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March 2005
Thursday, March 31 , 2005
In this Issue:
Stryker,
Smith & Nephew, Biomet, other orthopedics manufacturers announce
receipt of subpoenas related to orthopaedic service agreements
Monroeville hospital urges 200 colonoscopy
patients to get checked for hepatitis, HIV
MedAssets launches new
technology
M.S. drug linked to death
FDA aproves new drug for
hepatitis B
Pharmacy errors need reporting, including
unit-based cabinet dispensing units
Several large orthopedic implant manufacturers have confirmed that they have received subpoenas from the U.S. Justice Department regarding their relationship with surgeons. Stryker Corporation (Kalamazoo, MI) announced that it has received a subpoena from the United States Department of Justice requesting documents for the period January 2002 through the present as follows: “any and all consulting contracts, professional service agreements, or remuneration agreements between Stryker Corporation and any orthopedic surgeon, orthopedic surgeon in training, or medical school graduate using or considering the surgical use of hip or knee joint replacement/reconstruction products manufactured or sold by Stryker Corporation.” Based on an initial conversation with a Department of Justice representative, the Company understands that similar requests have been or will be directed to other companies in the orthopaedics industry. Stryker intends to fully cooperate with the Department of Justice regarding this matter. Biomet Inc. (Warsaw, IN) also announced that it has received a subpoena from the U.S. Department of Justice requesting documents related to any consulting and professional service agreements with orthopedic surgeons using or considering the use of Biomet's hip or knee implants. Biomet intends to fully cooperate with the inquiry. Smith and Nephew announced that its Orthopaedics division (Memphis, TN) had received a subpoena requesting consulting, professional service and remuneration agreements, in respect of reconstructive products, between Smith & Nephew Orthopaedics division and orthopaedic surgeons. Smith & Nephew is cooperating fully with this request. The New York Times reported that DePuy Orthopaedics, a unit of Johnson & Johnson based in Warsaw, IN, had also received a subpoena and was cooperating. The Times reported that Zimmer Holdings, also based in Warsaw, and the next largest orthopedics company after Stryker and DePuy, said it had not received a subpoena. Wright Medical, based in Arlington, TN, declined to say whether it had received a subpoena, according to The Times. The investigation does not, initially at least, appear to be related to whistleblower claims against a Medtronic unit, Medtronic Sofamor Danek, which has been accused of making illegal kickbacks to surgeons who used its spinal products, and Medtronic told The Times that it was not included in the subpoenas announced yesterday. Orthopedics manufacturers and other device makers have become more restrictive in the practices they follow for payments to surgeons in the last year, following guidelines adopted by Advamed, the medical device industry's largest trade group, reported The Times.
Monroeville hospital urges 200 colonoscopy
patients to get checked for hepatitis, HIV
Officials at Forbes Regional Hospital in Monroeville, PA, are warning about 200 patients who underwent colon examinations that they may be at risk for infection because the colonoscopes used had not been adequately cleaned. The risk of infection is extremely low, hospital officials and local and national health authorities said. But certain patients who had colonoscopies at Forbes between Oct. 28 and Feb. 26 nevertheless are being advised to have their blood tested for hepatitis and HIV as soon as possible. Only patients who underwent procedures with two specific colonoscopes purchased last fall are being notified for testing via certified letters. Lab workers only recently discovered that the two scopes were not being completely disinfected after each use. A toll-free hotline, 1-877-854-5450, has been established to provide information only to those patients who have received letters and to schedule them for testing. After being notified of the scope-processing problem at Forbes, the Allegheny County Health Department reviewed all cases of hepatitis B, hepatitis C and HIV reported since September. None of the new cases had undergone colonoscopies at the hospital or otherwise had contact with a Forbes colonoscopy patient. The disinfection problem concerns two colonoscopes refurbished by and purchased from Olympus Inc. Hospital staffers did not immediately notice that the scopes had auxiliary channels, which give doctors additional capabilities for cleaning an examination area. “It appears the difficulty arose in not recognizing this was a different model of scope with an additional channel,” Chakurda said. The unused, unrecognized channels thus were never specifically disinfected. Laura Tyler, director of regulatory affairs and quality assurance for Olympus America's medical systems group, said all the company's colonoscopes and other types of endoscopes are accompanied by user manuals that contain specific instructions for cleaning. Chakurda said there were no plans to discipline any staff members in response to the incident. But the hospital will implement a policy that no newly purchased equipment will be used without a training session, regardless of the equipment's similarity to other equipment already in use. (Source: Pittsburgh Post-Gazette) An article by Lawrence F. Muscarella, PhD, referencing similar problems and how to prevent them appeared in Gastroenterology Nursing: “Dear Los Angeles Times: the risk of disease transmission during gastrointestinal endoscopy. Gastroenterol Nurs. 2004 Nov-Dec; 27(6):271-8.”
MedAssets launches new technology
MedAssets announces CrossWalk(TM), a technology-enabled solution that manages
all patient-identifiable supplies automatically, continuously and seamlessly to
improve implant-item service line margins. Linking the hospital's supply and
revenue data streams, CrossWalk offers providers visibility enabling providers
to accurately capture and audit markups and set defendable pricing within key
service lines including orthopedics, cardiovascular, spinal, account for more
than 45 percent of all supply expenditures. The majority of hospitals currently
manage supply prices through one system, the item master, and bill for them
through another, the charge master. Although the supply cost data needs to be
communicated between the two systems, they aren't linked and manual processes
are used to keep the ever-changing information current. With tens of thousands
of items to update, inaccuracies in pricing are commonplace and often result in
missed charges, undercharges and overcharges. These are all costly mistakes in
terms of compliance and revenue. CrossWalk works to prevent such oversights by
providing: accurate, compliant pricing for supplies, procedures and services;
ongoing, accurate cost determination for each chargeable supply item; clean data
and management reports indicating areas for financial or compliance improvement;
on-going monitoring for the cost/charge relationship; and analysis of purchase
volume compared to charge volume.
M.S. drug linked to death
Biogen
Idec and the
Elan Corporation said that a third
patient had developed a fatal nervous system disorder linked to the multiple
sclerosis drug Tysabri, which the companies stopped selling last month. The
patient, who died in 2003, had Crohn's disease and took Tysabri in a clinical
trial, said a spokesperson for Biogen. Tysabri won approval in November as a
treatment for multiple sclerosis and the companies were studying use of the drug
for other conditions. (Bloomberg News)
FDA aproves new drug for hepatitis B
The Food and Drug Administration has approved a new drug for the treatment of chronic hepatitis B, the drug manufacturer said Wednesday. The drug, entecavir, is taken orally and is designed to work by preventing the virus that causes the illness from reproducing. The chronic form of hepatitis B can permanently damage the liver and lead to cirrhosis and liver cancer. Entecavir is made by Bristol-Myers Squibb and will be sold under the trade name Baraclude. The company said it could be available in early April. The Hepatitis B Foundation estimates that 1.2 million Americans have hepatitis B and another 100,000 are infected annually. (The Associated Press)
Pharmacy
errors need reporting, including
unit-based cabinet dispensing units
Saferating.com unveiled a web application to track the trends of UBC
discrepancies. The system uses Saferating’s Paperless Form Technology (PFT) to
generate pharmacy reports to conform to JCAHO and State Pharmacy Commission
requirements. Unit-Based Cabinet Dispensing Units (AccuDose, Pyxis, Omnicell)
are all useful devices, but those who use them cause discrepancies, said the
company. Analysis of these discrepancies can save you aggravation, bureaucratic
interference, and fines, according to Robert (Bob) Genest, CEO. Authorized users
of Saferating’s PFT can query by drug, pocket, users, date ranges and more. Data
can be viewed online and downloaded to authorized desktops in MS EXCEL, Access,
or FoxPro for further analysis and reporting to any authorized user. The queries
and reports can be accessed though the latest encryption technology from any
web-enabled computer wherever the authorized user is, any time of day or night.
