|
hpnonline Daily Update |
|||||||||
|
|
July 2001
Medical Indicators teams with two GPOs
Medical Indicators, Inc. has contracted with two group purchasing organizations for marketing disposable/reusable oral and axillary thermometers its (GPOs). AmeriNet has awarded a two-year contract to Medical Indicators; a three-year contract has been given to Health Services Corporation of America (HSCA), which was recently acquired by MedAssets Inc., the largest member-owned regional GPO in the nation.
Sulzer's execs begin to exit
Sulzer Orthopedics Inc., Austin, TX, has lost two executives following one of the largest recall of an orthopedic part in U.S. history. The recall of nearly 40,000 of Sulzer's Inter-Op hip shells has spawned more than 1,000 lawsuits. The company thinks that 12,800 of the recalled hips might have been contaminated by traces of oil that prevented the shells from bonding to patients' bones.
Report: Hospitals with more IT infrastructure control expenses better
An annual survey showed hospitals with the most information technology gear have better control of expenses, higher productivity and more efficient utilization management. Hospitals & Health Networks reported a total of 283 surveys were completed by organizations representing 1,177 hospitals. The "Most Wired" hospitals, for instance, have lower median expenses per discharge and greater productivity, as measured by full-time equivalent staff (FTE) per adjusted occupied bed, paid hours per adjusted discharge and net patient revenue per FTE, the survey explained.
Hospital mergers, acquisitions decline in second quarter
Hospitals were involved in 18 mergers and acquisitions in second quarter 2001, down from 22 deals in the previous quarter and 28 deals in second quarter 2000, according to the quarterly report by Irving Levin Associates Inc. Healthcare services saw 114 mergers and acquisitions totaling about $2 billion, including 14 managed care deals. The 210 deals announced in all healthcare sectors totaled $24.4 billion, of which 92 percent was spent in the healthcare technology sector.
Manufacturer agrees to replace hospital fire sprinklers
The Consumer Product Safety Commission and Central Sprinkler Co. have announced a voluntary replacement program and will provide parts and labor to replace 35 million fire sprinklers with O-ring seals installed nationwide in hospitals and other buildings. Central discovered the O-ring seals may corrode, causing the sprinklers not to activate in a fire. For more, click here.
Cruciate ligament screws marketed in U.S., European Union
Smith & Nephew, Andover, MA, is marketing bioabsorbable screws after obtaining Food and Drug Administration clearance and CE Mark approval in Europe. The company's BioRCI-HA (or hydroxylapatite) screws are for repairing anterior and posterior cruciate ligaments. The products may offer improved capacity for bone integration, according to the company, which notes that an estimated 200,000 such procedures are performed in the United States annually.
FDA OKs Israeli company's noninvasive test for stomach bacteria
Oridian Systems, Jerusalem, will market its BreathID breath device for detecting stomach bacteria, following recent certification from the Food and Drug Administration. The testing device is designed to detect Helicobacter pylori (H. pylori), a bacterium that can cause ulcers and other stomach problems. "We developed this device as a response to the medical community's demand for economical and accurate diagnostic tests that also offer the benefits of a noninvasive method," said George Yariv, Oridion's president and CEO.
Guidant feels financial sting of FDA's disapproval
Guidant Corp., Indianapolis, reported this week second quarter profits dropped 7 percent for a net income of $115.3 million for the period, compared to $124.3 million last year for the same period. Guidant was dealt a blow when the Food and Drug Administration recently rejected the company's Contak CD -- a device that electrically shocks a patient's heart to make it beat more efficiently. In addition, the FDA also voted to recommend approval of rival Medtronic Inc.'s biventricular pacing system to treat heart failure.
GOP: Rising Medicare costs likely due to prescription drug benefits
Healthcare costs of most seniors in the Medicare program appear likely to rise under reforms advocated by the Bush Administration, according to published reports. But Republicans said cost increases are inevitable as Congress seeks to provide a Medicare prescription drug benefit to a rapidly increasing Medicare population. "The question is, are we going to put in the obvious private sector efficiencies of competition and choice, which then allows us not to have to increase Medicare costs as much as we would under the old-fashioned prices?" said Rep. Bill Thomas (R-CA), Chairman of the Ways and Means Committee.
FDA releases hemostatic sealant FloSeal
Fusion Medical Technologies, Fremont, CA, received Thursday an approval from the Food and Drug Administration to market the FloSeal matrix hemostatic sealant (FloSeal), used to stop heavy bleeding in surgery. FloSeal combines specially engineered collagen derived particles and topical thrombin that delivers hemostatic sealant. During clinical trials and in the field, FloSeal stopped bleeding two to three times faster than devices used by surgeons, according to the company.
FDA allows HydroCision to sell chronic wound-cleaning device
The Food and Drug Administration this week gave market approval to the UlcerJet system, a device used for the excision of chronic, non-healing wounds. The proprietary high-pressure fluidjet used in the UlcerJet simultaneously cuts and removes tissue and cleans the wound site, stated the manufacturer, HydroCision, Andover, MA.
AORN brings material management, central service into the fold
Beyond its traditional ranks of registered nurses, the Association of periOperative Registered Nurses, Denver, has approved accepting as members material managers, central service personnel and other healthcare professionals. AORN is the professional organization of perioperative registered nurses whose mission is to promote quality patient care by providing its members with education, standards, services and representation. The association has approximately 40,000 perioperative registered nurses in the United States and abroad. For more information about AORN membership, call 1-800-755-2676, ext. 1, or view www.aorn.org.
GAO: BBA relief chips away at Medicare's 'fiscal discipline'
Legislation that added more than $50 billion for Medicare provider payments worsened the program's financial outlook, according to the General Accounting Office. Medicare spending increased 7.5 percent in the first eight months of fiscal 2001, compared with the same period of 2000. The added funding has eroded the "fiscal discipline" imposed on Medicare by the Balanced Budget Act of 1997.
