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November 2004
Tuesday, November 30, 2004
In this Issue:
Robert Wood Johnson hospital wins Baldrige
award
Lawyer says FDA may reassign whistleblower
Bariatric surgery increases in teenagers
HIV vaccine works in human tests
PAR Excellence to provide point-of-use supply
automation system to Baptist Health
Robert Wood
Johnson hospital wins Baldrige award
Robert Wood Johnson University Hospital at Hamilton (NJ) is the healthcare recipient of the prestigious Malcolm Baldrige National Quality Award for 2004. Among other successes, the 204-bed hospital achieved 90% patient satisfaction in its emergency room in 2004. In 1998 the hospital was one of the first in the country to implement a “15/30” program, promising all ER patients that they would see a nurse within 15 minutes of arrival and a physician within 30 minutes. Judges also highlighted the hospital's patient-focused model of care; its expectation that employees provide patients with “excellence through service” and uphold five-star service standards; and its commitment to improving community health. The hospital provides free health screenings to an average of more than 900 community residents each month. Its charity care has risen to about $23 million in 2003 from about $5 million in 1999. The Robert Wood Johnson hospital is the fourth healthcare provider to win the Baldrige award, the nation's only presidential award for quality and organizational performance, since a healthcare category was added in 1999. Recipients of this year's award were evaluated by an independent board of examiners in seven areas: leadership, strategic planning; customer and market focus; measurement, analysis and knowledge management; human resource focus; process management; and results. Congress established the award in 1987 to enhance competitiveness of U.S. businesses.
Lawyer says FDA may reassign whistleblower
U.S. Food and Drug Administration reviewer David Graham, who criticized the agency at a congressional hearing, may be forced to another position at the agency, Graham’s lawyer said on Monday. Graham sought counsel from a whistle-blower protection group before he testified at the Senate Finance Committee hearing. Graham’s lawyer said FDA Acting Commissioner Lester Crawford “aggressively offered (Graham) a post switching from drug safety to long-term management” before the hearing. If Graham is reassigned, he could challenge the move under the Whistleblower Protection Act but would not likely find refuge because of the law's inherent weakness, Graham’s lawyer said. In a letter on Monday, Finance Committee Chairman Sen. Charles Grassley asked FDA's Crawford to “address allegations that administrative action may be taken against Dr. Graham, including that he may be terminated or transferred against his wishes to a job other than conducting scientific research.” (Reuters)
Bariatric surgery increases in teenagers
The American Society for Bariatric Surgery estimates that the number of stomach-reduction operations has jumped from 16,000 in 1993 to more than 100,000 in 2003. And now many major hospitals are offering surgical options for obese teenagers. Dr. Harvey J. Sugerman, president of the American Society for Bariatric Surgery, said that hospitals across the country were increasingly operating on teenagers, reported The New York Times. No reliable total is available because the society does not break down its stomach-reduction surgery figures by age. But such surgery on children, which could possibly limit their nutritional intake as they grow, raises questions and possible complications, said The Times. Children as young as 12 have had the surgery in United States, according to Dr. Sugerman, said The Times. The number of overweight teenagers has tripled in the past two decades. Fifteen percent of children age 12 to 19 are now overweight, according to the Centers for Disease Control and Prevention. Although the National Institutes of Health endorsed gastric bypass surgery for adults 15 years ago, it has no formal guidelines for operating on teenagers. The surgery has many risks; roughly one in 200 patients die. For teenagers, who are still growing, there is particular concern about a loss of calcium, protein and general malnutrition. Because patients often eat fewer than 1,200 calories a day, they need to take vitamin and mineral supplements for the rest of their lives. And at more than $40,000, the surgery is expensive. Doctors at several hospitals said insurers sometimes covered the cost. The newer stomach-reduction procedure, called banding, is considered much safer, although the weight loss is more gradual. And since it is reversible, some in the medical community claim it is a better alternative to the bypass surgery, especially in teenagers. At $20,000 or more, the operation is much less expensive than bypass surgery. Doctors warn it is critical that there be a detailed screening process for teenagers, including a psychological evaluation, to determine if the patient is ready for a serious operation that will forever alter how they eat. One key, they said, is to make sure that the decision was made by the child, not the parents. In addition, doctors said follow-up visits with a nutritionist should be mandatory to ensure that patients maintain a proper dietary balance. (The New York Times)
HIV Vaccine works in human tests
A therapeutic vaccine that has stopped HIV in mice and monkeys has now been shown to stop progression of the virus in human tests. The vaccine is made from a patient's own dendritic cells and HIV isolated from the patient's own blood. Dendritic cells grab foreign bodies in the blood and present them to other immune cells to trigger powerful immune system responses to destroy the foreign invaders. HIV infection normally turns these immune system responses off. But animal studies show that when dendritic cells are “loaded” with whole, killed AIDS viruses, they can trigger effective immune responses that keep infected animals from dying of AIDS. Wei Lu, Jean-Marie Andrieu, and colleagues at the University of Paris in France and Pernambuco Federal University in Recife, Brazil, tested the vaccine on 18 Brazilian patients. All had HIV infection for at least a year and their T-cell counts were dropping. None was taking anti-HIV medications. After getting three under-the-skin injections of the tailor-made vaccine, the amount of HIV in the patients' blood dropped by 80%. After a year, eight of the 18 patients still had a 90% drop in HIV levels. All patients' T-cell counts stopped dropping. The findings appear in the December issue of Nature Medicine. The researchers warn that their study is only proof of principle. It's still not clear which patients do best with the vaccine, although there's evidence that vaccination should be given as soon after HIV infection as possible. Only clinical trials comparing people who get the vaccine to those who don't can show whether this vaccine really is an effective AIDS therapy. Similar approaches are being explored for the treatment of cancer and long-term viral infections such as hepatitis C. (WebMD Medical News)
PAR Excellence to provide point-of-use supply
automation system to Baptist Health
PAR Excellence Systems, which provides products and services to automate the way that healthcare supplies are documented, controlled, and replenished, announced an agreement with Baptist Health of Jacksonville, FL. PAR Excellence will be implemented in all Baptist Health hospitals over the next 18-24 months. The PAR Excellence System is a flexible, point-of-use supply chain management solution. In addition to automating the replenishment process, it eliminates the present system of manually tracking patient charges; while reducing supply utilization. The PAR Excellence software includes a unique, browser-based management tool (PAR Vision), that provides real time supply and compliance information with hit-lists, what-if scenarios and PAR level recommendations. With, the PAR Excellence solution, healthcare providers at Baptist Health will scan supplies used for a given patient at the time that they are utilized, instead of manually entering the data at the end of a shift.
Monday, November 29, 2004
In this Issue:
WHO warns of massive flu pandemic
FDA reviewing records on Baycol
More than 17 million flu vaccine doses shipped
in six weeks
Study shows obesity rates doubled among
the elderly between 1980-2002
Kodak receives FDA approval
for mammography CAD system
New guidelines promote "green"
design,
maintenance of healthcare facilities
Virginia Mason Medical Center
awarded HPN’s
2004 CS/SPD Department of the Year
WHO warns of massive flu pandemic
The World Health Organization has issued a warning that bird flu will trigger an international pandemic that could kill up to seven million people. The influenza pandemic could occur anywhere from next week to the coming years, WHO said. “There is no doubt there will be another pandemic,” Klaus Stohr of the WHO Global Influenza Program said. “Even with the best case scenario, the most optimistic scenario, the pandemic will cause a public health emergency with estimates which will put the number of deaths in the range of two and seven million,” he said. “The number of people affected will go beyond billions because between 25 percent and 30 percent will fall ill.” With a human vaccine to the bird flu virus not expected until March 2005 at the earliest, urgency is being placed on containment. The warning preceded a two-day meeting of regional health ministers in Bangkok that looked at ways to combat future outbreaks. Stohr said if bird flu triggers the next pandemic, the virus would likely originate in Asia. It is important that countries act quickly to guard against a possible pandemic and take stock of their inventories of antivirals, Stohr said. Two U.S. companies have said they plan to test experimental bird flu vaccines from January. Thai health officials said they expected that a vaccine to protect humans from bird flu would be ready by 2007, The Associated Press reports.
FDA reviewing records on Baycol
In what
could lead to a criminal investigation, the Food and Drug Administration is
reviewing its records to determine if drug maker Bayer AG was forthcoming about
safety concerns with its cholesterol-lowering Baycol drug that surfaced months
after the drug hit the market. If allegations prove true that the company knew
but was slow to inform the government that its drug was riskier than comparable
drugs, the Food and Drug Administration could begin a criminal investigation,
said an official. Bayer internal company records now in the public domain
indicated that by May 28, 1998,
three months after the drug went on the market, people who took the drug with
gemfibrozil, another cholesterol-lowering drug, had elevated levels of an enzyme
that accompanies muscle injury or had developed a rare muscle-wasting disorder.
Bayer did not warn doctors and patients not to take the two drugs together until
December 1999, four scientists wrote in a Journal of the American Medical
Association paper released last week. In addition Bayer scientists knew in late
1999 and early 2000 that using Baycol alone “substantially increased the risk”
of people getting a rare muscle-wasting condition, compared with a rival drug,
but they did not immediately alert physicians or patients. Bayer said in a
statement that the JAMA articles “contain no new information regarding Baycol
and Bayer's timely reporting of data. Bayer kept the FDA fully informed about
all pertinent safety information, including adverse event reports. Indeed, an
FDA audit of Bayer's postmarketing practices during the time Baycol was on the
market demonstrated no deficiencies.” Its pharmaceutical division withdrew
Baycol from the market on Aug. 8, 2001 after it was linked to a sometimes fatal
muscle-wasting condition, rhabdomyolysis. (The Associated Press)
More than 17 million flu vaccine doses shipped in six weeks
HHS Secretary Tommy G. Thompson announced that 17.2 million influenza vaccine doses have been shipped in the last six weeks to health providers serving high-priority groups as part of the program to reallocate the vaccine to those areas and people who need it most. Thompson also said that the Food and Drug Administration (FDA) has nearly completed its examination of vaccines from foreign manufacturers. An initial survey conducted by the Association of State and Territorial Health Officials (ASTHO) and CDC indicates a high demand for vaccine still exists in some areas, but a few states report a small amount of vaccine in excess of their needs. Plans are underway to reapportion this small amount of vaccine to other states. ASTHO and CDC plan on conducting a follow up survey to further assess the situation in early December. In addition, several million more doses of vaccine are scheduled to be shipped each week through early December. Thirty-two states have reported influenza activity to CDC thus far, which is well within the range of activity that might be expected for this time of year. Thompson also said FDA intends to make an announcement next week about the influenza vaccine it has identified from foreign manufacturers that could potentially be available under investigational new drug applications. Additionally, the federal government has purchased and stockpiled antiviral medicines to treat more than 7 million people. Supplies of antiviral medicines also exist in the private sector and manufacturers indicate that they have the ability to significantly increase production. The FDA estimates there could be enough medicine to treat tens of millions of people through the heart of flu season. For more information, call CDC's hotline at 1-800-CDC-INFO, or visit www.cdc.gov/flu.
Study shows obesity rates doubled among
the elderly between 1980-2002
During the last
four decades, the percentage of U.S. senior citizens who are obese doubled from
18% in 1980 to 36% in 2002, raising the elderly's risk for developing diabetes,
heart disease, certain cancers, osteoarthritis and disability, while
contributing to higher medical costs, according to a new federal study. The
share of overweight Americans ages 65 to 74 increased from 55% in 1980 to 73% in
2002, with older men more likely to be overweight than older women. During the
same period, diabetes-related deaths increased by 43%. The growing number of
obese and overweight senior citizens accounts for roughly $30-$40 billion in
annual health care costs, according to the report. The report also found that
the number of Medicare-covered hospital stays increased from 306 per 1,000
beneficiaries in 1992 to 365 per 1,000 beneficiaries in 2001. The report was
conducted by researchers from 12 federal agencies and compiled by the Federal
Interagency Forum on Aging-Related Statistics. It is available online at
www.agingstats.gov/.
Kodak receives FDA approval for mammography CAD system
Eastman Kodak Company has received approval from the U.S. Food and Drug Administration (FDA) for its mammography computer-aided detection (CAD) system. Kodak will immediately begin shipping its KODAK Mammography CAD System to healthcare facilities in the U.S. Kodak's mammography CAD software uses sophisticated algorithms to help identify suspicious areas on patients' digitized mammograms so radiologists can closely examine these regions for possible disease during a second review. Clinical trial results submitted to the FDA document that 39.4 percent of missed breast cancers could have been detected 14.8 months earlier using Kodak CAD technology. Approximately 95 percent of patient mammography images in the U.S are captured on x-ray film. Kodak's mammography CAD system is the newest CAD system available to aid the radiologist in the detection of breast cancer.
New guidelines promote "green" design,
maintenance of healthcare facilities
The newly released “Green Guide for Health Care” is designed to help healthcare providers build and maintain facilities that protect patients’ and employees’ health, as well as the health of the environment. The guide provides voluntary best-practice guidelines for those involved in healthcare building design, construction, operations and maintenance, and addresses topics such as building materials, energy and water efficiency, chemical use, and waste management. Though not intended to help providers meet regulatory requirements, the guide was designed to mirror the U.S. Green Building Council's Leadership in Energy and Environmental Design Green Building Rating System (LEED), among one of the best-known voluntary guidelines for “green” building. The tool was initiated by the Center for Maximum Potential Building Systems and sponsored in part by Hospitals for a Healthy Environment, a joint pollution-prevention project of the American Hospital Association, U.S. Environmental Protection Agency, Health Care Without Harm, and American Nurses Association. A one-year pilot-project is being conducted to test and hone the guidelines. To register to download a free copy of the guide, visit www.gghc.org. (AHA News Now)
Virginia
Mason Medical Center awarded HPN’s
2004 CS/SPD Department of the Year
From among many
noteworthy nominations Healthcare Purchasing News has selected Virginia
Mason Medical Center in Seattle, WA, as our 2004 CS/SPD Department of the Year.
Please join us in honoring this team that has clearly demonstrated how a
top-flight CS/SPD department should operate. Our December 2004 issue (in the
mail now or full story available online at www.hpnonline.com) will look at the
many reasons why Virginia Mason was chosen as this year’s winner. Also, in our
January 2005 issue, we’ll feature this year’s runners-up in the contest,
including Southwest General Health Center (Middleburg Heights, OH), F.F.
