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May 2005
Thursday, June 30, 2005
In this Issue:
Canada to ban bulk exports of prescription drugs
Panel affirms radiation link to cancer
EPA: Compound in Teflon a 'likely carcinogen'
MedAssets' Merge Technology
improves cash flow
from existing operations for healthcare providers
Baptist Memorial renews, expands relationship
with VHA
Panel affirms radiation link to cancer
The preponderance of scientific evidence shows that even very low doses of radiation pose a risk of cancer or other health problems and there is no threshold below which exposure can be viewed as harmless, a panel of prominent scientists concluded Wednesday. The finding by the National Academy of Sciences panel is viewed as critical because it addresses radiation amounts commonly used in medical treatment and is likely also to influence radiation levels the government will allow at abandoned nuclear sites. The nuclear industry, as well as some independent scientists, have argued that there is a threshold of very low level radiation where exposure is not harmful, or possibly even beneficial. They said current risk modeling may exaggerate the health impact. The panel, after five years of study, rejected that claim. “The scientific research base shows that there is no threshold of exposure below which low levels of ionized radiation can be demonstrated to be harmless or beneficial,” said Richard R. Monson, the panel chairman and a professor of epidemiology at Harvard's School of Public Health. The committee gave support to the so-called “linear, no threshold” model that is currently the generally acceptable approach to radiation risk assessment. This approach assumes that the health risks from radiation exposure declines as the dose levels decline, but that each unit of radiation, no matter how small, still is assumed to cause cancer. “It is unlikely that there is a threshold below which cancer are not induced,” said the report, although it added that at low doses “the number of radiation-induced cancers will be small.” And it said cancers from such low dose exposures may take many years to develop. The panel, formally known as the Committee on Biological Effects of Ionizing Radiation, or BEIR, generally supported previous cancer risk estimates, the last one by an earlier BEIR group in 1990. Contrary to assertions that risks from exposure from low-level radiation may have been overstated, the panel said “the availability of new and more extensive data have strengthened confidence in these (earlier) estimates.” The committee examined doses of radiation of up to 100 millisievert, a measurement of radiation energy deposited in a living tissue. A single chest X-ray accounts for 0.1 millisievert, average background radiation 3 millisievert a year and a whole body CT scan delivers 10 millisievert. The committee estimated that 1 out of 100 people would likely develop solid cancer or leukemia from an exposure of 100 millisievert of radiation over a lifetime with half of those cases being fatal. The report noted that exposure from a whole body CT scan is much higher than a normal X-ray, and it raised concerns about the frequency in which such medical diagnostics should be used. While medical radiation is often done for good reasons, said Monson, “exposure to unnecessary radiation should be avoided.” For report summary: www.nationalacademies.org (The Associated Press)
EPA: Compound in Teflon a 'likely carcinogen'
The Environmental Protection Agency's own scientific advisory panel has identified perfluorooctanoic acid, a chemical compound used to make Teflon, as a “likely carcinogen” in a report it plans to submit to the agency next month. The draft report, which EPA posted on its Web site, is significant because it could prompt agency officials to regulate the processing agent, known as PFOA or C-8, for the first time. Until now, the EPA has classified PFOA as a “suggested” carcinogen, which requires fewer health precautions. The EPA is in the midst of a major investigation into how the compound, which is used to make stain- and stick-resistant surfaces and materials for products including Gore-Tex fabrics and pizza boxes, gets into consumers' blood and whether it affects their health. It is also seeking millions of dollars in fines from DuPont Co., which makes PFOA in Parkersburg, WV, on the grounds that the Company failed for 20 years to report possible health and environmental problems linked to the compound. The scientific advisory panel, whose 17 members will discuss the draft assessment on July 6 before forwarding it to the agency, does not draw conclusions on whether using products made with PFOA, such as nonstick pans, poses a cancer risk. Instead, it says that the fact that animal studies have identified four different kinds of tumors in both male and female rats and mice that had been exposed to the compound convinced a majority of its members that it is a likely carcinogen. “Based on an evaluation of human health and toxicology studies, DuPont believes that the weight of evidence suggests that PFOA exposure does not cause cancer in humans and does not pose a health risk to the general public,” said DuPont spokesman R. Clifton Webb. "To date, no human health effects are known to be caused by PFOA, even in workers who have significantly higher exposure levels than the general population." (The Washington Post)
MedAssets'
Merge Technology improves cash flow
from existing operations for healthcare providers
MedAssets has developed Merge Technology, a suite of revenue cycle and supply chain technology applications designed to work collectively to address the key financial challenges affecting healthcare providers and help them improve business processes. The Merge Technology platform consists of a suite of tools that works with providers' existing IT products to continuously collect, audit and update supply and charge data. With the Merge Technology platform in place, providers have the accurate data needed to control supply costs, negotiate better payer contracts and ensure defensible pricing, which results in more cash flow from existing operations. By implementing Merge Technology, providers can realize a 1 percent to 3 percent increase in net patient revenue and a 3 percent to 10 percent reduction in supply costs, the Company said. The keystone of the Merge Technology platform is CrossWalk, which links the supply data in the item file to the charge data in the chargemaster. The transparency and consistency of data provided by CrossWalk ensure providers' charges cover their costs with a reasonable, payer-compliant markup. CCA.Net, BPI.Net and CRM.Net are the platform's revenue solutions, which help providers capture missed charges for services performed; manage charges to reduce billing errors; and set defensible pricing based on market-specific benchmarks. The platform's supply chain solutions (Local Custom Contract Catalog, Strategic Information, and Physician Preference Item Cost Management) ensure accurate contract pricing, detect price variances, reveal off-contract purchases, and reduce costs for medical device expenditures.
Baptist Memorial renews, expands relationship with VHA
Baptist Memorial Health Care (Memphis, TN) renewed and expanded its relationship with VHA Inc (Irving, TX). Through a new five-year agreement, Baptist and VHA are creating a customized approach to supply chain management and moving beyond the traditional group purchasing model: VHA and Novation (Irving, TX) will become extensions of Baptist's internal supply chain team. Baptist will use VHA and Novation expertise to purchase medical-surgical supplies, pharmaceuticals, capital equipment, food products, lab equipment and other supplies. Baptist estimates it will purchase nearly $170 million annually in supplies and services through VHA and Novation contracts.
Wednesday, June 29, 2005
In this Issue:
Ex-HealthSouth CEO Scrushy found not guilty
for role in $2.7 billion accounting fraud
Controversial report about U.S milk supply
vulnerabilities to be published
Guidant advises physicians on
safety information and
corrective action for implantable cardiac defibrillators
Boston Scientific announces worldwide recall of
Hemashield VANTAGE peripheral vascular grafts
Boston Scientific announces
settlement of Department of Justice
investigation of 1998 recall
Medtronic acquires
Transneuronix Inc.
for its new obesity unit
Consorta awards contract for uninterruptible
power supply services
Richard Scrushy, former CEO of HealthSouth Corp., was found not guilty Tuesday on all charges in the $2.7 billion accounting fraud at the hospital chain. Scrushy was the first major figure charged with violating the 2002 Sarbanes-Oxley Act. A federal jury in Alabama began deliberating about six weeks ago and appeared deadlocked until last week, when the judge replaced one juror on the 12-member panel with an alternate juror. The 52-year-old founder and ex-CEO of HealthSouth faced 36 counts, including fraud, money laundering, and conspiracy charges. Prosecutors accused Scrushy of masterminding the fraud in order to inflate the company's stock price and to finance his lavish lifestyle. Scrushy did not take the stand in his own defense, but his lawyers argued at trial that other former HealthSouth executives committed the fraud without Scrushy's knowledge. Legal experts noted, among other things, that five former HealthSouth chief financial officers had testified against their former boss, reported CNN. HealthSouth, based in Birmingham, AL, owns a national chain of rehabilitation hospitals and outpatient clinics. Scrushy co-founded HealthSouth in 1984. (CNN)
Controversial report about U.S milk supply
vulnerabilities to be published
The National Academy of Sciences is proceeding with publication of a study outlining how terrorists could contaminate the U.S. milk supply with botulism, despite complaints that the article is a “road map for terrorists.” The article theorizes that hundreds of thousands of people could be poisoned if terrorists exploited vulnerabilities in milk processing. It includes information on milk pasteurization, the dose of botulinum toxin for humans, the toxin's heat sensitivity and the capacities of the silos in which milk is stored. The paper “is a road map for terrorists and publication is not in the interests of the United States,” Department of Health and Human Services Assistant Secretary Stewart Simonson wrote in a May letter to Dr. Bruce Alberts, the science academy chief. But in an editorial accompanying the article, Alberts wrote that all of this information is “immediately accessible on the World Wide Web through a simple Google search.” “A terrorist who wants to do great damage will therefore not find anything in the article that is likely to increase his or her certainty concerning the minimum level of toxin to use,” Alberts wrote. Dr. Lawrence Wein, the Stanford University professor who wrote the article, praised the academy for acting “honorably and professionally.” He said the article offers concrete suggestions on how the security of the milk supply could be improved. “There has been very little shift from food safety to food security,” Wein said. The paper and editorial were published Tuesday on the Academy Internet site and will appear in the July 12 print edition of Proceedings of the National Academy of Sciences, The Associated Press reported. The National Academy of Sciences is a private, nonprofit society of scientists and engineers chartered by Congress to advise the government on science and technology. (CNN)
Guidant Corporation said it is voluntarily advising physicians about important safety information regarding certain devices. Guidant apprised FDA of this action, and FDA may classify this action as a recall. At this time, Guidant is in the very early stages of a diligent evaluation of the component failure described below, and will communicate further as more information is learned. As a precautionary measure, physicians should discontinue implants of these devices pending further notice, and should use this information to decide how best to treat their patients. The devices impacted are: CONTAK RENEWAL 3 and 4, RENEWAL 3 and 4 AVT, and RENEWAL RF. Guidant has determined that these devices are subject to a component failure that may limit available therapy. Guidant has determined that a magnetic switch in these devices may become stuck in the closed position, which in some cases inhibits the device’s ability to treat ventricular or atrial tachyarrhythmias and can accelerate battery depletion. Four occurrences have been confirmed out of approximately 46,000 devices; a fifth occurrence is suspected but cannot be confirmed. In the four occurrences in which the device was implanted, patients and/or physicians were alerted to the condition by audible device tones that signaled the magnetic switch was closed. These four occurrences have resulted in device replacement. One occurrence occurred prior to implant. To date, there have been no patient injuries beyond device replacement. It is Guidant’s recommendation to physicians that they consider programming “Enable Magnet Use” to “OFF” to ensure that appropriate therapy to treat ventricular and atrial tachyarrhythmias will be provided in the event that the magnetic switch becomes stuck in the closed position. In addition, patients should contact their physicians or go to the hospital emergency room immediately if they hear tones from their device. Additional information is available at 1-866-GUIDANT (1-866-484-3268) (24/7) and http://www.guidant.com/physician_communications/RENEWAL3_RENEWAL4.pdf. According to a report by The New York Times, the company's stock fell $4.70, or 6.85 percent, to $63.90 on Friday; analysts speculated that Johnson & Johnson might cut its price from the $25.4 billion it had planned to acquire Guidant. They also said the deal's planned closing in the third quarter of this year might be delayed, said The Times. Analysts said they thought the types of models involved in Friday’s alert, cardiac resynchronization therapy, or C.R.T., devices, made up 40 percent to 50 percent of Guidant’s defibrillator sales. C.R.T. devices are the fastest-growing part of the defibrillator market, which is expanding 20 percent annually, said The Times.
Boston Scientific announces worldwide recall of
Hemashield VANTAGE peripheral vascular grafts
Boston Scientific Corporation announced that it is voluntarily recalling worldwide all Hemashield VANTAGE Vascular Grafts, which are used in peripheral procedures. No other Hemashield products are affected by this recall. The Company is recalling all Hemashield VANTAGE Vascular Grafts manufactured in the last two years due to the potential of the device to fray or tear during suturing and the possibility that it could lead to post-operative complications. The Company is aware of three reported post-operative failures which occurred between three and seven days post-procedure. In all of these cases, the patients were successfully treated by re-suturing the graft or replacing it. The Company is working with the U. S. Food and Drug Administration and is notifying officials in other countries. The Company initiated the recall after a review of complaint records and analysis of product revealed the potential problem. The total number of devices shipped but not yet implanted is estimated to be 500. The Company ships approximately 2,180 Hemashield VANTAGE Vascular Grafts per year. The products were distributed to hospitals worldwide. Boston Scientific is notifying hospitals through detailed Recall Packages, including instructions on how to return recalled product, as well as physician letters. All unimplanted product is to be returned to Boston Scientific. Physicians with questions may contact the Company at 1-888-272-1001. Absent symptoms of graft failure, Boston Scientific is recommending that physicians continue routine post-operative clinical evaluation. The signs and symptoms that a Hemashield VANTAGE Vascular Graft might be starting to fail include: pain, swelling, bruising, bleeding through incision, rapid pulse or low blood pressure. If a patient experiences any of these symptoms, he or she should contact their physician immediately.
Boston
Scientific announces settlement of Department of Justice
investigation of 1998 recall
Boston Scientific Corporation
announced that it has entered into a civil settlement agreement with the U.S.
Department of Justice regarding the Department's investigation of the 1998
voluntary recall of the NIR ON Ranger with SOX stent system, a product Boston
Scientific no longer markets or sells, and related events. This civil settlement
brings to a conclusion a criminal investigation of the Company that has been
pending for more than six years. No charges were brought against the Company or
any employee. The Company agreed to pay $74 million as part of the agreement.
Medtronic
acquires Transneuronix Inc.
for its new obesity unit
Medtronic Inc. announced Tuesday, that it has agreed to acquire Transneuronix Inc., a privately held medical device company focused on the treatment of obesity by stimulation of the stomach with an implantable pacemaker-like device. The product delivers electrical pulses to the stomach. The transaction is expected to close within the week. The acquisition follows Medtronic's recent announcement regarding the formation of a new business unit, Medtronic Obesity Management. "The acquisition of Transneuronix plays a key part in our strategy to deliver therapeutic solutions for the worldwide challenges of obesity," said Bill Hawkins, Medtronic president and chief operating officer. "Because obesity is linked to so many associated health problems, there is a great sense of urgency to find successful long-term treatment options for these patients." Transneuronix has been conducting research using gastric electrical stimulation for the treatment of obesity for more than eight years in the United States and Europe. Since the first implant in 1995, more than 700 patients have been implanted with Transcend(R), the company's Implantable Gastric Stimulator (IGS(R)). More than 300 patients have been enrolled in Transneuronix-sponsored trials that have demonstrated meaningful reductions in excess weight with a good safety profile. The Transcend system has been commercially available in Europe for more than three years, and Transneuronix recently received regulatory approval to begin marketing the Transcend system in Canada. In the United States, Transneuronix has completed enrollment in its U.S. pivotal trial. "We look forward to the clinical results of the U.S. trial this fall and hope this therapy becomes available to patients in the United States in the near future," added Dr. Aronne. New York-Presbyterian Hospital/Columbia University Medical Center is one of eight sites in the United States participating in the trial.
Consorta
awards contract for uninterruptible
power supply services
Consorta has awarded an agreement for uninterruptible power supply services to JT Packard, Verona, WI. Through the agreement, Consorta member facilities will have access to special pricing on maintenance and service for all generators and uninterruptible power supply (UPS) systems. “Uninterruptible power supplies are mission critical devices that are often overlooked in terms of preventative maintenance,” said Dan Ingram, manager of imaging contracting for Consorta.
Tuesday, June 28, 2005
In this Issue:
Kimberly-Clark and Cardinal Health resolve
patent dispute on dual ply sterilization wrap
Private health insurance spending for obesity
rises
GAO report faults states’ use
of consultants
to draw Medicaid funding
New underpad helps protect
patient skin;
meets CMS incontinence guidelines
Orkin introduces ‘greener’
pest control option
for healthcare facilities
Healthcare professionals roast Tony Monaco
Kimberly-Clark Health Care announced today that Kimberly-Clark Corporation and Cardinal Health have reached a settlement resolving a patent infringement dispute filed by Kimberly-Clark early last year. The dispute centered on dual ply sterilization wrap used for sterilizing surgical implements. Under their settlement, Cardinal has agreed to discontinue all sales and related marketing of SIMUL-WRAP sterilization wrap as of June 30, 2006. Kimberly-Clark will continue to offer its KIMGUARD ONE-STEP Sterilization Wrap as a simultaneous wrapping product in addition to KIMGUARD Sterilization Wrap for sequential wrapping.