Researchers support new method for detecting diseased blood vessels
Combining echocardiography and high-dose dipyridamole technetium-99m sestamibi tomography is a safe and cost-effective strategy for detecting coronary vasculopathy (diseased blood vessels) in transplant patients, reported Italian researchers in Milan. Scientists studied 78 consecutive heart transplant patients within 48 hours after completion of a yearly angiogram. The patients also underwent echocardiography and high-dose dipyridamole technetium. Angiograms showed that 53 patients had no signs of coronary allograft vasculopathy, 13 patients had one coronary allograft vasculopathy lesion and 12 patients had two coronary allograft vasculopathy lesions, according to European Heart Journal.
FDA grants market status to Point 9 catheters
Spectranetics Corp., Colorado Springs, CO, announced Tuesday the Food and Drug Administration commercially approved its smallest Point 9 line of catheters with higher laser parameters for treating difficult lesions, stated a company release. "We were delighted to receive FDA approval for the modified Point 9 catheters so quickly," said Joseph A. Largey, president and CEO of Spectranetics. "Before they can be used, various upgrades must be performed on different generations of CVX-300 lasers in the field. We initially plan to test market the laser upgrades and higher-performance catheters in a small number of accounts."
Journal study refutes frequency of fatal hospital errors
New research has labeled the much-publicized 1999 Institute of Medicine's report on hospital medical errors as misleading and unreliable. Appearing in the Journal of the American Medical Association, the article contends medical errors are to blame for only two to three patient deaths per 10,000 hospital admissions, which is below IOM's estimate of 15 or more per 10,000 admissions. The research was conducted at seven Veterans' Affairs hospitals. "We're not contradicting (reports) that errors are common --the study confirms that," said Rodney Hayward, M.D., director for outcomes research at the Ann Arbor VA Health Care System in Michigan and co-author of the JAMA study. "(But) it suggests that the number of deaths due to errors, at least (those identified through chart review) have been overestimated."
Lawsuit: Neoforma.com's underwriters given 'excessive' commissions
Neoforma.com, San Jose, CA, and the securities firms that underwrote it's initial public offering have been served a class action lawsuit, alleging the offering's prospectus failed to say the firms solicited and received "excessive" commissions from investors. The suit also claims some investors in the IPO agreed to buy more shares later at predetermined prices. Neoforma officials called the charges frivolous, and the firm would mount an aggressive defense. Following Neoforma's January 2000 offering, shares skyrocketed to more than $78 a share but have since plummeted to less than $1.
Automated stroke therapy machine undergoing tests
A robotic walking machine tested at The Rehabilitation Institute of St. Louis may help people paralyzed by spinal cord injury or stroke recover more quickly and more completely. The AutoAmulator, developed by HealthSouth Corp., Birmingham, AL, relies on tireless robotic arms rather than therapists to move the legs of debilitated patients on a treadmill device.
Baxter recalls rare HIV-tainted burn treatment
Baxter International Inc., Deerfield, IL, has voluntarily recalled a burn treatment product when a test discovered a form of HIV in the plasma used to make the product. A Baxter release stated a subsequent evaluation using an experimental test for HIV-2 detected low levels of the rare HIV-2. Baxter's recall of Albumin Buminate 5 percent can be viewed on the Food and Drug Administration's Web site at www.fda.gov/cdrh.
EPA's dioxin study could impact hospitals
The Environmental Protection Agency is enforcing new mercury-reduction standards either by voluntary or punitive means. EPA Administrator Christie Whitman is expected to sign off on a 10-year study of dioxin pollution, which an environmental activist group said will could involve hospitals. "That is going to bring a lot of attention to it," said Bill Ravanesi, director for Washington-based Health Care Without Harm, a coalition of 250 organizations campaigning for environmentally friendly hospitals and providers. Hospitals are the second-largest dioxin polluter in the country, and the fourth largest of mercury, he said.
Future of first wireless artificial heart is unknown
Doctors are unsure if the first self-contained artificial heart will ever be a common medical option for patients with failing hearts. The AbioCor, produced by Abiomed Inc., Danvers, MA, was implanted July 2 in a seriously ill man at Jewish Hospital, Louisville, KY. A small, rechargeable battery powers an external, wireless pack that transmits electricity through the skin. "What we need is data to support going from one phase to the next, and right now we don't have any data," said John Watson, M.D., of the National Heart Lung and Blood Institute.
CMS organizes 'listening' committees for providers
The Centers for Medicare and Medicaid Services, formerly the Health Care Financing Administration, will create seven new committees to act as liaisons between the agency and hospitals, physicians, nursing homes and other providers. In addition, the CMS will hold "listening sessions" across the country to solicit ideas from providers, and it will put together teams of experts to simplify complex rules, officials said.
Employers show interest in health promotion programs
More employers are offering health promotion and management programs, according to a new survey from Hewitt Associates, noting 71 percent of the companies surveyed have training programs, up 5 percent from 1995. Hewitt health consultant Camille Haltom said employers are looking for creative and effective solutions, such as health promotion and medical management programs that can provide cost savings, reduce absenteeism and increase productivity. For more, view Hewitt's Web site.
GE purchases wireless tech systems
GE Medical Systems, Milwaukee, recently acquired Data Critical Corp., Bothell, WA, a maker of communication technologies for managing healthcare data. Critical Data produces a line of wireless alarm notification products for hospitals, wireless products for physicians and software for managing the care of cardiac patients with implanted devices. The company's systems are installed in more than 400 hospitals in the United States and provide more than 15,000 clinicians with real-time information to make informed decisions for their patients, according to GE.
Abbott and Weston Medical partner for needleless study
Abbott Laboratories, Abbott Park, IL, and Weston Medical, Peterborough, England, have entered into a licensing agreement to evaluate Weston's needle-free, drug delivery technology. Both companies will conduct studies to evaluate Weston's Intraject -- a single-use, disposable, pre-filled, needle-free injector for subcutaneous delivery of drugs for potential use with compounds in Abbott's pharmaceutical pipeline for the next 10 years.