Wednesday, March 30 , 2005
In this Issue:
Florida hospital hires first female
chief executive and president
Study: Prescription drug compliance
a challenge for many patients
Crdentia to acquire Health
Industry Professionals
Acupuncture found to lower
elevations in blood pressure
FDA clears Vanguard
reprocessed ultrasonic scalpels
Venetec announces contract with Adventist
Health System
The Brewer Company signs
agreement with MedAssets
Florida hospital hires first female chief executive and president
The Sarasota County (FL) Public Hospital Board has unanimously selected Gwen M. MacKenzie, RN, MN, MHSA, as president and chief executive officer of Sarasota Memorial Health Care System. MacKenzie will become CEO in mid-May following the retirement of Duncan Finlay, MD. MacKenzie currently is executive vice president and chief operating officer of The Detroit Medical Center (DMC), a nonprofit academic health system made up of nine hospitals with more than 2,000 licensed beds, 13,000 employees and 3,200 medical staff members. The system, which is the largest healthcare provider in southeast Michigan, is the teaching and clinical research site for Wayne State University’s School of Medicine, the fourth largest medical school in the U.S. MacKenzie was chosen for Sarasota Memorial’s top post following a national search and extensive interviews. MacKenzie, 50, joined the DMC in 1979 as an Advanced Practice Nurse and progressed to a number of leadership positions, including president of several DMC hospitals and interim CEO of the health system. In her current role, she has oversight for DMC’s $1.6 billion budget and its nine hospitals, as well as a number of support services. She was responsible for a $110 million system turnaround from 2003 to 2004. She began her career in healthcare as a staff nurse at the University of Michigan Hospital before becoming a research assistant and staff nurse at UCLA. In addition, the Sarasota Herald-Tribune reported that she will be paid an annual salary of $500,000 and receive a signing bonus of $12,500, according to an employment agreement with the Sarasota County Public Hospital Board. Finlay was paid $388,845, said the Herald-Tribune.
Study: Prescription drug
compliance
a challenge for many patients
One in three (33%) U.S. adults who have been prescribed drugs to take on a regular basis report that they are often or very often noncompliant with their treatment regimens for any number of reasons. Furthermore, nearly half (45%) say they have failed to take their medications because of concerns they had about the drugs themselves, and 43 percent report having not complied with their regimens because they felt the drug was unnecessary. These are some of the results of a Harris Interactive online survey of 2,507 U.S. adults who are online conducted between March 16 and 18, 2005 for The Wall Street Journal Online's Health Industry Edition. Of the 63 percent of adults who have had prescription drugs prescribed to them in the last year, drugs which are to be taken regularly, nearly two-thirds (64%) report that they have simply forgotten to take their medication, with 11 percent saying that this has happened “often” or “very often.” Other top reasons respondents cited for noncompliance with their treatment regimens include: I had no symptoms or the symptoms went away (36%); I wanted to save money (35%); I didn't believe the drugs were effective (33%); I didn't think I needed to take them (31%);I had painful or frightening side effects (28%); and The drugs prevented me from doing other things I wanted to do (25%). http://www.harrisinteractive.com/news/newsletters_wsj.asp
Crdentia to acquire Health Industry Professionals
Crdentia Corp., a U.S. provider of healthcare staffing services, announced that it has acquired Health Industry Professionals LLC, a provider of per diem nursing services throughout the Detroit metropolitan area. Founded in 1997, Health Industry Professionals has a strong existing client base with major hospitals in the region and several local Fortune 500 companies where it provides staffing for on-site private medical clinics. In addition to per diem nursing services, the Company also offers hourly and private duty homecare services. Health Industry Professionals has a database of approximately 900 healthcare professionals and will continue to operate under the direction of co-founders Matthew Cahillane and C. Michael Emery, who have joined Crdentia's senior management team. Health Industry Professionals represents one of two acquisitions recently announced by Crdentia in 2005 focusing on healthcare staffing services.
Acupuncture found to lower elevations in blood pressure
Acupuncture treatments using low levels of electrical stimulation can lower elevations in blood pressure by as much as 50 percent, researchers at the Susan Samueli Center for Integrative Medicine at UC Irvine have found. In tests on rats, the researchers found that electroacupuncture treatments provided temporary relief from the conditions that raise blood pressure during hypertensive states. Such treatments, they believe, potentially can become part of a therapeutic regimen for long-term care of hypertension and other cardiovascular ailments in people. The study appears in the March issue of the Journal of Applied Physiology. In previous studies, Longhurst and his UCI colleagues have identified at the cellular and molecular level how acupuncture excites brain cells to release neurotransmitters that either inhibit or heighten cardiovascular activity.
FDA clears Vanguard reprocessed ultrasonic scalpels
The U.S. Food and Drug Administration has determined that ultrasonic scalpels reprocessed by Vanguard Medical Concepts Inc. are “substantially equivalent” to new and has cleared the company to resume sales of the product. Vanguard voluntarily removed the scalpels from the market last fall pending an FDA request for additional documentation of the company's methodology for cleaning, testing and sterilizing the costly devices. At issue was whether the complex device, which is marketed for a single use, could be safely reconditioned for a limited number of additional uses and function “as new” without any health risk to patients.
Venetec announces contract with Adventist Health System
Venetec International, makers of StatLock safety securement devices for catheters and other medical applications, announced that it has signed a sole-source agreement to supply Adventist Health System with catheter securement devices in IV start kits for peripheral IVs. The agreement is one of the largest signed between Venetec and a healthcare system. Adventist Health System has committed to purchase StatLock IV Ultra and StatLock IV Select product line devices, to help achieve the hospital system's protocol of a 96-hour dwell period for peripheral IV catheters. Adventist Health System has 38 hospitals in 10 states covering more than 6,200 beds. The health system is the largest not-for-profit Protestant healthcare organization in the country, and one of the 10 largest integrated delivery networks. Implementation of the new agreement between Venetec International and Adventist Health System will begin with the seven hospital facilities of Florida Hospital in the Orlando area, representing 1,776 beds.