Thompson Hospital (Canandaigua, NY), Boone Hospital Center (Columbia, MO) and
The Cleveland Clinic (Cleveland, OH). Thank you to all who submitted
applications and congratulations to the winners!
Wednesday, November 24, 2004
In this Issue:
Veteran
FDA employee seeks whistleblower protection
FDA sets up national registry to follow Accutane
users
Half of adults with HIV are women
Officials
seize flu vaccine headed for
black market
FDA approves multiple sclerosis drug
Consorta awards agreement for
advanced wound care
products to Mölnlycke Health Care
Have a Happy Holiday!
Veteran FDA employee seeks whistleblower protection
Dr. David J. Graham, the Food and Drug Administration safety officer
who told a Congressional panel last week that his agency was
“virtually incapable of protecting America” from unsafe drugs, said
Thursday that he feared being fired and had sought legal help from a
group that protects whistle-blowers, reported The New York Times.
“My concern is retaliation from these people,” Dr. Graham told
The Times in an interview. Graham’s lawyer has said that he had
received anonymous telephone calls trying to discredit Dr. Graham
and that he believed the calls were from people in “FDA management.”
In response, the drug agency issued a statement acknowledging that
an employee had contacted the lawyer’s group but denied prior
knowledge of the contact. Graham appeared on ABC’s “Nightline”
saying that circumstances at the agency “forced'” him to become a
whistleblower to protect consumers from dangerous drugs. “We have a
system that is biased toward approving drugs almost regardless of
the safety risks,”' Graham said in his “Nightline” interview. Graham
is a 20-year veteran of the FDA, and has contributed to the
recalling of 10 medicines. Acting Deputy FDA Commissioner Janet
Woodcock defended her agency on “Nightline”, saying, “We have to
recognize that all drugs have side effects, and some drugs have very
rare side effects that are not going to be found until the drugs are
on the market for awhile.”'
FDA sets up national registry to follow Accutane users
The
U.S. Food and Drug Administration has set up a national registry to
follow women of childbearing age who are prescribed the acne drug
Accutane, which has been shown to cause serious birth defects. The
agency followed the suggestions of an expert advisory panel, which
in February said the agency should track women who could become
pregnant while taking the drug. Accutane, generically known as
isotretinoin, is known to cause brain and heart damage in the
fetuses of women who use the drug, even in small amounts. Under
changes to the drug's tougher risk minimization plan, women must
document a negative pregnancy test before they are able to obtain
the drug. The national registry will track each woman's name,
prescribing doctor, and pharmacy that dispensed the medication, said
the FDA. The registration system will incorporate patient and
physician codes that will protect the privacy of both, the agency
said. Last week, Accutane was singled out by FDA safety reviewer Dr.
David Graham as one of five drugs still on the market that posed
health dangers like Vioxx. The FDA's new Accutane rules include
provisions for providing ongoing patient education about the drug's
potential risks. Accutane has been shown to cause mental retardation
and physical birth defects, including cleft lip and palate. The
risks continue for about a month after a patient discontinues the
drug. Since 1982, when the drug was first introduced, the FDA has
had more than 2,000 reports of women becoming pregnant while taking
the drug. Most had an abortion, some gave birth to healthy babies,
but more than 160 babies were born with Accutane-related defects.
The FDA instituted a voluntary testing and contraceptive education
program in 2001 for patients considering the drug. (HealthDayNews)
Half of adults with HIV are women
According to
a United Nations report released this week, women make up nearly half of the
37.2 million adults living with HIV, and in sub-Saharan Africa women account for
almost 60 percent of the AIDS-affected population. The number of women infected with AIDS has risen worldwide during the
past two years. East Asia experienced the biggest jump in the number of infected women, at 56
percent, followed by
Eastern Europe and
Central Asia with 48 percent. The annual report by UNAIDS and
the World Health Organization (WHO) shows the number of adults and children
living with HIV reached its highest level ever in 2004 with an estimated 39.4
million, compared to about 36.6 million two years ago. Over 3 million people
died of the illness this year. New infections climbed by nearly 50 percent since
2002 in East Asia,
mainly because of growing epidemics in
China,
Indonesia and Vietnam. In Eastern Europe and Central Asia, there has been a 40
percent jump in the past two years, fueled by the growing number of infections
in the Russian Federation and Ukraine. But sub-Saharan Africa, where 25.4
million people are infected with the virus, is the worst affected region of the
world. Sixty-four percent of all HIV positive people worldwide and 76 percent of
all women with the virus are in sub-Saharan
Africa. Although spending to battle HIV/AIDS has almost tripled
from $2.1 billion in 2001 to $6.1 billion this year, less than one in five
people in low and middle-income countries has access to HIV prevention services.
As many as 6 million people need HIV treatment. The WHO has launched a “3 by 5”
program to get 3 million people on treatment by the end of 2005. An estimated
440,000 people in the developing world had access to life-prolonging
antiretroviral drugs by June 2004. (Reuters)
Officials
seize
flu vaccine headed for black market
Thousands of doses of flu vaccine smuggled from France through Saudi Arabia were destined for black-market sales in New Jersey, federal officials said Tuesday. Tipped off by a local hospital administrator who had been approached by someone about buying black-market vaccine, agents from U.S. Immigration and Customs Enforcement seized 8,000 doses on Nov. 16 at John F. Kennedy International Airport in New York. The vaccine was shipped from the French drug company Aventis Pasteur to Saudi Arabia. It was then shipped by air via commercial carrier to New York. Federal investigators searched a house in Somers Point, NJ, on Monday. No one has been arrested. There is no evidence pointing to a conspiracy or organized effort to smuggle flu vaccine, said the spokesman. The Aventis vaccine made in France is not approved by the Food and Drug Administration for use in the US. (USA Today)
Consorta
awards agreement for advanced wound care
products to Mölnlycke Health Care
Consorta Inc. has entered
into a preferred agreement with Mölnlycke Health Care Inc. Newtown, PA, for the
full line of Tendra advanced wound care products. The new agreement becomes
effective on December 1, 2004, and will help Consorta members to reduce cost by
14%, on average. The Tendra products covered under the new agreement include
dressings with patented Safetac soft silicone technology, Mepitel, Mepilex,
Mepilex Lite, Mepilex Transfer, Mepilex Border and Mepiform. The products can be
used on numerous wound types; including skin tears, venous leg ulcers, pressure
ulcers, burns and scar management. In addition, the products with Safetac
technology have proven very helpful with the dermatological condition
Epidermolysis Bullosa or EB. All of the products with Safetac are designed to
minimize trauma and pain during dressing changes. The unique medical grade soft
silicone provides gentle, but secure adhesion to intact dry skin, while the
hydrophobic nature prevents the dressing from adhering to moist wounds.
Have a Happy Holiday!
The staff of Healthcare Purchasing News wishes you and your family a safe and Happy Thanksgiving weekend. Enjoy the holiday and we’ll see you again on Monday!
Tuesday, November 23, 2004
In this Issue:
Journal calls for independent drug review
agency
Consorta becomes first GPO to contract with
Uniform Code Council for Global Location Number Access
Society of Laparoendoscopic
Surgeons awards Starion Instruments ‘2004 Innovation of the Year'
Frost & Sullivan gives Access
Genetics award
for innovation in medical diagnostics
University of Michigan receives $44 million
donation for diabetes research
Kimberly-Clark Professional
offers web-based
guides for health & hygiene
Journal calls for independent drug review agency
The Journal of the American Medical Association (JAMA) called Monday for the creation of an independent agency, separate from the Food and Drug Administration, to monitor the safety of drugs after they’re on the market. The call was prompted by what the agency cites as a slow lag time in pulling drugs from the market after research shows they could be dangerous. In the editorial, released in advance of its Dec. 1 publication, JAMA suggested that inherent conflicts of interest among researchers led to the suppression of findings that were unfavorable to drug companies. The editors also blamed the FDA for inadequately responding to reports of adverse side effects in newly approved medications and then said that only a separate agency could be trusted to monitor the safety of drugs once they were approved by the FDA. “It is unreasonable to expect that the same agency that was responsible for approval of drug licensing and labeling would also be committed to actively seek evidence to prove itself wrong,” said the editorial.
Consorta becomes first GPO to contract with Uniform Code Council for Global Location Number Access
Consorta Inc. announced an agreement with The Uniform Code Council Inc. (UCC), Lawrenceville, NJ, in which the Consorta membership will have access to the GLN Registry beginning on January 1, 2004. The Global Location Number is a globally-recognized “key” used to identify legal entities, trading partners, and customer locations in e-business activities. Expressed as a 13-digit data structure, the GLN standard provides globally unique identification of a functional entity, such as a nursing station; a physical entity, such as a warehouse or a hospital wing; or a legal entity or trading partner, such as a specific company or supplier. Dennis Byer, Senior Director of Information Services for Consorta, said, “The registry will allow us to establish a comprehensive and accurate list of healthcare facilities with corresponding GLNs for our healthcare providers.” As Subscribers, Consorta members can gain access to an updated and accurate list of industry manufacturers, distributors, retailers, hospitals, clinics, and retail and mail-order pharmacies to ensure the informational accuracy of their supply chain activities. Consorta members will have the potential to streamline internal processes and convert to a single account number instead of the thousands of numbers they may be using today. “Use of the GLN will enhance data integrity and allow Consorta members to improve collaborative commerce activities in key e-business processes such as invoicing and logistics,” said Byer. “In addition, we believe the GLN will give us the ability to establish greater accuracy in price eligibility and records for current GPO membership status.”
Society of Laparoendoscopic Surgeons awards Starion Instruments
‘2004 Innovation of the Year'
Starion Instruments announced that its TLS(2) Thermal Ligating Shears has been
recognized as one of the '2004 Innovations of the Year' by the Society of
Laparoendoscopic Surgeons (SLS) during its ‘13th International Congress and Endo
Expo 2004.’ The TLS(2) utilizes Starion's advanced Thermal Welding technology
for sealing and dividing tissue during laparoscopic surgical procedures,
including gastric bypass and Nissen Fundoplication. Because the TLS(2)
encompasses a very focused heating element to seal and divide tissue, there is
minimal undesirable collateral damage to surrounding tissue. The Society of
Laparoendoscopic Surgeons annually recognizes the most innovative products of
the past year that have a multidisciplinary application in minimally invasive
surgery.
Frost & Sullivan gives Access Genetics award
for innovation in medical diagnostics
Frost & Sullivan has awarded Access Genetics with the 2004 Technology Innovation Award in Medical Diagnostics for the company’s Web-enabled DNA testing system. This telemedicine solution allows clinical laboratories and pathology groups to conduct high-value molecular genetic testing using existing in-house resources. Laboratories are often deterred from molecular genetic testing by the high capital investment required in equipment, contamination issues, lack of specially trained physicians and staff, and the perception of poor reimbursement. “All such barriers can be eliminated with the use of Access Genetics’ technology, which can greatly reduce the complexity of DNA testing,” says Frost & Sullivan Research Analyst Miriam Nagel. “The turnaround time while using this testing system is measured in hours as compared to the days needed for traditional testing that involves sending physical specimens to reference laboratories.” Current applications for the technology include testing of inherited disorders such as thrombophilia and cystic fibrosis, and infectious diseases such as human papillomavirus (HPV), chlamydia and gonorrhea. Many of these tests focus on women’s health issues, and can all be performed using a single specimen from a routine PAP collection or blood sample.
University of Michigan receives $44 million
donation for diabetes research
The founder of an information technology company and his wife are giving 44 million dollars to the University of Michigan. The money will go for creation of a Type 1 diabetes research center. The donation comes from Bill and Dee Brehm of McLean, VA. Bill Brehm is a university alumnus and ex-Pentagon official who founded SRA International. Dee Brehm has Type 1, or insulin-dependent, diabetes. She was a long time patient of the late Dr. Jerome Conn, former chief of endocrinology at Michigan.
Kimberly-Clark Professional offers web-based
guides for health & hygiene
Kimberly-Clark Professional introduces workplace wellness guides, a series of web-based guides relating to health and hygiene issues in away-from-home settings including healthcare facilities, office buildings, lodging properties, manufacturing/industrial facilities, and educational facilities. The HealthCare resource offers detailed recommendations for respiratory etiquette, provides tips for creating a more hygienic restroom, and stresses the importance of proper hand hygiene and surface sanitation in reducing the spread of nosocomial infections. The guides are available for downloading and printing at www.kcprofessional.com/us/Resource-Center/wellnessguides.asp.