InTrack surgical clamps ready for European market
Novare Surgical Systems, Cupertino, CA, has received CE Mark approval to market its Intrack line of minimally invasive surgical clamps in the European Union. The devices employ comfortable pads loaded into a channel within the jaws of the devices, which reduce the potential for damage to diseased blood vessels during cardiac, thoracic and peripheral vascular surgeries, the company stated.
Hospital-altered bra 'eliminates' deep-sternal infections
Nurses at a Minnesota hospital have developed a modified sports bra that eliminates deep-sternal patient wound infections following cardiac surgery. Recent research shows the additional weight of breast tissue in large-chested women pulls at the incision following surgery, increasing their risk for deep-sternal wound infections by 19 to 39 percent. Made with advice from physicians at Mercy Hospital in Coon Rapids, MN, the bra features Velcro sewn into the strap so it can be easily put on without interfering with IV lines. Since the hospital began offering the altered bra to patients, none of them have developed a deep-sternal wound infection, according to officials.
AHA president warns ARC to hold cost on blood products -- or else
The American Hospital Association has warned the American Red Cross the long-standing relationship between the two healthcare organizations could suffer if the ARC continues to increase the price its blood products. AHA President Dick Davidson said the increases "will cripple the ability of many of the nation's hospitals to meet the needs of their patients and communities." An ARC statement said the price hikes will help curb $400 million in debt incurred over the last decade for new blood testing and filtering processes. Davidson's remark can be viewed at AHA's Web site.
Journal: Professional satisfaction drops among MA doctors
Unhappy physicians in Massachusetts could be an indicator for the rest of the nation's practitioners, a survey suggests recently conducted by Health and Human Services and the Robert Wood Johnson Foundation. The survey compared findings from 1986 and 1997 of the state's primary care physicians. By 1997, less than two-thirds of doctors surveyed were content with "most areas" of their practices, a decline of about 20 percent from 11 years ago. Blame was placed squarely on managed care. "Many of these physicians began practicing decades ago in a system with virtually no oversight or restraint on spending," said Dana Gelb Safran of the New England Medical Center, who was principal investigator for the project.
FDA grants Cyberonics 30-day trial for vagus nerve stimulator
The Food and Drug Administration will allow Cyberonics Inc., Houston, an investigational device exemption for a 30-patient study to assess the safety and efficacy of its vagus nerve stimulation therapy to treat patients with chronic migraine headaches. The company's NeuroCybernetic Prosthesis device is a stopwatch-sized generator implanted in the left chest, with a nerve stimulation electrode attached to the neck's vagus nerve. Using a laptop computer and programming wand, a neurologist programs the NCP system to deliver regular, mild electrical stimulation to the vagus nerve.
High expectations of new antibiotic tempered
Harvard Medical School researchers reported a staph supergerm has overcome a new antibiotic slightly more than a year after its introduction. The antibiotic Zyvox, the first of its kind in 35 years, infected an 85-year-old man on dialysis in the lining of his intestines. It is the first report of staph resistance to the medicine. Frustrated experts said that, although the finding is disappointing, the drug still should help many people.
FDA wants corrections at EP Medsystems' catheter center
EP Medsystems, Mount Arlington, NY, received a warning letter from the Food and Drug Administration concerning design controls and manufacturing process controls of a catheter-based treatment for atrial fibrillation, according to a company release. "Management is serious about its dedication to a thorough quality system, and we are working diligently with the FDA to resolve the six issues raised in the warning letter," said David A. Jenkins, EP MedSystems' chairman and CEO.
HHS funds $86.5 million for hospital improvements, equipment
The Department of Health and Human Services has awarded 44 grants totaling $86.5 million to upgrade buildings and equipment at hospitals, research facilities and clinics. The grants are part of the Health Care and Other Facilities program, administered by the Health Resources and Services Administration. Click here to view a complete list of grant winners.
Senate subcommittee: More ergonomics education a waste of time
A Senate subcommittee on employment, safety and training described renewed forums on ergonomics as a "costly delay" that will undo 10 years of work on the issue. Chris Spear, Assistant Secretary of Labor, believed the forums would bolster the credibility of the Occupational Safety and Health Administration and avoid a repeat of the agency's recently rescinded standard. Critics of the previous standard said it would have cost businesses billions of dollars more than agency estimates.
FDA accepts Ortec's skin substitute for burn victims
Ortec International Inc. announced Thursday the Food and Drug Administration approved in part the company's tissue-engineered skin substitute, OrCel, for use in treatment of donor site wounds in burn victims. "We are obviously pleased by the panel's favorable recommendation and look forward to working with the FDA towards obtaining a final marketing approval and making our product commercially available for this significant medical need," said Steven Katz, Ortec's chairman and CEO.
Neoforma.com's net revenue doubles
Neoforma.com, San Jose, CA, reported a second quarter loss of $47.7 million, compared with a loss of $59.6 million for the year-ago period. Net revenue more than doubled to $4.6 million. The gross volume of business conducted through Neoforma's marketplaces grew to $150.2 million, an 86 percent increase from the first quarter and about five times the volume of the fourth quarter of 2000.
Thompson aims to trim Medicare cost report
Health and Human Services Secretary Tommy Thompson said the agency plans to reduce by 10 percent the size of the Medicare cost report required of hospitals and skilled-nursing facilities. Also, management guidelines that physicians use for Medicare billing will be redesigned because doctors say they are too cumbersome. The secretary plans to convene a series of health-sector workgroups to provide ideas on reducing regulatory complexity.