The Brewer Company signs agreement with MedAssets
The Brewer Company (Menomonee Falls, WI) has signed an agreement with MedAssets Supply Chain System. (Atlanta, GA) to provide medical seating, procedure lights, IV poles, infusion stands, mayo/instrument stands, utility carts and other medical support products to MedAssets’ members nationwide.
Tuesday, March 29 , 2005
In this Issue:
CDC releases health data for
January–September 2004
Study questions practice of
hospital advertising
CMS publishes procedures for
certain HIPAA complaints
North Dakota investigating
possible identity theft scam
Medline launches new online reporting tool
CDC releases health data for January–September 2004
Early findings from the Centers for Disease Control and Prevention’s (CDC’S) National Health Interview Survey (January-September 2004) show that 41.6 million persons of all ages (14.5%) were uninsured at the time of the interview, compared to the 2003 estimate of 15.2%. In addition, 12.6% of employed adults had been uninsured for more than a year. The survey tracks 15 key health indicators including health insurance coverage, obtaining needed medical care, influenza shot, pneumococcal vaccination, obesity, leisure-time physical activity, current smoking prevalence, alcohol consumption, human immunodeficiency virus (HIV) testing, general health status, personal care needs, serious psychological distress, diagnosed diabetes, and asthma. Among other findings: For the period January through September 2004, the percentage of uninsured persons was 16.4% for persons under age 65 years. For children under age 18 years, the percentage uninsured at the time of the interview was 9.2% in the first three quarters of 2004, continuing the decline observed since 1997. For persons aged 18-64 years, from 1999 to September 2004, there was an increasing trend in public coverage (from 12.4% to 16%) and a decreasing trend in private coverage (73.1% to 68.6%). From 1998 through June 2004, an increasing trend has been observed in the percentage of persons who were unable to obtain medical care due to cost (4.2% in 1998 to 5.4% for the period January through September 2004). In the third quarter of 2004, the percentage of adults who had received an influenza shot during the past year was 66.4% for persons aged 65 years and over, 41.0% for persons aged 50-64 years, and 19.4% for persons aged 18-49 years. For the period January through September 2004, 24.5% of U.S. adults aged 20 years and over were obese, which is similar to the 2003 estimate of 23.7%. The prevalence of obesity among U.S. adults aged 20 years and over has increased over time from 19.4% in 1997 to 24.5% in September 2004. http://www.cdc.gov/nchs/data/nhis/earlyrelease/earlyrelease200503.pdf
Study questions practice of hospital advertising
A new study contends that while academic medical centers are relying more and more on advertising to attract patients, there appears to be little oversight of these practices. The result is that many of these ads seem to place the interests of the medical center above the interests of the patients, said the study. An internal review process would go a long way toward ensuring that the interests of patients are protected, said the authors of the study appearing in the March 28 issue of the Archives of Internal Medicine. To try to characterize ads aimed at attracting patients, the authors of the study looked at all 2002 non-research print ads in the five most widely circulating local newspapers for the 17 academic medical centers included in U.S. News & World Report's annual list of "America's Best Hospitals" and interviewed members of the hospital's marketing departments. Of the 17 institutions, which included Johns Hopkins in Baltimore and the Mayo Clinic in Minnesota, 16 reported advertising to attract patients. The authors identified a total of 127 print ads not related to recruiting participants for clinical trials. Three of these promoted community events sponsored by the institution, two announced “genuine” public services while the remaining 122 were geared to attracting patients. Of those 122 ads, 29.5 percent (36 ads) promoted the entire medical center, 53.3 percent (65 ads) promoted specific departments and 17.2 percent (21 ads) promoted single tests or interventions. Then, of those 21 ads for a single intervention, 28.6 percent were for cosmetic procedures. More than half of the ads outlined benefits of the procedure but only one mentioned potential dangers, the study found. The most popular marketing strategies included appealing to emotions (61.5 percent), highlighting the prestige of the institution (60.7 percent), singling out a symptom or disease (53.3 percent), and promoting introductory lectures or special offers (47.5 percent). These offers included complementary health screenings and first-aid kits. And while all 17 centers said they had an institutional review board to approve advertising for research subjects, none had a similar process in place for ads to attract patients. (Health Day News)
CMS publishes procedures for certain HIPAA complaints
The
Centers for Medicare & Medicaid Services on March 25 published a notice in the
federal register, describing the procedures for filing complaints of
noncompliance with certain provisions of the administrative simplification rules
under the Health Insurance Portability and Accountability Act, and CMS's
procedures for reviewing those complaints. The procedures pertain to all HIPAA
regulations except for the privacy rule. The notice is effective April 25, 2005.
http://a257.g.akamaitech.net/7/257/2422/01jan20051800
/edocket.access.gpo.gov/2005/pdf/05-5795.pdf
North Dakota investigating possible identity theft scam
The North Dakota attorney general and North Dakota Healthcare Association are warning hospitals about a scam artist requesting confidential information about patients in the state. They say a woman representing herself as a nurse for a Salt Lake City hospital has contacted hospitals in the state and requested confidential information such as patient social security numbers, claiming the patient has appeared in the caller’s emergency room, has an outstanding bill or has died. Attorney General Wayne Stenehjem said the callers most likely are targeting the patients for identity theft and urged healthcare facilities not to give out patient information if called. For more information, contact the Attorney General’s Consumer ProtectionDivision at (800) 472-2600 or NDHA at (701) 224-9732. (AHA News Now)
Medline launches new online reporting tool
Medline Industries Inc. is launching “Medline Insight,” a new online reporting tool that can help hospitals, health systems and nursing homes easily track their supply chain activity with Medline. Medline Insight provides customers valuable information in an easy to use self-service reporting style. Popular reports include: Descending Dollar Report, Invoice Summary & Detail Reports, Order Channel Utilization, Sales by Manufacturer, Usage by Ship-To Location, and Prime Vendor Implementation Status. Medline Insight's budgeting tool allows a budget to be set up based on the customer's general ledger codes. Reports show how budget numbers compare to actual purchasing, including per patient day calculations. Medline Insight also offers a scheduling tool that can be set to run any report at any time on a continual basis. It will then e-mail you the results which can come in a variety of formats including: PDF, MS-Excel and MS-Word.