Monday, November 22, 2004
In this Issue:
RFID tag to prevent surgical
errors
Injured soldiers are testing positive for rare
blood infection
FDA sets new standards for tissue banks
New treatment option for
angina and heart failure patients
Frost & Sullivan selects
Mobile
Aspects
for 2004 Product Innovation Award
SRI/Surgical Express Inc. announces new chief executive officer
RFID tag to prevent surgical errors
A radio frequency tag that patients can affix like a bandage to ensure doctors perform the right surgery on the right person was approved by the Food and Drug Administration (FDA) Friday. The tag, manufactured by SurgiChip Inc. of Palm Beach Gardens, FL, is the first surgical marking device approved by the FDA to use radio frequency identification. The FDA endorsed the same technology last week to track medicine bottles. The chip is part military dog tag and part high-tech smart chip, said The Associated Press. The patient's name and the site of surgery are printed on the SurgiChip tag. Inside is a chip encoded with the type of surgery, date of surgery and the surgeon's name. Before surgery, the tag is scanned and the patient is asked to confirm the information is correct. On the day of surgery, the tag is scanned again and reconfirmed again by the patient before the patient is sedated. The patient helps stick the tag, which has an adhesive backing, near the site of the surgery. Workers in the hospital's operating room scan the tag again to compare that information with the patient's chart. Before surgery, the tag would be removed. SurgiChip estimated its package, which includes the tag, scanner, printer and proprietary software that would be downloaded by each hospital, would cost a few thousand dollars. (The Associated Press)
An unexpectedly high number of U.S. soldiers injured in the Middle East and Afghanistan are testing positive for a rare, hard-to-treat blood infection in military hospitals, reported Army doctors. A total of 102 soldiers were found to be infected with the bacteria Acinetobacter baumannii. The infections occurred among soldiers at Walter Reed Army Medical Center in Washington, Landstuhl Regional Medical Center in Germany and three other sites between January 1, 2002, and August 31, 2004. Although it was not known where the soldiers contracted the infections, the Army said the recent surge highlighted a need to improve infection control in military hospitals. Eighty-five of the bloodstream infections occurred among soldiers serving in Iraq, the area around Kuwait and Afghanistan, the U.S. Army said in a report published by the Centers for Disease Control and Prevention. Military hospitals typically see about one case per year. A. baumannii, which is found in water and soil and resistant to many types of antibiotics, surfaces occasionally in hospitals, often spread among patients in intensive care units. Spread of the infection is often halted when healthcare workers wash their hands and those of their patients with alcohol swabs, actively monitor those with wounds to the extremities and promptly identify and quarantine the infected. Development of better drugs is needed to help contain future outbreaks of the infection, Army officials said. In some cases, the only effective antibiotic is colistin, an older drug that is rarely prescribed because of its high toxicity. The injured soldiers are being treated with a spectrum of drugs and are expected to recover from their infections. Healthcare providers in the United States are urged to watch for A. baumannii infections among soldiers who have been recently treated at military hospitals, especially those who were in intensive care units. (Reuters)
FDA sets new standards for tissue banks
The Food and Drug Administration has issued new regulations for tissue banks that process donated skin, ligaments and bones for transplant. The new federal safety standards, which will take effect in May, are designed to help prevent infection and disease, setting standards in a previously unregulated industry that has recently experienced explosive growth. In 2004 there have been a record 1 million tissue transplants, as compared to 350,000 in 1990. The new regulations require tissue processors to take specific steps to prevent the introduction or spread of disease when they recover, process, label, package and distribute human cells, tissues and similar products for transplant. They also require processors to report certain adverse reactions, to have accurate and complete labeling and to allow FDA inspections. The regulations published Thursday are the last of three sets defining federal standards for the industry. In January, the agency required all tissue banks to register with the FDA to allow for regular inspections. In May, the FDA said tissue donors, like blood donors, must be screened for infectious diseases. It also required tissue banks to test donors and donated tissue for diseases including HIV, hepatitis B and C, syphilis and and Creutzfeldt-Jakob disease.
New treatment option for angina and heart failure patients
Vasomedical, Inc. is launching its newest enhanced external counterpulsation therapy system at the American Heart Association Scientific Sessions this week in New Orleans. The Lumenair EECPR Therapy System is the latest in Vasomedical's line of devices for the treatment of patients with advanced heart disease, including angina and heart failure. The Lumenair EECPR Therapy System incorporates a modern ergonomic design that improves patient comfort, enhances patient monitoring, increases ease-of-use by medical personnel, standardizes cuff pressures and reduces space requirements. Data from clinical studies and patient registries confirm that approximately 80 percent of patients who complete EECPR therapy experience significant relief from chronic coronary artery disease (CAD) symptoms, including reduction or elimination of angina, reduced need for medication, increased functional capacity and improved quality of life. The Lumenair EECPR Therapy System is an integrated, all-in-one design comprised of an air compressor, a computer, a pressure cuff set tailored to the patient's size and an ergonomically designed treatment table.
Frost & Sullivan selects
Mobile
Aspects
for 2004 Product Innovation Award
Frost & Sullivan announced the selection of Mobile Aspects Inc., a provider of radio frequency identification (RFID) tracking solutions for the healthcare industry, as the recipient of the 2004 Frost & Sullivan Product Innovation Award. According to Frost & Sullivan’s 2004 study on U.S. RFID Markets for Healthcare, one substantial hurdle faced by healthcare facilities today is accounting for and receiving product and service reimbursement as allotted appropriately per clinician and patient. In U.S. emergency departments alone, an estimated 25 percent of all services do not receive compensation and approximately 12 percent of all chargeable products go unbilled, resulting in substantial financial losses for hospitals. “Mobile Aspects is a dynamic vendor of RFID products and solutions within areas such as Operating Rooms, Cath Labs, Radiology, Surgery, Acute Centers, and other high priority regions within the clinical landscape,” said Vivek Subramany, Frost & Sullivan industry analyst.
SRI/Surgical Express Inc. announces new chief executive officer
SRI/Surgical Express, Inc. (SRI), a Tampa, FL-based surgical supply company,
announces the appointment of Christopher Carlton as President, Chief Executive
Officer and member of the Board of Directors, effective December 1, 2004.
Carlton had been President, North America for Drager Medical, Inc. since 2001.
Prior to that, he spent 11 years with Marquette Medical Systems, Inc., a
division of General Electric, in several marketing and sales management
positions including Southern U.S. Manager, GEMS Cardiology and Director of Sales
at Marquette Medical Systems.
Friday, November 19, 2004
In this Issue:
FDA officer tells panel his agency is failing
in drug safety
FDA approves new pill
for lung cancer
HIMSS leads response to RFI
for the
National Health Information Network
Cap Gemini may sell its North American unit
Case Medical announces new president
FDA officer tells panel his agency is failing in drug
safety
A veteran Food
and Drug Administration safety officer told a Congressional panel on
Thursday that his agency was “virtually incapable of protecting
America” from unsafe drugs, and was likely to surrender to demands
of drug makers. In testimony before the Senate Finance Committee,
Dr. David Graham, the reviewer in the Food and Drug Administration's
Office of Drug Safety,
told the
senators that the FDA's role in reviewing and approving new drugs
sometimes conflicts with its duty to address safety issues.
He also named five drugs now on the market whose safety
needs "to be seriously looked at." He identified the drugs as:
the
cholesterol-lowering drug Crestor, the weight-loss drug Meridia, the
painkiller Bextra, the acne medication Accutane and the asthma
medication Serevent. Graham told the senators that each drug poses
different issues, but that they all require more aggressive FDA
action. AstraZeneca's Crestor, he said, poses risks of kidney
failure and a rare muscle disease; Abbott Laboratories' Meridia has
cardiovascular side effects; Roche's Accutane can cause birth
defects if used by pregnant women; Pfizer's Bextra carries
cardiovascular risks similar to those linked to Vioxx; and
GlaxoSmithKline's Serevent increases the risk of dying of asthma,
said Graham. The makers of all five drugs later defended their
products. A 20-year veteran of the FDA, Graham has played a
significant role in the withdrawal of nine drugs over the past
decade.
The exchange came during a hearing called by Senator Charles E.
Grassley (R-IW), the chairman of the Finance Committee investigating
the recall of the pain pill VIOXX.
After Graham's
comments, Grassley warned agency officials against disciplining
Graham in any way.
FDA approves new pill for lung cancer
Genentech and OSI Pharmaceuticals were granted federal approval Thursday to sell Tarceva, a pill to treat lung cancer. The approval by the Food and Drug Administration came well before the agency's late-January deadline, making it one of the fastest drug approvals ever, reported The New York Times. Tarceva was approved for patients with advanced non-small cell lung cancer, the most common form of the disease, who have failed to respond to at least one prior round of chemotherapy. The drug is expected to compete with AstraZeneca's Iressa, a similar drug that was approved in 2003. In a clinical trial, Tarceva was shown to prolong lives, by a median of 6.7 months compared to 4.7 months for patients who got a placebo. So far, Iressa has only been shown to shrink tumors, said The Times. Tarceva, a pill taken once a day, will be priced at slightly more than $2,000 wholesale for a month's supply, said an OSI spokesman.
HIMSS leads response to RFI for the
National Health Information Network
The Federal Register this week published the Request for Information (RFI) on the "Development and Adoption of a National Health Information Network (NHIN)". The RFI calls on the healthcare industry to provide input to the government on how such a network might be developed. HIMSS is leading the creation of a broad-based industry response, and is now seeking guidance from its committees, task forces, and members. Responses are due on January 18. Dr. David Brailer, National Coordinator for Health Information Technology, is initiating actions identified in the federal government's Framework for Strategic Action. Monday's Federal Register release details the network needed to achieve Goal #2, "Interconnect Clinicians," identifying interoperability as a major milestone for achieving improved healthcare delivery and the NHIN as the backbone for interoperability success. The government often uses an RFI as a preliminary process to gauge industry interest for a program prior to a full Request for Proposal (RFP) acquisition process. In the case of the NHIN, HIMSS anticipates a possible competitive bid RFP release in Spring 2005. The RFI is industry's opportunity to shape the interoperability model that the federal government plans to support to interconnect clinicians. The Office of the National Coordinator has set up an email address for inquiries on the RFI at NHINRFI@hhs.gov. Organizations interested in collaborating with HIMSS on a response should contact Tom Leary, HIMSS Director of Federal Affairs, at tleary@himss.org or (703) 299-9712.
Cap Gemini may sell its North American unit
Cap
Gemini, a Paris-based technology consulting and outsourcing firm, is considering
a sale of its business in North America, said an executive. Cap Gemini bought
the consulting business of the accounting firm Ernst & Young in February 2000.
The possible sale of the North American unit would be a strategic about-face for
Cap Gemini, which has long championed its global reach. But persistent losses at
the company and particularly acute problems at the North American operation have
led the board of Cap Gemini to consider a sale, the executive said. While a
final decision has yet to be reached about a sale, Cap Gemini has begun
canvassing for potential buyers. Last week, Cap Gemini reported its first
quarterly revenue growth in more than two years. In recent years, Cap Gemini's
consulting business has increasingly focused on providing clients with help
integrating different technologies, often customizing software programs, rather
than providing traditional strategic advice. Cap Gemini has expanded its
franchise to include technology outsourcing for large companies. Potential
bidders for the Cap Gemini business are expected to be traditional technology
hardware companies looking to expand into consulting and outsourcing and other
technology-focused consulting and outsourcing firms, analysts said. (The New
York Times)
Case Medical announces new president
Case Medical Inc. (Ridgefield, NJ) announces the appointment of Dan Marsh as the new President of Case Medical. Dan was previously Vice-President of Sales & Marketing for Medical Action Inc. During his 17 years tenure with Medical Action his leadership contributed to the company's accelerated growth which included nine major acquisitions. Allan Frieze the former president of Case will continue as a Consulting Director on a part time basis. Marcia Frieze will remain in the position of CEO.
Thursday, November 18, 2004
In this Issue:
Five years after IOM report
almost half of consumers
concerned about healthcare safety
Infections in low birth weight babies can have
lasting effects
B. Braun
Medical provides safer DEHP-free device
options for preemies, neonates, and others at-risk
Planar announces complete mobile imaging
solution for the OR
Blame the messenger, lose the
war for maturity and respect
Five years after IOM report almost half of consumers
concerned about healthcare safety
Five years after the 1999 Institute of Medicine report, “To Err is Human: Building a Safer Health System” which focused on medical errors in hospitals, Americans say that they do not believe that nation's quality of care has improved, according to a new survey by the Henry J. Kaiser Family Foundation, the U.S. Agency for Healthcare Research and Quality (AHRQ) and the Harvard School of Public Health. Four in 10 (40%) people say the quality of healthcare has gotten worse in the past five years, while one in six (17%) say the quality of care has gotten better and nearly four in 10 (38%) say it has stayed the same. The survey also finds that nearly half (48%) of U.S. residents say they are concerned about the safety of the medical care that they and their families receive, and more than half (55%) say they are dissatisfied with the quality of healthcare in this country, up from 44% who reported the same in a similar survey conducted four years ago. Respondents’ definitions of quality varied widely, with the greatest share (14%) citing cost and affordability as the most important factors in determining quality. Just 19% of Americans surveyed this summer said they had never heard the term “medical errors,” compared with 40% two years ago. About one in three people (34%) say that they or a family member had experienced a medical error at some point in their life. People with chronic health conditions are considerably more likely than other consumers to express concerns about their quality of care and report having personal experiences with medical errors. More than nine in 10 Americans (92%) say that reporting of serious medical errors should be required, and most (63%) want this information released publicly. Almost nine in 10 (88%) say that physicians should be required to tell a patient if a preventable medical error resulted in serious harm in the patient's own care. The complete survey results are available at http://www.kff.org/kaiserpolls/pomr111704pkg.cfm .
Infections in
low birth weight babies can have lasting effects
Infections in extremely low birth-weight infants are
associated with impaired cognitive development and physical growth problems,
said a study in the Nov. 17 issue of the Journal of the American Medical
Association. “We linked neonatal infections to an increased risk for
neurodevelopmental outcomes, such as cerebral palsy and low [cognitive] scores,”
said one of the study's authors, Dr. Barbara Stoll, chair of pediatrics at Emory
University School of Medicine in
Atlanta. Infection is a
common complication for premature infants, and many of the interventions that
help to save premature infants, such as ventilators and intravenous lines, can
increase their risk of infection. Using data from the National Institute of
Child Health and Human Development Neonatal Research Network, collected from
1993 through 2001, Stoll and her colleagues identified 6,093 babies in the
extremely low birth-weight category. Sixty-five percent of the babies in the
study had at least one infection while they were in the hospital. Overall, 41
percent of the infants, both those who had an infection and those who did not,
suffered from at least one neurodevelopmental problem. Because prematurity
itself increases the odds of complications such as cerebral palsy, Stoll said
the researchers attempted to control for other factors known to increase the
risk of neurodevelopmental problems. The odds of an infant who had at least one
infection developing cerebral palsy were between 40 percent and 70 percent
greater than a baby who didn't suffer from infection. Stoll and fellow
researchers said the study's findings pointed to the need for increased
vigilance in infection prevention as well as the need for neurodevelopmental
support programs and continued follow-up for these infants. (HealthDayNews).
B. Braun
Medical provides safer DEHP-free device
options for preemies, neonates, and others at-risk
To help improve patient outcomes and enable healthcare providers to comply more rapidly with FDA recommendations concerning limiting exposure to DEHP, a plasticizer in some PVC-based devices, B. Braun Medical Inc. announced that over 80% of its IV administration and medication pump sets are DEHP-free. In addition, 100% of its basic IV solution containers are DEHP-free. DEHP can harm the normal development of the male reproductive system in premature neonates, toddlers and adolescent boys. Healthcare providers are encouraged by the FDA to avoid DEHP products where possible, especially in perinatal and neonatal care. The polypropylene-based materials used to manufacture B. Braun EXCEL and PAB containers provide a safe and accurate means of administering IV medications without potential toxicity to the patient. In addition, B. Braun offers DEHP-free IV tubing, irrigation solutions, and parenteral nutrition solutions specifically formulated for neonatal and pediatric patients.