Private health insurance spending for obesity rises
Private health insurance spending on illnesses related to obesity has increased more than tenfold since 1987, according to the first research to quantify the trend. The growth in obesity has fueled a dramatic increase in the amount spent treating diabetes, heart disease, high cholesterol and other weight-related illnesses, says the study, which is published in the online journal Health Affairs. Overall, employers and privately insured families spent $36.5 billion on obesity-linked illnesses in 2002, up from an inflation-adjusted $3.6 billion in 1987. That's up from 2% of total healthcare spending on obesity in 1987 to 11.6% in 2002, the latest year for which data are available. On average, treating an obese person cost $1,244 more in 2002 than treating a healthy-weight person did. In 1987, the gap was $272. And the obesity problem is “only going to get worse,” said lead author Kenneth Thorpe, chairman of the department of health policy and management at Emory University in Atlanta. “The costs are up because so many more Americans are obese and because they're being more aggressively treated for weight-related illnesses.” About 31% of U.S. adults are obese, 30 or more pounds over a healthy weight. That's up from 23% in the late 1980s and 15% in the late 1970s. “Most of what is going on now to try to control healthcare spending is missing the target,” Thorpe said. “Companies are tweaking co-pays and talking about healthcare savings accounts when really they need to redirect their focus to reduce the prevalence of obesity among children and workers.” Thorpe and his colleagues analyzed national surveys of about 14,000 people from 1987 and 2002. The data included healthcare spending, medical conditions and trips to the doctor, hospital and pharmacy. Findings include: The percentage of obese people being treated for high cholesterol, mental disorders and upper gastrointestinal disorders increased 10 percentage points. The increase in adult-onset diabetes contributed to a 64% rise in diabetes treatment from 1987 to 2002. About 25% of the extremely obese (80 or more pounds overweight) were being treated for six or more conditions in 2002, compared with 14% in 1987. A study last year by RTI International in Raleigh, NC, and the Centers for Disease Control and Prevention showed that obese and overweight Americans accounted for about $75 billion in weight-related medical bills in 2003. Because much of this is covered by Medicare and Medicaid, taxpayers pay about half the total, the study found. (USA Today)
GAO report faults states’ use of consultants
to draw Medicaid funding
Two-thirds of the states use consultants to help them get more federal Medicaid money, often by using “questionable billing practices,” and then reward those consultants by giving them a share of the money as a contingency fee, Congressional investigators said on Monday. These consultants are driving up Medicaid costs by recommending financial tactics that violate federal law or policy, the investigators, from the Government Accountability Office, said in a report to Congress. Kathryn G. Allen, director of healthcare issues at the auditing agency, said, in some cases states have exploited federal Medicaid rules to obtain more federal money without increasing state contributions to the program. But Allen also said, “A lack of oversight and clear guidance from the Centers for Medicare and Medicaid Services has allowed states to develop new financing methods that generate additional federal costs.” Senator Charles E. Grassley (R-IA), chairman of the Finance Committee, who requested the study, said that Congress and federal Medicaid officials had “an obligation to establish clear-cut ground rules and make sure they're followed.” The accountability office said that federal officials did not routinely review the states' use of contingency-fee consultants. Dr. Mark B. McClellan, administrator of the Centers for Medicare and Medicaid Services, said his agency “does not have the authority to require states to disclose their use of contingency-fee consultants.” The Government Accountability Office said that a consultant helped Georgia obtain $1.5 billion of additional federal Medicaid money from 2000 to 2004, in return for contingency fees of $82 million. Massachusetts increased its federal Medicaid revenue by nearly $570 million with help from consultants who were paid $11 million, the report said. Federal guidelines, issued by the White House Office of Management and Budget, generally prohibit states from charging the federal government for contingency fees paid to contractors for securing federal money. Neither Georgia nor Massachusetts claimed federal reimbursement for such fees. But the inspector general of the Department of Health and Human Services found that Colorado had received $179,267 and Virginia $338,982 for fees improperly billed to the federal Medicaid program. Officials in Colorado said they had been unaware of the federal prohibition. The accountability office said that federal officials, instead of issuing uniform national standards, had treated states differently, allowing Georgia and Massachusetts to use techniques forbidden to Maryland, Illinois and Texas. (The New York Times)
New
underpad helps protect patient skin;
meets CMS incontinence guidelines
Medline Industries Inc. announced the launch of Ultrasorbs underpads, a new disposable pad that wicks moisture away from the skin while also protecting the patient’s bedding. Released this month, the new CMS Incontinence Guidance document F(315) notes that managing skin moisture is critical to maintaining skin integrity and reducing the incidence of pressure ulcers. The Guidance document also notes that provision of care must take into account and respect resident dignity. Dignity issues can include embarrassment or discomfort, which can result from laying in wet, cold urine as well as from odor. If facilities are cited for violations of the new guidelines, they could face thousands of dollars in fines. “Ultrasorbs has allowed us to start open-airing at night as part of our updated pressure ulcer prevention program. Our patients are more comfortable, and the staff can do a change easier and faster than with briefs,” said Pauline Obura-Wilkes, RN, director, staff development and wound care coordinator, Hamden Health Center. Made with an advanced thermo-bonded core that provides superior absorbency and maximum strength, using Ultrasorbs can reduce costs by as much as 20 –35% as compared to polymer underpads and reusables.
Orkin introduces ‘greener’ pest control option
for healthcare facilities
As the healthcare industry becomes increasingly concerned with reducing hazardous chemicals in its facilities, Atlanta-based Orkin Inc. is introducing Gold Medal Protection for Health Care, a program designed to guide healthcare providers toward more environmentally friendly pest control practices. Gold Medal Protection is modeled on the pest control recommendations of Health Care Without Harm, and aims to move facilities away from reliance on pesticides and toward a more comprehensive system of countermeasures. The program’s rigorous Integrated Pest Management (IPM) protocols are also consistent with the recommendations of the American Society of Healthcare Environmental Services (ASHES) and Hospitals for a Healthy Environment (H2E). If pesticides must be used in response to a specific problem, Gold Medal Protection helps minimize the potential for patient and staff exposure by choosing least hazardous formulations and applying them deep in cracks and crevices, said Zia Siddiqi, Ph.D., Orkin’s Director of Quality Assurance. For added safety, Gold Medal Protection employs a formal notification process so patients and staff are aware of any pesticide applications. In addition to being a “greener” alternative, Gold Medal Protection boasts a comprehensive documentation system for quality assurance. A variety of on-site reports maintained by Orkin Technicians provide a full record of actions taken, pesticides applied and resulting changes in pest presence for reviews by facility administration, public health inspectors, medical personnel and health care accreditation boards. Annual audits by Orkin’s Quality Assurance Team of professional entomologists, sanitarians, food safety experts and commercial and industrial specialists further ensure the effectiveness of the program. For more information, www.orkin.com/commercial.
Healthcare professionals roast Tony Monaco
On April 27, 2005, over 70 New Jersey healthcare professionals convened to “roast” Anthony “Tony” Monaco of the New Jersey State Department of Health. The roast was organized by Nancy Chobin, sterile processing educator/consultant at the Saint Barnabas Health Care System and executive director for the Certification Board for Sterile Processing and Distribution; Tam Maresca and Nora Wikander with assistance from Chris Voorhees and Dave Henderson. According to Chobin “this event was to officially thank Tony for the dedication, time and commitment he has continually displayed for the infection control, sterile processing and Operating Room professionals.” The roast was attended by representation from the northern and southern chapters of the Association for Practitioners in Infection Control (APIC), the New Jersey Healthcare Central Service Association, the International Association of Healthcare Central Service Materiel Management (IAHCSMM), Association of peri-Operative Registered Nurses (AORN) and various New Jersey Department of Health Sanitarians and licensing personnel. Many of the attendees performed skits; both chapters of APIC, Tony Campano representing IAHCSMM, Maresca and Chobin dedicated Tina Turner’s song “Simply the Best” to Tony. A plaque recognizing Tony for his work was presented at the end of the evening by Chobin and Ann Cofiell. According to Chobin, “this evening was not just about certification. This evening was a chance to formally thank Tony for going above and beyond his job to enhance patient care and promote the sterile processing profession. How lucky can we get to have someone like him?”
In this Issue:
HPN
names The
Cleveland
Clinic Health System as
2005 Materials Management Department of the Year
56 hospitals collaborate to prevent surgical
infections;
QIO-led program cuts infection rate 27% in a year
Senators
want funding to
fill VA's $1 billion deficit
National HIV Testing Day:
Number of HIV cases among
women on the rise; most new infections reported in South
ASHES award applications and
nominations due July 15
Healthcare Purchasing News (HPN), the market’s first choice for hospital and healthcare facility business news and analysis, has selected The Cleveland Clinic Health System – an IDN comprising 11 hospitals and multiple non-acute care facilities in the Cleveland, OH, metropolitan area and South Florida – for its second annual Materials Management Department of the Year Award. The Cleveland Clinic’s materials management team, under the leadership of senior director Nancy Huber, was chosen from among many applicants across the country based on logistics and supply chain performance in the areas of teamwork, innovation/creativity, savings to hospital, originality, long-lasting results, contribution to quality care, productivity, efficiency and customer service. Huber is supported by directors Dennis Mullen, Donald Diver, Alan Wilde Jr., and William Feran. According to HPN senior editor Rick Dana Barlow, “Although we selected three finalists from a stack of noteworthy nominations, each of which reported some very impressive accomplishments and seemed to be ahead of the curve in many ways, we felt that The Cleveland Clinic captured the winning edge. The facility’s materials management department simply is a top-flight organization.” During the last five years, the materials management department at The Cleveland Clinic generated more than $66 million in cost reductions through various techniques and technologies that leveraged its considerable investments in people, innovation and technology. One of the hallmarks of The Cleveland Clinic’s success is its ability to manage external operational support as part of its internal staff’s responsibilities. “Working to streamline processes for its customers, including clinical end users and administrative back office staff members, the department not only has embraced information systems to automate functions and improve productivity, but also has mastered the delicate balance between relying on internal expertise and external sources,” said Barlow. “While some organizations can attribute much of their success to the efforts and recommendations of a consulting firm, GPO or supplier, if not a combination of all three, The Cleveland Clinic instead maintains more control over its destiny, tapping outside experts when it fulfills an internal purpose – essentially using them as a means to an end rather than the end itself.” Assisting the HPN staff in evaluating entries were John Mateka, editorial board member and a former past president of the Association for Healthcare Resource and Materials Management; Joe Colonna, former president, Strategic Initiatives in Healthcare; and Kary LeBlanc, director of materials management for Terrebonne General Medical Center, HPN’s 2004 Materials Management Department of the Year award winner. Barlow added, “One of our judges perhaps said it the best. ‘What impressed me most is that they seem to have blended different technologies and concepts into a customized model that works well for their organization. They have not taken a single ‘solution’ off the shelf but instead have worked with several different tools to create an environment that will allow them to be successful today and in the future.’” The Cleveland Clinic, and its 64-member materials management team, will be featured in HPN’s July issue. The Cleveland Clinic’s materials management department is hosting an open house event on Thursday, July 7, from 2pm to 5pm.
Fifty-six hospitals from 50 states and U.S. territories, collaborating to improve surgical care, significantly cut the rate of surgical infections for more than 35,000 patients in a year-long, nationwide effort sponsored by the federal Centers for Medicare & Medicare Services (CMS) and led by Qualis Health, the Quality Improvement Organization (QIO) for Washington, Alaska, and Idaho. Results of the National Surgical Infection Prevention Collaborative were reported in an article published in the American Journal of Surgery. Forty-four hospitals that provided data throughout the collaborative reduced their surgical site infection rate by 27 percent. Conducted in 2002-2003, the National Surgical Infection Prevention Collaborative also involved 43 Quality Improvement Organizations (QIOs) working under contract to CMS and laid the groundwork for ongoing QIO assistance to help groups of hospitals in every state prevent surgical infections. The collaborative model for helping healthcare institutions deliver better care was pioneered by the Institute for Healthcare Improvement (IHI) of Cambridge, MA, which recently launched a nationwide campaign to save 100,000 lives by encouraging hospitals to implement a series of patient safety interventions. All teams in the Collaborative agreed to focus on improving performance on three processes that CMS uses as national quality measures: administration of antibiotics within 60 minutes of surgical incision, use of appropriate antibiotics, and discontinuation of antibiotics within 24 hours of the end of surgery. Most of the teams also worked on improving performance on one or more of the following: control of glucose levels during surgery, avoiding hypothermia during surgery, use of supplemental oxygen during surgery and recovery, and clipping rather than shaving the surgical site. Over the course of the collaborative, the median performance of participating hospital teams improved on all process measures. The overall infection rate fell more than a quarter, from 2.3% in the first three months of the collaborative to 1.7% in the last three months. While the final results of the national QIO effort have not yet been announced by CMS, QIOs in more than 30 states report hospitals taking part in this training have shown significant improvement. www.ahqa.org
Senators want funding to fill VA's $1 billion deficit
The Department of Veterans Affairs told Congress that its healthcare costs grew faster than expected and left a $1 billion hole in its budget this year, lawmakers said. Veterans' Affairs Committee Chairman Rep. Steve Buyer (R-IN) said the VA can meet this year's healthcare costs by drawing on spare funds and money from other operations, including construction. But several Democrats, including Senators Dick Durbin and Barack Obama of Illinois, urged the Bush administration to push for an emergency spending bill to fill the deficit. Obama also called for more funding. (Associated Press)
According to a Centers for
Disease Control and Prevention (CDC) report issued earlier this month, the
estimated number of AIDS cases increased 15% among females and only 1% among
males, from 1999 to 2003. Additionally, women develop AIDS at a lower viral
level than men, and consequently, progress more quickly from HIV to AIDS. The
efficiency of male-to-female infection of HIV is more than two times higher than
that of female-to-male infection. Early diagnosis is therefore key to survival.
Further studies show that the increase in reported HIV infections among women is
concentrated in the south. According to data from 32 states which reported to
the CDC, 76% of new HIV infections occurred in southern states, while only 29%
of the nation's women reside there. Other concentrated areas of new HIV cases in
women include the midatlantic and northeast. For women, it is fairly common to
have a sexually transmitted disease and not know it, especially in the early
stages. This can have serious consequences that are specific to women including
infertility or passing the disease to the baby during birth or pregnancy.
June 27th is National HIV Testing Day. The goal of National HIV Testing Day
is to identify HIV-positive people who are unaware they are infected so they may
access treatment and live longer, healthier lives. Getting tested also prevents
new HIV infections by increasing education, awareness, and access to voluntary
counseling and testing. One of the most important challenges is reaching an
estimated 25 percent of HIV-infected persons who don't even know they have it.
www.hivtest.org.
ASHES award applications and nominations due July 15
The American Society for Healthcare Environmental Services (ASHES) provides several awards programs to recognize those who are setting the standard and raising the bar for the healthcare environmental services profession. The awards will be presented at the ASHES Annual Conference in Phoenix on Sept. 28, 2005 during the “A Night with JaniKing” Awards Banquet. The following award applications and nominations are due July 15, 2005. The Phoenix Award recognizes an individual who has made outstanding contributions to the growth and professionalism of the Society and the field of environmental services. The J. Owen Flynn Memorial Award is presented to one who, without compensation, performs services to the benefit of their hospital, community, state, or country. The James Wolffbrandt Mentor Award recognizes an individual who has made a selfless commitment of their time and expertise to mentor professionals in the field of environmental services. The Environmental Stewardship Award is presented to an individual who has worked to preserve our environment through waste reduction, pollution prevention and/or mercury elimination. The Innovator Award is bestowed upon an individual who has developed new and improved methods of achieving cost reduction, quality improvement and enhanced efficiencies. The Recognition Program Award recognizes a member who has developed and implemented a successful employee recognition program. The Scholarship Award provides a limited number of Certified Healthcare Environmental Service Professional exam scholarships. The Excellence in Communication Award recognizes affiliated societies that have excelled in their efforts to communicate with their members, the community, national ASHES, and other affiliated societies. The Excellence in Education Award recognizes affiliated societies that have made a commitment to providing educational opportunities to environmental services professionals. The Networking for Professionalism Award recognizes individual affiliated societies that have accomplished a 10 percent or greater growth in membership over the previous year. Full award descriptions, criteria and online and printable nomination forms are available at www.ashes.org. For more information, contact Becky Adams at (312) 422-3857 or radams@aha.org.
In this Issue:
HIGPA reorganizes; new management to be determined
Flaw found in software used to accredit
hospitals
Guidant requests independent
panel to recommend
physician and patient communication guidelines
Hologic agrees to acquire the
mammography
intellectual property of Fischer Imaging
Cardinal Health, Lahey Clinic
establish a five-year,
$200 million supply agreement
For over two decades, Robert Betz Associates Inc., (RBA) has been serving the public policy interests of various healthcare organizations, including hospitals, pharmaceutical companies, state and national trade associations, and group purchasing organizations, among others. Today, RBA announces that after 15 years of serving the Health Industry Group Purchasing Association (HIGPA) the contract for public policy and association management services will not be renewed. HIGPA is undergoing a reorganization of its structure, governance, membership and staffing of the Association. On June 23rd the HIGPA Board of Directors convened and voted 8 to 5 not to renew the current HIGPA-RBA contract. Since HIGPA plans to operate under an employee-based business model and RBA has a client-based business model, HIGPA and RBA have come to a crossroads. RBA will be unable to serve HIGPA in the new capacity they are seeking. As a result, the current relationship between RBA and HIGPA will end on December 31, 2005, the last day of the current five-year contract. A contractual relationship for certain consulting services may exist beyond January 1, 2006 between RBA and the new trade association to assist with certain components of the new association's organizational structure. RBA wishes HIGPA, its Officers and members the best for the future. Additionally, RBA welcomes the opportunity of serving new healthcare organizations and helping them to meet their public policy objectives.
Flaw found in software used to accredit hospitals
A national organization that enforces quality standards for hospitals said that it had found a flaw in software that it had sold to more than 1,000 hospitals, which use the program to help them qualify for accreditation and payments from Medicare. Joint Commission Resources, a unit of the Joint Commission on Accreditation of Healthcare Organizations, disclosed the defect in a note on its Web site. Many hospital officials across the country said they were reluctant to publicly criticize the commission, which sends auditors to check whether hospitals are meeting more than 1,300 criteria. Robert Curran, director of clinical excellence at the O'Connor Hospital in San Jose, CA, said many hospitals were concerned that they might have lost quality- control data already entered into their systems, reported The New York Times. The software, which costs members several thousand dollars a year for hospital groups, and $495 to $1,095 for small hospitals, is used to help create files showing, for example, that a hospital has fully informed patients of their rights. The problem was a missing identification marker that alerts a hospital to the 250 standards among the 1,300 that the commission and its auditors regard as essential. Without the marker, a hospital might overlook essential categories in which it must verify its compliance. Hospitals failing to meet the essential standards must come into compliance within 90 days and demonstrate to auditors that they remain in compliance during the following four months, a commission spokesman said. Diane Martin, the executive director of Joint Commission Resources, said in a telephone interview that the error was minor and would be fixed today, said The Times. On its Web site, the joint commission said the error was “a production glitch.” Hospitals seeking accreditation are not required to use the Joint Commission Resources software. Jeff Cleary, a spokesman for Xpediate Consulting, said his computer specialists found the omission a few days ago and warned hospital clients of possible problems. Xpediate sells software to assist hospitals with the Joint Commission requirements. (The New York Times)
Guidant requests independent panel to recommend
physician and patient communication guidelines
Guidant Corporation announced its intention to establish an independent panel of experts to recommend guidelines for when to disseminate information to physicians and patients about life-sustaining implantable devices. Ronald W. Dollens, president and CEO of Guidant Corporation, said, “We believe that the industry and the public have the opportunity to learn from the experience that Guidant and its physicians and patients have been through. Recent issues with some of our devices have highlighted the need for clear guidelines for communication about infrequently occurring events. Although Guidant certainly understands and fulfills current regulatory reporting requirements, questions remain as to how companies can most effectively engage in a dialogue with physicians and patients. We believe that establishing this panel is an appropriate step in finding answers to these questions.” Guidant proposes an independent, blue ribbon panel comprised of nationally recognized leaders of both electrophysiology and non-electrophysiology cardiology, as well as an expert patient-consumer advocate, to provide formal and specific recommendations regarding processes and methods to improve, among other things: Surveillance and understanding of infrequently occurring events among life-sustaining implantable devices that may affect physician decisions for their patients; Assessment of benefit and risk to the patients; and Processes of communication to physicians and patients. Guidant also welcomes the announcement that the Heart Rhythm Society will form a Task Force on Device Performance to develop uniform notification standards to inform patients and physicians about device safety. Guidant understands that FDA is undertaking its own initiatives to address concerns about timely and accurate risk communications to patients and physicians. Guidant welcomes the FDA's continued leadership in this matter and looks forward to participating in any effort undertaken by FDA.