Monday, March 28 , 2005
In this Issue:
Genome cancer project proposed
Study: Vaccine protects against
pneumococcal disease
FDA approves monthly drug for
osteoporosis
Medicare publishes proposed
rule updating
hospital conditions of participation
Consorta signs agreement for plain paper
radiology printing solution
Genome cancer project proposed
Federal officials are planning to compile a complete catalog of the genetic abnormalities that characterize cancer. The proposed Human Cancer Genome Project would be greater in scale than the Human Genome Project, which mapped the human genetic blueprint. It would seek to determine the DNA sequence of thousands of tumor samples, looking for mutations that give rise to cancer or sustain it. Proponents say a databank of all such mutations, which would be freely available to researchers, would provide invaluable clues for developing new ways to diagnose, treat and prevent cancer. The project would cost roughly $1.35 billion over nine years, but where the money will come from is still uncertain. For now, the government is likely to start with some smaller pilot projects, officials said. Some scientists are dubious about the cost and are concerned that a big science project could take money away from smaller ones run by individual scientists. The project, which might end up with a different name, would determine the sequence of the DNA in at least 12,500 tumor samples, 250 samples from each of 50 major types of cancer. By comparing the order of the letters of the genetic code in the tumor samples with one another and with sequences in healthy tissue, it should be possible to pinpoint mutations responsible for cancer. (The New York Times)
Study: Vaccine protects against pneumococcal disease
The World Health Organization (WHO) welcomed the results of a pneumococcal conjugate vaccine trial conducted in The Gambia which are published in the Lancet. Dr Lee Jong-wook, Director-General, WHO, declared: “The results of this vaccine trial hold great promise for improving health and saving lives in resource-poor populations. The international community's task now is to continue to work together productively to make the pneumococcal conjugate vaccine widely available to children in Africa, as lives are lost every minute to pneumococcal disease.” The Gambia vaccine trial has demonstrated that a significant proportion of illness, disability and death in African children can be averted through vaccination against this disease. Pneumonia is estimated to kill nearly two million children every year; it is responsible for approximately 18% of the more than ten million annual childhood deaths worldwide. Pneumococcal disease is caused by infection with the Streptococcus pneumoniae bacterium. In the Gambia and other African countries, rates of invasive pneumococcal disease are up to ten times higher than in industrialized countries and the disease is a major cause of hospital admissions and deaths. WHO estimates that between 700,000 and 1 million children under five die from pneumococcal diseases each year. A randomized, controlled, double-blind trial of a pneumococcal conjugate vaccine took place in eastern Gambia starting in August 2000. 17 437 children aged 6-51 weeks were enrolled in the study. Those 8719 children in the control group received a diphtheria-tetanus-pertussis-Haemophilus influenzae serotype b vaccine. 8718 children received pneumococcal conjugate vaccine, mixed with the tetravalent vaccine received by the control group. Results of the trial indicated that in the group of children who received pneumococcal conjugate vaccine, there were: 37% fewer cases of pneumonia (as confirmed by chest X-ray); 15% fewer hospital admissions; 16% reduction in overall mortality; and half the rate of laboratory-confirmed pneumococcal pneumonia, meningitis and septicaemia. Moreover, the vaccine was 77% effective in preventing infections caused by nine serotypes (strains) of pneumococcal bacteria whose sugar capsules make up the vaccine. Full details of the trial are available in a paper published in the Lancet on 26 March 2005.
FDA approves monthly drug for osteoporosis
A once-a-month pill to help women fight osteoporosis has been approved by the Food and Drug Administration. Boniva will be the first monthly osteoporosis medication, said Dr. Richard Emkey of Radiant Research in Reading, PA, which conducted trials of the drug. Current medications are taken weekly. Boniva is being jointly promoted by the drug companies, GlaxoSmithKline and Roche. The companies estimate that 44 million Americans over age 50 suffer from osteoporosis Known as ibandronate sodium, the 150 milligram tablets are intended for both treatment and prevention of postmenopausal osteoporosis. The drug is expected to go on sale, by prescription, in April. The companies said they were setting up a patient support program to help patients remember to take the drug every month and to stay on the medication. In trials over three years the drug reduced the number of new vertebral fractures in women with osteoporosis and increased bone density in women who had not developed the disease. The most common side effects reported were abdominal pain, high blood pressure, upset stomach, joint pain, nausea and diarrhea. (Associated Press)
Medicare publishes proposed rule updating
hospital conditions of participation
The Centers for Medicare & Medicaid Services (CMS) announced a proposed rule to alleviate hospitals of overly burdensome regulations and allow doctors and nurses to focus more time and energy on patient care. The proposed rule would revise requirements in the hospital conditions of participation (CoPs) for completion of history and physical (H&P) examinations, authentication of verbal orders, securing medications, and completion of post anesthesia evaluations. The proposed rule would expand the number of permissible practitioners who may perform the H&P and the time frame for its completion; would require that all orders, including verbal orders, must be dated, timed, and authenticated by a practitioner responsible for the care of the patient. During a five year transition period from publication of the final rule, it would allow all orders, including verbal orders, to be dated, timed and authenticated by the prescribing practitioner or another practitioner responsible for the care of the patient. CMS expects that sunsetting this flexibility after a five year period is sufficient time for the adoption of changes in healthcare information technology to make it easy for prescribing practitioners to authenticate all of their own orders in a timely fashion. The proposed rule also requires that all drugs and biologicals be kept in secure areas, or locked when appropriate, to prevent unauthorized persons from obtaining access and permits the post anesthesia evaluation for inpatients to be completed and documented by any individual qualified to administer anesthesia. The proposed rule may be found at http://www.cms.hhs.gov.
Consorta signs agreement for plain paper
radiology printing solution
Consorta Inc. has awarded an agreement to Strong Value Group, Ft. Lauderdale, FL, to provide aycan Medical Systems’ plain paper x-ray printing solution to Consorta’s member hospitals. Strong Value Group is a value-added reseller of aycan Medical Systems, and resells the aycan x-ray printing solution as Print Solution One. Print Solution One combines a high-resolution laser printer with an aycan DICOM print server to produce any kind of medical image on plain paper, up to 11” by 17”, at near-diagnostic image quality.
Tronex International Inc., a New Jersey based company specializing in the manufacturing and marketing of superior hand and body protection has been awarded an agreement for examination gloves by MedAssets. The agreement calls for Tronex to offer its line of latex, vinyl, synthetic and nitrile gloves for the healthcare industry. The agreement runs through November, 2007.
Friday, March 25 , 2005
In this Issue:
Tommy Thompson speaks out about unmet goals,
future plans
MDMA: Masimo verdict a
victory for
patients, innovation and hospitals
Boston Scientific announces jury verdict in patent
litigation with Johnson & Johnson
Johnson & Johnson and Guidant
Corporation proposed
merger registration declared effective
STERIS adds to surgical table offering
with acquisition of FH Surgical SAS
Epidemic in northern Angola spreads to capital of Luanda
Tommy Thompson speaks out about unmet goals, future
plans
At a press conference at the Henry J. Kaiser Family Foundation office in Washington, D.C., former Health and Human Services Secretary Tommy G. Thompson, said Thursday that his biggest regret in leaving HHS was not pushing through sweeping changes in Medicaid during his four-year term. “I really feel sad that what I didn't get done is Medicaid,” he said. He applauded Donna Shalala, former HHS leader, currently President of University of Miami, for her eight years of service. Mr. Thompson stated his reasons for what was initially thought of as an abrupt departure after four years, saying his departure had been planned for a year and that he left his post last month to pursue jobs in the private sector after spending 38 years in government. He served as a Republican Wisconsin governor before heading up HHS. “If I was ever going to get into the private sector, I was going to have to do it now,” he said. Mr. Thompson joined international law firm Akin Gump Strauss Hauer & Feld LLP as a partner. He also became the chairman and senior adviser for the Deloitte Center for Health Care Management and Transformation in Washington, part of New York auditing and consulting subsidiary Deloitte & Touche USA LLP, and recently joined Logistics Health Inc., a health services contractor in La Crosse, WI, as president. In addition, Mr. Thompson said Harvard University has asked him to teach a class on medical diplomacy, a way he feels will promote the U.S., through health services and aid to foreign countries in need. While in office, he pushed for a "radical" transformation in Medicaid in an effort to change how state governments manage expenses. But Thompson said governors rebuffed his plan to have acute care funded by the states and long-term care paid for by the federal government. Medicaid "can't continue on the way it is. It needs a complete transformation," Mr. Thompson said. When asked about his publicized final departing comments from the HHS, Mr. Thompson had no regrets about his remarks and repeated warnings that the federal government has not done enough to adequately secure the nation's food supply from terrorist attacks. "I feel good about what we accomplished, but there is so much more we need to do in food security," he said.