Planar announces complete mobile imaging solution for the OR
Planar Systems Inc. has developed a new solution to help hospitals improve
digital imaging capabilities in the operating room (OR) for better patient care
and faster response to emergency situations. The company says the new Dome
Surgery Review Cart family is the first line of mobile display workstations to
cost-effectively extend the benefits of picture archiving and communications
systems (PACS) to hospital ORs. The Dome Surgery Review Cart solves application
challenges particular to the OR, such as space limitations, costs and disruption
associated with remodeling, sub-optimal lighting conditions and cleanliness.
“We're seeing a tremendous growth rate in the PACS market, thanks to the
benefits that digital imaging has brought to the healthcare enterprise,” said
Antonio Garcia, medical imaging industry analyst at Frost & Sullivan. “We expect
to see PACS grow at a compound annual growth rate of 10 percent over the next
seven years, with digital imaging reaching areas that have been impractical
before, like the OR.” Available in different configurations, including color and
grayscale options, the Dome Surgery Review Cart enables referral and diagnostic
viewing of imaging modalities including X-rays, computed tomography (CT),
magnetic resonance (MR), nuclear and ultrasound in an easy-to-clean, all-in-one
solution.
Blame the messenger, lose the war for maturity and respect
In the “Fast Foreward” column of the November 2004 issue of Healthcare Purchasing News, senior editor Rick Dana Barlow reported on allegations made against, and the subsequent resignation of, Jackson Memorial Hospital’s (FL) former purchasing director Al Cook. The editorial column has since garnered several replies in defense of the well-liked and well-respected former AHRMM president.
What follows is an excerpt from a response penned by Barlow to those that question his reporting of details that appeared in The Miami Herald.
“Even though it may be painful for fellow professionals to read details about a fallen comrade it’s important for the media to report on those details – but not to condemn, convict or even criticize the individual, which in this case should be left to the court of public opinion and his most recent and future employers. Instead, media like HPN – specifically, the Fast Foreward column – report on these details to stimulate critical thinking about their own individual behavior and conduct, as well as that of the profession at large.”
Please click here for Barlow’s full response.
Wednesday, November 17, 2004
In this Issue:
Leapfrog Group releases latest hospital survey
results
House members support increase in funding
for nursing workforce development
CDC updates hospital groups on flu vaccine
allocation
Do hospital administrators and
CEOs
really “get” materials management?
MEGADYNE
Medical Products Inc. donates
medical supplies to DreamWeaver Medical
Amerinet signs new contract
with Angelica Textile Services Inc.
Leapfrog Group releases latest hospital survey
results
The Leapfrog Group has released the results of the Leapfrog Hospital Quality and Safety Survey. This year’s survey is the first to include measures that cover all 30 of the safety practices endorsed by the National Quality Forum (NQF). Among the survey results of over 1,000 hospitals: 8 in 10 have implemented procedures to avoid wrong-site surgeries and 7 in 10 hospitals require a pharmacist to review all medication orders before medication is given to patients. However, 7 in 10 hospitals report they do not have an explicit protocol to ensure adequate nursing staff, or a policy to check with patients to make sure they understand the risks of their procedures; 6 in 10 lack procedures for preventing malnutrition in patients; 5 in 10 report they do not have procedures in place to prevent bed sores (pressure ulcers); and 4 in 10 lack policies requiring workers to wash their hands with disinfectant before and after seeing a patient. The Leapfrog Hospital Quality and Safety Survey collects data on a hospital’s progress toward implementing practices in four categories: Computerized Physician Order Entry (CPOE); ICU Physician Staffing (IPS); Evidence-Based Hospital Referral; and the Leapfrog Quality Index. The Leapfrog website, www.leapfroggroup.org, displays each hospital’s results and is updated each month with data from additional hospitals. “The Leapfrog hospital survey gives consumers reliable information about a hospital’s quality and safety so that when it comes time to choose a hospital, they can make an informed choice,” said Suzanne Delbanco, CEO of The Leapfrog Group.
House members
support increase in funding
for nursing workforce development
Forty-six U.S. representatives urged House appropriators in a letter Monday to
support at least a $20 million increase in funding for Title VIII nursing
workforce development programs in fiscal year 2005, as approved by the Senate
Appropriations Committee. “The United States is currently facing a nursing
shortage of critical proportions…All of these programs play a vital role in
recruiting and retaining nurses and making sure that they have the training that
they need to care for patients,” the House members wrote. The letter will be
available soon at
www.aha.org
under “What's New.”
CDC updates hospital groups on flu vaccine allocation
During a conference call Tuesday with hospital groups, officials with the
Centers for Disease Control and Prevention said each state health department has
received an allocation of vaccine based on an estimate of the ratio of the
state’s unvaccinated high-risk population compared to the national unvaccinated
high-risk population. Each state is responsible for apportioning their
allocation to address best the high-need areas in their state. Officials also
reported that five urban areas with large-scale coordinated vaccination
programs, Washington, New York City, Chicago, Philadelphia and San Antonio, will
receive a separate allotment of vaccine. The CDC urged hospitals to contact
state health departments to receive vaccine, and also urged that healthy
healthcare workers under age 49 who do not work with immuno-suppressed patients
receive the FluMist vaccine. (AHA News Now)
Do hospital
administrators and CEOs
really “get” materials management?
Unfortunately, many underestimate and undervalue materials management in favor of their distributor, dot-com, GPO or third-party consultant. However, some are forward-thinking enough to recognize the value materials management brings to their organizations and serve as key advocates of the profession through genuine support of their employed staff members. We at Healthcare Purchasing News would like to introduce them to you in our January 2005 issue where we plan to recognize “Supply Chain Minded CEOs.” These hospital administrators/CEOs may have purchasing and materials management in their professional backgrounds or they may simply value the function so much as a strategic contributor to bottom-line savings and top-line revenue. But we need your help in telling us who these forward-thinking executives are why they are so SURE about the profession. Recommend worthy candidates by e-mailing us reasons how and why they Support, Understand, Recognize and Empower materials management - no more than two paragraphs for each of the four categories. Deadline for submissions is November 22.
MEGADYNE Medical Products Inc. donates
medical supplies to DreamWeaver Medical
MEGADYNE has made a product donation to DreamWeaver Medical, a non-profit organization dedicated to providing appropriate supplies and services for humanitarian healthcare worldwide. According to Susie Adams, DreamWeaver’s Executive Director, the Utah-based nonprofit’s main focus is to make it easier for surgical teams to go on humanitarian medical missions. MEGADYNE has donated 17 MEGA 2000® Soft Patient Return Electrode pads to DreamWeaver’s efforts that will specifically help during electrosurgical procedures. Compared to small, peel-and-stick disposable electrodes that make contact with only a limited area of the patient's body, the reusable MEGA 2000 Soft extends to the length and width of an adult torso. The MEGA 2000 Soft also reduces pressure, shear, and friction to protect against the formation of Decubitus Ulcers.
Amerinet signs new contract with Angelica Textile Services Inc.
Amerinet has signed a contract with Angelica Textile Services Inc. to provide members with laundry/linen system consulting services and programs. As of November 1, 2004, Angelica will offer a full range of customer-oriented, value-added linen programs including laundering, servicing, delivery and distribution to health care providers. These services include laundry and linen program consulting services (no fee for business evaluations), on premise laundry conversion programs (cash for facility assets), linen and garment rental services, laundry processing, surgical pack preparation, dust control, clinic offerings and linen management services.
Tuesday, November 16, 2004
In this Issue:
HDMA applauds FDA’s commitment
to EPC/RFID
technology for product delivery
WHO board supports genetic
engineering
experiments with smallpox virus
AHA, HCCA surveying healthcare
organizations
on HIPAA security activity
NIH uses computers to simulate
flu outbreak
Artromick introduces keyless self-locking
anesthesia cart line
HDMA applauds FDA’s commitment to EPC/RFID
technology for product delivery
The Healthcare Distribution Management Association (HDMA) strongly supports the U.S. Food and Drug Administration’s (FDA) commitment to ensuring patient safety and product integrity through the use of EPC/RFID technology in the healthcare system. “We commend the FDA for proactively communicating expectations to companies with pilot programs utilizing EPC/RFID,” said HDMA President and CEO John Gray. “We’ll continue to work with the FDA, state regulatory authorities and all stakeholders in the prescription drug supply chain, to maintain our focus on the safe, secure and efficient delivery of healthcare products.” “HDMA believes EPC/RFID, combined with other safeguards such as authentication technologies, tough anti-counterfeiting laws, enhanced wholesale distributor licensing standards, and the adoption of best practices by all members of the supply chain, will dramatically improve public safety,” said Gray. In the past two weeks, the HDMA Healthcare Foundation released a report, “Adopting EPC in Healthcare: Costs and Benefits,” which concluded that annual benefits of between $200 and $400 million can be achieved in reducing the many incidents of prescription drug counterfeiting. “The most important goal is clear – enhanced patient safety,” said Gray. HDMA has worked steadily with the FDA and industry partners over the past three years to explore case studies and best business practices for efficient, timely and economical uses of EPC/RFID technology in continued efforts to enhance the safety and integrity of the nation’s pharmaceutical supply. “In essence, these guidelines will assist the industry in moving forward on improvements that succeed because they are efficient, economical and clearly benefit consumers.”
WHO board supports genetic engineering
experiments with smallpox virus
An influential World Health Organization committee is recommending that researchers be permitted to conduct genetic-engineering experiments with the smallpox virus in hopes of being able to better combat the disease. The WHO had previously opposed such work for fear that a “superbug” might emerge. Because the disease is so deadly, the WHO has at times recommended destroying the world's two known smallpox stockpiles. The new recommendation has rekindled a debate over whether such research will help or hinder bioterrorism defenses. The World Health Assembly, the ruling body of the WHO, would make a final decision on whether to approve the experiments, which would include splicing a “marker” gene into the smallpox virus so its spread can be better tracked in the laboratory. The WHO committee said inserting the marker gene wouldn't make the disease any more dangerous, and that allowing such experimentation would speed depletion of the remaining smallpox virus stocks. It has been U.S. policy to refrain from genetically engineering smallpox, but that is expected to change if the WHO endorses such research. The WHO committee said further research should be carried out before a final decision is made. The WHO said the modified version of the virus would only be used in testing drugs for people who already have the virus and not for smallpox vaccines. (The Associated Press)
AHA, HCCA surveying healthcare organizations
on HIPAA security activity
The AHA and the Health Care Compliance Association are conducting a survey to learn the current level of activity surrounding the Health Insurance Portability and Accountability Act Security Rule, and its impact on healthcare organizations' daily operations and activities. Healthcare organizations can complete the survey online through Nov. 30 at http://www.surveymonkey.com/s.asp?u=86938687408. Survey participants will receive a “HIPAA Security Board Briefing Document,” a PowerPoint presentation that can be customized and used to update and educate board and committee members. Organizations that encounter difficulty accessing the survey should send an email to fsi-technology@aha.org.
NIH uses computers to simulate flu outbreak
Researchers are developing computer models that can simulate an outbreak of bird flu in a hypothetical human community in an effort to learn how best to contain the potentially deadly virus should such an outbreak emerge, the National Institutes of Health reports. Preliminary results from the models could be available by early January 2005. Officials said the project will provide a tool that policymakers, public health workers and researchers can use to test the impact of various intervention strategies in different scenarios. NIH also is collaborating with other researchers on an influenza genome sequencing project to better understand how flu viruses evolve and spread in an effort to enhance flu preparedness efforts.
Artromick introduces keyless self-locking
anesthesia cart line
Artromick International, Inc. announced the release of its new Avalo AC Anesthesia Cart line that feature keyless automatic relocking. The new Avalo AC Anesthesia Carts are available in a choice of two model sizes with generous capacity and design flexibility. The line features security upgrades including cart user audit, badge ID security access, and remote cart security control.
Monday, November 15, 2004
In this Issue:
RFID labels to track medicine bottles
Experimental pill may stop drug abuse, aid
weight loss
Infection control pioneer dies
Broadlane acquires National
Oncology Alliance
Cardinal Health introduces
central supply chain registry
RFID labels to track medicine bottles
The Food and Drug Administration and several major drug makers are expected to announce initiatives Monday that will put tiny radio antennas on the labels of millions of medicine bottles to combat counterfeiting and fraud, reported The New York Times. Among the medicines to be tagged are Viagra, one of the most counterfeited drugs in the world, and OxyContin, one of the most abused medicines in the U.S. The tagged bottles, which for now will include only the large bottles from which pharmacists fill prescriptions, will start going to distributors this week, officials said. Experts say this is only the beginning of the technology, reported The Times. Wal-Mart and the Department of Defense have already mandated that their top 100 suppliers put the antennas on delivery pallets beginning in January. The radio-frequency identification labels consist of computer chips embedded into stickers that emit numbers when prompted by a nearby radio signal. For drug makers, radio labels could help clean up the wholesale distribution system, where most counterfeit drugs enter the supply chain, said The Times. With initial label costs at 20 to 50 cents, the technology is still too expensive for individual consumer goods. But prices are expected to drop as the labels become more popular. Radio labels fight counterfeiting by providing a unique identifier that is almost impossible to copy. When pharmacists receive delivery, they should be able to pass a wand over the bottles and, through an online database, check the history of each. Any bottles that have been reported missing or previously sold, have an unusual delivery history or are not recognized by the system will be flagged as suspicious. The FDA is currently relying on a nonprofit industry group, EPCglobal, based in Lawrenceville, NJ, to set standards for radio labels. The labels will remain voluntary until 2007. After that, the agency may require the labels and specify which types must be used, said the FDA. (The New York Times)
Experimental pill may stop drug abuse, aid weight loss
Scientists say an experimental drug, called rimonabant or Acomplia, might be versatile enough to help people lose weight and keep it off, quit smoking and even help stop drug and alcohol abuse. The French pharmaceutical firm Sanofi-Aventis plans to seek federal approval for rimonabant next year. Animal studies suggest rimonabant can block the effects of marijuana and fight relapse in alcohol and cocaine abuse, researchers said. No human test results for rimonabant in alcohol abuse have yet been published. But researchers at the National Institute on Drug Abuse reported in 2001 that a single dose of the drug could block the effects of smoked marijuana in people, not just animals. The institute is now pursuing follow-up research. Rimonabant works by blocking the effects of the brain’s reward system. (The Associated Press)
Infection control pioneer dies
Bertha Yanis Litsky, PhD, passed away last week. Ms. Litsky was a true infection control and sterile processing champion and pioneer. 3M Healthcare has sponsored the Bertha Yanis Litsky, Ph.D. Educator of the Year Award for IAHCSMM members dedicated to the advancement of education in the profession. In addition to her work as a Research Microbiologist with the University of Massachusetts, Amherst, Ms. Litsky was an active member of the central service community.