Hologic agrees
to acquire the mammography
intellectual property of Fischer Imaging
Hologic Inc., a provider of diagnostic imaging and digital imaging systems directed towards women’s health, announced it has entered into a definitive agreement to acquire the intellectual property of Fischer Imaging Corporation relating to its mammography business and products, including the rights to their SenoScan digital mammography and MammoTest stereotactic breast biopsy systems. Fischer Imaging located in Denver, CO, designs, manufactures and markets medical imaging systems for the screening and diagnosis of breast cancer. Under the terms of the agreement, Hologic has agreed to acquire Fischer’s mammography intellectual property for a cash purchase price of $32 million. The acquisition is expected to close in 90-120 days and is subject to customary closing conditions and the approval of Fischer’s shareholders.
Cardinal Health, Lahey Clinic establish a five-year,
$200 million supply agreement
Cardinal Health Inc. announced a five-year, $200 million supply agreement with
Lahey Clinic Medical Center that is designed to improve efficiency at the
nonprofit group practice and hospital, based in Burlington, MA. Under the
agreement, Cardinal Health will establish a system to automate and improve the
ordering, management and replenishment of pharmaceuticals and medical and
surgical supplies at Lahey Clinic. Through Cardinal Health’s LogisticSource
program, supplies will be reordered automatically upon their use and delivered
directly to the point of care. Cardinal Health will use its Pyxis products to
automate the dispensing, tracking and reordering of medications and supplies.
Its Procedure-Based Delivery System will be employed to provide custom surgical
kits with the supplies required for specific surgical procedures. Consulting
services from Cardinal Health will help facilitate operations. In addition,
Lahey Clinic will continue to utilize the Cardinal Health Pyxis PatientStation
system in patient rooms.
In this Issue:
Kansas
reports nation's first human case
of West Nile in 2005
New FDA approved Chlorhexidine
Gluconate
antimicrobial swabs and swabsticks from PDI
New reports detail DUHS fluid
mix-up; four hospitals
received hydraulic fluid instead of detergent
Chlorascrub, a
new Chlorhexidine Gluconate-based (CHG) product, heralds the
expansion of Professional Disposables International’s (PDI) presence
in the Pharmaceutical market. PDI’s new Chlorascrub features 3.15
percent Chlorhexidine Gluconate and 70 percent Isopropyl Alcohol,
the most precise, effective level of CHG available for healthcare
professionals.
PDI said the Chlorhexidine Gluconate in Swab and Swabstick delivery
systems help address customer demand for ease of use and
affordability. Chlorascrub may be used for a variety of antiseptic
skin preparation needs such as peripheral IV’s, blood cultures and
minor surgical procedures. PDI’s Chlorascrub products will be
available in October 2005. Chlorascrub, The CHG Swab will be sold in
quantities of 100-swabs per box, while Chlorascrub, The CHG
Swabstick will be sold in 50-swabsticks per box, and Chlorascrub,
The CHG Maxi Swabstick will be sold in 30–maxi swabsticks per box.
PDI, Professional Disposables International, is the Healthcare
Division of Nice-Pak Products Inc.
New reports detail DUHS fluid mix-up; four hospitals
received hydraulic fluid instead of detergent
Duke administrators announced Monday that an independent analysis
concluded that hydraulic fluid accidentally used in place of
detergent to wash surgical tools last fall did not compromise the
sterilization process of the instruments. Details of the analysis
were included in a letter sent to the approximately 3,800 patients
who were exposed to the tainted tools at Duke-run Durham Regional
Hospital and Duke Health Raleigh in November and December 2004. The
analysis was performed by Dr. William Rutala, a University of North
Carolina professor and director of the Statewide Program in
Infection Control and Epidemiology at the UNC School of Medicine. He
said he recreated the set-up using samples of the used hydraulic
fluid provided by Duke. “In these laboratory experiments, we found
that replacing cleaning detergent with hydraulic fluid did not alter
the effectiveness of the sterilization process as high numbers of
clinically-relevant bacteria and standard test spores... were
completely inactivated,” Rutala said in the letter. The letter—the
second sent to the affected patients—came on the heels of a report
released June 16 by the Centers of Medicare and Medicaid and the
North Carolina Department of Health and Human Services that said
Duke “failed to ensure quality and safety of supplies” and put
patients in “immediate jeopardy.” CMS officials have since said Duke
is now in full compliance with its standards. Several patients have
stepped forward and blamed post-operative problems on the tools. The
News and Observer reported that 50 patients have contacted lawyers
about the incident. Dr. Victor Dzau, president and CEO of Duke
University Health System and chancellor for Health Affairs, spoke
publicly for the first time about the incident and patients’
responses June 15. “No causal connection has been established
between any of these patients’ outcomes and instruments exposed to
the fluid,” Dzau said. “I want to assure you that the health and
welfare of our patients will always be our top priority.”
According to the CMS report, the root of the incident was an Automatic Elevator Co. employee who, while inspecting an elevator at Duke Health Raleigh, drained hydraulic fluid into empty drums labeled as containing detergent last September. The drums were mistakenly sent back to Cardinal Health, the supplier of the detergent. Without checking the contents, Cardinal Health returned the drums to four hospitals in North Carolina: Duke, Durham Regional, Duke Health Raleigh and Wake Forest University Baptist Medical Center in Winston-Salem. Only the fluid in the barrels at Durham Regional and Duke Health Raleigh, however, were used. The report said the fluid color of the detergent is normally milky, but photographs examined in January 2005 revealed that at least one bin had fluid the color of “maple syrup,” which was later determined to be the hydraulic fluid. Staff interviews at Durham Regional included in the report revealed that several employees noticed “oily instruments” and reported their condition in November. One worker said the instruments had to be “rewashed several times” and that the Engineering Department came to examine the potential problem “at least 6 or 7 times.” According to the report, staff felt “frustrated and ticked off that no one would listen” to its complaints that a problem existed. “The oiliness created double work for all of... [the] staff,” the report states. “They were rewashing by hand as many of the loads as possible.” In December, some staff members said instruments had become even more oily and that “some of the trays were leaving a yellow stain on the white liners.” The fluid mix-up was not identified as the source of the problem until later that month. The report revealed “no surgeries were cancelled based on these complaints.” In addition to rewashing and sterilizing all instruments, Duke changed several of its policies in the wake of the incident. According to the report, for instance, all containers five gallons or larger will be destroyed after being used and container labels will be defaced with a black marker. Duke recently sent a sample of the used hydraulic fluid to an independent laboratory for chemical analysis to determine whether any foreign chemicals or particles were present in the liquid. Officials will report the results of the analysis within a few weeks.
Jeff
Molter, director of the Medical Center News Service, said the Exxon Mobile
Corporation, which produced the hydraulic fluid, was slow to provide the
University with the information about the chemical make-up of the liquid. Duke
asked for the data soon after the incident but only received it June 7.
According to Exxon’s data, if the liquid is injected into or under the skin,
individuals should immediately seek medical attention for “a surgical emergency”
because “surgical treatment within the first few hours may significantly reduce
the ultimate extent of injury.” Bennie Holland, a resident of Coats, NC, was the
first patient to file a lawsuit because of the mix-up. The suit was aimed at
Cardinal Health and Automatic Elevator Co. After surgery Nov. 10,
Holland was diagnosed with a severe infection at Duke Health
Raleigh. He was released but returned two days later complaining of high fever
and other symptoms of infection. Frustrated with the hospital and Duke’s
response, Holland said he sought medical help from the Center for
Occupational and Environmental Medicine in
North Charleston, S.C. A
doctor there diagnosed him with petroleum poisoning.
Holland
said he was taking upwards of 50 pills each day to purify his body and build up
immunity. The medicine worked, he said, adding that his color returned, and he
felt better. But when he returned home to
North Carolina,
Holland had to undergo surgery to have his gall bladder removed because it was
infected. Doctors told him the infection could have been a result of the
petroleum poisoning. Holland said he is still experiencing the effects of the
infection he believes was caused by the tainted tools.
Holland
noted that he hopes Duke will provide patients with more information about the
fluid mix-up. ” (Source: The Duke Chronicle)
http://www.chronicle.duke.edu/vnews/display.v/ART
/2005/06/23/42ba929c5c067
In this Issue:
The new color and shape of
infection prevention
introduced at APIC
ChloraPrep Swabstick also
announced
MedAssets gives three-year
contract to Sage Products
Broadlane awards three-year contract to Propper
DuPont introduces AAMI level 2 and 3 isolation apparel
Task Force To Begin Drafting Recommendations On Manufacturer Notification Standards
ChloraPrep is now available with a new ScrubTeal tint. The new product delivers 10.5-mLs of tinted ChloraPrep solution in a unique applicator that keeps the hands away from the prep site and provides a friction scrub. The patented new tinting technology adds color to the ChloraPrep solution as it passes through the sponge pad. In surgical procedures, specialized nurses and technicians prepare the patient; the ScrubTeal tint assures the surgical staff, including the surgeon, exactly where the patient has been prepped.
ChloraPrep Swabstick also announced
Utilizing an innovative design in swabstick technology, the ChloraPrep Swabstick is now available in single and triple applicators with a design that provides significant improvement in performance over traditional swabsticks. The reinforced handle provides friction while the new polyester, polyurethane foam tip provides non-linting application. Clinical studies comparing chlorhexidine to povidone iodine consistently demonstrate reduction rates of 50% for catheter-related bloodstream infections. Furthermore in clinical practice ChloraPrep has consistently demonstrated a reduction in healthcare associated infections (HAI) when replacing alcohol and iodine. It is now widely used for procedures such as central line insertion, cardiac catheterization, interventional radiology, minor surgery, peripheral IV insertion and blood culture. Also, unlike povidone iodine, ChloraPrep remains active in the presence of blood or organic matter is the only 2% chlorhexidine gluconate/70% isopropyl alcohol preoperative skin prep approved by the FDA that meets CDC guidelines. The ChloraPrep® family of products is manufactured by Medi-Flex, Inc., a Leawood, Kansas-based company.
Effective June 1, Sage Products has been awarded a three-year contract from MedAssets for its Toothette Oral Care, Comfort Bath and Comfort Shield products. The contract was awarded through May 31, 2008. In April, MedAssets honored Sage Products with a Silver Supplier Award at the MedAssets Annual Meeting in Las Vegas. This award recognizes outstanding vendors and is based on improving customer savings and customer satisfaction, filing reports and submitting fee schedules in a timely manner, continuous growth in purchase volume, and supporting MedAssets’ philanthropic efforts.
Broadlane awards three-year contract to Propper
Broadlane Inc. has awarded a three-year contract for fiber optic laryngoscope blades and handles to Propper Manufacturing Co Inc. The contract is effective July 1, 2005 through June 30, 2008.
DuPont Medical Fabrics has announced the availability of DuPont Isolation Wear medical fabrics for level AAMI level 2 isolation apparel and DuPont Suprel Isolation Wear medical fabric for AAMI level 3 isolation apparel. The new medical fabrics meet the new guidelines for protective barriers published by the Association for the Advancement of Medical Instrumentation (AAMI). The fabrics have been developed with DuPont advanced composite technology (ACT). The new bi-component materials offer comfort and protection while making it possible to help protect against the spread of infection. The Suprel Isolation Wear fabric is designed for use during procedures with moderate risk of exposure such as obstetrics, cardiac catheterization and decontamination. The DuPont Isolation Wear is designed for use in procedures with low risk of exposure such as dialysis, outpatient surgery and blood draws.
Task Force To Begin Drafting Recommendations On Manufacturer Notification Standards
The Heart Rhythm Society has formed a task force to begin drafting recommendations for uniform notification standards to inform physicians and patients about safety alerts and recalls of implantable cardioverter defibrillators (ICDs). The Task Force on Device Performance will finalize the standards-including recommendations for physicians on when to replace an ICD-at a public policy conference in Washington in the fall. The meeting will include representation from the Food and Drug Administration (FDA), clinicians, media, manufacturers, and cardiac and patient organizations. “These new guidelines will focus on what is always our first priority: patient safety,” says Anne B. Curtis, MD, president of the Heart Rhythm Society. While the guidelines are being developed, Dr. Curtis says the Heart Rhythm Society concurs with the FDA in recommending that patients affected by recalls seek the medical advice of their heart rhythm specialists. “Patients need to discuss the variety of treatment options available with the heart rhythm specialist overseeing their care,” she says. “Each patient is unique and the decision regarding ICD treatment based on recall information from the manufacturer and the FDA will depend on the patient’s specific medical condition. “Despite recent device recalls, the benefits of sudden cardiac arrest prevention conveyed by the ICD, far outweigh the risk of device failure,” she concludes.
In this Issue:
Medline launches new aloe-lined & latex-free glove
Medical display market shifts
from CRT to flat panel LCD displays
University Of Missouri
hospitals and clinics bring advanced monitoring and telemetry
systems to patient care
Ulcer-causing gatric microbe linked to irregular heartbeat
Hardy Diagnostics earns ISO certification
Medline Industries Inc. is launching Aloetouch 3G , a new latex-free exam glove. Aloetouch 3G gloves are free of latex proteins and coated with pure aloe vera gel. Aloetouch gloves are also certified by the International Aloe Science Council for aloe content and purity. These gloves provide a critical benefit for healthcare workers who commonly develop dry, chapped hands as a result of frequent glove changes and hand washing. As Aloetouch gloves moisturize, hydrate and soothe the skin they help alleviate the discomfort of raw, chapped hands that can often become a barrier to proper hand washing and glove use. Staff morale also improves when their hands look and feel better. Aloe, which comes from the Aloe Vera plant has for centuries been used to help moisturize and soothe dry, chapped skin. Extensive research indicates that aloe enhances skin hydration and softens the skin. In studies, Aloetouch gloves have been shown to effectively moisturize, soothe and hydrate the skin.
Medical display market shifts from CRT
to flat panel LCD displays
Although analog-based cathode-ray tube (CRT) medical display monitors dominated the market until recently due to favorable pricing and economies of scale, liquid crystal display (LCD) monitors are fast gaining ground over them, reports Frost & Sullivan. Compared to CRT displays, high-resolution LCD monitors are far more sophisticated and guarantee radiologists the highest level of differentiation in diagnostic procedures. New analysis from Frost & Sullivan, U.S. Medical Display Monitor Markets, reveals that revenue in this industry totaled $281.1 million in 2004 and can reach $602.9 million in 2011. "Even the field of mammography, one of the last bastions for high-end CRT-based displays, has gradually started adopting LCD monitors following the recent Food and Drug Administration (FDA) approval of five mega pixel high-resolution screens for diagnostic analysis," said Frost & Sullivan Senior Industry Analyst Katherine Shariq. Cheaper CRT displays continue to retain some appeal for many hospital units that often have tight capital budgets. In those circumstances many end users tend to consider the price factor alone when purchasing medical display monitors, and this prevents them from making informed long-term analysis of the pros and cons of true ownership costs. For instance, CRT-based displays are prone to image degradation and drift as early as a year and a half after installation, and require regular manual calibration for the next three to four years of their active life. On the contrary, flat panel display images are very stable and in the rare event of drift occurring, putting in a new backlight can correct the error. However, regular calibration testing continues to be a critical requirement for both types of displays to ensure compliance with the Digital Imaging and Communication in Medicine (DICOM) standard as well as to guarantee that clinicians obtain the most accurate diagnostic images. Such frequent calibration across an entire radiology and picture archiving communication systems (PACS) environment requires a huge amount of administrative time and labor. Many medical diagnostic PACS display manufacturers now offer automated calibration testing, although this has typically been limited to a single display. Due to the routine calibration requirements for both CRT and LCD displays and the similar administrative costs in both cases, end users with tight budgets have not fully evaluated the significantly lower cost of ownership afforded by LCD displays. Flat panel LCD displays are now available with automated calibration software packages. Although more expensive than their manually calibrated counterparts, these automatic solutions offer numerous advantages. If you are interested in a virtual brochure, send an e-mail to Melina Gonzalez, Corporate Communications at mgonzalez@frost.com with your full name, company name, title, telephone number, fax number and e-mail address. http://www.medicalsystems.frost.com
University Of Missouri hospitals and clinics bring advanced monitoring and
telemetry systems to
patient care
Healthcare professionals at University of Missouri Hospitals & Clinics, Columbia Regional Hospital and Missouri Rehabilitation Center are partnering with Spacelabs Medical to enhance patient care and safety by installing state-of-the-art patient monitors and telemetry throughout their facilities. The approximate $6.3 million investment in enterprise-wide patient monitoring and telemetry systems is part of Missouri's initiative to improve the flow of information so that clinicians have instant access to complete, real-time data from anywhere in the university healthcare system. The new system will support rapid, informed decision-making by providing physicians, nurses and other healthcare staff with secure access to patients' vital signs, orders, medication charting, medical records, laboratory reports, test results and other records right at bedside or via the Internet. From an information technology perspective, Spacelabs monitors and networking feature a cost-effective, easily maintained infrastructure that will interface with the hospital's state-of-the-art Cerner information system. Spacelabs patient monitoring systems will be installed in operating rooms and post-acute intensive care units, as well as in intensive care units for pediatric, adolescent, cardiac, post-surgical and burn patients and in telemetry areas for cardiovascular monitoring.