MDMA: Masimo verdict a victory for patients,
innovation and hospitals
The Medical Device Manufacturers Association (MDMA) hailed Masimo
Corporation's victory this week in its federal antitrust case against Tyco
International as “a critical step” in addressing the anticompetitive and other
questionable practices by certain dominant manufacturers and hospital group
purchasing organizations (GPOs). In determining that Tyco Healthcare violated
antitrust laws related to the sales of its pulse oximetry technology, a federal
jury in the Central District of California awarded Masimo $140 million, which
was then trebled to $420 million plus attorneys fees. The jury found that Tyco
had utilized various anticompetitive practices, including sole-source and high
compliance agreements, bundled rebates and co-marketing agreements, to exclude
Masimo from the marketplace. These exclusionary contracting practices have also
been the subject of three Senate Judiciary Antitrust Subcommittee hearings led
by Senators Herb Kohl (D-WI) and Mike DeWine (R-OH). “This decision is a victory
for patients, innovation and the healthcare system as a whole,” said MDMA
Executive Director Mark Leahey. “Dominant manufacturers should not be able to
prevent doctors, nurses and patients from accessing innovative, cost-effective
products.” The verdict also represents a victory for hospitals seeking to
negotiate contracts with manufacturers, said MDMA. Over the years, GPOs have
been accused of facilitating anticompetitive contracts between hospitals and
dominant manufacturers in exchange for millions of dollars in “fees” from the
manufacturers. Yet GPOs claimed the dominant manufacturers were responsible for
the terms of the contracts. “With this verdict, GPOs and their member hospitals
will have the legal cover to refuse onerous contracts from dominant suppliers.
The result will be a higher quality of care at a lower cost,” said Leahey.
http://www.medicaldevices.org
Boston Scientific announces jury verdict in patent litigation with Johnson & Johnson
Boston Scientific Corporation announced that a jury in Delaware issued a verdict in a retrial of patent litigation between Boston Scientific and Johnson & Johnson. The jury found that a single claim of Johnson & Johnson's Palmaz patent was valid and infringed by the NIR(R) stent, which was designed and manufactured by Medinol Ltd. and formerly sold by Boston Scientific. The jury only determined liability; any monetary damages will be determined in a later hearing. In addition, there are likely to be significant post-verdict motions and hearings, as well as an appeal of the decision. Boston Scientific no longer markets or sells the NIR stent. The jury's findings will not affect Boston Scientific's ability to sell its TAXUS(R) Express(TM) paclitaxel-eluting stent system or its next-generation TAXUS(R) Liberte(TM) paclitaxel-eluting stent system.
Johnson & Johnson and Guidant Corporation proposed merger registration declared effective
Johnson & Johnson and Guidant Corporation announced that the Securities and Exchange Commission has declared effective the S-4 Registration Statement concerning their planned merger. The S-4 filing contains the Prospectus/Proxy Statement for the previously announced transaction in which Johnson & Johnson will acquire Guidant. If approved by Guidant shareholders, the transaction will still be subject to certain other conditions that are described in the Prospectus/Proxy Statement. It is anticipated that the transaction will close during the third quarter of 2005.
STERIS adds to surgical table offering with acquisition of FH Surgical SAS
STERIS Corporation announced that it has completed the acquisition of FH Surgical SAS, a privately-held manufacturer of surgical tables with approximately 40 employees and manufacturing facilities in Orleans, France. The business offers a variety of surgical tables targeted at different hospital needs and sold primarily in Europe. The acquisition will be integrated into STERIS's Healthcare segment. Under the terms of the transaction, STERIS acquired FH Surgical for 8.8 million euros (approximately $11.6 million) in cash and assumed liabilities. For the year ending March 31, 2005, FH Surgical is expected to have revenues of approximately $10.7 million. STERIS is a provider of surgical and critical care products, including operating room tables and surgical lighting systems. The acquisition will strengthen STERIS's product portfolio by adding a new technology platform in surgical tables for North America.
Epidemic in northern Angola spreads to capital of Luanda
The epidemic of Marburg hemorrhagic fever that has claimed 106 lives in northern Angola has spread to the capital of Luanda, killing three others by Thursday, a health official confirmed on Friday. At least two other people have been diagnosed with the virus in the capital, he said. The health official said that the provincial government is taking measures for combat the epidemic, and called on local residents to drink clean water. Health officials urged travelers on Wednesday to avoid Uíge Province, in northern Angola. Angolan Deputy Health Minister Jose Van-Dunem said earlier that the Marburg disease is a viral infection originated from the green monkey, which clinically manifested by a hemorrhagic fever syndrome. The transmission occurs through the contact with animals, infected human beings or through the semen during unprotected sex, as well as by way of body fluids handling. The virus causes a high fever, diarrhea, vomiting and extensive hemorrhaging in the lungs and digestive tract. (Xinhuanet)
Thursday, March 24 , 2005
In this Issue:
Over 38 million surgical
procedures to be performed in 2012,
most at outpatient or freestanding facilities
States consider obesity
surgery coverage
India passes illegal patent drug bill
FDA approves first-of-kind device to treat
descending thoracic aneurysms
A 7th child is treated for kidney disease
after visiting Florida petting zoo
Consorta receives Champion for
Change award from H2E
for second consecutive year
Over 38 million surgical procedures to be performed
in 2012,
most at outpatient or freestanding facilities
The number of U.S. surgical procedures performed is on the rise due
to the aging population, the active baby boomer generation, and
increased elective surgeries, while at the same time the percentage
of these procedures performed on an inpatient basis is declining
with the increasing use of outpatient and same-day surgery. The
total number of open and minimally invasive surgical procedures and
device implantations in the United States, including those used in
cardiovascular and thoracic, orthopedic and spinal, and cosmetic
surgery, among many other categories, are forecast to exceed 38
million in 2012, up from approximately 28.5 million in 2004,
according to a detailed new report from Medtech Insight, titled
“U.S. Surgical Procedure Volumes.” This 326-page analysis provides
current and forecast U.S. surgical procedure volumes data for
leading surgical procedures in nine major categories, for the years
2004 through 2012: cardiovascular and thoracic, cosmetic, general,
gynecologic and obstetric, major organ and tissue transplantation,
ophthalmic, orthopedic and spinal, urologic, and other miscellaneous
procedures, including breast and ear, nose and throat (ENT)
procedures. Included in the analyses are annual percentage growth
rates, compound annual growth rates, procedure descriptions, medical
indications, disease prevalence, inherent surgical risks, and
emerging surgical technologies. A full table of contents and
ordering information can be viewed on the Medtech Insight Web site
at
http://www.medtechinsight.com/ReportA605.html.