Broadlane acquires National Oncology Alliance
Broadlane announced the acquisition of National Oncology Alliance Inc. (NOA), a
premier provider of services for oncology physician practices in the U.S. NOA is
a privately held company based in San Rafael, CA. Executives at Broadlane and
NOA expect that the combination of their two companies will open new
opportunities for both to expand their services for the benefit of their
customers. Customers spend more than $7 billion annually using the two
companies’ contracts, with more than $3 billion of that coming from
pharmaceuticals. The total U.S. pharmaceutical market for chemotherapy and
supportive care medications is approximately $10 billion annually, with the
office-based oncology market representing approximately $8 billion of that
total. According to the latest industry surveys, there are approximately 6,000
office-based oncologists in the United States with an average spend per
oncologist of $1.2 million per year. NOA, founded in 2000, today serves more
than 50 percent of the physician office-based oncology market. As a wholly owned
subsidiary of Broadlane, NOA will continue its deep relationships with its
physician practice customers. Broadlane and NOA will remain separate companies,
with just a few adjustments within the NOA executive leadership.
Cardinal Health introduces central supply chain registry
Cardinal Health, Inc. announced the introduction of SupplyCentral, a healthcare product synchronization database. The SupplyCentral database is a central registry of medical and surgical product information that will increase the accuracy, speed and efficiency of the supply chain for Integrated Delivery Networks (IDNs), hospitals, distributors and manufacturers. According to one recent study, 24 percent of all supply management employee time at hospital and distributor sites is spent on correcting data integrity errors. Cardinal Health’s SupplyCentral database will help reduce the number of invoice errors, out-of-stock incidences, and rework errors as well as the manual resources used to correct them.
Friday, November 12, 2004
In this Issue:
Booz Allen: greater
collaboration across
health disciplines could save lives
Institute for Healthcare
Improvement to host
16th annual national forum December 12-15
NJ hospitals, other providers
agree on
common emergency codes
MedAssets Supply Chain Systems
announces
Environmentally Preferable Purchasing Program
Scope of medical laser safety
standard broadened
Food service preparedness web-based seminar Nov. 17
Booz Allen: greater collaboration across
health disciplines could save lives
Greater collaboration among healthcare professionals could prevent some of the tens of thousands of patient deaths and injuries that occur in hospitals and clinics each year, according to a recently concluded strategic simulation. The exercise conducted by Booz Allen Hamilton for the New Port Richey, FL,- based American Board of Quality Assurance and Utilization Review Physicians, Inc., is the second simulation in six months to show systems, communications, contingency planning and the involvement of a broad spectrum of stakeholders is critical in preventing patient errors. Key findings of the study include: Separate disciplines within hospitals or clinics, such as doctors, administrators and nurses, have a tendency to try solving problems within their own groups, rather than reaching out to the other disciplines to get a broader picture. Healthcare professionals may tend to find ways to work around safety processes that were cumbersome, indicating to some that the processes in place may not be working or are in need of updates and improvements. Staffing shortages were placing incredible burdens on entire hospital infrastructures. These findings point out that communications with each other, and even with patient families, is often overlooked in exchange for expediency, Booz Allen Vice President, Susan Penfield, said. “During the course of the exercise, the participants recognized that the immediate post-event formation of multidisciplinary teams to address and understand medical errors improves the ability of providers to respond and react to issues and fallout,” Penfield said. “Although such behavior is understood as necessary, it was the first time the wargame participants had worked toward immediately responding to a medical error in a multidisciplinary team.”
Institute for Healthcare Improvement to host
16th annual national forum December 12-15
“But
How?” That's the theme of this year's 16th National Forum on Quality
Improvement in Health Care, hosted by The Institute for Healthcare
Improvement (IHI) in Orlando, FL, from December 12 to 15, 2004. The forum is expected to attract 4,000 healthcare leaders from around
the world and another 6,000 via satellite. The Forum will address such questions
as: How do we use lessons from other industries to improve healthcare systems?
How do we improve our ability to reduce suffering and improve health? How do we
revitalize our workforce? How do we create a culture of change that leads to
continuous improvement? Plus, IHI will be announcing and introducing a national
campaign to reduce avoidable hospital deaths. Among the pressing healthcare
delivery issues to be addressed at more than 100 workshops and presentations are:
Patient Safety, Patient-Centeredness,
Workforce Development, Critical Care, Leadership and Governance,
Innovation and Spread, Flow through the Acute Care Setting, and Office Practices
and Outpatient Settings. The National Forum will mark the launch of a new series
of educational and motivational videos from IHI and The Robert Wood Johnson
Foundation entitled “Pursuing Perfection in Health Care.”
Please visit IHI.org for
additional information.
http://www.ihi.org/IHI/Programs/ConferencesAndTraining/16th
NationalForum.htm - Then click on “Agenda”
NJ hospitals, other providers agree on common emergency codes
The New Jersey Hospital Association and other groups unveiled a voluntary system of 10 common codes that hospitals and other healthcare providers in the state can use to designate emergency situations in their facilities. For example, a Code Red under the system will always mean fire, while Code Blue will signify an adult medical emergency and a Code Orange a hazardous materials incident. Since many hospitals and other healthcare providers share physicians, nurses and other staff, a common code system reduces staff confusion and allows providers to more clearly communicate with each other and authorities during natural disasters or terrorist incidents, officials said.
MedAssets Supply Chain Systems announces Environmentally Preferable Purchasing Program
MedAssets Supply Chain Systems announced its continuing efforts to protect the environment through the MedAssets Environmentally Preferable Purchasing (EPP) Program. The main objectives of the EPP Program are pollution prevention, including mercury elimination and waste and toxicity minimization, as well as providing products and services from suppliers that adhere to best environmental practices. The MedAssets EPP program includes an On-Line Resource Center offering information and tools that support and encourage practice changes that protect the health of the community and the environment. For healthcare providers initiating an environmental effort, information is readily available to assist in prioritizing first steps, provide instructions to implement these steps, and to serve as a source for the specific tools needed to complete the process. Additionally, MedAssets was recently awarded the Hospitals for a Healthy Environment (H2E) Champion for Change status.
Scope of medical laser safety standard broadened
The Laser Institute of America (LIA) has revised its Z136.3 Safe Use of Lasers in Health Care Facilities. The revision was driven by the movement of the widespread use of medical lasers, from hospital operating rooms to the office and/or clinic environment. The use of ophthalmic refractive surgery (excimer) lasers, dermatological lasers and other medical lasers moved from the closely regulated hospital environment into broad applications in conventional medical, surgical and allied professions. The majority of medical laser systems are now found in private medical offices. From this venue they have expanded into cosmetic uses in areas that may have limited or part-time medical supervision, such as in spas and beauty salons. Medical laser systems now range in output energy from microjoules to tens of joules and in power from a fraction of a watt to megawatts and greater. Not only has the environment of these laser systems been greatly broadened, but the training of the people using them has become far more diverse. The Z136.3 represents many necessary compromises to make it fit the needs of this diverse population of users of these medical laser systems. Due for release in January 2005, orders are now being accepted by LIA. For a limited time, the pre-publication price is $99, for non-members as well as LIA members. After this offer has expired, the price increases to $110 for LIA members and $130 for non-members. To order, visit www.laserinstitute.org/catalog or call LIA at 1.800.34.LASER.
Food service preparedness web-based seminar Nov. 17
The American Society for
Healthcare Food Service Administrators, an AHA affiliate, will host a Web-based
seminar Nov. 17 from
2 to 4 pm EST,
on the food service
preparedness lessons learned from Hurricane Charley. Food service directors,
clinical dieticians and other staff from three Florida hospitals temporarily
closed by the hurricane will share their perspectives.
For information contact
ASHFSA at 1-800-620-6422 or visit www.ashfsa.org.
To register, go to
http://www.ashfsa.org/associations/1976/files/WebinarTwofer
Registration.doc. ASHFSA members will receive a discount on the registration
fee. A portion of the registration fees will be donated to Hurricane Relief
efforts.
Thursday, November 11, 2004
In this Issue:
Canadian government may halt drug shipments to
US
Too much Vitamin E increases
risk of death
Olympus introduces EndoEYE videoscope for
gynecologic and thoracic Surgical Procedures
Lawson signs software and
services contract
with Pomona Valley Hospital
General Electric Healthcare signs new Amerinet contract
Canadian government may halt drug shipments to US
Growing concerned about domestic supplies, a top official said the Canadian government may stop shipments to the US if the trade continues to grow. Canadian Health Minister, Ujjal Dosanjh, said “We certainly cannot be the drugstore for the United States of America.” Some large pharmaceutical companies have been halting supplies to Canadian wholesalers that they believe are supplying prescription drugs to US citizens. When asked whether Canada should increase its prices so that it becomes less attractive for US buyers, Ujjal Dosanjh said “The issue that you have in the US is a domestic issue.” Canada-to US sales of prescription drugs are estimated to be between $1.3 billion to $1.7 billion. Internet sales are about $800 million. Ujjal Dosanjh added that Canada can manage current levels of trade. However, if state purchasing programs kicked in, Canada's domestic supply would be affected. Dosanjh said “If they try and contain this situation in the US, we may not have to take any action. The trade may die off by itself. If there are laws passed to allow or encourage bulk imports from Canada to the US, we will have to act at that point.” (Medical News Today)
Too much Vitamin E increases risk of death
High doses of Vitamin E, which millions of people take to protect themselves against heart attacks, Alzheimer's disease and other ailments, appear to actually increase the overall risk of dying, researchers have reported. A new analysis of data from 19 studies involving nearly 136,000 people concluded that the overall risk of dying began to increase at the dose in a typical single capsule of Vitamin E, and that the more Vitamin E people took, the more their risk of death rose. Someone taking 400 international units of Vitamin E a day for five years, for example, would face a 5 percent higher risk of dying, the researchers found. The study found no increased risk from lower doses, particularly at doses of 200 international units or below, and perhaps even a benefit. Although the study did not examine how high-dose Vitamin E might increase the risk of death, other studies have suggested that the substance may boost the danger of heart attacks and strokes, perhaps by affecting blood clotting or blocking the beneficial effects of other nutrients, the researchers said. The findings indicate that no one should take high doses regularly and that current guidelines for what is considered a safe maximum daily intake should be lowered, the researchers said in a study presented at an American Heart Association meeting.
Olympus introduces EndoEYE videoscope for
gynecologic and thoracic Surgical Procedures
Olympus announced the introduction of the newest member of the EndoEYE family of surgical videoscopes at the annual American Association of Gynecologic Laparoscopists (AAGL) meeting this week. The EndoEYE Operating Surgical Videoscope was developed to help make operative laparoscopy easier to master. Gynecologic applications of the technique include diagnosis and treatment of endometriosis, evaluation and treatment of ovarian cysts and removal of uterine fibroids. Thoracic surgery applications include video-assisted thoracic surgery (VATS), diagnostic VATS, empiema debridement, and lung biopsy. The operative laparoscopy technique, which is also known as single port laparoscopy, reduces the number of surgical ports needed and gives the surgeon direct control of the scope and hand instruments for greater precision and efficiency. However, the fragile, multi-component rod lens laparoscopic equipment (i.e.: camera head, light guide cable, laparoscope and hand instruments) traditionally used to perform the technique can be cumbersome to handle. As a result, many surgeons have not attempted to master the technique. The new EndoEYE Operating Surgical Videoscope’s sleek, single-piece design facilitates the passage of hand instruments through its 5mm working channel, and makes working with laser beams and laser fibers easier as well.
Lawson
signs software and services contract
with Pomona Valley Hospital
Lawson Software signed a multi-suite contract with Pomona Valley Hospital Medical Center in Lawson's first quarter of fiscal 2005, which ended Aug.31. The healthcare organization licensed the Lawson Enterprise Performance Management, including Reporting Suite and Budgeting and Planning, and Lawson Financials, Healthcare Supply Chain Management, including Surgical Instrument Management, and Human Resources Suites. The new system will automate manual processes that support PVHMC's patients and more than 2,400 employees and 800 volunteers. Additionally, PVHMC has signed a services agreement with Lawson for implementation and training of the system. Nationally recognized as a 100 Top Hospital, PVHMC is a 436-bed acute care, not-for-profit teaching hospital serving Eastern Los Angeles and Western San Bernardino counties. PVHMC will use the Lawson suites to integrate a number of its back office systems, eliminating its multiple legacy systems that will sunset in the next two-to-three years. As part of an IT strategy established to replace PVHMC's disparate technology systems to create a competitive advantage for PVHMC, Lawson will assist PVHMC in implementing more effective management of its operations.
General Electric Healthcare signs new Amerinet contract
Amerinet has signed a renewal agreement with General Electric Healthcare (GEHC for three years, effective October 1, 2004. The renewed agreement covers GE Capital Modular Space, Mobile & Modular Buildings and Trailers. Members will have the option to lease and/or purchase these products. This renewal increases the discounts to the most market competitive level available through General Electric Healthcare. With the exception of c-arms, this agreement includes all GE multi-modality imaging products. In addition, GE includes modular and mobile buildings and trailers, Intellimotion Asset Tracking, service and Product Performance Improvement (PPI).
Wednesday, November 10, 2004
In this Issue:
CDC’s distribution plan for
flu vaccine
C. difficile epidemic in
Montreal hospitals
Study: Drug-eluting stents
benefit elderly
patients with coronary artery disease
Gift of $10M to benefit S. Miami Hospital
Baxa launches CyTwo-Fer Needle for safe
reconstitution of drugs
CDC’s distribution plan for flu vaccine
Federal health officials have announced a distribution plan for the
remaining 10.3 million doses of flu vaccine, allocating it to states
based on how many high-risk people each has and the number of doses
already received.