The gastric microbe, Helicobacter pylori, that's the cause of most stomach ulcers also has an effect on the heart, Italian investigators report. They found that people with rapid beating of the upper chamber of the heart, atrial fibrillation, are nearly 20 times more likely to be infected with Helicobacter than are healthy “controls,” according to a report in the medical journal Heart. While the exact mechanism is unknown, Dr. A. S. Montenero, from Policlinico Multimedica in Milan, and colleagues theorize that it may relate to autoantibodies that develop in some H. pylori-infected patients. These antibodies, which normally attack an acid pump found on gastric cells, may instead attack a similar pump on cardiac cells, ultimately triggering atrial fibrillation. The new findings are based on a study of H. pylori tests in 59 patients with atrial fibrillation and 45 healthy controls. In the overall analysis, 97.2 percent of atrial fibrillation patients were positive for H. pylori compared with just 5.3 percent of controls. While the link is “highly significant,” the investigators note that "more data will be necessary from controlled studies to further identify how H. pylori can influence the pathogenesis of atrial fibrillation." (Reuters Health)
Hardy Diagnostics earns ISO certification
Hardy Diagnostics became certified as an ISO 13485 company by the international register, QMI. ISO certification is a quality management standard that began in Europe and has more recently become a globally recognized benchmark of quality. The ISO 13485 standard is designed specifically for medical device manufacturers.
In this Issue:
Ex-Tyco CEO Dennis Kozlowski found guilty
AmerisourceBergen to sell
Bridge Medical to Cerner
Guidant defibrillator recall
Encompass Medical launches
healthcare pillows
made with DuPont fabric
Medline partners with Unilink
Associates
More Specific Criteria
Needed to Classify
Inpatient Rehabilitation Facilities
Tyco International CEO Dennis Kozlowski and former Tyco finance chief Mark H. Swartz were convicted Friday of looting more than $600 million from the company. A state court jury deliberated over 11 days before returning the verdict in the second prosecution of Kozlowski, 58, and Swartz, 44. Both were convicted of grand larceny, falsifying business records, securities fraud and other charges. The verdict came after a four-month trial. They could face up to 30 years in prison according to prosecutors. Kozlowski and Swartz were allowed to remain free on $10 million bail apiece pending an Aug. 2 pre-sentencing hearing. The pair had testified they were unaware of any wrongdoing when they accepted enormous corporate bonuses and hefty loans that were later forgiven by Tyco. Both indicated they would appeal the verdict. Tyco has been reorganizing under new management since Kozlowski left in 2002 amid the charges against him. The company, based in Bermuda but with operational headquarters in West Windsor, N.J..
AmerisourceBergen to sell Bridge Medical to Cerner
AmerisourceBergen Corp (Chesterbrook, PA) signed a definitive agreement to sell substantially all of the operating assets of its Bridge Medical (Solana Beach, CA) subsidiary to Cerner Corp (Kansas City, MO) for approximately $11 million. The agreement also provides for contingent payments based on achievement of performance targets through January 1, 2006. Under the terms of the agreement, AmerisourceBergen will be able to work with Cerner to continue to make available Bridge Medical products as part of AmerisourceBergen's broad suite of patient-safety solutions. The transaction is expected to close in July 2005.
A recall was announced friday by Guidant which includes the Prizm 2 DR, the Contak Renewal and Contak Renewal 2, the Ventak Prizm AVT, Vitality AVT, Renewal 3 AVT and Renewal 4 AVT ICDs. The company said about 63,000 of the devices had been implanted, of which nearly 50,000 are still in use. The recall includes about 38,000 devices used by patients in the United States. Guidant said patients implanted with those devices should continue to see their doctors at three-month intervals and any patients who recently received a defibrillator shock should consult with their physician. Guidant has offered to replace some of the defibrillators, but has not said that removal or replacement is necessary. Guidant said a programming change can be performed for the Prizm AVT, Vitality AVT and Renewal AVT devices at a physician's office to reduce the risk of a short circuit, while defective Prizm 2 DR and Contak Renewal devices will be replaced at no charge. Guidant shareholders in April voted overwhelmingly in favor of a planned $25.4 billion acquisition by Johnson & Johnson Inc. The merger, which needs regulatory approval in the United States and Europe, would be the largest business deal in the 119-year history of New Brunswick, N.J.-based Johnson & Johnson.
Johnson & Johnson continues to work toward a third quarter 2005 close of the acquisition of Guidant Corporation. Nonetheless, the events reported by Guidant are serious matters, and Johnson & Johnson is engaged in discussions with Guidant to help the Company understand the issues.
Encompass Medical launches healthcare pillows made with DuPont fabric
Encompass Medical, a division of Encompass Group LLC is launching two new healthcare pillows made with DuPont Suprel medical fabric. These healthcare pillows offer patient comfort and fluid and stain resistance. Encompass Medical and DuPont will jointly promote the new pillows at the upcoming Association for Professionals in Infection Control & Epidemiology (APIC) convention in Baltimore, MD. Encompass Medical is the exclusive provider of healthcare pillows made with DuPont Suprel medical fabric. Encompass Medical is a provider of disposable and limited use medical products to the healthcare industry. The four Encompass Medical manufacturing entities which are represented and supported by an experienced sales and marketing team headquartered in Dallas, Texas are: Albahealth, Avcor, The Pillow Factory, and TechStyles.
Medline partners with Unilink Associates
Medline Industries recently teamed up with Unilink to offer healthcare employee, surgical and patient apparel to Members of Unilink Associates purchasing organization. Based in Goodlettsville, TN, Unilink's membership includes more than 180 independent uniform/textile rental companies, and more than 400 uniform dealers that sell departmental uniforms, scrubs and patient apparel to hospitals, surgery centers and nursing homes. Throughout this new partnership, Unilink Members are expected to save up to 20 percent on their Medline apparel including scrubs, lab coats and patient and surgical apparel purchases.
More Specific Criteria Needed to Classify Inpatient Rehabilitation Facilities
Medicare classifies inpatient rehabilitation facilities (IRF) using the “75 percent rule.” If a facility can show that during a 12-month period at least 75 percent of its patients required intensive rehabilitation for 1 of 13 listed conditions, it may be classified as an IRF and paid at a higher rate than for less intensive rehabilitation in other settings.Because this difference can be substantial, it is important to classify IRFs correctly. GAO was asked to discuss issues relating to the classification of IRFs, and in April 2005 it issued a report, Med care: More Specific Criter a Needed to C assify Inpatient Rehabilitation Facilities (GAO-05- 366). For that report, GAO analyzed data on all Medicare patients (the majority of patients in IRFs) admitted to IRFs in fiscal year 2003, spoke to IRF medical directors, and had the Institute of Medicine (IOM) convene a meeting of experts to evaluate the use of a list of conditions in the 75 percent rule. This testimony is based on theApril 2005 report. In its April 2005 report, GAO recommended that CMS take several actions, including describing more thoroughly the subgroups of patients within a condition that require IRF services, possibly using functional status or other factors in addition to condition. CMS generally agreed with the recommendations.
As noted in the April 2005 report, GAO found that in fiscal year 2003 fewer than half of all IRF Medicare patients were admitted for having a primary condition on the list in the 75 percent rule. Almost half of all patients with conditions not on the list were admitted for orthopedic conditions, and among those the largest group was joint replacement patients. The experts IOM convened said that uncomplicated unilateral joint replacement patients rarely need to be admitted to an IRF, and GAO analysis suggested that relatively few of the Medicare unilateral joint replacement patients had comorbid conditions that suggested a possible need for the IRF level of services. Additionally, GAO found that only 6 percent of IRFs in fiscal year 2003 were able to meet a 75 percent threshold.
GAO also found that IRFs varied in the criteria used to assess patients for admission, using patient characteristics such as functional status, as well as condition. The Centers for Medicare & Medicaid Services (CMS), working through its fiscal intermediaries, had not routinely reviewed IRF admission decisions to determine whether they were medically justified, although it reported that such reviews could be used to target problem areas.
The experts IOM convened and other clinical and nonclinical experts GAO interviewed differed on whether conditions should be added to the list in the 75 percent rule. The experts IOM convened questioned the strength of the evidence for adding conditions to the list—finding the evidence for certain orthopedic conditions particularly weak—and some of them reported that little information was available on the need for inpatient rehabilitation for cardiac, transplant, pulmonary, or oncology patients. They called for further research to identify the types of patients that need inpatient rehabilitation and to understand the effectiveness of IRFs. There was general agreement among all the groups of experts interviewed that condition alone is insufficient for identifying appropriate types of patients for inpatient rehabilitation, since within any condition only a subgroup of patients require the level of services of an IRF, and that functional status should also be considered in addition to condition.
GAO concluded that if condition alone is not sufficient for determining which types of patients are most appropriate for IRFs, more conditions should not be added to the list at the present time and the rule should be refined to clarify which types of patients should be in IRFs as opposed to another setting.
In this Issue:
New antibiotic for resistant bacteria
Red meat fuels bowel cancer
risk
Implant industry lacks
standards
Panel urges limits on use of
heart drug
Super-oxygenated water may
have potential to kill bacteria
Fungal pesticides may reduce
malaria transmission
Alcon
Receives Approvable Letter from FDA for
RETAANE Suspension
Cost analysis brochure
available on external defibrillators
The Food and Drug Administration approved a new treatment thursday for hospital patients with serious bacterial infections, including those resistant to most other antibiotics. The new drug called Tygacil, from Wyeth Pharmaceuticals, is from the first new class of antibiotics to be marketed in several years. Wyeth said the intravenous drug will be used as a first-line treatment for stomach and skin infections and is effective against enough different bacteria that it will enable its use before doctors know which germs are causing the infection. About 70 percent of the hospital infections are resistant to at least one class of antibiotics. The new drug is from a class of medicines called glycylcyclines, which is related to the tetracycline class. The two are different enough, however, that Tygacil can be used to treat infections including a number of broadly resistant bacteria such as methicillin-resistant Staphylococcus aureus , and because E. coli. The company said it is exploring other uses for the drug, including fighting pneumonia and some pediatric infections. (Washington Post)
People who eat too much red and processed meat increase their risk of bowel cancer by up to a third, according to a new study. The European Prospective Investigation into Cancer and Nutrition (EPIC) concluded the risk of developing the disease for people who regularly ate more than two portions of red and processed meat a day was a third (35 percent) higher than for those who ate less than one portion a week. The latest research, published Wednesday in the Journal of the National Cancer Institute, used data from a study of the diets of more than half a million people across Europe. The study also found the risk of developing bowel cancer increased for those people who had a diet low in fiber. Poultry was not found to influence the risk, but the researchers did find that people who ate more fish faced less chance of developing the disease. The risk of bowel cancer dropped by nearly a third (30 percent) for people who ate one portion or more of fish every other day -- compared to those who ate fish less than once a week. The research was funded by the Medical Research Council. Other risk factors for the disease include obesity and lack of physical activity, smoking and excess alcohol.
Implant industry lacks standards
Even as sales of pacemakers and other widely used heart devices soar, exceeding $8 billion a year, uniform standards do not exist among manufacturers about when, or even if, to notify doctors and patients when the devices have flaws, reports The New York Times. The recent death of a 21-year-old student with an implanted defibrillator made by the Guidant Corporation has thrown a spotlight on the issue, increasing calls that device makers adopt such guidelines. This year, Medtronic alerted doctors about a problem in a defibrillator. Cardiologists and other experts said the episodes underscored a broader issue, that each maker of critical heart devices decides on its own whether to disclose a product flaw. Along with patient safety issues, manufacturers may also consider potential loss of business to competitors and legal liability. Dr. Anne B. Curtis, the president of the Heart Rhythm Society, a group that represents doctors who treat heart problems, and chief of the division of cardiology at the University of South Florida, said the organization was likely to set up a task force soon to try to develop industry-wide guidelines on physician alerts. Several medical experts said it was difficult to monitor how heart devices performed because the Food and Drug Administration, which regulates such products, does not adequately collect data about them after they are approved. In addition, doctors and hospitals, for a variety of reasons, do not notify the F.D.A. about all device-related problems. A similar push a decade ago by physicians for notification standards failed because of a lack of industry and government support, said one doctor involved. But since then, both the use of implanted heart devices and public financing of them have rapidly expanded. Last year, combined sales of pacemakers and defibrillators exceeded $8.3 billion, according to one estimate. In January, Medicare expanded by one-third the number of people who could qualify for defibrillator implants, extending coverage to about 500,000 patients. Under F.D.A. rules, producers of medical devices must report product problems and inform the agency when they decide to recall a product or alert physicians about an issue. But the agency gives manufacturers discretion over how to judge the seriousness of a problem.
Super-oxygenated water may have potential to kill bacteria
Super-oxygenated water has
been used for years as a powerful disinfectant, but now a California company has
developed a non-toxic formula that can kill bacteria without hurting healthy
tissue. Microcyn, made from water and salt, is produced by a company called
Oculus, which spent four years developing the spray. Its makers say it can speed
up the healing of life-threatening burns and wounds, including diabetic ulcers.
Another benefit promoted by the company is that instead of a shelf life of hours
or days, the substance can stay effective for years. The product is already
being used as a disinfectant in Europe, Canada and India. In the United States,
Microcyn has won approval from the Food and Drug Administration as a medical
device. A veterinary version of Microcyn is available to treat wounded pets, but
starting next month a human version will be available to U.S. doctors and
hospitals. Clinical trials testing a variety of possible applications for
super-oxygenated water are in the planning stages.
Fungal pesticides may reduce malaria transmission
Mosquitoes carrying a
malaria parasite that were exposed to surfaces coated with fungus-based
pesticides had a dramatically reduced ability to transmit malaria, findings from
an animal study suggest. Fungal pesticide sprays "might replace or supplement
chemical insecticides for malaria control, particularly in areas of high
insecticide resistance," senior author Dr. Matt B. Thomas, from Imperial College
London, and colleagues write in the journal Science.
The researchers used
rodents to assess the effect that various fungal pesticides had on reducing
mosquito-borne transmission of Plasmodium chabaudi, a malaria parasite that
affects rodents. Exposure to surfaces treated with the fungal pesticides reduced
the number of mosquitoes that were able to transmit malaria by a factor of about
80, the researchers found. Moreover, with exposure periods comparable to what is
likely to occur in natural settings, greater than 90 percent mosquito mortality
rates were achieved. In a related study, Dr. Bart G. J. Knols, from Wageningen
University in the Netherlands, and colleagues showed that a control strategy
using fungal insect pathogens can be implemented in Africa, at the rural village
level, and could markedly reduce malaria transmission rates. (Reuters Health)
Alcon Receives Approvable Letter from FDA for
RETAANE Suspension
Alcon Inc. announced that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for its New Drug Application (NDA) for RETAANE(R) 15 mg (anecortave acetate suspension). RETAANE suspension is an investigational treatment for preserving the vision of patients with wet age-related macular degeneration (AMD). Alcon said it will meet with the FDA to discuss the approvable letter, the clinical studies submitted with the NDA and other ongoing clinical studies for RETAANE suspension to determine the steps necessary to gain final approval for the wet AMD indication. RETAANE suspension is an investigational treatment for maintaining vision in patients with wet AMD. The drug is an angiostatic cortisene that inhibits the abnormal growth of blood vessels, a process scientifically known as angiogenesis. Angiostatic cortisenes are derived from the steroid class and engineered to remove chemical groups responsible for side effects, such as the development of cataracts and elevated intraocular pressure leading to glaucoma, while preserving potency against angiogenesis. RETAANE suspension is administered with a blunt-tipped, curved cannula to deliver the drug behind the eye without puncturing the eyeball. This method of delivery avoids the risk of intraocular infection and retinal detachment, the most common side effects associated with injecting therapeutic agents directly into the eye. In addition, RETAANE(R) suspension requires less frequent dosing (once every six months) compared to some other investigational drugs, which are injected into the eye as often as 9 to 12 times a year. No clinically relevant side effects related to the medication or application procedure were reported in the study.
Cost analysis brochure available on external defibrillators
The demand for cost effective products in the external defibrillator market is driving manufacturers to focus on increasing the sales volume and developing higher-end products to sustain their revenues and profit margins. New analysis from Frost & Sullivan (http://www.healthcare.frost.com), U.S. External Defibrillator Markets, reveals that revenue in this market totaled $323.4 million in 2004 and projects to reach $498.3 million in 2011. If you are interested in a virtual brochure, which provides manufacturers, end-users, and other industry participants an overview of the latest analysis of the U.S. External Defibrillator Markets, then send an e-mail to Melina Gonzalez, Corporate Communications at melina.gonzalez@frost.com with the following information: your full name, company name, title, telephone number, fax number and e-mail address. Upon receipt of the above information, an overview will be sent to you through e-mail. Frost & Sullivan Research Analyst Nathan Cohen says, "While most manufacturers are trying to stabilize the standard industry price, smaller companies are using lower prices to gain a competitive edge in the market." Lower prices also ensure easier entry into the cost-conscious public access market that is likely to account for 60.0 percent of AED unit shipments in 2011. However, in addition to the falling device prices, the additional expenses of installation, training of first responders, establishing emergency protocols, tracking device status, maintaining accessories, and data management, among many others are increasing the overall cost for manufacturers. While basic AEDs are critical to maintain market share and increase market penetration, expensive devices with advanced functionalities are essential to increase overall profit margins. Additional monitoring parameters such as cardiopulmonary resuscitation (CPR), pulse oximetry, blood pressure, temperature, and wireless data transfer in high-end non-AEDs are vital to sustain demand from the hospital and pre-hospital markets. U.S. External Defibrillator Markets, part of the Healthcare Patient Monitoring subscription, offers a comprehensive analysis of current dynamics in the U.S. external defibrillator market. The study identifies key market trends, industry challenges, and factors driving overall growth for both AEDs and non-AEDs. Visit www.frost.com.