States consider obesity surgery coverage
A proposal before Connecticut lawmakers would require insurance companies to cover the surgery for people with a body-mass index of 30 or more if a doctor deems the surgery medically necessary. Georgia lawmakers are considering a similar bill this year. And in Louisiana, 40 state employees were chosen last year from 1,200 applications to have the surgery paid for by the state. Blue Cross and Blue Shield of Alabama recently stopped paying for the operations while it decides how to handle claims; Blue Cross and Blue Shield of Florida has also decided to stop paying for the operation. In Connecticut, many major plans offer coverage only for large numbers of employees. Others are considering offering the coverage for an additional charge. Last year the federal government opened the door for Medicare coverage of gastric bypass surgery. (The Associated Press)
India passes illegal patent drug bill
India, a major source of inexpensive AIDS drugs, passed a new patent law that patient advocate groups fear will hinder the supply of new drug treatments to the world’s poor. The new law, amending India's 1970 Patent Act, affects everything from electronics to software to medicines, and has been expected for years as a condition for India to join the World Trade Organization. Millions of poor people in India and elsewhere, including by some estimates half the AIDS patients in the Third World, rely on India's generic drug industry. All the generic drugs already approved in India can still be sold, though sellers must now pay licensing fees. There are also provisions allowing companies that make generics to copy drugs in the future. But there are relatively tough criteria for such copying, and activists predicted that prices for newly invented drugs will be much higher, because drug makers will have the same 20-year patent monopolies as they have in the West. All Western countries grant "product patents" on new inventions. Since 1970, India has granted "process patents," which allow another inventor to patent the same product as long as it was created by a novel process. (The New York Times)
FDA approves
first-of-kind device to treat
descending thoracic aneurysms
The Food and Drug Administration (FDA) has approved a new device that is intended to prevent ruptures of descending thoracic aneurysms by making a new path for blood flow. The GORE TAG Endoprosthesis System is the first endovascular grafting system approved to treat aneurysms of the thoracic aorta. The GORE TAG Endoprosthesis System consists of an endovascular graft made of ePTFE (expanded polytetrafluoroethylene) and a metallic support structure, and a delivery system used to implant the graft. The endovascular graft is delivered by a catheter inserted into the femoral artery in the groin. The graft re-lines the inside of the weakened aortic wall, thus strengthening the vessel and relieving pressure that could cause a rupture. The procedure, while less-invasive, than conventional surgery, does require regular follow-up medical visits and tests to monitor the success of the treatment over time. Typically, descending thoracic aneurysms are managed either medically with blood pressure-lowering drugs to reduce risk of rupture, or by surgical repair. FDA approved the Endoprosthesis System based on review of two clinical studies, involving approximately 200 people, of the System’s safety and effectiveness. Results showed that aneurysm-related deaths were lower in patients who had received the endoprosthesis than in the surgical control group. FDA is requiring that Gore conduct post-approval studies to assure that when the endovascular grafting system is used in the large general population, its safety and effectiveness will be comparable to the clinical trials, and to evaluate the long-term clinical performance of the device. The GORE TAG Endoprosthesis System is manufactured by W.L. Gore and Associates, Inc. of Flagstaff, AZ.
A 7th child is treated for
kidney disease
after visiting Florida petting zoo
Doctors
in Orlando diagnosed a seventh child with a potentially fatal kidney ailment
Wednesday. The child, as well as others admitted to hospitals in the past week,
is in critical condition with kidney failure after visiting a petting zoo in
recent weeks. Investigators are checking to see if the children became sick from
bacteria that can be found in animal feces. Sources other than petting-zoo
animals are being explored, and doctors say they won't be surprised if more sick
children show up at area hospitals. The children are suffering from an uncommon
condition called HUS, or hemolytic uremic syndrome, which causes the kidneys to
malfunction. Of the four children at
Florida
Hospital,
three were listed in critical condition Wednesday, with one child on dialysis.
The fourth child's condition improved from critical to guarded. Two more
children in critical condition are receiving care at
Arnold
Palmer
Hospital for Children & Women, where the new case was identified Wednesday
night. A seventh child was treated at Arnold Palmer several weeks ago, and it is
not clear if that case is connected to the others. The children currently
hospitalized all touched animals recently at area fairs, including the Central
Florida Fair in Orlando and the Florida Strawberry Festival in
Plant City.
Both events were held March 3-13. Another possibility is that the children were
exposed to trouble-causing bacteria through contaminated food or beverages. Many
children with HUS recover without lasting effects, but some die or suffer
permanent kidney damage that could require dialysis later in life. (Orlando
Sentinel)
Consorta receives Champion for Change award from
H2E
for second consecutive year
For the second consecutive year, Consorta has received the
Champion for Change Award from the national Hospitals for a Healthy Environment
(H2E) program. The award recognized Consorta’s ongoing efforts to promote the
H2E program within healthcare facilities, recruit new H2E partners and support
H2E’s goals. For example, Consorta has developed a searchable database of
suppliers’ responses to an environmental practices survey. Consorta makes this
data, which is updated regularly, available to its member healthcare
organizations via its Web site. Consorta’s environmental goals for 2005 include:
Designing and testing a method to measure and report trends in the use of
mercury-free products within the Consorta membership; Developing methods to
measure and document suppliers’ waste reduction initiatives; Collaborating with
an international effort to develop a chemicals policy for healthcare; Providing
accredited continuing education programs for health care professionals that
focus on vital environmental issues; Supporting green building initiatives;
Implementing a food policy to support elimination of inappropriate antibiotic
use in food production.
Consorta’s Web site at
www.consorta.com provides its member
healthcare facilities with guidelines and tools to use in developing and
facilitating environmental initiatives.
Wednesday, March 23 , 2005
In this Issue:
Smiths completes $925 million acquisition of
Medex
New FDA guidance aims to speed personalized
medicines
Nellcor to challenge jury
decision in antitrust case
FDA seizes potentially deadly hospital beds
Cosmetic surgery on the rise
Premier receives third
consecutive
environmental leadership award
Smiths completes $925 million acquisition of Medex
Smiths Group confirmed that it has completed the acquisition of medical device company Medex Inc. The consideration comprised $655million for the shares and the assumption of net debt of $270million. Medex will be integrated into Smiths Medical to provide critical care devices used in healthcare systems worldwide. Smiths Medical is a supplier of devices and equipment used in hospitals and other locations providing intensive and continuing care for patients. Smiths Group designs and manufactures safety-critical systems and products in the markets of aerospace, detection systems, medical devices, mechanical seals and interconnect products.
