MI, whose uncompensated care has increased by 20 percent a year since 2005. There is still plenty of debate, to be sure, over how effective the legislation would actually be in expanding coverage for the uninsured. Many of the legislation’s most significant aspects would not take place for years — like the insurance industry overhaul aimed at making it easier for more Americans to find affordable coverage and the federal subsidies meant to bring the cost of a policy within reach of more people. Given the weak economy, moreover, hospitals would probably face a challenging environment over the next few years even if the president signed a healthcare bill tomorrow. But hospital executives and analysts say that without the legislation, many hospitals will struggle under the burden of caring for greater numbers of people who cannot pay. In the short term, “it’s almost no harm, no foul,” said Sheryl Skolnick, a healthcare analyst at CRT Capital in Stamford, CT. “But over the longer term, there is plenty of foul,” Skolnick added. “Hospitals should not be the insurers of last resort.” Even for many patients who do have coverage under Medicaid or Medicare, some experts say, severe state and federal budget constraints mean hospitals will probably get squeezed by significant government payment cuts, whether or not the overhaul legislation moves forward. Under the proposed legislation, hospitals had already agreed to significant cuts under the Medicare program as part of their deal with the White House to come up with $155 billion of savings over 10 years to help pay for the coverage expansion. Many hospital executives worry that Congress will enact those cuts even in the absence of more comprehensive legislation meant to help ease the burden of caring for so many people who cannot pay. There could also be greater resistance by the private insurance industry. Under the current system, private insurers pay hospitals more than the government does — meaning that private insurers and their customers help make up for low payments by government programs. But few expect the private insurers to continue footing the bill for the shortfall. “If the public payers continue to ratchet down the reimbursement enough,” hospitals will not be able to charge the private insurers enough to make up the difference, said Michael J. Dowling, the chief executive of North Shore-Long Island Jewish Health System, a large New York hospital system. “The private sector won’t be able to carry it.” The private insurers are likely to take an increasingly harder line against hospitals, as they try to contain the underlying medical costs that have helped fuel the steady rise in the premiums they charge. Meanwhile, the gulf may widen between large, well-capitalized hospital systems and smaller institutions that are clearly struggling, said Lisa Martin, a senior vice president at Moody’s Investors Service. Moody’s recently released a report on nonprofit hospitals predicting that the next year and a half could be “one of the toughest environments in decades.” “The smaller to medium-size single-site hospitals are the ones who are going to be most at risk,” said Martin, who predicts that some of those hospitals will end up being purchased or absorbed by larger systems. Regardless of what happens in Washington, some hospital executives say the industry should already be working on ways to improve care, like reducing the number of times a patient is readmitted to the hospital, said Dowling at North Shore-Long Island Jewish. “Reform at the national level is not the panacea everyone thought it was,” he said. But executives like Dr. Abelson at Park Nicollet say they are still disappointed that some aspects of the healthcare legislation may not materialize if the effort dies. He cited proposed experiments aimed at moving the system away from simply paying more for more care to instead rewarding hospitals and doctors for better care. “The various bills contained some pilots in the right direction,” he said, and Park Nicollet had been interested in participating. “We were positioning ourselves for reform.” Visit the New York Times for the article. What goes around Last year, when the staff at Beth Israel Deaconess Medical Center agreed to give up raises and benefits so the hospital would not have to lay off its lowest-paid workers, the story went viral. In the face of unremitting bad economic news and rising unemployment, the idea that highly educated professionals at a big city hospital would take a hit for janitors and housekeepers and people who push patients around in wheelchairs was wildly counterintuitive. Turns out the selflessness and generosity of the people at BIDMC was more than life-affirming: It was successful.
  5. 5. Paul Levy, the medical center’s president and chief executive, was looking at the prospect of laying off 600 of the hospital’s 6,400 staff when he had the revolutionary idea of appealing to the best instincts of his employees. In the end, only about 70 people received pink slips, and most of them would have been let go any way, for various reasons, he said. None of those laid off were on the lowest salary rung. And now this news: The foregone raises will be restored in April. Beyond good intentions, the transparency of the process has made it work. “This could have been a disaster,’’ Levy said. “It could have engendered resentment or a feeling that people were taken advantage of or people saying, ‘I can’t get a raise; I’m going to another hospital.’ But the feeling is, ‘Hey, we all did a good thing.’ We’ve shown that not only can we take good care of patients; we can take good care of one another.’’ The decision to save the lowest-paid workers was made after a series of town meetings Levy held with staff at the hospital. The first session led to a spontaneous explosion of applause when Levy first floated the idea. Levy ended up getting 3,600 suggestions from employees on how to share the budget cuts. Lois Hartsough, a registered nurse and project manager in the hospital’s Department of Medicine, realized that after the warm feelings of the town meetings wore off, she would be sacrificing a lot with no guarantee it would save anybody’s job. Hartsough eventually listened to that heart and endorsed the plan. And even before she got the e-mail the other day, notifying employees that raises will be restored, Hartsough knew she and her co-workers made the right decision. “I had never worked in a place where these things were discussed so openly,’’ she said. “For me, the most rewarding part has been the sense of everyone pulling together, of having our values tested and seeing how we reacted as a community, so that we can live out those values of generosity and compassion.’’ Visit the Boston Globe for the article.
  6. 6. Paul Levy, the medical center’s president and chief executive, was looking at the prospect of laying off 600 of the hospital’s 6,400 staff when he had the revolutionary idea of appealing to the best instincts of his employees. In the end, only about 70 people received pink slips, and most of them would have been let go any way, for various reasons, he said. None of those laid off were on the lowest salary rung. And now this news: The foregone raises will be restored in April. Beyond good intentions, the transparency of the process has made it work. “This could have been a disaster,’’ Levy said. “It could have engendered resentment or a feeling that people were taken advantage of or people saying, ‘I can’t get a raise; I’m going to another hospital.’ But the feeling is, ‘Hey, we all did a good thing.’ We’ve shown that not only can we take good care of patients; we can take good care of one another.’’ The decision to save the lowest-paid workers was made after a series of town meetings Levy held with staff at the hospital. The first session led to a spontaneous explosion of applause when Levy first floated the idea. Levy ended up getting 3,600 suggestions from employees on how to share the budget cuts. Lois Hartsough, a registered nurse and project manager in the hospital’s Department of Medicine, realized that after the warm feelings of the town meetings wore off, she would be sacrificing a lot with no guarantee it would save anybody’s job. Hartsough eventually listened to that heart and endorsed the plan. And even before she got the e-mail the other day, notifying employees that raises will be restored, Hartsough knew she and her co-workers made the right decision. “I had never worked in a place where these things were discussed so openly,’’ she said. “For me, the most rewarding part has been the sense of everyone pulling together, of having our values tested and seeing how we reacted as a community, so that we can live out those values of generosity and compassion.’’ Visit the Boston Globe for the article.

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