In this Issue:
AHRQ reveals five most costly medical conditions
Indonesia finds first human case of bird flu
Hospital
investigates TB exposure
DOJ issues opinion on scope of
criminal liability under HIPAA
The Council of Supply Chain
Executives
announces new corporate members
Health Future chooses MedAssets for supply chain
and revenue cycle solutions
A report by the the Agency for Healthcare Research and Quality Medical Expenditure Panel Survey shows five medical conditions (heart conditions, cancer, trauma, mental disorders, and pulmonary conditions) ranked higher than all other medical conditions in terms of direct medical spending in 1997 and 2002. Medical expenditures (in 2002 dollars) increased the most for mental disorders ($11.3 billion) and pulmonary conditions ($10.0 billion) between 1997 and 2002. A comparable pattern was observed in 1997 and 2002 for the mean medical expenditures per person with expenses for medical events associated with the five most costly medical conditions. Among these top five conditions, the mean expenditure was highest for cancer and heart conditions and lowest for pulmonary conditions in both years. These five conditions were determined by totaling and ranking the expenses for the medical care delivered for the diagnosis and treatment of acute and chronic conditions. In 1997, the largest share of total medical expenditures (in 2002 dollars) was for heart conditions (10.4 percent), cancer (8.2 percent), and trauma (8.0 percent). In 2002, the share of total healthcare expenditures for cancer was 6.0 percent, comparable to the shares for mental disorders (5.9 percent) and pulmonary conditions (5.6 percent). A comparable pattern was observed in 1997 and 2002 for the mean medical expenditures per person with expenses for medical events associated with these five most costly medical conditions. Among the top five, the average was highest for cancer ($6,351 and $4,462) and heart conditions ($4,120 and $3,434) and lowest for pulmonary conditions ($854 and $901) in 1997 and 2002, respectively. Average medical expenditures for people with expenses for mental disorders ($1,798 and $1,522) and trauma ($1,454 and $1,561) were less than for cancer and heart conditions but more than for pulmonary conditions ($854 and $901) for 1997 and 2002, respectively. Between 1997 and 2002, the number of people with medical expenses increased for all of the top five medical conditions except trauma. The largest percentage increase during this period was for mental disorders (55.0 percent, 20.1 to 31.2 million), followed by cancer (24.3 percent, 8.7 to 10.9 million) and pulmonary problems (21.7 ercent, 41.3 to 50.2 million). http://www.meps.ahrq.gov/papers/st80/stat80.pdf
Indonesia finds first human case of bird flu
The
first human case of bird flu was identified in Indonesia after a poultry worker
tested positive this month, a World Health Organization (WHO) official said on
Thursday. But the poultry worker shows no symptoms of the disease, and due to
the low concentration of antibodies he no longer carries the virus, an official
said. The poultry worker was first tested in March after an outbreak hit South
Sulawesi province killing around 25,000 fowl. Out of the 81 people tested, his
test at a Hong Kong laboratory showed a positive result, prompting another
examination. The H5N1 virus has killed 54 people across Asia, including 38
Vietnamese, 12 Thais and four Cambodians since late 2003. (Reuters)
Hospital investigates TB exposure
A Veterans Affairs
hospital is asking hundreds of patients and staff to be tested for tuberculosis
after learning a worker was diagnosed with the disease. Dr. Michael Charness,
chief of staff at the
West Roxbury, MA hospital, said Wednesday the hospital, after
consulting with the Boston Public Health Commission, is asking more than 200
staff and more than 700 patients to be tested. A spokesman for Democratic
Massachusetts Rep. Stephen Lynch said he learned from the House Veterans Affairs
Committee that the worker was a female surgical intern who also had worked at
Cape Cod
Hospital,
Boston Medical Center and Brockton Hospital. A spokesman for Brockton Hospital,
said the worker was at the hospital about six months ago, and the hospital was
in the process of assessing who should be tested.
Cape Cod
Hospital said the intern had worked at the hospital in January; a spokesman said
the hospital was working to identify who should be tested, and to determine if
she was tested when employed there. (The Associated Press)
DOJ issues opinion on scope of
criminal liability under HIPAA
In a June 1 opinion requested by the Department of Health and Human Services, the Justice Department's Office of Legal Counsel said that covered entities, which would include hospitals, may be prosecuted for criminal violations under the Health Insurance Portability and Accountability Act. The "knowingly" element of the offense requires the government to prove only that the violators had knowledge of the facts that constitute the offense, but not that they knew their conduct violated the law, the opinion adds. Depending on the case facts, directors, officers and employees of covered entities may be directly liable for HIPAA violations in accordance with general principles of corporate criminal liability. In addition, the opinion says, others who may not be directly liable may be prosecuted under principles of aiding and abetting and conspiracy. (AHA News Now) http://www.usdoj.gov/olc/2005opinions.htm
The
Council of Supply Chain Executives
announces new corporate members
The Council of Supply Chain Executives (The Council), a division of the Institute of Healthcare Executives and Suppliers (IHES), announced the addition of two new corporate clients to its network of supply chain companies. The Council provides insight and offers hospital leadership information to companies seeking to grow their hospital supply businesses. The new corporate members are Cook Medical Inc. and Philips Medical Systems. www.Councilhome.com.
Health Future chooses MedAssets for supply chain
and revenue cycle solutions
MedAssets announced a new agreement with Health Future, a Medford, Oregon-based
hospital group, for supply chain management and purchasing solutions. The five
year agreement was effective May 23, 2005. Health Future formerly utilized
Amerinet supply chain management services and has a total annual supply budget
of $200 million. Health Future was formed in 1979 by
several hospitals in
Oregon for the
purpose of offering programs and services to its members that not only provided
cost savings, but offered additional value as well. Since this time, the
organization has expanded to include facilities in Oregon, southern Washington
and northern California.
As part of the agreement,
Health Future will be using an online custom catalog that will streamline
operations and increase purchasing efficiencies in this multi-hospital system.
The MedAssets agreement will enable Health Future to maintain regional and local
contracts that offer significant cost savings, as well as take advantage of
national MedAssets contracts. Health Future will also access MedAssets’
Strategic Information tool which allows users to aggregate, analyze and act upon
their procurement data to maximize savings opportunities. Consideration will be
given to implementing MedAssets Net Revenue Systems’ revenue cycle tool suite
that includes chargemaster monitoring and maintenance, charge capture auditing
on a prebill basis, and comparative rate modeling.
Wednesday, June 15, 2005
In this Issue:
Integrated Surgical Systems ceases operations
Bristol-Meyers self-imposes
ban on new drug advertising
ISMP alerts lead to important safety changes
AAEEH to select purchasing
partner
for new five year agreement
Hospitalizations
for diabetes fall
Integrated Surgical Systems Inc. (Davis, CA) terminated its employees and ceased operations on June 2, 2005, days after winning a court ruling that dismissed a lawsuit against the company over its robotic surgery tools. President and CEO Ramesh Trivedi has stated that his attorneys advised him not to talk to the media. The company made Robodoc, a surgical robot for computer-assisted hip- and knee-joint replacements. Revenue in 2004 was $2.4 million, down 60 percent from 2003. Further details were not disclosed.
Bristol-Meyers self-imposes ban on new drug advertising
The drug
maker
Bristol-Myers Squibb
said that it had imposed a ban on advertising its new drugs to consumers in
their first year on the market, adopting voluntary restrictions that go further
than what is anticipated in an industrywide advertising code to be announced
next month. The company said it wanted to give doctors time to understand new
products before patients begin asking for them. The 12-month ban is part of a
new advertising code the company has posted on its Web site. In the eight years
since the Food and Drug Administration lifted a prohibition on consumer
advertising, drug ads have become a $3.8 billion business, reported The New
York Times. The Pharmaceutical Research and Manufacturers of America, the
trade group known as PhRMA, is expected to adopt its industry-wide code next
month, but apparently will stop short of embracing anything like the 12-month
moratorium on advertising new drugs. The chief executive of Bristol-Myers, Peter
R. Dolan, is slated to become chairman of the industry trade group next year.
(The New York Times)
ISMP alerts lead to important safety changes
Advocacy by the Institute for Safe Medication Practices (ISMP) has contributed to two major medication safety advances that will help safeguard patients: a recall of several Tylenol products and more requirements for labeling containers used in the sterile operative field. In late March, the USP-ISMP Medication Errors Reporting Program received a practitioner report regarding confusion over the labeling and packaging of children’s Tylenol Meltaways (acetaminophen). The product comes in blister packs that contain either one or two 80mg tablets, but the front of the carton indicates “medicine per dose 80 mg,” and all of the packs are labeled “Children’s Tylenol 80mg.” With the two tablet packs, parents or healthcare practitioners may assume that BOTH tablets should be given to provide the 80mg, resulting in a dangerous double dose that could cause liver damage. ISMP followed up with both the Food and Drug Administration (FDA) and Johnson & Johnson’s McNeil Consumer & Specialty Pharmaceuticals division to stress that the blister package design and labeling could lead to improper dosing. On Friday, June 3, McNeil announced the recall of several Tylenol products for children as a direct result of ISMP’s alert. The Institute has also promoted labeling of containers being used in the sterile field during operations, following a well-publicized fatal error last December in Seattle. Due in part to ISMP’s advocacy, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) announced last week that a new 2006 Patient Safety Goal will focus on labeling of all medications, medication containers (e.g., syringes, medicine cups, basins), or other solutions on and off the sterile field in operative and other medical procedure settings. Actions like these can only occur with cooperation between consumers and practitioners who report their concerns to safety agencies like ISMP, USP, and FDA, and ultimately the medical products industry. www.ismp.org.
AAEEH to
select purchasing partner
for new five year agreement
The American Association of
Eye and Ear Hospitals (AAEEH) announced that the Association is moving forward
with the development of an RFP (request for proposal) for its group purchasing
program. The AAEEH currently contracts with Premier Inc. and is currently one of
its oldest affiliates. The AAEEH has selected Howard Sanders, President of H. E.
Sanders & Associates, of Mahwah, NJ, as its consultant for the RFP and selection
process. Howard Sanders has had a distinguished career in the health care supply
chain having served as a senior executive with Johnson and Johnson and as a
former Senior Vice President and Chief Operating Officer of Premier Purchasing
Partners. The AAEEH plans to release the written RFP around July 1, 2005. “We
are encouraging all qualified group purchasing organizations, as well as other
types of purchasing entities, to submit proposals for this small but important
group of healthcare facilities and institutes,” said Robert Betz, Ph.D., AAEEH
Executive Director. Current plans envision an AAEEH bidder’s conference in Palm
Springs, CA, on October 26, 2005. Notification of award is anticipated by
January 1, 2006 with implementation of new AAEEH GPO contract on or about May 1,
2006. Questions about the RFP process or the AAEEH purchasing program can be
addressed by contacting Dr. Betz at (703) 243-8848 or by email at rbetz@robertbetz.com.
Hospitalizations for diabetes
fall
In this Issue:
CDC: 1 million living with HIV in U.S.
Justice department
investigating Quest Diagnostics
lab test contracts
GAO Report on specialty
hospitals: Information
on potential new facilities
FDA backs plan to monitor drug
safety
through Medicare program
Medline
launches new cost management program
Quest Diagnostics, a provider of medical lab tests, said that the Justice Department was investigating its contracts and business dealings with major public and private healthcare providers from 1993 through 1999. The investigation is not the first for Quest, which belongs to an industry whose practices have drawn government scrutiny for more than a decade. Among other things, the testing companies have been accused of overcharging, double-billing, paying kickbacks to doctors and classifying services fraudulently in order to receive higher reimbursement. Last October, Quest was among four companies to report that they had received subpoenas as part of an investigation of a hormone test being used on kidney dialysis patients. The new investigation, which is being conducted by the United States attorney's office in New Jersey in Newark, was disclosed in a filing Monday with the Securities and Exchange Commission. Quest said in the filing that it was cooperating with the Justice Department. Although the current chairman and chief executive, Surya N. Mohapatra, became president and chief operating officer of Quest in June 1999, four months after he joined the company, most of the period under investigation predates Quest's current top management. Quest said that the inquiry involved contracts that provided comprehensive testing services to the government or private insurers for a fixed per-patient fee. Quest said that the government wanted information on unspecified “risk sharing” provisions in the capitation agreements, as they are known. Such contracts are often exceptionally complex because they typically cover millions of patients and may include tests the diagnostics company must send out to subcontractors. Some run as long as five years, and the parties must anticipate how technology will develop. (The New York Times)
GAO Report on specialty hospitals: Information
on potential new facilities
To help Congress consider the likely consequences of the expiration on June 8, 2005, of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) moratorium on new specialty hospitals, Congress asked GAO to provide updated information on the potential growth in the number of physician-owned specialty hospitals. Specialty hospitals in operation as of November 18, 2003, are grandfathered under the moratorium and are allowed to expand within limits. This report addresses: (1) How many applications for grandfather determinations has CMS received from specialty hospitals under development, what types of specialty hospitals applied, where were these hospitals located, and how many of the applications have been approved? (2) What information exists to indicate the likely number, location, and type of specialty hospitals not exempt from the moratorium that may be developed following its expiration? As of April 29, 2005, CMS had received 40 applications from specialty hospitals under development seeking determinations that they were grandfathered under MMA's moratorium, including 38 applications for new specialty hospitals and 2 for specialty hospital expansions. Slightly more than half (22) of the 40 applications were from surgical hospitals, while the rest were from cardiac hospitals (9), orthopedic hospitals (5), or hospitals that did not indicate their specialty (4). Three-fourths of the applications came from hospitals in four states: Texas (19), Louisiana (6), California (3), and Oklahoma (3). After reviewing the applications, CMS issued 12 favorable opinions (approvals) and 2 unfavorable opinions (denials). For the full report, go to http://www.gao.gov/new.items/d05647r.pdf
The Food
and Drug Administration on Monday endorsed an idea that experts said could
greatly improve the nation's drug safety system: using information from the
forthcoming Medicare prescription benefit to spot problems with new medications.
The “FDA strongly supports the use of data from Medicare … to identify safety
risks for recently approved medications and to learn more about the real-world
outcomes of medication use,” Dr. Janet Woodcock, the FDA's acting deputy
commissioner for operations, said in a statement. Agency officials had
previously been noncommittal about the Medicare idea, which originated under the
offices of Medicare Administrator Mark McClellan. A former FDA chief, McClellan
is interested in creating a computerized system to automatically monitor the
safety and effectiveness of the medications the government will subsidize for
seniors starting Jan. 1. The FDA's database relies on voluntary reports of
problems and is estimated to miss 90% or more of serious drug reactions. But
McClellan wants to take billing data from the prescription program and combine
it with healthcare information already collected when doctors and hospitals
submit claims for services to Medicare beneficiaries. Personal information would
be removed from the files. Computer programs could look for statistical
associations between taking a prescription and medical outcomes. In theory, it
could shed light on whether one type of cholesterol drug is more effective than
others. It might also be able to pick up early signs that taking a medication
could make some patients more susceptible to heart problems, for instance. The
system would cover four out of every 10 prescriptions written in the country.
Medicare officials hope it would also identify problems resulting from the “off
label” use of medications. Medicare and FDA officials held a public meeting in
Baltimore on Monday to gather suggestions from insurers, the medical community,
the drug industry and others. (The Los Angeles Times)
Medline launches new cost management program
Medline Industries Inc. is launching “Medline Optimal,” a new cost management
program that helps hospitals and health systems assess and streamline operations
to generate improved efficiency and significant savings. The two-phased program
provides a complete logistical, labor and PAR (inventory) level analysis which
will identify opportunities to streamline methods and systems focusing on total
cost reduction. Optimal's Impact Assessment Study covers warehouse operations,
distribution processes, FTE allocation and purchasing practices. In addition,
the program plots the facility's labor performance to comparable averages and
norms. Also each PAR area is analyzed and optimal inventory levels are
established. Optimal's supply chain consulting and utilization and
standardization programs include: Supply Chain Consulting Services; E-Commerce
Impact Assessment; and Utilization and Standardization Programs.
In this Issue:
Surgery tools were washed in hydraulic fluid
Deadline approaches for
hospitals to review
CMS validation results
FDA to review heart drug
intended for African Americans
FDA approves a new combination
vaccine to help protect
adolescents and adults against whooping cough
Aggresive diabetes treatment
helps
prevent pregnancy complications
About 3,800
patients at two hospitals run by Duke University Health System
(Raleigh, NC) were operated on last year with instruments that were
washed in hydraulic fluid instead of detergent, hospital regulators
said. Duke Health Raleigh and Durham Regional hospitals put patients
in “immediate jeopardy” in November and December by not detecting
the problem, despite complaints from medical staff about slick
tools, according to a report by the Centers for Medicare & Medicaid
Services. The hospitals did not fix the problem for weeks, said the
agency. The mix-up apparently occurred when an elevator company
drained hydraulic fluid into empty detergent barrels last summer.
The detergent supplier later picked up the barrels and mistakenly
redistributed them as washing fluid. Duke Health officials assured
patients in January that the likelihood of infection from the tools
was “no more than the risk normally associated” with the procedures
that the patients underwent. However, dozens of patients who were
exposed to the surgical instruments have reported lingering health
concerns ranging from fatigue and joint pain to problems requiring
hospitalization, The (Raleigh) News & Observer reported Sunday. At
least 50 patients who developed complications have taken their
concerns to lawyers, though no one has sued Duke or the hospitals.
Two lawsuits have been filed against the elevator company and the
detergent supplier. Duke Health officials declined to comment
further, citing possible lawsuits. (The Associated Press)
Deadline approaches for hospitals to review
CMS validation results
Hospitals have 10 working days from the date of posting to review the results of
a recent validation audit of their third-quarter 2004 quality data and make any
necessary appeals, according to the Centers for Medicare & Medicaid Services.