Smith & Nephew goes commercial with bipolar arthroscopy adaptor
Following the Food and Drug Administration's recent approval, Smith & Nephew, Andover, MA, has launched the Dyonics Control, a new approach to bipolar arthroscopic radio frequency (RF) techniques, the company stated this week. The system's RF is designed to adapt the energy output of a hospital's standard electrosurgical generator to the high-frequency waveforms required for bipolar arthroscopy procedures.
FDA accepts eye surgery protector
Anika Therapeutics, Woburn, MA, stated this week the Food and Drug Administration has cleared its Shellgel product, designed to protect sensitive eye tissue and maintain eye shape during ophthalmic surgery. Anika Therapeutics develops, manufactures and commercializes therapeutic products and devices intended to promote the repair, protection and healing of bone, cartilage and soft tissue.
FDA allows recalled device for some surgeries
The Food and Drug Administration will permit the recalled device Ancure Endograft, an arterial implant made by Guidant Corp., Indianapolis, to be used at 300 hospitals by physicians experienced with the Ancure, a minimally invasive method to repair abdominal aortic aneurysm. Guidant voluntarily recalled the Ancure last March, saying it had identified "certain deficiencies" in regulatory processes with the FDA.
Research: Right heart catheterization may harm patients
A heart-monitoring method used during major operations may not be beneficial and may raise the risk of heart attacks, according to researchers at Brigham and Women's Hospital, Boston. Researchers identified 215 matched pairs of patients who did and didn't undergo right-heart catheterization, but had similar medical risks. Those who underwent the procedure had a threefold greater risk of cardiac problems. However, it's unclear whether the procedure causes problems or data provided by the monitoring leads to overly aggressive corrective treatments that may harm patients, said Thomas Lee, a physician and associate professor at Harvard Medical School, who led the study.
GAO criticizes HHS' fraud management plan
The General Accounting Office has faulted Health and Human Services' fiscal 2002 plan to fight Medicare and Medicaid fraud. For example, a GAO report stated the HHS plan lacks clear standards for how to modernize its outdated financial management system. Also, the GAO knocked HHS for not addressing a nursing-home improvement initiative that it has been directed to monitor by the Senate's Special Committee on Aging.
Federal judge tells Medicare to open investigations of providers
Medicare officials have been ordered by a federal judge to disclose investigative findings whenever a hospital's care has been sub-standard or has committed medical errors that injured the patient. A consumer's complaint can now activate the process, according to the ruling in District Court in Washington. The decision overturns a policy that for more than 20 years prevented Medicare beneficiaries from obtaining data on doctors who botched their care. The Clinton and Bush administrations had defended the policy, saying secrecy was essential to the peer-review process by which doctors evaluate one another.
Livewire catheter for heart arrhythmias is commercially ready
St. Jude Medical Inc., Minneapolis, announced Tuesday the Food and Drug Administration accepted its Livewire TC Compass catheter for managing overly rapid heartbeats. The Livewire is designed to locate the triggers of heart arrhythmias that cause abnormally rapid heartbeats, or supraventricular tachycardias (SVTs), including atrial fibrillation. A company release said the catheter system also features ablation capabilities for the radio frequency ablation of selected SVTs, including Wolff-Parkinson-White syndrome, atrioventricular nodal re-entrant tachycardia and atrioventricular node ablation.
FDA approves implant for treating eye glaucoma
The Food and Drug Administration has cleared for mark the AquaFlow collagen glaucoma drainage device for patients with open-angle glaucoma, a condition in which fluid is produced faster than it can drain out of the eye. Manufactured by Staar Surgical, Monrovia, CA, the device swells to five to 10 times its original size and is absorbed within six to nine months into the eye to create a new drainage pathway. Glaucoma affects about 67 million people a year, with about 100,000 new cases diagnosed each year. The worldwide glaucoma market is about $1.4 billion, according to the company.
Government OKs catheter for hemodialysis grafts
The Food and Drug Administration will allow Bacchus Vascular Inc., Santa Clara, CA, to sell its catheter-based device that removes blood clots in hemodialysis access grafts. The Solera thrombectomy catheter also has been awarded CE Mark approval for marketing in the European Union. The catheter is a hand-held battery-operated device that mechanically and rapidly breaks down blood clots, according to a company release. Its design prevents the macerating unit from coming in contacted with the graft wall.
AHRQ publishes research on improving patient safety
A 640-page federal report released Tuesday contains 73 practices to improve patient safety, one of which prescribes giving patients antibiotics just before surgery to prevent infections. The Agency for Healthcare Research and Quality's study, "Making Health Care Safer: A Critical Analysis of Patient Safety Practices," also recommends using beta blockers with cardiac patients and sterilizing intravenous catheters. Both are considered highly effective but aren't performed routinely in the nation's hospitals and nursing homes. For more, visit www.ahrq.org.
FDA accepts hepatitis B test
Ortho-Clinical Diagnostics, Raritan, NJ, has earned the Food and Drug Administration's approval for marketing its hepatitis B surface antigen assay - the Vitros immunodiagnostic product. In conjunction with other serological and clinical information, the Vitros can be used for the laboratory diagnosis of individuals with acute or chronic hepatitis B.