Julie Gerberding, director of the federal Centers for Disease
Control, said that of the 10.3 million doses of the vaccine that
remain, state and local health departments will receive 100 percent
of the 3.1 million doses ordered. Health officials in those areas
will decide who will be vaccinated. The remaining 7.2 million doses
will be distributed nationwide over the next few weeks, based on
unmet needs among high-priority populations, Gerberding said.
The CDC will set
aside about 1.3 million doses in case of an emergency or large
outbreak. In addition, about 3 million doses of FluMist are being
given to healthy adults. The Bush administration has signed a $10
million contract with Aventis to expand its supply of chicken eggs,
the critical component in producing flu vaccine. With the ability to
stockpile eggs and other supplies, Aventis will be able to produce
the vaccine year-round if needed.
Gerberding
discouraged states from trying to buy vaccine outside the United
States on their own, saying the Food and Drug Administration is
pursuing a way to acquire and quickly license reserves from other
countries.
There are no reports of widespread flu activity, Gerberding said.
People in
populations at risk for flu can call the CDC Hotline, 800-CDC-INFO,
for help with finding doses or reporting irregularities such as
price gouging, she added.
C. difficile epidemic in Montreal hospitals
Officials believe an epidemic of a strain of bacterial infection that is centered in Montreal is particularly dangerous to vulnerable patients. In the first six months of this year, Clostridium difficile enterocolitis or C. difficile killed 109 patients in 10 hospitals in Quebec and contributed to 108 other deaths, according to health experts in Montreal. Clifford McDonald, an infectious disease specialist at the CDC, expects it will spread to other hospitals in North America, reported the Washington Post. Typically, the rate of C. difficile infection is low, and few die of its complications. But in an urgent report issued last month, an infection control specialist, Vivian Loo, found twice the normal rate of infection in hospitals in Quebec this year. And death rates rose to nearly 8 percent from the past rate of 1 percent to 2 percent, she reported. In the first six months of 2004, the bacterium killed as many people in Quebec hospitals as had died from it throughout Canada in the three previous years, her report concluded. Quebec's public health system, made up of older hospitals, has undergone budget cuts and staff reductions, and critics say the hospitals are no longer being kept clean, said The Post. Some experts say hospital staff members who do not wash their hands after dealing with every patient and physicians who over-prescribe broad-spectrum antibiotics are responsible for the epidemic by creating opportunities for C. difficile to grow. At the CDC, McDonald said problems of hygiene and the overprescribing of antibiotics are compounded by the new virility of this strain of C. difficile, called B-I. He and Loo independently examined samples of C. difficile and found that the normal strain had mutated and caused outbreaks in Quebec, probably in Pittsburgh and at six other hospitals elsewhere in the United States in 2000 and 2001. According to McDonald, the strain has an extra toxin, called a binary toxin, that has in the past only been found in 6 percent of U.S. strains, but it is uniformly present in this one. “And it has a mutation in a gene that normally suppresses toxin production,” said McDonald. Those two aberrations may make it resistant to some of the antibiotics often used in hospitals, and make it more lethal, he said. McDonald suspects this superbug is present but still unnoticed at other hospitals. The CDC is recommending hospitals with outbreaks require all healthcare workers wear gloves and gowns, stop using rectal thermometers and other shared equipment, return to washing their hands with water instead of alcohol-based gels, clean infected rooms with diluted bleach, and more closely scrutinize the use of antibiotics. (The Washington Post)
Study: Drug-eluting stents benefit elderly
patients with coronary artery disease
Elderly patients treated with the CYPHER Sirolimus-eluting Coronary Stent should expect the same benefit in repeat coronary procedures as seen with younger patients, according to a report presented at the 2004 American Heart Association Scientific Sessions. The data were taken from the e-CYPHER Registry which was designed to better understand the safety and clinical benefits of the CYPHER Stent in treating coronary artery disease in difficult-to-treat patient groups. The octogenarian group, comprised of 505 patients aged 80 years or older, had a low target lesion revascularization (TLR) rate, which was similar to the rate in the patient group under the age of 80 (0.8 percent vs. 1.3 percent). As a result, another key endpoint of the analysis, Major Adverse Cardiac Events (MACE), which includes heart attacks, TLR and death, was also low for the elderly population (6.3%). Also, the late stent thrombosis rate was not significantly higher for the elderly patients (0.2% vs 0.14%). Among the elderly group treated with the CYPHER Stent in the study, 39.5 percent were female, 44.8 percent had unstable angina (chest pain), 15.5 percent had restenotic lesions and 35.6 percent had three-vessel disease.
South Miami Hospital Foundation said it has received a $10 million gift, the largest donation ever received by Baptist Health. The money is to fund three components of a center of excellence to study and treat abnormalities of the heart's electrical system. These include a new clinical area equipped with electrophysiology and angiography equipment; an outpatient cardiac rhythm management clinic for the diagnosis and management of heart rhythm problems; an extensive commitment to physician and public education about heart rhythm disturbances and their treatment. Construction of the clinical areas is under way as part of a major renovation and expansion at South Miami Hospital, the hospital said. Donor L. Austin Weeks received treatment from Dr. John R. Dylewski, a cardiac specialist in electrophysiology, for atrial fibrillation. After Dylewski prescribed a medication that helped Weeks, the patient asked the doctor if there was anything he could do for him. “Dr. Dylewski said he had in mind this center of excellence in electrophysiology, and that's how it started,” Weeks said. Dylewski said he expects to launch public awareness and educational efforts next year, in addition to planning an international medical education conference. Weeks, a retired petroleum geologist and former director of Weeks Petroleum, and his wife, Marta, are long-time benefactors of the University of Miami and other philanthropic causes. (South Florida Business Journal)
Baxa launches CyTwo-Fer Needle for safe reconstitution of drugs
Baxa Ltd. announces the launch of the CyTwo-Fer Needle, featuring a unique hub design that provides vented access to vials or non-vented access to IV bags, performing the work of two devices. Both bags and vials may then be accessed in one procedure, avoiding the expense and time involved in changing needles. The CyTwo-Fer Needle features a 16G stainless steel cannula with a Huber point for smooth and safe vial access, without the coring often associated with plastic spike devices. The Huber point also allows users to direct liquid flow into the vial to reduce foaming during admixture. Designed to prevent environmental contamination during cytotoxic drug reconstitution, the CyTwo-Fer Needle has a 0.2 micron vent filter, allowing safe and efficient vial reconstitution, aspiration and subsequent injection of drugs into bags or other IV delivery devices. This filtered vent balances air pressure in the vial or container for fast and easy liquid addition and removal, minimizing the risk of upper limb disorder. Finger grips and a tethered cap also facilitate ease of use. CyTwo-Fer Needles are available for sale now in Europe, the Middle East and Africa, directly through Baxa Ltd. or through dealer representatives.
Tuesday, November 9, 2004
In this Issue:
FDA
clarifies decision and action on reprocessed SUDs
Healthcare
Supply Chain Performance, December 6-7, 2004
International
Business Solutions Alliance LLC signs
printing services agreement with Novation
3M offers cold
and cough posters
FDA clarifies decision and action on reprocessed SUDs
Contrary to spiraling popular opinion, the Food and Drug
Administration’s recent decision identifying selected reprocessed
single-use devices that could no longer be distributed because they
were “not substantially equivalent” to their original form has less
to do with safety threats than it does with paperwork completion.
In fact, FDA officials sought to quell any clamor over the
perception of safety concerns that emerged during an educational
session at the Fall meeting of the International Association of
Healthcare Central Service Materiel Management in Boston last month.
Larry Spears, the FDA’s deputy director of regulatory affairs, who
announced the FDA’s decision and presented the agency’s strategies
and tactics at the IAHCSMM conference, wanted to set the record
straight after attendees peppered him with questions about potential
recalls and safety concerns.
“First of all, any reference to the specific devices that can no
longer be legally marketed as being dangerous or unsafe is
incorrect,” Spears told Healthcare Purchasing News. “These devices
were found through a review by our Office of Device Evaluation to be
not substantially equivalent (NSE) to a previously marketed
device. This does not mean they are unsafe or ineffective.”
Spears also noted that the FDA did not conduct any post-reprocessing
review inspections of the targeted devices as the impetus for
sending the NSE letters. That decision merely was based on data
submitted to the federal agency. “The FDA has determined that a
number of submissions of validation data for reprocessed single use
devices were considered inadequate or, in FDA terms, not
substantially equivalent to another marketed device,” Spears
said. “Thus, they can no longer be legally marketed."
Spears also indicated that the FDA does not have any plans to issue
recalls unless the affected reprocessing companies are
uncooperative. “FDA will contact each of the reprocessors to
determine their plans to retrieve distributed product that was
determined as not substantially equivalent or where the product
application was withdrawn,” he noted. “If the reprocessor fails to
retrieve the device, on a case by case basis, FDA will evaluate
whether devices in those categories should be recalled using FDA's
mandatory recall authority."
But cooperation by AMDR’s three member companies, which represent
the lion’s share of reprocessing services in the industry, really
isn’t an issue at all. Dan Vukelich, AMDR’s deputy executive
director, told HPN that "[AMDR] Reprocessors have voluntarily agreed
to withdraw those products noted by the FDA.” Vukelich also
re-emphasized that "there's no evidence that these devices are in
any way unsafe for use." He further noted that the reprocessing
companies are working with the FDA to provide the additional
information required to resolve any outstanding issues.
In fact, AMDR estimated that approximately 95 percent of their
members’ products remain legally marketable.
On November 2, the FDA completed its review of reprocessed medical
devices that required supplemental validation submissions (SVSs)
under the Medical Device User Fee and Modernization Act of 2002. The
federal agency then issued a “talk paper” regarding its resulting
actions on reprocessed SUDs, which can be found at the following Web
address:
http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01323.html.
Last week, the FDA issued letters to five reprocessors in response
to the agency’s call for those submissions as required by the MDUFMA
legislation. The actions involved either clearances or NSE findings.
“Some products were also withdrawn from review,” said Tim Ulatowski,
director of the FDA’s Office of Regulatory Affairs. “Reprocessed
single-use devices that require a cleared premarket notification or
approved premarket approval submission and do not now have either
one cannot be legally distributed.”
Ulatowski noted that any submissions that his office did not clear,
or submissions for withdrawn products, “may be resubmitted at any
time in the future with the required data and information.”
Furthermore, “there is no statement whatsoever by FDA based on our
actions that the devices not cleared or withdrawn were determined by
our actions to be unsafe or ineffective,” he said. “In fact, as
noted in prior posted statements by FDA, if FDA had information
leading us to believe a reprocessed single-use device was unsafe or
ineffective we would move immediately to have the device recalled.
This is not the case with any of the devices we took action on last
week.”
Ulatowski acknowledged that the affected reprocessors “have been
immediately forthcoming and cooperative in our request for
information.”
Healthcare Supply Chain Performance, December 6-7, 2004
Healthcare Purchasing News and The American Strategic Management Institute have aligned to host “Healthcare Supply Chain Performance”, a training designed to improve the efficiency of your hospital supply chain. Materials costs account for at least 25% of hospital expenditures and most hospitals spend 40 cents for every dollar on logistics for purchased materials. Optimizing supply chain processes within your hospital can help cut this cost significantly. Learn to apply effective measures and metrics to improve your supply chain performance. Hear case studies from the Nation's Leading Hospitals: Saint Luke's Hospital of Kansas City, New York Presbyterian, Baxter Regional Medical Center, Shands Healthcare and others. For a full agenda and information on how to receive a 15% discount contact Blake Humble at bhumble@managementweb.org or (858) 874-6876.
International Business Solutions Alliance LLC signs
printing services agreement with Novation
International Business Solutions Alliance LLC (IBSA), an alliance of independent printing distributors, announced it has signed a multi-million dollar supplier agreement with Novation. The agreement, effective January 1, 2005, sets a precedent in the print services industry, marking the first time a participatory organization has created a national distribution network that gives their clients an alternative to working with large national companies. Working with IBSA will give Novation members more localized access to print services. Under the contract agreement, IBSA will supply Novation’s clients with 13 different product offerings, including: custom forms, traditional printing, envelopes, marketing printing, stock paper, labels, filing products, high density mobile shelving, patient admitting solutions, automated data collection, electronic print to mail, document destruction, and promotional products.
3M offers cold and cough posters
With the
current flu vaccine shortage, proper cough etiquette and good hand
hygiene is more important than ever. 3M Health Care, manufacturer of
hand antiseptics and patient care masks, has created a poster in
English and Spanish instructing persons to cover their cough and
practice good hand hygiene to reduce the spread of germs. Click on
the link below to download and print the poster for your facility or
office: http://www.3m.com/us/healthcare/professionals
/infectionprevention/jhtml/handprep.jhtml.
Monday, November 8, 2004
In this Issue:
Nation’s health assessment gets
mixed reviews
CMS: Not enough data on obesity
surgery
for Medicare patients
FDA to strengthen drug safety
checks
Mesh stocking could help weak hearts
Will
you help Healthcare Purchasing News find a S.U.R.E. thing?