New FDA guidance aims to speed personalized medicines
As part of an agency-wide initiative to speed development of new medical products through the science of pharmacogenomics, the Food and Drug Administration (FDA) issued a final guidance titled "Pharmacogenomic Data Submissions." Pharmacogenomics allows healthcare providers to identify sources of an individual's profile of drug response and predict the best possible treatment option for this individual. For example, genomic tests are helping to identify cancers that have a good chance of responding to a particular medication or regimen. This technology has enabled the development of targeted therapies like Herceptin for metastatic breast cancer, Gleevec for chronic myeloid leukemia and Erbitux for metastatic colorectal cancer. "FDA's efforts will bring us one step closer to 'personalizing' medical treatment," explained Janet Woodcock, M.D., Acting Deputy Commissioner for Operations, FDA. "This new technology will allow medicines to be uniquely crafted to maximize their therapeutic benefits and minimize their potential risks for each patient." Doctors should eventually be able to analyze a patient's genetic profile and prescribe the best available drug therapy and dose from the start. Both the guidance and a new Web page are part of a broad effort underway at FDA to foster pharmacogenomics during drug development. FDA also recently approved the first laboratory test, the Amplichip Cytochrome P450 Genotyping Test, which will enable physicians to use genetic information to select the right doses of certain medications for cardiac, psychiatric diseases and cancer. The guidance "Pharmacogenomic Data Submissions," clarifies how pharmacogenomic data will be evaluated. The final guidance describes what data will be needed during the marketing application review process, the format for submissions, and the data that will be used during regulatory decision making. The guidance also explains a new mechanism for industry to voluntarily submit research data to further the scientific exchange of information as we move into more advanced areas of pharmacogenomic research. FDA's new pharmacogenomics Web page is available at http://www.fda.gov/cder/genomics/default.htm.
Nellcor to challenge jury decision in antitrust case
Nellcor announced that it will challenge in post-trial motions and, if necessary, appeal a Los Angeles jury's finding of antitrust violations in a case brought by Masimo, a manufacturer of pulse oximeters. Nellcor is part of Mallinckrodt, a Tyco Healthcare Company. Nellcor asserts that the company's business practices have always been in full compliance with Federal and state antitrust laws. Masimo claims that Nellcor's contracts with hospital group purchasing organizations (GPOs) and other contracting practices limited the amount of pulse oximetry sales that Masimo could achieve in the marketplace. The jury awarded Masimo $140 million in damages, which are automatically tripled under antitrust laws to $420 million, with attorneys' fees also added. However, Nellcor will not pay any monetary damages unless there is a final ruling against Nellcor, after all appeals and other steps in the case are complete.
FDA seizes potentially deadly hospital beds
The U.S. Food and Drug Administration, citing a risk of suffocation, said on Tuesday it ordered the seizure of enclosed hospital beds made by Toledo, OH- based Vail Products Inc. The FDA said it was aware of 30 people who became trapped in the beds, seven of wom died. The FDA said it directed U.S. marshals to seize all finished Vail 500, 1000, and 2000 enclosed beds as well as components, labeling and promotional materials for those models. The agency said the beds are misbranded because they are dangerous when used as recommended in the labeling. They also lack adequate directions for use and adequate warnings, it said. The FDA said Vail Products failed or refused to furnish requested information, and inspections show that the company has continually failed to follow quality requirements. (Reuters)
Americans continue to turn to facial plastic surgery according to a recent study released by the American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS). Facial plastic surgeons report a 22 percent increase overall in cosmetic surgical and non-surgical procedures compared to last year. The annual study, which reports the latest trends in facial plastic surgery gathered from board certified AAFPRS members, shows that overall the most sought after procedures from 2003 to 2004 were filler injections, up 115 percent, and Botox, up 107 percent. In addition, there have been significant increases in procedures among men. Laser resurfacing and forehead lifts both increased almost 300 percent, while Botox injections were up 210 percent. Approximately 130,400 men and women underwent blepharoplasty (eyelid surgery) in 2004 and 107,400 patients did undergo rhinoplasty (nose surgery). AAFPRS surgeons report that men and women consistently cite looking younger as the primary motivation for having cosmetic surgery. Over half of all patients (54 percent) have had multiple procedures in the same year. Another trend is an increase in teens undergoing cosmetic surgery (37 percent of surgeons identified this as a trend). The most common surgical procedures for females were eyelid surgery, nose surgery and facelifts. In addition, more than one-third (37 percent) of doctors feel that overall patients are getting younger. http://www.FACEMD.org.
Premier receives third consecutive
environmental leadership award
For the third consecutive year, Premier Inc. has been recognized for its national leadership in helping healthcare facilities with their environmental efforts, including waste minimization and the elimination of the use of mercury. Premier, a national alliance of hospitals and healthcare systems, is the recipient of a 2005 “Champion for Change” Award from Hospitals for a Healthy Environment (H2E). Premier, the first hospital group purchasing organization to earn the award (in 2003) now becomes the first GPO to be honored three consecutive years. A partnership that includes the American Hospital Association and the Environmental Protection Agency, H2E is an industry-wide collaborative effort that educates healthcare professionals about pollution prevention opportunities and assists hospitals in reducing mercury use and minimizing waste. Catholic Healthcare West, one of Premier's members and shareholders, also has been named a Champion for Change award winner. Premier's environmentally preferable purchasing program is administered by its Safety Institute in collaboration with group purchasing services. Another factor in Premier's selection was the ongoing education offered through its Safety Institute, including comprehensive Web-based tools and resources available at www.premierinc.com/safety. Premier offers the only publicly available list of mercury-containing pharmaceuticals to help hospitals identify, manage, and dispose of these potentially hazardous drugs. The 2005 Champion for Change awardees include Premier, Catholic Healthcare West, Baxter Healthcare, California Department of Health Services, Hospital Pollution Prevention Program, Consorta, New Hampshire Department of Environmental Services, Novation, Ohio Hospital Association, U.S. Environmental Protection Agency Region 1, Vanguard Medical Concepts, Virginia Department of Environmental Quality, and Wheaton Franciscan Services. For more information, visit www.h2e-online.org.