Best hospitals named for 2001, winners cited for low mortality, high technology
U.S. News has selected 16 institutions as "America's Best Hospitals" for 2001, in which they were ranked on a U.S. News Index that combined reputation, mortality and a group of other factors related to patient care, such as nursing and technology. They were:
1. Johns Hopkins Hospital, Baltimore, 32 points in 16 specialties
2. Mayo Clinic, Rochester, MN, 27 points in 14 specialties
3. Massachusetts General Hospital, Boston, 26 points in 14 specialties
4. Cleveland Clinic, 23 points in 12 specialties
5. UCLA Medical Center, Los Angeles, 22 points in 14 specialties
6. Duke University Medical Center, Durham, NC, 20 points in 12 specialties
7. Barnes-Jewish Hospital, St. Louis, 18 points in 12 specialties
7. University of Michigan Medical Center, Ann Arbor, 18 points in 12 specialties
9. University of California, San Francisco Medical Center, 18 points in 11 specialties
10. Stanford University Hospital, Stanford, CA, 17 points in 11 specialties
11. Brigham and Women's Hospital, Boston, 16 points in 10 specialties
12. University of Washington Medical Center, Seattle, 12 points in 8 specialties
13. New York Presbyterian Hospital, 12 points in 7 specialties
14. Hospital of the University of Pennsylvania, Philadelphia, 11 points in 8 specialties
15. University of Chicago Hospitals, 9 points in 8 specialties
16. University of Pittsburgh Medical Center, 9 points in 7 specialties
CE Mark given to ICD featuring venous access
Ela Medical, Paris, has received CE Mark approval for its first defibrillation lead for use with implantable cardioverter defibrillators and will be marketed in Europe. The ELA Swift 4040 1CT is a bipolar, single coil defibrillation lead with passive fixation. The device features a slim body that enables the lead to be inserted through a smaller introducer (10 French) to allow easier venous access. In addition, the lightweight single coil makes the lead easy to maneuver and enables physicians to reach the desired location in the heart quickly, according to the company.
Guidant agrees to supply extra data on FDA-rejected device
Guidant Corp. officials have stated the Indianapolis-based medical device maker will provide additional data to the federal government on its Contak CD for treating congestive heart failure. Last week, the Food and Drug Administration rejected Guidant's device on a 6-2 vote after panel members noted that Guidant's study of the device did not meet its primary goal of cutting progression of heart failure by 25 percent. "We are pleased that this device remains under an expedited review process," said Fred McCoy, president of Guidant cardiac rhythm management.
St. Jude Medical warns docs of possible flaws in ICD
St. Jude Medical Inc., St. Paul, MN, announced it will notify physicians of potential problems with the Profile MD implantable cardioverter defibrillator that may require replacement of the device in some patients. The Profile MD (Model V-186HV3) has shown inconsistencies in its sensing capabilities, and batteries have been prematurely depleted. No deaths or serious injuries have been reported, and a replacement ICD will be provided free of charge, the company said.
Artificial-heart makers cut press access to patient's surgeon
A surgeon who recently implanted the first self-contained artificial heart said officials of the device's manufacturing company, Abiomed, will not let him talk to news organizations on the patient's progress. Medical ethicists said the news restrictions limit public debate about a device whose early development was financed by the government. Cardiologist Valentin Fuster, a former president of the American Heart Association, said, "The public has a right to know about what's going on." Abiomed said it contractually reserved the right to withhold news of the implant for up to 30 days and impose "a quiet period" during the recipient's recovery. The surgery was performed at Jewish Hospital, Louisville, KY.
Noninvasive hemodynamic test on the market
The Food and Drug Administration has approved the DynaPulse Pathway designed for noninvasively providing hemodynamic data for evaluating cardiac function. The system, manufactured by Pulse Metric Inc., San Diego, uses a simple upper-arm blood pressure cuff to measure systolic, diastolic and mean arterial pressures and heart rate.
FDA approves BioSphere's microsphere's for embolization
BioSphere Medical, Rockland, MD, has received Food and Drug Administration clearance for its new microsphere, the EmboGold, designed to improve handling and visibility for facilitating controlled, targeted embolization, stated a company release. "This is the first of a number of new products and product improvements we are planning to introduce that will support our strategy of maintaining leadership in the rapidly emerging field of embolotherapy," said John M. Carnuccio, president and CEO of BioSphere Medical.
AMA: Bush's new Medicare plans benefit seniors
The American Medical Association praised President Bush's Medicare reform program as a "positive first step toward improving the program for America's seniors." An AMA statement Friday said the proposed Medicare discount card for drugs will bring improvements to seniors. "We are also particularly pleased that President Bush has focused on Medicare reform proposals that will reduce the need for seniors to purchase secondary insurance, or medigap plans," said Richard F. Corlin, M.D., president of the American Medical Association.
Hospital mergers not always the financial answer, says AHRQ
A division of Health and Human Services, the Agency for Healthcare Research and Quality, believe merged hospitals may not achieve cost savings that they are often expected to generate. "The presence and extent of (merger-related) savings vary based on market and hospital conditions," researchers concluded. "Savings appear to be the highest in competitive markets and also when low-occupancy, nonteaching or nonprofit hospitals merge." The study analyzed changes in costs and prices from 1989 to 1997 for nearly 1,800 hospitals.
FDA accepts St. Jude Medical's AF pacemaker
St. Jude Medical Inc., St. Paul, MN, released its Integrity AFx DR Model 5346 pacemaker for suppressing atrial fibrillation (AF) through stimulation therapy, following the Food and Drug Administration's recent approval. About 25 percent of heart failure patients have AF, the company stated, adding until recently medication was mostly used to treat the condition.
FDA forays into regulating experimental fertility drugs
The Food and Drug Administration will start approving a controversial class of fertility treatments, marking the federal government's first significant move into regulating that field. Before, FDA oversight was limited to fertility doctors' use of drugs and medical devices. The FDA now requires fertility doctors fill out an investigational new drug application (IND) if they want to experiment with fertility procedures involving the mixing of male and female genetic material that differ from the conventional union of sperm and egg.
Bush launches Medicare reforms, supports competitive device bidding, managed drugs
Unveiling plans for changing Medicare, President Bush Thursday wants to impose competitive bidding for such services as durable medical equipment. Yet, his most attention-getting idea is offering Medicare beneficiaries access to prescription drugs through pharmacy benefit management companies, a move expected to save beneficiaries 15 percent to 25 percent on drug costs, he said. His principles also ask Medicare to make claims-processing contract awards more competitive.