Nation’s health assessment gets mixed reviews
The United Health Foundation has released its 15th annual assessment of the health of the nation, and of each state, as measured by a composite of 18 variables. According to the Minnesota-based public health organization, healthiness has increased for the country and every state since the first report was produced in 1990. Overall improvement has slowed in the past five years, however, and by some measures, including obesity rates, lack of health insurance, poverty levels and infant mortality, national performance is worsening, said the report. The three healthiest states are Minnesota, New Hampshire and Vermont, with their high rankings reflecting low rates of poverty and premature death, safer-than-average drivers and generous spending on public health. Tennessee, Mississippi and Louisiana were in last place. Their low rankings arise from high rates of poverty, infant mortality and cancer; large numbers of smokers; and, with the exception of Tennessee, many people without health insurance. States are scored using data from the Centers for Disease Control and Prevention, the National Safety Council, the Census Bureau and similar agencies. The data fall into four categories: risk behaviors, such as smoking and obesity; health outcomes, such as death rates; community environment, such as crime rates and the number of uninsured; and health policies, as measured by public health budgets. Nationally, motor vehicle deaths fell by 36 percent from 1990 to 2004. Infant mortality fell 31 percent. The percentage of Americans who are smokers dropped from 30 percent to 22 percent. In recent years, governments have spent more on public health, much of it on homeland defense and bioterrorism prevention. The prevalence of obesity almost doubled, from 12 percent to 23 percent. In a small, but significant change, infant mortality rose for the first time in 40 years, from 6.9 to 7 deaths in the first year of life for every 1,000 live births. The United States is now 28th in the world in infant mortality. The full report, "America's Health: State Health Rankings," is available at http://www.unitedhealthfoundation.org/default.cfm. (The Washington Post)
CMS: Not enough data on obesity surgery
for Medicare patients
A panel of experts told U.S. Regulators Thursday that while obesity surgery has helped many patients lose weight and improve their health, there was not enough data on how well it has worked for elderly patients covered by Medicare, reported Reuters News Service. The Centers for Medicare and Medicaid Services (CMS) is considering whether Medicare should change its payment policy for the surgery. The panelists' advice is not binding but will help CMS officials decide if changes are needed. The agency already covers weight loss surgery to alleviate serious obesity-related conditions like diabetes, but coverage varies among regions. Most Medicare patients who get coverage for the surgery are younger, disabled patients, according to the American Obesity Association. The panelists examined data on several types of surgeries, including gastric bypass and gastric banding. Doctors and advocates called on the panel to recommend that CMS cover all obesity surgeries, including the adjustable band, as well as psychiatric and nutrition counseling, reported Reuters.
FDA to strengthen drug safety checks
In response to criticism that it mishandled internal warnings regarding Vioxx’s dangerous side effects and the misprescribing of antidepressants for children, the Food and Drug Administration announced that it will strengthen its system for reviewing the safety of drugs already on the market. Acting Commissioner Lester M. Crawford outlined a series of steps the agency will take to become more aggressive about responding to reports of potentially harmful side effects. The steps include establishing an internal program to ensure that the views of dissenting scientists are heard, a formal request to the National Academy of Sciences for a study of the FDA's safety monitoring procedures, and a renewed, nationwide search for a new director of the Office of Drug Safety. The position has been vacant for more than a year. Merck is facing hundreds of lawsuits from Vioxx users who claim the drug harmed their health. Judges in the California and New Jersey state courts have already ruled that Vioxx-related lawsuits can be treated as class actions involving hundreds of plaintiffs. Hundreds of plaintiffs' lawyers are scheduled to gather next week in Las Vegas to coordinate efforts to bring additional cases in federal and state courts. (The Washington Post)
Mesh stocking could help weak hearts
A mesh stocking pulled up over the bottom of a weak heart can help it pump better and even shrink back to a more normal size, according to a study described Sunday at an American Heart Association Conference, reported the Associated Press. About 150 heart failure patients who received this simple device felt better, were less likely to need heart transplants or other operations, and improved in other ways when compared with people who did not get the fabric wrap, the researchers said. “There was a 75 percent overall improvement,” said Dr. Douglas Mann, a cardiologist at the Baylor College of Medicine who led the study for the device's maker, Acorn Cardiovascular (St. Paul, MN), according to AP. Experts said the surgically implanted polyester stocking could fill a gap for people who were not helped by drugs or pacemakers and who did not want, or could not have, a mechanical heart pump or an organ transplant. The heart wrap is still experimental, but Acorn Cardiovascular has approval to sell it in Europe and plans to seek approval from the federal Food and Drug Administration early next year. The study included 300 patients at 28 hospitals in the United States and one in Canada.
Will you help Healthcare Purchasing News find a S.U.R.E. thing?
Are you tired of hearing about how administrators and CEOs underestimate and undervalue materials management to the point that they see their distributor, dot-com, GPO or third-party consultant as the de facto department? Us, too. That’s why we’re looking to recognize “Supply Chain Minded CEOs” in our January 2005 issue. We want to meet and introduce readers to chief executives who are so S.U.R.E about materials management that they Support, Understand, Recognize and Empower the department to do what needs to be done to achieve bottom-line savings and top-line revenue. But we need your help. Recommend worthy candidates by e-mailing us (editor@hpnonline.com) reasons how and why they support, understand, recognize and empower materials management – no more than two paragraphs for each of the four categories. Deadline for submissions is November 22.
Friday, November 5, 2004
In this Issue:
VaxGen wins anthrax vaccine contract under
$877 million Project Bioshield deal
New Mexico wants to buy foreign flu vaccine
HIGPA membership elects 2005
Board of Directors
Whooping cough booster shot
New warnings added to Fluoroquinolones
CA eases nurse staffing law
VaxGen wins anthrax vaccine contract under
$877 million Project Bioshield deal
The Northern California biotechnology company VaxGen this week received an $877.5 million contract to provide the federal government with a new anthrax vaccine. The contract is the first to be granted under Project Bioshield, the $5.6 billion federal program to develop and stockpile antidotes to biological and chemical weapons. “The intentional release of anthrax spores is one of the most significant biological threats we face,” Health and Human Services Secretary Tommy Thompson said in a statement. The move could open the door for other companies who are working on potential Bioshield drugs, including Chimerix, which is developing a smallpox treatment, and Hollis-Eden Pharmaceuticals, which is testing a drug to treat radiation sickness. Under the Bioshield contract, VaxGen will supply enough vaccine to protect 25 million civilians against inhaled anthrax. Treatment will involve a regimen of three injections per person, or 75 million doses of vaccine. The new vaccine is designed to be purer and more effective than the current vaccine made by Michigan-based BioPort Corp., which must be given in six doses. The full six-dose regimen reportedly costs about $64; VaxGen's three-dose course would cost about $35 per person. VaxGen's vaccine still requires approval by the Food and Drug Administration.
New Mexico wants to buy foreign flu vaccine
New Mexico has joined Illinois in saying it wants to buy flu vaccine from a foreign plant. New Mexico has contracted for 150,000 doses, and Illinois for 300,000, both using the same European wholesaler. But the vaccine has not been approved by the FDA, although Illinois health officials say it's the same as the FDA-approved vaccine for the U.S. market. The FDA is checking the vaccine, which is produced by Aventis Pasteur at a plant in Lyon, France. The same company makes the U.S.-approved vaccine in Swiftwater, PA.
HIGPA membership elects 2005 Board of Directors
The Health Industry Group Purchasing Association's (HIGPA) membership elected six new members to the 2005 term of the Association's Board of Directors at the 2004 International EXPO in Orlando, FL on October 18. The new members joining the ranks of the Board of Directors for two year terms running from January 1, 2005 to December 31, 2006 include Howard Sanders of H.E. Sanders Associates, Inc., Patrick Horan of Medtronic, Inc., Laura Gronowski of CHAMPS, Lynn Britton of ROI /Mercy, Bruce Hanks of Intermountain Health Care and Don Black of CHCA. Departing members of HIGPA's Board include Todd Ebert of Amerinet, Allan Fine of Navigant Consulting, and Ed Gravell of Cardinal Health. For a complete list of the 2005 Board of Directors visit www.higpa.org.
An experimental whooping cough booster shot called Boostrix may help eradicate the infection, a new study shows. If approved by the U.S. Food and Drug Administration, Boostrix could be added to a booster shot against diphtheria and tetanus. In a clinical trial of more than 4,000 adolescents aged 10-18, Boostrix was as safe and effective as the current diphtheria vaccine. It also triggered a greater immune response against whooping cough than that seen in infants who had received the primary immunization for diphtheria-tetanus-pertussis and were protected against pertussis. The vaccine’s maker, GlaxoSmithKline, conducted the study. In the last 20 years, whooping cough diagnoses have nearly tripled, despite the fact that more babies and young children are getting the pertussis vaccine. In 2003, there were 11,000 cases of whooping cough reported to the Centers for Disease Control and Prevention.
New warnings added to Fluoroquinolones
Fluoroquinolones should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. In the absence of a proven or strongly suspected bacterial infection or a prophylactic indication, the use of drugs within this class is unlikely to provide benefit to the patient and increases the risk of the development of serious and irreversible adverse drug reactions. As with any potent antimicrobial drug, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, is advisable during therapy. The FDA has recently added new warnings to the drugs found within this class bringing the following to the attention of both the patient and the physician: Irreversible Peripheral neuropathy; Tendon Effects such as spontaneous tendon rupture both during and after therapy; Caffeine accumulation resulting in CNS stimulation; Pseudomembranous colitis (life-threatening diarrhea); QTc interval prolongation (ventricular arrhythmias including torsades de pointes); Commitment use of Non-steroidal anti-inflammatory agents (provoking convulsions). A review of the various letters sent to the manufacturers of the drugs within this class, appears to indicate that the FDA considers these adverse drug reactions to be class effects and not limited to a specific fluoroquinolone. For more visit, www.fqresearch.org
Citing concerns about hospital closings and delays in critical patient care, the state Department of Health Services said it will give California hospitals a three-year reprieve from meeting stricter nurse staffing rules to take effect in 2005. In the 10 months since California implemented the nation's first law dictating how many patients each nurse can treat, state officials said the nurse-to-patient ratios have led 11 hospitals to close or eliminate staff-intensive departments such as emergency rooms and psychiatric wards, reported the Sacramento Bee. California hospitals have complied with the staffing law at times by turning away ambulances, leaving beds empty while patients wait for care, and cutting back on support staff to divert funds to nurse salaries, state officials said. Under the new plan, hospitals would have until Jan. 1, 2008, to achieve a staffing ratio of five patients for each nurse on the general medical/surgical wards. In addition, the new rules will relax enforcement of staffing ratios in emergency rooms, allowing hospitals to temporarily break the four-patients-per-nurse rule when necessary to respond to a rush of ambulances.
Thursday, November 4, 2004
In this Issue:
FDA: Some reprocessed medical
devices no longer legal
Skin injection may stretch flu vaccine supply
California approves $3 billion
for stem cell research
Chicago hospital joins fake
blood study
Medical instrument tracking could reduce health risks
Quebec to provide funding to hire infection prevention
nurses
FDA: Some reprocessed medical devices no longer legal
In a session Monday, at the Fall 2004 IAHCSMM meeting, Larry Spears, Deputy Director Regulatory Affairs, Food and Drug Administration (FDA), announced that the FDA was going to release a list of reprocessed medical devices that can no longer be legally distributed. The devices were originally designated as Single Use Devices (SUDs) and the FDA has determined that after review inspections of a number of these devices after reprocessing, they were not safe. Hospitals will be able to access the list of newly designated illegal devices November 10, on the FDA website. Manufacturers/reprocessors will be asked to stop marketing these products. Asked if there would be any mandatory recalls, Spears said, “The FDA has not come up with a list yet, but depending on the severity and the seriousness of the potentially dangerous device, there may be future recalls.” Many of these reprocessed SUDs are still safe to be legally marketed based on their ability to be substantially equivalent to a new device after reprocessing.
It
may be possible to stretch the supply of flu vaccine by giving some people
reduced doses that are injected into the skin instead of a muscle, researchers
report. Two research teams tested the theory, using 40 percent of the normal
dose in one study, 20 percent in the other, and found that in healthy adults up
to age 60, smaller doses in the skin worked just as well as full-sized doses
into the muscle. These intradermal injections were less successful in people
older than 60. The two studies, to be published in The New England Journal of
Medicine, have been posted on the journal's Web site,
www.nejm.org. Some researchers contend that
the findings may be of limited use, partly due to the small number of test
subjects, and the fact that researchers studied blood tests and not cases of
influenza to measure how the immune system responded to the vaccine.
California
voters approved a ballot measure on Tuesday to spend $3 billion over the next 10
years on research of human embryonic stem cells, the largest state-run
scientific research effort in the U.S. Unofficial results showed the measure,
Proposition 71, passed with 59 percent of the vote. The measure calls for the
establishment of the California Institute for Regenerative Medicine, which is
expected to become the nation's incubator for stem cell studies. The state will
pay for the effort by issuing $3 billion in general obligation bonds at an
estimated cost of $6 billion over the next 30 years.
Chicago hospital joins fake blood study
Loyola University Medical Center has joined a nationwide study of an artificial blood product that's being tested in trauma patients without prior consent, authorities said. Doctors say the product, called Polyheme, could transform trauma care if it saves lives by quickly replacing blood loss prior to the patient arriving at the hospital, reported the Associated Press. After months of preparation, including efforts to give local residents a chance to refuse participation, Loyola began the study Monday by equipping its medical helicopter with Polyheme. A hospital spokesman said in coming weeks Polyheme, made by Northfield Labarotories, will be used in as many as six ambulances in three Chicago suburbs, reported AP. Because trauma patients often are unconscious or in shock, and unable to give the consent required for experimental treatment, the researchers are being allowed to bypass the consent rules under a 1996 federal exemption that applies to emergency, potentially lifesaving research. Polyheme is made by extracting oxygen-carrying hemoglobin from human red blood cells. It can be used in patients with any blood type and lasts longer than blood.
Medical instrument tracking could reduce health risks
A paper, “The future of RFID in the Healthcare Industry”, published by RFID Journal, suggests the technology could address the problem of infections transmitted via medical instruments. According to the authors of the paper, Brad Sokol and Patni Corporation, the tracking of medical instruments could reduce the threat of transmitting infections through the placement of RFID tags on the instruments and then transmitting the instrument's TTL (time, temperature and location). This ability to track the TTL elements of any medical instrument would ensure that each instrument was properly sterilized, and that instruments are left in the right place at the right time. RFID could also be used to track each instrument's full history regarding involvement in patient surgical procedures. According to Sokol, it is estimated that the cost of infections caused by medical instrumentation during the year 2003 resulted in some $3.1 billion in claims paid to affected patients in the U.S. (UsingRFID.com)
Quebec to provide funding to hire infection prevention nurses
Quebec hospitals will receive funding to hire nurses dedicated to preventing infections as part of the province's battle against the C. difficile bacteria, said the Health Minister. The Quebec Order of Nurses had passed a motion demanding the government respect the ratio of one nurse specialized in infection prevention for every 133 short-term hospital beds; and one per 250 long-term care beds. The Clostridium difficile epidemic has claimed the lives of at least 109 patients in the first half of this year. The Health Minister said funds have already been provided to regional agencies to hire these nurses.