The data includes a validation rate for all quality measures applicable to the
five patient charts audited, as well as a validation rate for the 10 quality
measures hospitals must report to CMS for a full Medicare inpatient payment
update. A recent CMS proposed rule would require hospitals to achieve an 80%
validation rate, meaning CMS must be able to confirm 80% of the data is accurate
to qualify for a full update in fiscal year 2006. The validation results are
available for review at the
QualityNet Exchange Web
site at
http://qnetexchange.org/public/ (AHA News Now)
FDA to review heart drug intended for African Americans
Eight years after the heart failure treatment drug BiDil was rejected for use in the general public due to inconclusive evidence, a Food and Drug Administration panel will consider whether BiDil should become the first drug intended for one racial group, in this case, African-Americans. A study of 1,050 African-American heart failure patients showed that BiDil significantly reduced death and hospitalization, prompting the American Heart Association to call BiDil one of the top developments of 2004. BiDil increases levels of nitric oxide, which widens blood vessels. The drug's maker, NitroMed Inc., says its decision to test and market BiDil as a drug for African-Americans is based on solid science. But BiDil's application has stirred controversy, with many scientists convinced that race is too broad and ill-defined a category to be relevant in determining a drug's approval, especially since geneticists have failed to identify a biological divide separating one race from another, reported The New York Times. The idea of seeking approval of BiDil for African-Americans grew out of a study at veterans hospitals in the 1980's. The research indicated that the drug, a combination of two generic drugs, worked better in African-Americans than in whites. But the strategy of focusing on African-Americans carries extra benefits for NitroMed, which used the drug's racially specific indication to extend BiDil's patent protection by 13 years, to 2020. And to prove the drug works in African-Americans, NitroMed conducted narrowly focused clinical trials, which cost less than the trials required in the broader population. Many physicians contend that BiDil will work in other races, too. Recognizing racial controversy as a potential deterrent to BiDil's approval, NitroMed reached out to African-American politicians and physicians, including the Association of Black Cardiologists. After considerable debate, the heart doctors agreed to be co-sponsors of BiDil's clinical trial. According to the executive director of the Association of Black Cardiologists, Dr. B. Waine Kong, NitroMed paid the group $200,000 for its assistance with the BiDil trial. (The New York Times)
FDA approves a new combination vaccine to help protect
adolescents and adults against whooping cough
The Food and Drug Administration (FDA) approved a new vaccine for a single
booster immunization against pertussis (whooping cough), in combination with
tetanus and diphtheria, for adolescents and adults 11-64 years of age. The
vaccine will be marketed as Adacel by Aventis Pasteur Limited located in
Toronto, Canada. Adacel is the first vaccine approved as a pertussis booster for
adults. Adacel is a Tetanus Toxoid (T), Reduced Diphtheria Toxoid (d) and
Acellular Pertussis Vaccine (ap), Adsorbed. Adacel contains the same components
as Daptacel, a DTaP vaccine indicated for infants and children manufactured by
Aventis Pasteur Limited, but the diphtheria toxoid and one of the pertussis
components are in reduced quantities. Recently, FDA approved a similar vaccine
called Boostrix, manufactured by GlaxoSmithKline, for use in adolescents 10-18
years of age. Since 1980, the rates of reported pertussis cases have been
increasing in adolescents and adults, as well as in young infants. The ability
of Adacel to protect against pertussis was assessed by comparing the antibody
responses of adolescents and adults who received it with the antibody responses
of infants who had received Daptacel in a clinical trial. The antibody responses
of the adolescents and adults who received a single dose of Adacel were at least
as good as those observed in the infants following three doses of Daptacel. For
diphtheria and tetanus, the antibody responses following Adacel were comparable
to those following immunization with a U.S. licensed Td vaccine. In clinical
trials, the safety of Adacel was compared to a U.S. licensed Td vaccine. Among
adolescent recipients of Adacel, injection site pain and low grade fever were
observed more frequently than among those who received Td vaccine. Rates of
adverse reactions were similar in adults receiving Adacel vaccine or receiving
Td vaccine.
Aggresive diabetes treatment helps
prevent pregnancy complications
Women who develop diabetes during pregnancy give birth to healthier babies if they are aggressively treated, concludes a large new study that helps bolster the case for testing all pregnant women for this condition. The study, by Australian researchers, is the first to show that treatment can help avoid serious problems at birth. Although complications are uncommon, they were four times lower among babies of mothers who were aggressively treated. No babies born to the 490 women getting more aggressive care died. There were three stillbirths and two other infant deaths among the 510 mothers who got regular care. Results of the study will be published in the New England Journal of Medicine on Thursday and were to be presented Sunday at an American Diabetes Association meeting in San Diego. Gestational diabetes affects 3 percent to 7 percent of pregnant women in the United States, a number that is on the rise because of the growing obesity problem. The American College of Obstetricians and Gynecologists, backs diabetes screening for all pregnant women. In the study, researchers followed 1,000 women diagnosed with gestational diabetes. During their third trimester, the women were separated into two groups: One group was taught to aggressively manage their diabetes through special diet, blood sugar monitoring and insulin therapy. The other group received regular prenatal care. Researchers found that aggressive treatment was linked to better birth outcomes. Four percent of babies whose mothers received routine care developed complications, such as shoulder damage, bone fracture, nerve problems or death, compared to 1 percent of babies whose mothers received aggressive care. Women who tightly controlled their diabetes were less likely to deliver extremely large babies weighing more than 8 pounds, 21 percent of babies whose mothers were regularly treated were oversized compared to 10 percent in the other group. Researchers also compared depression and mood in 573 mothers three months after delivery and found that women who were rigorously treated fared better. (The Associated Press)
In this Issue:
CMS outlines next steps as moratorium
on new specialty hospitals expires
Joe Colonna to step down as CEO of SIH
Court rules stent infringes
patents
AHRQ awards more than $8
million to further
evidence-based patient safety practices
Cardinal Health launches Pyxis
ParAssist handheld
inventory management system
In the Medicare Modernization Act of 2003, Congress instructed CMS to prohibit physician-investor referrals to specialty hospitals for a period of 18 months, ending June 8, 2005, unless the hospitals were already under development as of November 18, 2003. The Centers for Medicare & Medicaid Services will undertake over the next six months a review of its procedures for enrolling specialty hospitals in the Medicare program. In addition, CMS will undertake a series of steps to reform Medicare payments that may provide specialty hospitals with an unfair advantage over other types of providers, such as community hospitals and ambulatory surgical centers. The steps are designed to promote true and fair competition in hospital services, while improving quality and avoiding unnecessary costs for patients and for the Medicare program. Key steps include: Reform payment rates for inpatient hospital services through changes to the DRG system; Reform payment rates for ambulatory surgical centers (ASCs); Review procedures for approving hospitals for participation in Medicare and closely scrutinize processes for approving and starting to pay new specialty hospitals; CMS also plans to seek public comment on the appropriate standards for specialty hospitals. Specifically CMS will seek advice from the EMTALA Technical Advisory Group (TAG) and will solicit public input on certification issues related to specialty hospitals. CMS will host an Open Door Forum in September 2005 that will provide an opportunity for live dialogue between CMS and the provider community at large. For more on the Open Door Forum, visit www.cms.hhs.gov/opendoor. During this review, CMS is instructing its regional offices not to issue new specialty hospital provider agreements or authorize an initial survey by the state survey agency for new specialty hospitals. Medicare fiscal intermediaries have been instructed not to process new provider enrollment applications for specialty hospitals until further notice. The suspension does not apply to those specialty hospitals that have prior to June 9, 2005, submitted an enrollment application or have requested an advisory opinion from CMS concerning whether they were subject to the moratorium under section 507 of the MMA. CMS plans to complete its review process by January 2006. http://www.cms.hhs.gov/media/press/release.asp?Counter=1478
Joe Colonna to step down as CEO of SIH
According to Bill McFaul, Chairman of Strategic Initiatives In Healthcare, LLC, Joe Colonna, the company President and CEO has decided to resign from his position effective June 17, 2005. McFaul stated: “When we took a look at the incredible impact SIH could have on the industry, we realized that it has grown into something that healthcare has never seen before. Given the nature of the expansion of our direction, Joe believed it was going to take a different kind of leadership to bring SIH's innovative processes to market. Over the past 18 months, he has been a huge asset in contributing to our 15,000 hours of R&D. His input and insight will be missed. We are pleased that Joe has agreed to assist with the transition and to complete several research projects prior to leaving the organization.” According to McFaul, Thomas MacVaugh has been appointed Interim President and CEO. In addition to having been the CEO of his own healthcare consulting firm, over the past 30+ years Mr. MacVaugh has held key executive positions with Premier as well as with Sodexho/Marriott and McFaul and Lyons Inc. Tom was a Founding Board Member of the Health Industry Group Purchasing Association (HIGPA) and is active with the American College of Healthcare Executives (ACHE), the Healthcare Executive Forum (HEF) and the Healthcare Financial Managers Association (HFMA). MacVaugh joined SIH in November 2004 and has been instrumental the growth and development of the organization. www.SIHealthcare.com
Court rules stent infringes patents
Days
before Boston Scientific and Johnson & Johnson head into a federal court in
Delaware over domestic stent patents, Boston Scientific has won a related legal
battle in the Netherlands, reported The New York Times. Boston Scientific
said that a Dutch court ruled that a Johnson & Johnson subsidiary can be forced
to end production of its Cypher stents in the Netherlands and to halt sales of
the drug-coated devices there. The court ruled that the catheter system used to
deploy Cypher into coronary arteries infringes on patents owned by Boston
Scientific. Cordis, the Johnson subsidiary that makes the stent, said that it
would appeal the verdict. Cordis also said that it had enough inventory and
production capacity elsewhere to meet customer demands. The two companies are
the only device makers currently cleared to sell such drug-eluting stents in the
United States.
These include the Cypher stent from Johnson & Johnson and the Taxus from Boston
Scientific. The companies will appear Monday in
Federal District Court
in Delaware over the issue of whether Boston Scientific's stent designs infringe
on two Cordis patents. Cordis won a judgment that earlier Boston Scientific
designs infringed, but Boston argues that the new designs bear no resemblance to
the products in that case. That trial will be followed by a case, starting June
20, in which Boston Scientific will argue that Cordis's use of drugs on the
stents infringes Boston's patents. (The New York Times)
AHRQ awards more than $8 million to further
evidence-based patient safety practices
HHS' Agency for Healthcare Research and Quality announced that it will award
over $8 million in funding for 15 projects over 2 years that are designed to
help clinicians, facilities, and patients implement evidence-based patient
safety practices. The 15 Partnerships in Implementing Patient Safety grants will
use interventions that are ready to be implemented now and will have both an
immediate and a long-term impact. Over half the projects focus on reducing
medication errors, an area known to be in need of patient safety solutions. Many
of the projects will apply interventions to improve healthcare team
communications, also a well-known source of errors. In addition, the
interventions are designed to be generalizable to other settings of care. A key
component of the projects is the development of a set of free, publicly
available toolkits for healthcare providers and others that will share lessons
learned on how to best implement patient safety practices. For example, toolkits
will be developed to help patients keep track of their prescription medicines
when they are admitted to or discharged from the hospital. The projects span a
wide spectrum of settings and populations, including small rural facilities and
large urban hospitals, clinics, and emergency departments, as well as pediatric
and geriatric patients. Because some of the projects involve health systems that
have locations in multiple states, the research projects will span nearly half
of the States. For a complete listing of the 15 projects, go to
www.ahrq.gov/qual/pips.htm.
Cardinal Health launches Pyxis ParAssist handheld
inventory management system
Cardinal Health Inc. launched the Pyxis ParAssist handheld inventory management system in conjunction with the next version of its Pyxis supply product line. The Pyxis ParAssist system helps manage inventory at remote supply locations by collecting data using handheld bar code scanners. This information is stored with data from other Pyxis supply products, such as the SupplyStation secure inventory management system and the JITrBUD wireless open-access inventory management system, at the SupplyCenter console server. With information for all supply locations stored in one central repository, hospitals can increase inventory accuracy, refill efficiency and proactive management of par levels.
Thursday, June 9, 2005
In this Issue:
Grassley letter asks Congress to eliminate
physician self-referral
Study: Uninsured cost insured
$900 more
Drug safety panel urged to examine all
involved
Study finds less-invasive
aneurysm procedure
not better in long run
Harvard study: Sick infants in
hospital ICUs exposed
to high levels of toxic phthalate
Unotron recommends hospitals
conduct computer keyboard
’Germ Audit’, launches first test site
Health
insurance premiums will cost families and employers an extra $922 on average
this year to cover the costs of caring for the uninsured, according to a report
released Wednesday. With the added cost, the yearly premiums for a family with
coverage through an employer will average $10,979 in 2005, said the report from
consumer group Families USA. By 2010, the additional costs for the uninsured
will be $1,502, and total premiums will hit $17,273. In 11 states, the costs of
the uninsured will exceed $2,000 per family. For individuals, the extra charge
this year is estimated to be $341 on average, rising to $532 in 2010. Total
premium charges for individuals will be $4,065 in 2005, and $6,115 in 2010.
Nearly 48 million Americans will lack health insurance for 2005, the report
said. Uninsured patients pay about one-third of the costs of their care provided
by doctors and hospitals, the report said. The remaining costs, more $43 billion
in 2005, are considered “uncompensated care.” The government picks up part of
the tab and most of the rest is added to insurance premiums for people with
health coverage, perpetuating a vicious cycle in which fewer people can afford
insurance, the report said. The report was based on data from the Census Bureau,
the Agency for Healthcare Research and Quality, the National Center for Health
Statistics and other sources. (Reuters)
Drug safety panel urged to
examine all involved
Food and
Drug Administration officials Wednesday urged a panel charged with assessing the
U.S. drug safety system to consider all the players involved, not just the FDA.
“We cannot look at FDA's role in isolation,” FDA Deputy Commissioner Janet
Woodcock told the Institute of Medicine (IOM) committee. The panel, at the
agency's request, is studying how to better protect Americans against harm from
their prescription drugs. The IOM study is one of a handful of steps outlined by
FDA Acting Commissioner Lester Crawford in early November to strengthen the
safety of prescription drugs on the market. The committee will continue to meet
over the next year and plans to issue a report in July 2006, said Blumenthal,
IOM committee Co-chairman David Blumenthal. "How FDA operates is very, very
(much) linked to the larger (healthcare) system," Steven Galson, acting
director of the FDA's Center for Drug Evaluation and Research, told the IOM
committee. Alan Goldhammer, an associate vice president at the Pharmaceutical
Research Manufacturers of America (PhRMA), the prescription-drug industry's
lobbying group, asked why the IOM did not include anyone with industry
experience on the committee. American Pharmacists Association CEO John Gans
called for a larger role for pharmacists in ensuring the correct prescribing and
taking of drugs. (USA Today)
Study finds less-invasive aneurysm procedure
not better in long run
A promising technique for fixing aneurysms in the biggest abdominal artery saves more lives than open surgery initially, but not over the long term, researchers found. In a technique called endovascular repair, a cloth patch is threaded up an artery from the groin to cover the aneurysm in the abdominal aorta. A stent holds the patch in place. Last fall, Dutch researchers reported that the approach reduced patients' chances of dying within a month of surgery by about three-fourths, compared with cutting open the abdomen and sewing in a patch. A larger British study had similar findings. In Thursday's New England Journal of Medicine, the Dutch group reported that after nearly two years spent following 350 patients, about 90 percent were still alive in both groups. The frailest patients were more likely to die soon after the open surgery, but very sick patients surviving the endovascular procedure were more likely to die over the next two years, said lead researcher Dr. Jan D. Blankensteijn, chief of vascular surgery at Radboud University Nijmegen Medical Centre in the Netherlands. “For high-risk patients, endovascular repair is clearly the way to go,” said Dr. Peter J. Pappas, director of vascular surgery at New Jersey Medical School in Newark. Pappas and Blankensteijn said relatively healthy patients likely to live another decade or more should opt for the open surgery. A ruptured aneurysm kills about 80 percent of patients, often within minutes, so if the bulge is big enough, surgeons repair it. About 40,000 procedures are done in this country each year. A growing number of patients are now demanding the endovascular procedure, believing it is best, Pappas said, despite the suspicions of many vascular surgeons that open surgery is better in the long term. He said that over years, the endovascular grafts can slip out of place, leak or be punctured by the metal stent. The results of a few years' follow-up from the British study, expected within weeks, could disprove that. Better grafts now in development may improve survival, Pappas added. (The Associated Press)
Harvard study: Sick
infants in hospital ICUs exposed
to high levels of toxic phthalate
A first-of-its-kind study released by Harvard University scientists found that babies in Neonatal Intensive Care Units (NICUs) receiving intensive therapy with polyvinyl chloride (PVC) medical devices were exposed to a toxic phthalate at very high levels, an average of 25 times higher than the general population and up to 50 times higher for the most exposed. As their medical treatments intensified, the sick infants were exposed to progressively higher exposures of di(2-ethylhexyl) phthalate, or DEHP. DEHP is a reproductive toxicant that alters development of the male reproductive system in laboratory animal studies. The phthalate is used to soften PVC (vinyl) plastic medical devices such as IV bags and tubing, and it oozes out of the plastic and into patients’ bodies. The U.S. Food and Drug Administration (FDA) has warned healthcare providers to protect certain vulnerable patients, including male infants, from DEHP-containing PVC medical devices, but many hospitals are still using these devices despite the availability of cost-effective alternatives. The peer-reviewed study, published in Environmental Health Perspectives, compared infants in two Boston-area NICUs and found significantly lower phthalate levels in the babies who received care at the hospital that had switched to DEHP-free medical devices for some applications. http://www.noharm.org
Unotron recommends hospitals conduct computer keyboard
’Germ Audit’, launches first test site
Amid growing documentation that computer keyboards are a source of contamination and may account for the spread of infection, Unotron invites infectious disease (ID) professionals and other information technology decision-makers at hospitals and healthcare organizations to evaluate the extent of contamination and potential risk of transmission of pathogens to patients. In conjunction with LibertyHealth Meadowlands Hospital Medical Center, Unotron (www.unotron.com), manufacturers and marketers of SpillSeal washable computer keyboards, is developing protocols for assessing keyboard contamination and effective disinfection. Marc Cisneros, chief operating officer at Unotron, said, “Studies show that a disinfectant that remains on a keyboard for 10 minutes before cleaning is even more effective than one that was supposed to be removed after five minutes.” He also points to a study assessing the extent of contamination on computer keyboards in the acute care, ambulatory care, and long-term care areas of a Veterans Affairs Medical Center. The study showed that of 100 cultures performed, 95 had growth of one or more microorganisms, and most were positive for skin organisms (e.g., coagulase-negative Staphylococcus, Bacillus species, or Corynebacterium species) while five percent were positive for pathogens known to be associated with nosocomial transmission. Unotron’s patented SpillSeal technology, which seals and protects keyboards from liquid or airborne penetration, addresses these unique infection control challenges.