Democrat insists Bush will plunder Medicare trust fund
The Office of Management and Budget told Senate lawmakers Thursday the nation's finances were strong despite a slowing economy. However, Senate Budget Committee Chairman, Kent Conrad (D-ND), said recent reports show the Bush administration will spend all of the Medicare trust fund on other programs. OMB Director Mitch Daniels countered, saying congressional spending restraints, along with economy-boosting initiatives such as opening up trade, and regulatory and paperwork reduction would ensure surpluses while paying down the nation's debt.
Roche Diagnostics markets two new hepatitis C tests
Roche Diagnostics Corp., Indianapolis, announced Wednesday the Food and Drug Administration gave marketing approval for two hepatitis C tests designed to detect the hepatitis C virus in patients who have evidence of liver disease. The Amplicor HCV Test and the Cobas Amplicor HCV Test are the first qualitative RNA tests to be approved for marketing by the FDA, stated a company release. "The introduction of the Amplicor HCV Tests to the laboratory setting will help meet the growing demand for reliable, standardized hepatitis C testing and diagnosis -- and when appropriate, for treatment," said Michael Fried, director of clinical hepatology, University of North Carolina at Chapel Hill.
FDA approves 'first' implant for managing heart failure
The Food and Drug Administration approved the InSync cardiac resynchronization system on Wednesday for treating moderate and severe heart failure with left ventricular dysynchrony. "It's a major breakthrough in that it's the first time that a device has
been approved for management of heart failure," said Jay Cohn, a physician and professor of medicine at the University of Minnesota Medical School and former
president of the Heart Failure Society of America. About 5 million people in the United States have the condition, and about 70% of them are 60 or older, according to Medtronic Inc., Minneapolis, the maker of InSync.
JCAHO notified of CJD cases
The Joint Commission on the Accreditation of Healthcare Organizations, Oakbrooke Terrace, IL, has received reports of 14 patients possibly exposed to Creutzfeldt-Jakob disease through brain surgerical instruments. Though CJD is rare, the new incidents signal a need for renewed awareness of preventive measures in healthcare organizations in regards to infection control, stated a JCAHO release. For more information, click here.
Tenet Healthcare reports high earnings
Tenet Healthcare Corp., Santa Barbara, CA, the nation's second-largest hospital chain, had record profits for the fourth quarter that ended May 31. Tenet reported a profit of $116 million, up from $20 million, including one-time gains and charges. Tenet's earnings from operations rose 40.6% to $225 million, starting at $160 million in the 2000 quarter. Net operating revenue for the quarter also rose more than 10% to $3.2 billion from $2.9 billion.
Owens & Minor partners with Broadlane to serve Kaiser Permanente
Owens & Minor, Richmond, VA, has signed a distribution contract with Broadlane Inc., a deliverer of healthcare supply chain services. The agreement until 2007 extends services to one of Broadlane's newest customers, Kaiser Permanente, Oakland, CA.
Westerman, Donatelli up for AHRMM's top-elected position
The Association for Healthcare Resource & Materials Management, Chicago, has released the names of president-elect candidates, one of whom will be elected Oct. 11. Marc Westerman, CMRP, FAHRMM, is administrative director of materials management for Orlando Regional Healthcare System, Orlando, FL. He is also a Region 4 board representative for the association. Dee Donatelli, CMRP, is a senior manager for Cap Gemini Ernst & Young US LLC, Newton, KS. Donatelli is also an at-large board member of AHRMM. The elected candidate will serve as president-elect for one year, followed by president and past-president for one year each.
FDA approves the Wand Plus for podiatry, colorectal surgery
Milestone Scientific Inc., Livingston, NJ, announced Tuesday the Food and Drug Administration approved for marketing the Wand Plus computer-controlled anesthetic delivery system for medical procedures. Possible uses include the injection of lidocaine subcutaneously or intramuscularly for infiltration and nerve block. "The clearance of the Wand Plus for medical use is extremely exciting and will pave the way for our launch into this significant market. The timing is outstanding, as it comes on the heels of favorable clinical studies in podiatry and colorectal surgery," said Stuart Wildhorn, Milestone's marketing director.
Guidant begins marketing stent for small coronary arteries
Guidant Corp., Indianapolis, has received Food and Drug Administration approval of the first stent available in the United States designed for small coronary arteries in patients with abrupt or threatened abrupt closure due to unsuccessful interventional therapy, according to a company release Tuesday. The Multi-link Pixel fits with Guidant's strategy of augmenting an existing line of broad use coronary stent systems with lesion-specific stents designed for particular types of coronary artery disease.
CA Blue Cross to award docs for quality patient care
Blue Cross of California will replace the insurers' program of giving bonuses to doctors who control costs with "linking bonus payments directly to patient satisfaction," the Los Angeles Times reported. Under the new system, physician groups that participate in Blue Cross' HMO network may receive up to a 10-percent bonus on quarterly capitation payments by meeting certain quality of care issues. Blue Cross of California is a unit of WellPoint Health Networks.
Bush pushes Congress to move on patients' rights
President Bush challenged Congress on Tuesday, telling lawmakers to deliver "reasonable" patients' rights legislation to sign before the August recess. "We've got the makings for a good bill, and Congress ought to act," said Bush, who criticized the Democrat-approved bill in the Senate for rights it would give patients to sue their health plans. The House bill Bush supports, sponsored by Rep. Ernie Fletcher (R-KY), would place more limits on patients' ability to sue and would cap pain and suffering damage awards in federal court at $500,000, according to published reports.
Ascension's PIP marketed in Europe
Ascension Orthopedics Inc., Austin, TX, has received CE Mark approval in the European common market for its second PyroCarbon implant product -- the Ascension PIP. The device is designed to replace the proximal interphalangeal (PIP) joint of the hand, and it is produced in four interchangeable sizes. "This regulatory approval once again confirms Ascension's revolutionary technology and will allow us to provide another solution to hand surgeons dealing with patients with debilitating arthritis," said Jerry Klawitter, president and CEO of Ascension.
