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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 ke