Wednesday, November 3, 2004
In this Issue:
Medicare broadens cancer
coverage
FDA memo on Vioxx
details heart attack risk
U.K.
government says drugmakers will cut prices by 7%
Kodak announces new family of
professional services
Given gets FDA
approval for esophagus imaging device
Stratum Med saves more than $2 million with
Amerinet
Medicare broadens cancer coverage
The Centers for Medicare & Medicaid
Services has proposed expanding Medicare coverage for certain cancer
drugs and diagnostics, and
announced a $300-million
national demonstration project aimed at better managing pain, nausea
and fatigue in cancer patients undergoing chemotherapy. CMS plans to
expand Medicare coverage of several colorectal cancer drugs to
include their use in nine clinical trials to determine if the drugs
have additional, effective “off-label” uses for other types of
cancer. The drugs include xaliplatin (Eloxatin), irinotecan (Camptosar),
bevacizumab (Avastin), and cetusimab (Erbitux). The agency also
proposes to expand coverage of positron emission tomography for
cervical cancer and for studies involving additional types of
cancer. Oncologists participating in the one-year chemotherapy
demonstration will receive $130 per patient per day to measure
patients’ pain, nausea, vomiting and fatigue using new billing codes
describing a patient’s status in those areas. (AHA News Now)
FDA memo on Vioxx details heart attack risk
Providing
details from an August report, the Food and Drug Administration published a
memorandum that indicated
Merck's Vioxx
painkiller might have contributed to 27,785 heart attacks and deaths from 1999
through 2003. The memo, based on a sample of patient records, concluded that
people taking Vioxx were more likely to have heart attacks or die from sudden
cardiac arrest than people taking a competing painkiller, Celebrex from
Pfizer. The
report was part of a study that an FDA researcher, Dr. David J. Graham,
conducted with Kaiser Permanente. The memo by Dr. Graham, an associate director
in the FDA's office of drug safety, was dated Sept. 30, the same day that Merck
announced it was pulling Vioxx from the market. Merck attributed the move to its
own study indicating that patients who took Vioxx for 18 months or longer were
more likely to have a stroke or heart attack than patients taking a placebo.
(Bloomberg News)
U.K.
government says drugmakers will cut prices by 7%
The UK
government said drugmakers agreed to reduce by 7 percent the price they charge
for branded prescription medicines. The reductions, negotiated with the
Association of the British Pharmaceutical Industry, will help save the UK's
National Health Service more than 1.8 billion pounds ($3.3 billion) over five
years, the UK Department of Health said. The
UK
government is targeting a goal of 21.5 billion pounds in spending cuts by fiscal
2008 and plans to use the savings to fund “frontline NHS services”, the
Department said. The ABPI, which represents about 80 drug companies, opposed the
price cuts but accepted the agreement because it provides a long-term plan and
some financial incentives, said a spokesman. The NHS spends about 11 billion
pounds on medicines each year, the agency said. The agreement was negotiated
under the government's pharmaceutical price regulation scheme, or PPRS, which
sets a target rate of return on capital, provides allowances for research and
marketing expenses. Companies that exceed the level of profit are required to
repay the excess. The agreement also increases the allowance for research and
development and provides financial incentives for introduction of innovative
medicines and those for children. (Bloomberg News)
Kodak announces new family of professional services
Eastman Kodak Company announced KODAK Healthcare Solution Services, a new family within Kodak’s Professional Services portfolio designed to apply proven workflow and change management techniques to achieve process improvements with measurable business outcomes. This family of services includes: Benefit Assessment/Business Case; Workflow Design; Business Outcomes Measurement; Change Management; Client Project Management; and Policy and Procedure Development.
Given gets FDA approval for esophagus imaging device
Video-capsule manufacturer Given Imaging has received marketing clearance from the U.S. Food and Drug Administration for its Given Diagnostic System, including the PillCam ESO video capsule for imaging the esophagus, said the firm. The PillCam ESO capsule includes two imaging sensors, one at each end of the capsule. Each imager captures two frames per second for a total capture rate of four frames per second. The company also has submitted a special 510(k) application to the FDA for a higher frame rate version of the PillCam ESO. Following FDA clearance of the 14-frame per second camera, Given intends to upgrade its installed base with Rapid 3 image processing software and an enhanced data recorder.
Stratum Med saves more than $2 million with Amerinet
Stratum Med has extended its Amerinet membership agreement for three additional years, through September 2007. Amerinet will continue to support the non-acute care integrated delivery network and provide its shareholders prime access to pricing and group purchasing services. Since Stratum Med partnered with Amerinet in 1997, contract utilization has increased more than 250 percent. In 2002, the shareholder organizations purchased more than $32 million in medical, laboratory, imaging and pharmaceutical supplies through Amerinet contracts, realizing a savings of more than $2 million.
Tuesday, November 2, 2004
In this Issue:
Study: vaccine protects against cervical
cancer
Kaiser Health poll on
employer-sponsored health insurance
Certification Commission for Healthcare
Information Technology moves toward EHR goals
Omnicell’s OptiFlex will
help St. Patrick
track implanted medical devices
Amerinet announces new ID band
contract
Study: vaccine protects against cervical cancer
New test results suggest that the world’s first vaccine to prevent cervical cancer can provide long-lasting protection, reported the Associated Press. Four years after receiving the vaccine, 94 percent of women were protected from infection with the virus that causes most cervical cancers and none had developed worrisome precancerous conditions, a study showed. Merck & Co., maker of the vaccine, plans to seek U.S. Food and Drug Administration approval next year for an expanded version of the vaccine that also could be used to prevent genital warts in both women and men. The new study was funded by Merck and led by University of Washington researchers who presented results at a meeting of the American Society for Microbiology.
Kaiser Health poll on employer-sponsored health insurance
The September/October Kaiser Health Poll Report examines the public's expectations and priorities for health insurance and their attitudes towards employer-sponsored coverage. It also explores people's opinions about several alternative health insurance plans that are currently under consideration and explores how they might respond to these new options. Highlights from the 2003 Kaiser Health Insurance survey include: A large majority of non-elderly adults says that the most important reason to have insurance is to protect against high medical bills (71%), rather than to pay for everyday healthcare expenses (25%); Nearly six in ten (57%) insured adults under age 65 say they feel well protected by their insurance plan while nearly four in ten (38%) say they worry that they may have healthcare needs that will not be covered; When given the choice, 55% of adults with employer-sponsored insurance would prefer to continue to have their employer pay for their coverage, rather than receive cash to buy insurance on their own (7%); 37% say it wouldn't make much difference either way; Large majorities of people with employer-sponsored insurance say purchasing their own coverage would make it more difficult for them to get a good price for insurance (81%), to find or keep insurance if they are sick (79%), to handle administrative issues (73%), and to find a plan that matches their needs well (71%). http://www.kff.org/healthpollreport.
Certification Commission for Healthcare Information Technology moves toward EHR goals
The Certification Commission for Healthcare Information Technology (CCHIT) is moving decisively toward its goal of starting certification of ambulatory care EHR products by Summer 2005. The Commission is forming Work Groups to address the following four areas: •Functionality – the features and functions that must be provided by the EHR product; •Security and Reliability – ensuring that the software protects the privacy of data and is sufficiently robust to prevent data loss; •Interoperability – the ability of the EHR product to perform standards-based data exchange with other sources of healthcare information; •Certification Process – determining how vendors will apply for certification, how product compliance will be tested, and how the database of certified products will be maintained and publicized. On or around November 8th, the Commission will issue a Call for Participation, seeking nominations for individuals from the industry to serve as co-chairs and members of these groups. There will be approximately 10 members in each group. The announcement will be made at http://www.cchit.org. To provide another avenue of participation for vendors, HIMSS has formed the HIT Certification Commission Vendor Advisory Council. For information about upcoming Council meetings, contact Pat Wise at pwise@himss.org.
Omnicell’s
OptiFlex will help St. Patrick
track implanted medical devices
St. Patrick Hospital and Health Sciences Center, a medical
teaching center and leading heart surgery center in Montana, has purchased
Omnicell, Inc. OptiFlex technology for its operating rooms and the
catheterization lab to improve inventory management and patient charge capture
capabilities. Omnicell's OptiFlex product line provides end-to-end solutions to
help optimize the healthcare facility's medical-surgical supply chain, reducing
consumption and inventory, as well as increasing the overall efficiency and
productivity of both materials management and nursing.
Amerinet announces new ID band contracts
Amerinet has signed a new agreement with Hollister, Inc. The new agreement offers additional savings and benefits for patient ID bands compared to the previous contract agreement. Hollister has also added additional commitment tiers for increased savings. Also, beginning October 1, 2004, Amerinet members can take advantage of a renewed agreement with Precision Dynamics. This agreement offers savings on patient ID bands. Precision Dynamics manufactures identification bands, cadaver bags, covers-armboard, covers-mattress-waterproof, drainage bags, footprinters, identification systems-blood transfusion, markers-skin, medical alert identification and perforators (amniotic membrane).
Monday, November 1, 2004
In this Issue:
Critics say Wal-Mart’s
inadequate employee
healthcare coverage costs state programs
MedPAC: Physician-owned
specialty hospitals
have more profitable patients
Brookdale
University Hospital and Medical Center
receives honors for long-term infection control study
Hospitals reminded to check
quality data by Nov. 6
Medical Journal to be available online
Will you help Healthcare Purchasing News find a S.U.R.E. thing?
Critics say Wal-Mart’s inadequate employee
healthcare coverage costs state programs
Wal-Mart, the country’s largest employer, is finding itself under
attack for its employee healthcare policies, that critics contend
forces many of its workers and their families into state insurance
programs or makes them rely on charity care by hospitals, reported
The New York Times. Wal-Mart defends its healthcare policies,
saying it offers affordable coverage for all employees. The company
says it has no way of knowing how many of its employees or their
families are insured under state programs. A survey by Georgia
officials found that more than 10,000 children of Wal-Mart employees
were in the state's health program for children at an annual cost of
nearly $10 million to taxpayers, said The Times. A North
Carolina hospital found that 31 percent of 1,900 patients who
described themselves as Wal-Mart employees were on Medicaid, while
an additional 16 percent had no insurance at all, reported The
Times. And supporters of a measure that will be on California's
ballot, which would force large employers like Wal-Mart to either
provide affordable health insurance to their workers or pay into a
state insurance pool, say Wal-Mart employees without company
insurance are costing California's state healthcare programs an
estimated $32 million a year. The company said last week that it was
spending $500,000 to defeat the California measure, Proposition 72.
MedPAC: Physician-owned specialty hospitals
have more profitable patients
Physician-owned specialty heart, orthopedic and surgical hospitals have a more profitable mix of patients than community hospitals and other freestanding specialty hospitals, the Medicare Payment Advisory Commission said. Its conclusion is based on preliminary findings from a study it is conducting of physician-owned specialty hospitals, as required by the Medicare Modernization Act. The early findings suggest that the limited service providers treat patients in diagnosis-related groups, and types of patients within those DRGs, that have above-average profitability. The trend is a function of unintended financial incentives within the current Medicare payment system, MedPAC said. MedPAC’s findings “confirm that the profitability of limited-service providers comes at the expense of community hospitals and has a greater impact on community access to care,” said Ellen Pryga, AHA director of public policy development. The final MedPAC report and recommendations are due to Congress next spring. (AHA News Now)
Brookdale University Hospital and Medical Center (Brooklyn, NY) is gaining national honors for a long-term study showing promise in reducing the incidence of bloodstream infections. The hospital has been awarded a grant from the New York State Department of Health, and the study will be featured in an upcoming Joint Commission Satellite Network (JCSN) live and interactive broadcast of infection control best practices. The study, conducted over a three-year period, outlines Brookdale’s efforts to reduce central venous catheter (CVC)-related bloodstream infections by implementing the Centers for Disease Control and Prevention’s Healthcare Infection Control Practices Advisory Committee (HICPAC) recommendations. The four key interventions used in the study included the establishment of an education and awareness program; conversion of silver-chlorhexidine (CHG) to silver-platinum catheters; use of a barrier kit containing sterile gloves, gown and mask; and use of a 2 percent chlorhexidine gluconate/70 percent isopropyl alcohol skin preparation. Data shows that the four key interventions utilized in the study, including the use of ChloraPrep One-Step (2 percent w/v chlorhexidine gluconate and 70 percent v/v isopropyl alcohol), resulted in the overall avoidance of 237 CR-BSI cases over a 39 month period and a potential annual savings of more than $2.5 million. The JCSN 90-minute broadcast, titled “Infection Control: Reducing Risk of Infections and Preparing for Emerging Pathogens” will occur April 15 and can be accessed by visiting http://www.pwpl.com/healthcare/jcsn/schedule04.asp.
Hospitals reminded to check quality data by Nov. 6
Hospitals taking part in the Hospital Quality Alliance, formerly known as the
Quality Initiative, are encouraged to preview their first-quarter 2004 data at
www.qnetexchange.org by Nov. 6. Unless a hospital alerts its QIO to a
significant problem with its data, the data will be displayed on the CMS website
in late November.
Medical Journal to be available online
A new
online medical journal will make its research articles available to the public
free of charge and accessible through the Internet. The Public Library of
Science Medicine (PLoS Medicine) was launched earlier this month and will be
available to physicians, patients, scientists and anyone with Internet access.
Readers will be able to copy and distribute the articles for teaching or
personal purposes and thereby further expand the reach of the research. The
directors hope that people in poor countries or scientists at small research
colleges will be able to benefit from medical research that otherwise would be
unavailable without an expensive subscription. To bypass the need for
subscriptions, the journal will charge scientists $1,500 per article to publish
their findings. The articles will be peer-reviewed by other scientists.
Will
you help Healthcare Purchasing News find a S.U.R.E. thing?
Are you tired of hearing about how administrators and CEOs underestimate and undervalue materials management to the point that they see their distributor, dot-com, GPO or third-party consultant as the de facto department? Us, too. That’s why we’re looking to recognize “Supply Chain Minded CEOs” in our January 2005 issue. We want to meet and introduce readers to chief executives who are so S.U.R.E about materials management that they Support, Understand, Recognize and Empower the department to do what needs to be done to achieve bottom-line savings and top-line revenue. But we need your help. Recommend worthy candidates by e-mailing us (editor@hpnonline.com) reasons how and why they support, understand, recognize and empower materials management – no more than two paragraphs for each of the four categories. Deadline for submissions is November 22.