California patients with Sulzer's implants may undergo surgery
Eighteen Sacramento-area patients face the possibility of corrective surgery to replace hip implants recalled in December by a Texas medical technology company. The patients were among thousands who received hip implants that were recalled by Austin-based Sulzer Orthopedics, leading to more than 800 lawsuits nationwide, including a class-action suit in San Francisco, reported the Modesto Bee in California.
FDA accepts coated BiodivYsio stent
Biocompatibles International, London, recently announced the Food and Drug Administration has approved the company's BiodivYsio added support coronary stent, a device designed to inhibit thrombosis and other complications. The phosphorylcholine coating is designed to mimic the outside surface of the natural cell membrane of the red blood cell, in an effort to reduce the body's response to implanted devices, the company stated.
Neoforma.com asks for new stock arrangement, name change
Company officials at Neoforma.com want shareholders to OK a reverse stock split that could create one new share for every 10 current shares. After reaching a high of nearly $80 a share in March 2000, Neoforma's stock has been trading near the $1 mark for several months and for less than 90 cents a share since May 15. Also, the e-commerce company wants to eliminate the dot-com from its name to reflect its status as a private online marketplace for its customers. Neoforma, San Jose, CA, operates the Internet marketplace for Novation, the joint supply company of VHA and University HealthSystem Consortium, reported Modern Healthcare.
AHA begins recruiting workers to healthcare profession
Several healthcare providers and organizations are planning an ad campaign that focuses on the shortage of healthcare workers. Sponsored by the American Hospital Association, the summer campaign highlights a Fitch report that describes the shortage as "The most significant problem facing the industry today." The Coalition to Protect America's Health Care will begin its ad campaign after the congressional Labor Day recess. For more, go to www.aha.org/workforce/index.asp.
FDA certifies nerve restoration implant
Integra LifeSciences, Plainsboro, NJ, received the Food and Drug Administration's approval to market the NeuraGen nerve guide, an absorbable implant for repairing severed peripheral nerves in the extremities. "Although the axons of severed peripheral nerves regenerate spontaneously, they will not establish functional connections unless the nerve stumps are surgically reconnected," said Simon Archibald, Integra NeuroSciences' vice president of research and development. "The NeuraGen nerve guide offers a rapid method for rejoining severed peripheral nerves, in contrast to conventional microsurgical techniques."
Legislation cuts time to receive ALS Medicare coverage
Legislation to eliminate the 24-month wait for Medicare coverage of amyotrophic lateral sclerosis (ALS), commonly known as Lou Gehrig's disease, recently became effective. The new waiting period is five months. "This new law will help ease the financial burden of ALS and improve the lives of thousands of patients and families struggling with this devastating disease," said Rep. Lois Capps (D-CA), who authored the bill.
HHS schedules patient study of anesthesia nurse issue
The Department of Health and Human Services Friday ordered a test for conducting patient safety outcomes when anesthesia nurses are supervised by physicians. During the Clinton Administration, that requirement was discontinued. HHS will accept public comments on the rule until Sept. 4 and is expected to release its final rule by mid-November.
HHS issues first HIPAA guidance
he Department of Health and Human Services released its first guidance Friday on implementing the Health Insurance Portability and Accountability Act, titled "Standards for Privacy of Individually Identifiable Health Information." The document provides advice on complying with HIPAA's privacy provisions on the minimum necessary use and disclosure of information. Other sections cover oral communications, business associate agreements, regulations regarding minors, communications and government access to health information. HHS plans to release more materials to help healthcare providers comply with the regulations, which are effective April 2003. For more, go to www.hhs.gov/ocr/hipaa.
FDA charges CT facilities with performing unnecessary scans
Food and Drug Administration officials believe that a growing popularity of full-body scans for early health screening might be exposing thousands to potentially dangerous radiation. Clinics offering heavily-advertised computed tomography (CT) examinations are sprouting nationwide and promise customers early warnings of cancers, heart problems and other diseases, but the clinics are giving healthy consumers higher-than-conventional doses of radiation, according to the FDA.
Cardiac marker test Troponin ready for European market
World Diagnostics Inc., Miami Lakes, FL, has received approval from the European equivalent of the Food and Drug Administration - the CE Mark - to sell its Tropnin test, a cardiac marker for early warning heart attack detection. A study at St. George's University and Medical School, London, showed more than 90% correlation of WDI's results to Roche, Dade and Spectrol, the market's leaders, according to a company statement, adding the WDI brand is offered at less than half the competitions' prices.
Israel's FDA-approved Handmaster treats muscles
The Food and Drug Administration has given commercial clearance to neuromuscular electrical stimulation systems, Ra'anana Israel, for marketing its Handmaster in the United States by 2002. The device, which fits over the hand and forearm like a wrist splint, delivers low-level electric shocks that stimulate muscles to perform basic tasks, alleviating some of the physical disability caused by paralysis, the company said.
Doctors want bargaining power, but managed care execs charge antitrust
The American Medical Association has reported that while doctors want more clout to bargain collectively when facing reduced fees and rising costs, officials at large health plans strongly oppose antitrust exemptions, warning that doctors' fees would rise dramatically. The study, written at the Boston University School of Public Health, was designed to examine the impact of antitrust legislation on the balance of power between physicians and managed care plans.
Guidant awarded $140 million from St. Jude Medical
An Indiana jury has awarded $140 million in damages to Guidant Corp., Indianapolis, in a lawsuit concerning unwillful patent infringement with St. Jude Medical, St. Paul, MN, for an implantable cardioverter defibrillator. Michael J. Coyle, St. Jude's divisional president, said the company will ask the judge to set aside the verdict or reduce the damage award. Guidant had sought damages of $313 million.
Theratrx's TMx-2000 released in U.S. market
The Food and Drug Administration has approved a transurethral microwave thermotherapy system made by Theratrx Inc, Chicago, for treating benign prostate hyperplasia, or enlarged prostate, the company announced this week. The TMx-2000 system uses heat generated by microwave to treat patients suffering from BPH, a noncancerous growth of the prostate tissue that obstructs bladder function.