In this Issue:
Court says OxyContin patent is invalid
Woman has baby after ovary transplant from
twin
U.K. superbug outbreak may be linked to
Canada
Sharp claims new technology can combat bird
flu virus
Texas hospital implements QuadraMed point-of-care
medication management system
Court says OxyContin patent is invalid
A
federal appeals court found yesterday that Purdue Pharma had deliberately misled
the government to win patent protection for its powerful painkiller OxyContin.
The ruling, which makes patents on the drug not enforceable, opens the door to
increased generic competition, as well as potentially huge legal awards against
Purdue, reported The New York Times. The unanimous ruling by a three-judge panel
of the United States Court of Appeals for the Federal Circuit in Washington is a
victory for Endo Pharmaceuticals Holdings, which is seeking to market a generic
form of OxyContin. Purdue Pharma is privately held. OxyContin is a time-release
formulation of a long-used narcotic known as oxycodone. Over the last five
years, its annual sales have averaged about $1.5 billion. Purdue Pharma, a
company based in Stamford,
CT, said yesterday that it believed that it had
properly obtained patent protection for OxyContin and that it planned to seek to
have the court's full panel of 12 judges hear an appeal. Yesterday's appellate
decision upheld the most critical and damaging portion of a trial court ruling
against Purdue Pharma last year. The ruling last year, by Judge Sidney H. Stein
of United States District Court in Manhattan, found that Purdue Pharma had
intentionally deceived patent officials to secure OxyContin's patent by implying
that the company had clinical evidence to show that OxyContin was easier for
doctors to use to control pain, when in fact such data did not exist. That
finding of “inequitable conduct” invalidated Purdue's patent. The three-judge
appeals panel also found, in reviewing the facts of the case that Purdue had
“failed to disclose material information that was inconsistent with its
arguments for patentability.” Currently, 65 lawsuits have been filed by insurers
and others seeking to force the drug maker to disgorge “monopoly,” or excessive,
profits as a result of the improper patent and the higher prices OxyContin
commanded as a result of it. (The New York Times)
Woman has baby after ovary transplant from twin
A woman whose ovaries stopped working when she was a teenager has given birth to a girl after an ovary transplant from her identical twin sister, doctors in St. Louis said on Tuesday. Three months after the operation, the 24-year-old woman began having normal menstrual cycles and she became pregnant two months later, according to the medical team led by Sherman Silber of St. Luke's Hospital. The surgery, which doctors said would probably remain rare, came after two failed attempts at test tube fertilization using eggs donated by her sister. The successful outcome, Silber's team said, may open the possibility for female cancer patients facing treatments that could make them sterile to freeze their ovary tissue and reimplant it later to make them once again fertile. Details of the operation, scheduled to be published next month in the New England Journal of Medicine, were posted on the Journal's web site, www.nejm.org. (Reuters)
U.K. superbug outbreak may be linked to Canada
British health authorities said Tuesday they are investigating a new virulent
strain of bacteria that may have been imported from the United States or Canada.
The germ, a new variety of the bacterium Clostridium difficile, has killed 12
people, almost all elderly, in a hospital outside the capital over the last 18
months, Britain's Health Protection Agency said. Clostridium difficile is one of
the most common hospital-acquired infections around the world and the most
frequent cause of diarrhea in hospital patients. It is found in the gut of about
three per cent of people. The infection usually develops during or after
antibiotic therapy when the drugs disturb the normal balance of bacteria in the
intestine. As with other bacteria, new strains emerge from time to time and some
can be more lethal. Hardy strains of Clostridium form spores, which allow it to
survive on surfaces and make it more difficult to destroy because it resists
normal chemical disinfectants. Initial investigation has found that the strain
found at the Stoke Mandeville Hospital appears similar to one circulating in the
United States
and Canada, the Health Protection Agency said. Stoke Mandeville often attracts
patients from overseas to its highly regarded spinal injuries unit. Scientists
from the Health Protection Agency are speaking with hospitals in the United
States and Canada to determine whether the strain matches the North American one
or whether it evolved in Britain. (Associated Press)
Sharp claims new technology can combat bird flu virus
Tests by Japanese electronics maker Sharp Corp. have found an air-purifier using plasmacluster ion technology was 99 percent effective in killing off the bird flu virus in a controlled environment, a company spokeswoman said. Plasmacluster ions also proved effective against 26 other kinds of harmful airborne substances, including bacteria, mold fungi, viruses and allergens. Plasmacluster ion technology, developed in 2000, is an air-purification technology that disables airborne micro-organisms by releasing positive and negative ions into the air. The Osaka-based company began five months of experiments, testing the technology on bird flu in collaboration with British research institute Retroscreen Virology Ltd, in January before announcing the results. The virus was sprayed into a one-cubic meter box, then plasmacluster ions were turned on. Samples were then taken at 10-minute intervals and injected into cell cultures. The experiment showed that 99 pct of the H5N1 virus was eliminated. Four days after injection, the cells injected with the virus that had not been exposed to plasmacluster ions were deformed and damaged. 'In contrast, cells injected with the virus that had been exposed to plasmacluster ions retained their normal condition with almost no change in evidence,' the company said in a statement. The H5N1 virus has been identified as a possible new strain of flu that could prove devastating if it genetically mutates and develops the capacity to be transmitted from human-to-human. The technology can be installed in air conditioners, dehumidifiers and air purifiers for home and industrial use.
Texas hospital implements QuadraMed point-of-care
medication management system
QuadraMed Corporation announced that Nacogdoches Memorial Hospital, Nacogdoches, TX, is enhancing its existing QuadraMed Pharmacy system by implementing Point of Care MAR with a Medication Ordering module to increase patient safety. QuadraMed Point of Care MAR will give Nacogdoches Memorial the ability to positively identify the care provider, patient and medication at the point of care using bar code scanning.
In this Issue:
Secretary Leavitt takes new steps to advance Health IT
Study shows superbugs live for
weeks on surfaces
Ansell Healthcare’s latest
educational module
explores the hazards of glove powder
Venetec introduces StatLock
IV Premium
Imprivata and Forward Advantage
sign partnership to deliver
enterprise single sign-on to Meditech users
Consorta awards agreement for
image archive services
Health and Human Services Secretary Mike Leavitt announced the formation of a national collaboration and four requests for proposals (RFPs) that will advance efforts to reach President Bush’s call for most Americans to have electronic health records within ten years. The announcement provides a way for patients, doctors, hospitals, insurance companies, and employers to agree on standards for electronic health records and ways to achieve interoperability: the ability to access this vital medical information immediately and efficiently. “The national strategy for achieving interoperability of digital health information is for federal agencies, who pay for more than one-third of all healthcare in the country, to work with private-sector healthcare providers and employers in developing and adopting an architecture, standards and certification process,” Secretary Leavitt said. The cornerstone of this effort, a private-public collaboration called the American Health Information Community (AHIC), will help nationwide transition to electronic health records, including common standards and interoperability, in a smooth, market-led way. The AHIC, which will be formed under the auspices of the Federal Advisory Committee Act, will provide input and recommendations to HHS on how to make health records digital and interoperable, and assure that the privacy and security of those records are protected. HHS will solicit nominations for people to serve on the AHIC and Secretary Leavitt will appoint up to 17 commission members, as well as serve as chairperson. The AHIC will be chartered for two years, with the option to renew and duration of no more than five years. The department intends for the AHIC to be succeeded within five years by a private-sector health information community initiative that, among other things, would set additional needed standards, certify new health information technology, and provide long-term governance for healthcare transformation. HHS will also issue four RFPs to pave the way for interoperability. These RFPs will create processes for setting data standards, certification, and architecture for an Internet-based nationwide health information exchange, as well as assess patient privacy and security policies. In total, HHS will spend $86.5 million on health IT in FY 2005, and President Bush has requested $125 million for health IT in FY 2006. www.hhs.gov/healthit.
Study shows superbugs live for weeks on surfaces
The mutated, drug-resistant “superbugs” that cause an increasing number of hospital infections and deaths can live for weeks on bed linens, computer keyboard covers and under acrylic fingernails, U.S. researchers have reported. The study supports other research that shows super-strict hygiene is needed to battle the bacteria, some of which are now nearly impossible to kill even with the strongest antibiotics. A team at sanitation-services company Ecolab Inc. dabbed methicillin-resistant Staphylococcus aureus onto samples of bed linen, keyboard covers and acrylic fingernails. MRSA could be detected eight weeks later on acrylic fingernails, six weeks later on computer keyboard covers and five days later on bed linens, the researchers told a meeting in Atlanta of the American Society for Microbiology. “The results of this study clearly demonstrate the need for frequent hand washing and environmental disinfection in healthcare settings,” said researcher Kris Owens of Ecolab. Staphylococcus aureus is usually harmless and very common, found on skin or in the noses of about 30 percent of people. It can cause stubborn problems such as rashes and boils and an infection is often mistaken for a spider bite. In hospitals, MRSA can cause serious and sometimes deadly infections, including necrotizing fasciitis or “flesh-eating” disease. It resists almost everything but an intravenous antibiotic called vancomycin. (Reuters)
Ansell Healthcare’s latest educational module
explores the hazards of glove powder
Ansell
Healthcare recently announced the availability of a new self-study educational
module for healthcare professionals. Entitled Understanding the Hazards of Glove
Powder, this module addresses staff, patient, and healthcare economic issues
relative to the wide range of adverse reactions associated with glove powder.
The self-study module, which is available at no charge, has been developed for
use by professionals who are responsible for or involved in hand barrier
protection activities. These areas include educating other healthcare personnel,
establishing organizational policies and procedures, maintaining regulatory
compliance, and managing employee health and infection control services. Upon
completion of this module, the healthcare professional should be able to:
Understand the impact of a powdered glove environment on healthcare personnel;
Describe where powder is used in the manufacturing process; Cite examples of
problems a patient may encounter from powdered glove use; List some of the
materials used to powder gloves. The educational module is accredited by the
Association of periOperative Registered Nurses (AORN), an accredited approver by
the American
Nurses
Credentialing Center’s Commission on Accreditation. The AORN has designated this
educational activity for a maximum of 1.2 contact hours. For more information
about this module and other Ansell educational programs on hand barrier-related
topics, please contact Ansell Healthcare Education Services at 800.952.9916 ext.
7277 or visit Ansell’s online educational services at
www.ansellhealthcare.com
Venetec introduces StatLock IV Premium
Venetec International, makers of StatLock safety securement devices for catheters and other medical applications, announced the introduction of StatLock IV Premium. This device for safely and cost-effectively securing peripheral IV catheters is specially configured to secure the luer-lock of IV extension sets by Hospira Inc. and selected other manufacturers. IV Premium replaces tape securement, providing improved patient comfort, cost savings, and reduced needlestick risk to healthcare workers, by minimizing unscheduled catheter restarts and complications related to tape securement. The new device features a refined, more intuitive design, including an over-the-top, snap-fit retainer, that makes it easier and faster to apply than tape. Clinical studies have shown StatLock products improve catheter dwell times and reduce unscheduled IV catheter restarts by more than 70 percent. Studies also have demonstrated that the devices reduce catheter-related complications such as phlebitis and infiltration by restricting catheter micro-movements.
Imprivata Inc., a provider of enterprise single sign-on (ESSO) technology and Forward Advantage Inc., a provider of workflow solutions to the healthcare industry, announced a strategic alliance to deliver joint identity management solutions to hospitals using MEDITECH worldwide. Meditech’s applications unify clinical, administrative, and financial information across a healthcare organization, including acute care, long-term care, home healthcare, and physician’s practices. Forward Advantage chose Imprivata OneSign as a strategic partner and will resell OneSign through its im-one initiative to Meditech customers. The combined solutions from Imprivata and Forward Advantage bring single sign-on to Meditech users without disruption to the user environment.
Consorta awards agreement for image archive services
Consorta
has awarded an agreement for image storage services to InSiteOne Inc.,
Wallingford, CT. InSiteOne’s advanced technology and fee-per-study pricing offer
Consorta members an alternative to in-house image archiving. InSiteOne’s InDex
product line, available through the Consorta contract, offers a complete range
of DICOM storage services. InDex Online comprises on-site storage on RAID or SAN
with secure off-site permanent archiving in two redundant data centers. InDex
Recovery provides off-site disaster recovery storage for medical images,
ensuring data integrity and business continuity. Using an Internet or network
connection, InDex Web enables real-time, secure Web-based access to images
stored on InSiteOne’s remote DICOM archive. InSiteOne InDex Online for Breast
Imaging is specifically configured to accommodate large data sets and provides
ultra-fast, local access to up to three years of studies.
In this Issue:
HHS report summarizes public’s recommendations
for national health IT network
Medicare offers solution to
drug safety
New vaccines prevent Ebola and
Marburg in monkeys
Florida hospitals brace for
hurricanes
with new systems and safeguards
Tools and models for planning and preparedness
for
bioterrorism
and other public health emergencies
Scientists are reporting a new type of vaccine that prevents Marburg and Ebola viruses in monkeys. Two new vaccines, one for Marburg and one for Ebola, were 100 percent effective in a study of 12 macaques being published in the journal Nature Medicine. Monkeys given just one shot of vaccine and later injected with a high dose of virus did not even get sick. Normally, all the animals would be expected to die. The Marburg and Ebola viruses are closely related, and in both people and monkeys they cause hemorrhagic fevers that can be fatal within a week. There is no vaccine or treatment for either disease. The two new vaccines are still experimental, and will not be ready to be tested in people for at least two years. If human trials are successful, products might be ready for licensing five or six years from now, the researchers said. The vaccines would not be used for routine immunization, but would be given to health workers in high risk areas, virus researchers and people who had been exposed to the disease, such as relatives and others in close contact with sick patients. Eventually, it might be possible to combine the vaccines to protect people from both diseases with a single shot. An earlier vaccine, first proved to protect monkeys in 2003, may go into safety studies in people in the U.S. later this year. Each vaccine has its advocates, and researchers say it is advantageous to have several candidates. The work described in Nature Medicine was done by scientists from the U.S. and Canada, led by Dr. Steven M. Jones and Dr. Heinz Feldmann of the Public Health Agency of Canada in Winnipeg, and Dr. Thomas W. Geisbert of the United States Army Medical Research Institute of Infectious Diseases in Fort Detrick, MD. Dr. Jones said the goal of the research was to provide a vaccine that could be used to stop outbreaks like the one in Angola or to protect people from germ warfare. (The New York Times)
Florida hospitals brace for hurricanes
with new systems and safeguards
Hurricane Charley changed the way Southwest Florida's healthcare facilities
prepare for disasters, reports the Herald Tribune. Storm shutters,
satellite phones and a new roof are in the works at hard-hit Fawcett Memorial
Hospital in Port Charlotte. Streamlined evacuation plans for patients are ready
at Charlotte Community Mental Health Services. And several hospitals are urging
their workers to better prepare their own homes and families for storms this
time around. The changes aren't unique to facilities that sustained heavy damage
last year. Charley forced healthcare companies across the region to use
preparedness plans that had never been battle-tested in a hurricane. Patients
flooded the two emergency rooms still open in Charlotte County immediately after
the storm. After Punta Gorda's Charlotte Regional Medical Center sustained heavy
damage in the storm, officials set up a mobile emergency room across the street.
At Fawcett Memorial in Port Charlotte, the storm damaged the hospital's fourth
floor, where workers today are still wrapping up $7 million worth of repairs.
Concerns over storm surge forced the hospital staff to move the emergency
department to a higher floor. Today, the new roof is ready for severe weather,
said Tom Rice, Fawcett Memorial's president and chief executive. Storm shutters
are planned for doors and windows on the first floor. The hospital's power
connections are now “plug and play.” Portable emergency generators the size of
tractor-trailers can be quickly linked to the hospital's air conditioning and
ventilation systems, something that didn't happen right away last year. Some
hospitals are also sending out a message that, in a disaster situation, only
patients with life-threatening illnesses or injuries should head to the
hospital. The chief nursing officer at Doctors Hospital of Sarasota said the
public needs to understand, before another storm hits, that hospitals can't
double as public shelters, as some assumed during Charley. To improve
communications during and after a disaster, some hospitals across the region
have purchased satellite phones in case landlines and cell phones fail as they
did after Charley. If a hurricane damages Venice Regional Medical Center this
year its administrators said they will have 400 contractors rebuilding the
hospital within 48 hours. Based on experiences learned from hospitals that were
hardest hit, other hospitals in the area are preparing for the worst with
activities such as performing dry run disaster preparedness drills; fortifying
waterlines; making arrangements with vendors to get food, linens and bottled
water quickly; strengthening roofs, doors and windows; tying down equipment
outside the hospital; creating a well system for emergency drinking water; and
making sleeping and child care arrangements for employees who must work long
shifts during storms. Riverside Behavioral Center has been working with hospital
employees who lost homes last year. According to a spokeswoman, just under 100
hospital workers are still in temporary housing. (Herald Tribune)
Tools and models for planning and preparedness for
bioterrorism
and other public health emergencies
The Agency for Healthcare Research and Quality (AHRQ) has released The Emergency Preparedness Resource Inventory (EPRI), a tool allowing local or regional planners to assemble an inventory of critical resources that would be useful in responding to a bioterrorist attack. In addition to a Web-based software tool, EPRI includes an Implementation Report, a Technical Manual, and an Appendix. The implementation report presents the features and contents of the inventory software (EPRI) and describes a pilot test conducted during the summer of 2003. The EPRI tool can be customized to create an inventory appropriate for any region, State, or locality. It is Web-based so that all selected organizations in an area can enter information about their resources. It creates automated reports for use in preparedness and planning as well as incident response. EPRI also has extensive security protections. The tool and report were produced by Abt-Geisinger Associates. This project was funded under the Agency's bioterrorism research portfolio. http://www.ahrq.gov/research/epri/
In this Issue:
CDC team investigates outbreak of obesity in West Virginia
Hospitals reduce in-house infections
Inquiry on sales of heart device
CDC recommends
meningococcal vaccine
for adolescents and college freshmen
FDA advises consumers about recalled drugs
from Able Laboratories
For the first time, the Centers for Disease Control and Prevention has sent a
team of specialists into a state, West Virginia, to study an outbreak of obesity
in the same way it studies an outbreak of an infectious disease, reported The
New York Times. Kerri Kennedy, the program manager at the West Virginia
Physical Activity and Nutrition Program, said the state had requested the
agency's investigation, said The Times. The state ranked third in the
nation for obesity, 27.6 percent of its adults were obese, compared with 20.4
percent in the country as a whole. Accompanying the obesity was a high
prevalence of diabetes and high blood pressure.