Tuesday, March 22 , 2005
In this Issue:
World Tuberculosis Day: U.S. rate at all
time-low
FDA issues nationwide alert on
ONE lot of Pharmedium
Services magnesium sulfate
solution
Bill would require
hospitals to report
prices for display on Internet
Newborn dies from MRSA infection in UK
Study: J&J heart drug impairs kidney function
Consorta signs agreement for
hood certification services
World Tuberculosis Day: U.S. rate at all time-low
More than one-third of the global population is infected with the
tuberculosis (TB) bacterium, and TB disease remains one of the
world’s leading causes of disease and death. Each year, 8 million
people become ill with TB, and 2 million people die from the
disease. World TB Day on March 24, the date in 1882 that scientist
Robert Koch announced his discovery of the TB bacterium, is an
international call to action against the disease. In the United
States, the latest national surveillance data show a significant,
but slowing, decline in the case rate of TB. In 2004, a total of
14,511 TB cases were reported in the U.S. The overall TB case rate,
4.9 per 100,000 persons, was the lowest rate ever recorded since
reporting began in 1953. However, the decline in the case rate from
2003 to 2004 was one of the smallest in more than a decade (3.3
percent compared with an average of 6.8 percent per year). Seven
states now bear more than half the total burden of TB disease in the
U.S. California, Florida, Georgia, Illinois, New Jersey, New York,
and Texas account for 59.9% of the national case total. Hawaii once
again reported one of the nation's highest rates of active TB, twice
the national figure, largely because the state has a significant
population of immigrants from Southeast Asia. Globally, Asia
accounts for the largest number of TB cases. CDC is working to
strengthen global partnerships to address TB among populations
hardest-hit by the disease. These efforts include improving overseas
screening for immigrants and refugees, and testing recent arrivals
from high-incidence countries for latent TB infection. CDC is also
improving the notification system that alerts local health
departments about the arrival of immigrants who are known or
believed to have TB, and collaborating with public health teams in
Mexico to improve TB control among those who frequently cross the
U.S.-Mexico border. Along with state and local health departments,
CDC is working to ensure that adequate local resources are in place
in communities with the greatest burden of TB. For more information,
visit
www.cdc.gov/nchstp/tb/WorldTBDay/2005.
FDA issues nationwide alert on ONE lot of Pharmedium
Services magnesium sulfate solution
The
FDA is issuing a nationwide alert against the use of PharMEDium Services
Magnesium Sulfate 1 gram in 50mL D5W (piggyback) IV solution, lot number
100504900049 and expiration date 4/4/05. This product is manufactured by
PharMEDium Services of Houston, TX, and may be contaminated with Serratia
marcescens bacteria that can cause serious, life-threatening illness in patients
with compromised immune systems. This product is frequently administered
intravenously to patients undergoing cardiac surgery and was apparently
distributed to several hospitals around the country. To date it has been
associated with at least 5 recent cases of Serratia marcescens infection in a
hospital in New Jersey. All patients have responded to treatment with
antibiotics and are reportedly recovering well. The firm has notified FDA that
it is in the process of withdrawing this lot from hospitals. FDA, the U.S.
Centers for Disease Control and Prevention, and other public health authorities
are investigating this problem to determine if other lots of this product may be
affected. More information will be provided as the investigation develops.
Hospitals with questions may contact the company at 1-847-457-2300. Persons
wanting to report anything to the Food and Drug Administration regarding this
products may contact FDA's MedWatch office at 1 800-FDA-1088.
fda.gov/bbs/topics/news/2005/NEW01166.html
Bill would require hospitals to report
prices for display on Internet
Legislation introduced in the U.S. House Friday would require hospitals to report prices for their 25 most commonly performed inpatient and outpatient procedures and 50 most prescribed medications to the Department of Health and Human Services for posting on the Internet. Rep. Dan Lipinski, D-IL, sponsored the Hospital Price Disclosure Act (H.R. 1362) with Rep. Bob Inglis, R-SC. (AHA News Now)
Newborn dies from MRSA infection in UK
A newborn at Ipswich Hospital, UK at died when he was just 36 hours old from the superbug MRSA he contracted at the hospital. His parents initially refused to sign his death certificate because it had no mention of MRSA. The hospital eventually did include (in the death certificate) MRSA infection as the cause of death. The action has led some to question the true number of deaths caused by MRSA infection. Health experts are still investigating the source of the MRSA. There were 7,647 MRSA bloodstream infections from 2003 to 2004, an increase of 3.6% in England over the last year. National Audit Office (NAO) estimates there have been 5,000 deaths a year attributable to hospital-acquired infections. The Office for National Statistics (ONS) study found that MRSA was mentioned as a contributory factor in 800 death certificates in 2002. The Chief Medical Officer's report called for an audit of deaths from healthcare associated infections which will be introduced from 2006. Proposed changes should enable death certification to be done electronically. Information from patient records will be linked electronically to the registration, with the consent of a family member, registering the death. (Medical News Today)
Study: J&J heart drug impairs kidney function
Johnson & Johnson's treatment for congestive heart failure, Natrecor, became the latest drug to come into question over safety issues when an article in the journal Circulation said that the drug had reduced kidney function. An accompanying editorial in the journal, published by the American Heart Association, questioned why the Food and Drug Administration had failed to follow up on concerns about Natrecor's impact on the kidneys and suggested that the drug should have received stronger labeling when it was approved in 2001. A cardiologist at the Cleveland Clinic said he had had concerns about the drug's safety since he cast the only vote against it while serving on an FDA advisory panel. The cardiologist, Dr. Steven Nissen, said his concerns were based on data showing excessive renal problems. Johnson & Johnson defended the product yesterday and criticized the analysis, which was conducted by three cardiologists, saying they had relied on data from patients who had received higher doses than are now recommended. The analysis, by Dr. Jonathan D. Sackner-Bernstein and Dr. Hal A. Skopicki of North Shore University Hospital in Manhasset, N.Y., and Dr. Keith D. Aaronson of the University of Michigan, was based on a review of clinical trial data submitted to the F.D.A. before the drug's approval. The article concluded that Natrecor caused a 40 percent to 50 percent greater risk of reduced kidney function when compared with more conventional therapies for heart patients. (The New York Times)
Consorta signs agreement for hood certification services
Consorta Inc. has awarded an agreement for fume hood testing and certification
services to Independent Certification Services (ICS), Plymouth, MN. Under the
two-year agreement, ICS will provide Consorta members with competitive pricing
for its services, which include calibration, testing, repair and certification
of biological safety cabinets, laminar flow clean benches, chemical fume hoods
and barrier isolators. In addition, ICS provides the cleanroom testing required
under United States Pharmacopeia (USP) Chapter 797 for sterile compounding
pharmacies.
Monday, March 21 , 2005
In this Issue:
Rubella virus eliminated in the
United States
Cancer center to reimburse government $382,400
Researchers discuss risk
factors for allergic disease
Sani-Cloth germicidal disposable wipes receive
EPA approval as virucidal against HBV and RSV
Ansell’s new Micro-Touch
Smooth Nitrile exam gloves
are FDA approved for handling chemotherapy drugs
Rubella virus
eliminated in the
United States
Fewer than 10 people a year in the United States now contract the rubella virus or German measles. Since 2002, all cases have been traceable to foreigners who carried the virus in from abroad. Between those rare events, however, no rubella virus has circulated in the United States. After years of assiduous vaccination, virtually the entire U.S. population is immune. A woman infected with the rubella virus in the first three months of pregnancy will probably suffer miscarriage, or deliver a stillborn or permanently disabled child. “This is a milestone,” said Julie L. Gerberding, director of the Centers for Disease Control and Prevention. "It is a major step forward in our ability to eliminate this problem in the Western Hemisphere, and then in the world." She will announce rubella's disappeara