AMA hopes mechanical heart will lead development
Surgeons from the University of Louisville, KY, have implanted a self-contained, mechanical heart replacement in an experimental operation. Surgeons expect the implants, considered a technological leap forward, will extend the patients' life only a month or so. Experts hope the heart, made by Abiomed Inc., Danvers, MA, will lead to new hope for patients with failing hearts. "I think it's potentially a major step forward in the artificial heart development," said David Faxon, M.D., president of the American Heart Association.
FDA grants commercial status for needle-free system
Equidyne Corp., San Diego, announced Tuesday it received approval from the Food and Drug Administration for its Injex single-use, needle-free drug delivery system. The disposable item integrates a jet injection device and disposable ampule for added convenience and ease of use, according to a company statement.
FzioMed's adhesion barriers sold in Europe
FzioMed Inc., San Luis Obispo, CA, stated Tuesday it has been awarded the CE Mark certification in Europe for its Oxiplex adhesion barrier technology for use in spine, abdominal and pelvic surgery. Oxiplex gel and Oxiplex film are bio-absorbable adhesion barriers applied during surgery to reduce post-operative internal scarring. Post-surgical adhesions are a leading complication of many surgical procedures, said a company release.
FDA approves addition to arthroscopic system
HydroCision Inc., Andover, MA, announced this week the Food and Drug Administration has granted 510(k) clearance for their arthroscopic bone burr. The burr represents an additional component to the previously approved ArthroJet soft tissue-cutting tools that make up HydroCision's breakthrough arthroscopic system, according to the company.
Medicare expands preventive services
Medicare beneficiaries can now receive expanded coverage for screening for breast, cervical and colorectal cancers, the Centers for Medicare and Medicaid Services said this week. In addition, starting Jan. 1 Medicare will cover an annual glaucoma screening test and medical nutrition therapy for people with diabetes and renal disease. The extended coverage results from the Beneficiary Improvements and Protections Act of 2000. For more, go to www.medicare.gov.
HHS pays out benefits for surgical urinary incontinence treatment
Health and Human Services Secretary Tommy Thompson recently announced that Medicare will cover a surgical treatment known as sacral nerve stimulation for urinary incontinence and other voiding difficulties. "This coverage decision emphasizes our commitment to making the best in proven new technologies available to Medicare beneficiaries," Thompson said. Urinary incontinence affects about 13 million adults in the United States, with nearly half of nursing home residents having some degree of incontinence, according to a HHS release.
PowerLink Suprarenal system gets FDA's acceptance for trials
Endologix Inc, Irvine, CA, stated this week it received approval by the Food and Drug Administration to begin a second phase of clinical trials for the PowerLink Suprarenal system for treating abdominal aortic aneurysms. The Suprarenal System is an endoluminal covered stent, with a single uncovered segment that simultaneously excludes blood flow to the weakened wall of the aorta, while the uncovered segment permits continuous blood flow to the arteries that perfuse the kidneys, according to a company release.
House GOP patients' rights bill will differ from Senate's version
House Republicans believe the patients' rights bill passed Friday in the Senate will fail in their assembly. Speaker Dennis Hastert (R-IL) said Sunday he and other Republicans will not block a vote on a House bill similar to the Senate's, but added a GOP "will be much more balanced." The Senate version, approved 59-36 with nine Republicans in support, would increase the number of Americans without health insurance coverage because employers might drop for fear of lawsuits over medical decisions, Hastert contended.
FDA approves further testing of CorCap cardiac support tool
The Food and Drug Administration will allow Acorn Cardiovascular Inc., St. Paul, MN, to move ahead with clinical trials of a jacket device that is implanted around diseased hearts to treat heart failure. The study evaluating the CorCap cardiac support device now can be expanded from six to 20 centers under the investigational device exemption. The trials will test the safety and efficacy of the CorCap CSD in stabilizing or reducing heart size and improving cardiac function in patients with heart failure.
C.R. Bard's ablation catheter is market ready
C. R. Bard Inc., Murray Hill, NJ, announced Friday it received Food and Drug Administration approval to sell the Stinger S ablation catheter for treating cardiac arrhythmias. The new catheter offers a firmer distal tip than the standard Stinger ablation catheter, resulting in greater column strength and catheter tissue contact, according to a company release.
FDA accepts Florence Medical's blood flow data equipment
The Food and Drug Administration has given commercial clearance to Florence Medical Inc., Wellesley, MA, to market its SmartFlow device for real-time blood flow information during cardiac catheterization procedures. The system uses computational fluid dynamics to calculate coronary flow reserve and fractional flow reserve from intravascular pressure advanced cardiac systems for analysis of intravascular flow.
Scully: Let CMS choose best-qualified fiscal intermediaries
The Centers for Medicare and Medicaid Services could improve its selection of fiscal intermediaries by paring down the pool to 18 of the best based on performance, instead of giving hospitals that responsibility, said the center's administrator, Tom Scully. In a recent address before a House panel, he also expected the change to be phased in over a number of years, and that he plans to begin Medicare contractor demonstration programs this fall.
Humana agrees to settle in Florida Medicaid case
Humana, Louisville, KY, will pay an $8 million settlement to end allegations that it illegally received double monthly payments for patients enrolled in both Medicare and the Florida Medicaid program. The company stated the incidences stem from its 1997 acquisition of the Physician Corporation of America Plan, reported Modern Healthcare.
FDA told to increase blood donation restrictions
The Food and Drug Administration may soon ban blood donations from people who have spent 5 years or more in Europe from 1980 to the present, due to the possible risk of variant Creutzfeldt Jakob disease. Expert advisors to the FDA recently voted 10 to 7 to endorse expanding the agency's current policy of deferring donors who spent 6 months or more in the United Kingdom to include the entire European continent.