West Virginia ranks fourth in
the nation for diabetes, with 10.2 percent of the population affected, compared
with 6.4 percent nationwide. And it is No. 1 in its prevalence of high blood
pressure, with 33.1 percent having the condition, compared with 25.8 percent of
people nationwide. The state asked the agency's disease detectives to tackle its
obesity problem, and a three-week investigation began on April 25. It focused,
Kennedy said, on two places that represented towns and cities in the state,
Gilmer County, with 7,160 residents, and Clarksburg, a city with 16,743
residents. The investigative teams spent a week and a half in each place, going
to schools and asking about physical education programs and about what sort of
food was provided. They went to workplaces, asking whether there were policies
to encourage physical activity. Dr. Julie Gerberding, the director of the
disease centers, said in a press conference that this type of investigation was
a first for the agency. The centers held the news conference to clarify its
position on weight and obesity. Agency scientists recently published a study
concluding that overweight people had a lower risk of death than normal-weight
people and that even obese people did not have much of a risk of early death
unless they were extremely obese. A year earlier, different researchers at the
agency published a study saying that obesity and extra weight were markedly
raising death rates in this country. Dr. Gerberding said that there were still
questions about the best ways to estimate death risks from extra weight but that
there was no question about the health impacts of being obese or overweight,
which can increase the risk of diseases like diabetes, high blood pressure,
arthritis and some cancers. The West Virginia data are now at the agency, being
analyzed. Some preliminary information may be available in August, Kennedy said.
Some statisticians said it was hard to see what could be learned from the
agency's investigations, reported The Times. (The New York Times)
Hospitals reduce in-house infections
The Food and Drug
Administration is examining the
Guidant Corporation's
decision to sell older heart defibrillators after the company made an improved
version that it says fixed a potential flaw, an agency spokeswoman said,
according to a New York Times report. The inquiry is part of the broader
agency review started last week into how Guidant handled issues related to the
device, said the spokeswoman. Guidant acknowledged Wednesday that it continued
to sell older units of the device well after it produced an improved version
that appeared to fix the flaw. Separately,
Johnson & Johnson,
which in December said it planned to buy Guidant for $25.4 billion, appeared to
increase its involvement in issues involving the defibrillator, the Ventak Prizm
2 Model 1861. In a statement, the company said it remained committed to the
acquisition but added that it was “working with Guidant staff to better
understand and evaluate information regarding the Prizm 2 defibrillator.” (The
New York Times)
CDC recommends meningococcal vaccine
for adolescents and college freshmen
The Centers for Disease Control and Prevention (CDC) now recommends routine
vaccination of children 11-12 years old, previously unvaccinated adolescents at
high school entry, and college freshmen living in dormitories with the newly
licensed meningococcal conjugate vaccine (MCV4). The new recommendation is
designed to help achieve vaccination among those at highest risk for
meningococcal disease. As the vaccine supply increases, CDC hopes, within three
years, to recommend routine vaccination all adolescents beginning at 11 years of
age. CDC recommends routine meningococcal vaccination for young adolescents at
the pre-adolescent doctor visit at about age 11-12, and for those who have not
previously been vaccinated, before entering high school at about age 15. CDC
also recommends that college freshmen living in dormitories be immunized to
reduce disease risk. Also, all other adolescents who wish to reduce their risk
of disease may elect to receive vaccine. Meningococcal disease strikes up to
3,000 Americans, killing 300 people every year. Ten to 12 percent of people with
meningococcal disease die, and among survivors, up to 15 percent may suffer
long-term permanent disabilities including hearing loss, limb amputation or
brain damage. This new vaccine should offer longer protection than previous
vaccines, is a single shot, and the most common reaction is a sore arm. However,
it does not protect people against meningococcal disease caused by serogroup B
bacteria. This serogroup of bacteria causes one-third of meningococcal cases in
the United States.
More than half of the cases among infants under the age of 1 year are caused by
type B, for which no vaccine is licensed or available in the U.S. The new
meningococcal vaccine was licensed by the U.S. Food and Drug Administration
(FDA) on January 14, 2005 for use in people 11-55 years of age. It is
manufactured by Sanofi Pasteur and is marketed as Menactra.
FDA advises consumers about recalled drugs
from Able Laboratories
The Food and Drug Administration (FDA) is taking action to ensure that the public is fully aware that Able Laboratories of Cranbury, NJ, is conducting a nationwide recall of all of its manufactured drugs (mostly generic prescription drugs, including drugs containing acetaminophen) because of serious concerns that they were not produced according to quality assurance standards. Able Laboratories has ceased all current production. “The FDA continues to evaluate the situation at Able Laboratories to determine the safety and quality of their products and will update the public on our findings as necessary,” said Margaret O'K. Glavin, Associate Commissioner for Regulatory Affairs. “In the meantime, the Agency recommends that people who have been taking drugs produced by this firm speak with their healthcare provider or pharmacist to obtain a replacement drug product. Consumers should continue taking the medication until they have spoken with their healthcare provider." A list of the names of the recalled drugs and their imprint codes can be found at http://www.fda.gov/bbs/topics/NEWS/2005/NEW01182.html. It is important to note that this recall only applies to the drugs produced by Able Laboratories, and not to the same drugs produced by other manufacturers. Consumers with questions may contact Able Laboratories at 1-800-982-2253. Persons wanting to report any adverse events to the FDA may contact FDA’s MedWatch office at 1-800-FDA-1088.
In this Issue:
Experimental vaccine helps reduce shingles outbreaks
GAO report on influenza
pandemic:
Challenges remain in preparedness
16 people infected by HIV virus
in blood transfusion in China
Greater risk of death for
cardiac surgery
patients with long ICU stay
New drugs spend $39 million to
launch
Experimental vaccine helps reduce shingles outbreaks
Researchers reported Thursday in the New England Journal of Medicine that, in a study of 38,546 volunteers enrolled in a test for an experimental vaccine to prevent shingles, the vaccinated half of the test group had half as many cases of shingles. Those who got it had a milder case, and there were far fewer cases of lasting excruciating nerve pain. Dr. Michael N. Oxman of the San Diego VA Healthcare System led the study of the vaccine made by Merck & Co. The research was spearheaded by the Veterans Affairs Department along with the National Institute of Allergy and Infectious Diseases and Merck, which helped fund the study and is seeking approval of the vaccine in the United States and Europe. Shingles can attack anyone who has had chickenpox, and an estimated 1 million Americans are afflicted every year. If the vaccine is approved by the federal government, it could eventually be added to the shots recommended for older Americans. Unlike traditional vaccines which prevent a new disease, the shingles shot would keep a long-ago acquired infection in check. In the VA test, volunteers got the vaccine or a dummy shot and were followed for about three years. There were 315 cases of shingles in the group that got the vaccine, about half the 642 shingles cases in the group that didn't, the researchers said. The vaccine also reduced pain and discomfort by 61 percent and reduced long-term severe nerve pain, a serious complication, by two-thirds. As people age, their immunity to the dormant chickenpox virus wanes and it can re-emerge as shingles. Those with weakened immune systems are also at risk. Treatment includes antiviral drugs but they must be used early. The vaccine tested in the VA study was a stronger version of the chickenpox vaccine that has been given to children in the United States since 1995. "We will be evaluating how long the vaccine benefit lasts and ... whether subsequent doses would be needed, and if so, when," said Dr. Jeffrey L. Silber, who headed Merck's research team for the study. While the vaccine's price isn't known yet, Dr. Donald H. Gilden of the University of Colorado Health Sciences Center in Denver said it should be cost-effective since shingles is expensive to treat. New England Journal: http://www.nejm.org (The Associated Press)
GAO report
on influenza pandemic:
Challenges remain in preparedness
GAO was asked to discuss surveillance systems in place to identify and monitor an influenza pandemic and concerns about preparedness for and response to an influenza pandemic. This testimony is based on GAO’s 2004 report on disease surveillance; reports and testimony on influenza outbreaks, influenza vaccine supply, and pandemic planning that GAO has issued since October 2000; and work GAO has done in May 2005 to update key information. Federal public health officials plan to rely on the nation’s existing influenza surveillance system and enhancements to identify an influenza pandemic. CDC currently collaborates with multiple public health partners, including the World Health Organization (WHO), to obtain data that provide national and international pictures of influenza activity. Federal public health officials and healthcare organizations have undertaken several initiatives that are intended to enhance influenza surveillance capabilities, however challenges remain with regard to other aspects of preparedness for and response to an influenza pandemic. In particular, the Department of Health and Human Services (HHS) has not finalized planning for an influenza pandemic. In 2000, GAO recommended that HHS complete the national plan for responding to an influenza pandemic, but the plan has been in draft format since August 2004. Absent a completed federal plan, key questions about the federal role in the purchase, distribution, and administration of vaccines and antiviral drugs during a pandemic remain unanswered. Other challenges with regard to preparedness for and response to an influenza pandemic exist across the public and private sectors, including challenges in ensuring an adequate and timely influenza vaccine and antiviral supply; addressing regulatory, privacy, and procedural issues surrounding measures to control the spread of disease, for example, across national borders; and resolving issues related to an insufficient hospital and health workforce capacity for responding to a largescale outbreak such as an influenza pandemic. www.gao.gov/cgi-bin/getrpt?GAO-05-760T.
16 people infected by HIV virus in blood transfusion in China
At least 16 people have been affected by the HIV virus after contaminated blood was used for transfusions at a hospital in Bei'an County, Heilongjiang Province, the Beijing-based China Daily reported. An ongoing investigation by the county court and other officials has disclosed at least five farm workers received contaminated blood from 1999 to 2004, it said. The nature of the disease, however, was undisclosed. Four others were infected by the original five with the disease at the farm 330 km north to provincial capital Harbin. But the China Daily said “there could be as many as 16 infected by HIV.” A statement from the Ministry of Health confirmed that nine victims “were infected” because five received tainted blood from a supply at Workers' Hospital, located on a construction farm. An official with the Bei'an farm court said it is still investigating the incident. He said he was not sure how much in reparation each victim might receive. The statement from the Ministry of Health said some relevant officials have been disciplined within the Party and others are subjects of the criminal investigation. (Xinhua)
Greater risk
of death for cardiac surgery
patients with long ICU stay
A recent study determined that patients who underwent recent cardiac surgical procedures and had prolonged stay in the intensive care unit had lower survival rates and lower quality of life. Dr. Vinayak Bapat at St. Thomas’ Hospital, London and his team looked at a study group of 89 patients who had undergone various cardiac procedures and survived the following 30 days, and a control group with similar parameters but who were discharged from the ICU within 48 hours postoperatively. They discovered that of the 89 patients, those with a mean ICU stay of 11 days survived longer than one year after surgery. Those who stayed in the ICU an average of 16 days died within one year of surgery, representing a 33% mortality rate. Quality of life of the surviving patients was studied using eight parameters of the SF36 Scales including physical function, vitality, general health and pain. Factors that contributed to a lower quality of life were noted more in the study group, i.e. longer ICU stay. More research is needed of the preoperative health of candidates undergoing certain cardiac procedures. Those with poor organ function before surgery will require longer ICU stay and puts them at greater risk of death after surgery. This study is published in the Journal of Cardiac Surgery.
New drugs spend $39 million to launch
Niche pharmaceutical brands invest an average of $39 million in marketing between Phase III trials and the first year on the market, according to a new report from Cutting Edge Information. Niche drugs are those products slated to peak at annual sales of less than $500 million. The largest of these products have a shot at mid-level status ($500 million to $1 billion in annual sales), but most drugs will fall well shy of that mark. The study, "Pharmaceutical Product Commercialization: Phase III to Post-Launch Resource Allocation," examines marketing investments for 16 brands. The report concludes that niche drugs are important portfolio fillers, but they cannot claim the resources of mid-level or blockbusters that are slated to make billions of dollars annually. In order to derive the greatest returns on niche products, companies carefully balance their resources. In their efforts to hit key objectives, it is not uncommon for brand teams to overload one spending area, advertising, for example, at the expense of others. It is important to note that a niche brand's strategic role within its company's portfolio will help determine the support the company will be willing to provide for commercialization. For example, one brand received significant financial backing because the product is expected to hold the fortune of the mid-sized pharmaceutical company. The report is available at http://www.PharmaLaunch.com.
In this Issue:
GAO report on health information technology
Canadian Red Cross pleads guilty
to distributing tainted blood
American Heart Association: Bypass methods
comparable
New chargemaster solution helps
reduce claim denials
for improved reimbursement
Alliance Medical selected by
MedAssets
for medical device reprocessing
GAO report on health information technology
The U.S. Government Accountability Office (GAO) was asked to provide an overview of the Department of Health and Human Service’s (HHS) recent efforts to develop a national health information technology (IT) strategy to guide the nationwide implementation of health IT in both the public and private healthcare sectors, and to identify lessons learned from the experiences of the Departments of Defense (DOD), Veterans Affairs (VA), and other countries in implementing health IT. HHS plans to address the goals and strategies of its framework for strategic action, released in July 2004 by the National Coordinator for Health IT, with a three-phased approach over a number of years and is currently implementing phase I. HHS has not established milestones for the completion of phase I activities nor has it made detailed plans or set milestones for the completion of activities for phases II and III. DOD, VA, Canada, Denmark, and New Zealand provided GAO with valuable lessons learned that can be applied to the United States’s efforts. Among other lessons learned, they reported the need to: Obtain the endorsement of top leadership; Define and adopt standards; Address the needs of stakeholders; and Deploy IT solutions in small increments and build on successes. To accelerate the adoption of interoperable IT for healthcare, GAO recommends that the Secretary of Health and Human Services establish and follow detailed plans and set milestones for each phase of HHS’s framework for strategic action. In commenting on a draft of this report, DOD, HHS, and VA concurred with the results; HHS agreed with the recommendation. Technical comments were incorporated in this report as appropriate. For the full report, go to www.gao.gov/cgi-bin/getrpt?GAO-05-628.
Canadian Red Cross pleads guilty
to distributing tainted blood
The Canadian Red Cross was fined $5,000 (US $4,000) Monday after pleading guilty to distributing blood tainted with HIV and hepatitis C in the 1980s. The charity will also put aside $1.5 million (US $1.2 million) to pay for post-secondary scholarships for family members of those affected as well as a medical research project. More than 1,000 Canadians became infected with blood-borne HIV and up to 20,000 others contracted hepatitis C after receiving tainted blood products in the 1980s and early 1990s. About 3,000 people had died by 1997 and the death toll has grown, but recent estimates were not available. "(The) Canadian Red Cross Society is deeply sorry for the injury and death ... for the suffering caused to families and loved ones of those who were harmed," said Dr. Pierre Duplessis, the secretary general of the Red Cross. "We accept responsibility through our plea for having distributed harmful products for those that rely on us for their health." The Canadian Red Cross no longer engages in blood collection or distribution. The proceedings Monday were separate from other charges against Dr. Roger Perrault, former director of blood transfusion for the Red Cross. He is charged along with three other doctors and the US-based Armour Pharmaceutical Co. They are accused of criminal negligence and endangering the public for allegedly allowing Armour's blood-clotting product, infected with HIV, to be given to hemophilia patients. The charges allege Perrault and other Red Cross officials failed to take adequate measures to prevent people infected with the HIV virus from donating blood, failed to institute blood testing in a timely manner and allowed the distribution of tainted blood products. (The Associated Press)
American Heart Association: Bypass methods comparable
Heart bypass patients fare about the same no matter which of two surgery
methods doctors use, concludes an American Heart Association review of more
than four dozen studies. The review compared the standard procedure of stopping
the heart and using a heart-lung machine with the newer method of operating with
the heart still beating. Lead author Dr. Frank Sellke, of the heart
association's Council on Cardiovascular Surgery and Anesthesia, said, "The
advantages and disadvantages tend to be quite small when you compare one to the
other." He noted the cost is about the same for both. The traditional surgery is
used on more than 75 percent of bypass patients. That process carries a small
risk of stroke and neurological complications. However, Sellke said that
research shows the difference in brain function in the two surgeries was slight
and that when those problems do occur they usually disappear in three to four
months. The heart association's statement on the matter, published Tuesday in
the journal Circulation, was based on a review of clinical trial data and other
studies. “It's a little harder to do the grafts off-pump," said Dr. Timothy
Gardner, a co-author of the heart association statement and medical director of
the Center for Heart and Vascular Health at Christiana Care Health System in
Wilmington, DE. He said that people who undergo the on-pump surgery tend to have
more grafts. The patient benefiting the most from off-pump surgery is someone
with a severely calcified or diseased aorta, the heart association said.
Clamping a calcified aorta can cause a piece of the calcium to break off and
give the patient a stroke, Sellke said. In addition to patients with calcified
aortas, the technique may also be used if the patient is high-risk and can't
afford to lose too much blood. (The Associated Press)
New chargemaster solution helps reduce claim denials
for improved reimbursement
3M Health Information Systems introduces 3M Chargemaster Online, a new Web-based
software solution designed to help hospital finance and billing departments
maintain an accurate, up-to-date chargemaster throughout the healthcare
facility. 3M Chargemaster Online easily integrates with a hospital's charge
capture workflow to provide online access to chargemaster data. Missing charges
and incorrect codes can be quickly identified and corrected before the patient
bill is finalized. The result is improved payer reimbursement through reduced
claim denials and fewer account receivable days for bill payment. Recent
regulations require that coding changes to the chargemaster must be incorporated
on the effective date of services or claims using out-of-date codes will be
rejected and payment delayed.
Alliance Medical selected
by MedAssets
for medical device reprocessing
Alliance Medical Corporation (Alliance), a reprocessor of single-use devices
(SUDs), announced the signing of a three-year agreement with MedAssets, a supply
chain management company based in Atlanta, GA. MedAssets' members will have
access to Alliance's full compliment of reprocessing services and their AIM(TM)
program consultation services that assures proper implementation and maximum
supply-cost savings.