News briefs

New Safety IV catheter meets NIOSH and OSHA directives

B. Braun Medical’s new Introcan Safety IV product has a safety clip covering the needletip that activates automatically when the needle bevel exits the catheter hub. The manufacturer says the product could eliminate nearly 50,000 of the most dangerous accidental needlestick injuries faced by health care workers each year — those from hollow-bore IV needles that could be filled with blood containing infectious agents like HIV or hepatitis B and C.

Dan Rice, vice president of marketing at B. Braun, says, "The key to designing safety devices is engineering a product that requires no change in technique, something that nurses and doctors do not have to think twice about. When health care workers use the Introcan product, safety is automatic." Rice adds that several prestigious teaching hospitals and medical centers have already converted to the Introcan Safety IV product.

Health care workers sustain between 600,000 and 800,000 accidental needlestick each year in the United States. According to a 1997 study, injuries from IV catheter stylets rank first in the "blood-filled needles" category, those that have a high risk of carrying bloodborne pathogens, despite the fact that they comprise only 6% of the total number of injuries.

On Nov. 22, 1999, the Center for Disease Control and Prevention’s National Institute for Occupational Health and Safety issued a safety alert urging hospitals to adopt needlestick-safety devices. Two weeks earlier, the Occupational Safety and Health Administration issued a directive that emphasized the "use of effective engineering controls, to include safer medical devices." The Senate (S.1140) and House (H.R. 1899) introduced the Health Care Worker Needlestick Prevention Act during 1999. In addition, four states (California, Tennessee, Maryland, and Texas) have enacted legislation on needlestick prevention and health care worker protection. Sixteen more states introduced bills in 1999.


ECRI topics for 2000 telephone seminar series

The Emergency Care Research Institute (ECRI) topics for interactive telephone seminars to be held during 2000 include "Revisiting the Reuse of Single-Use Products" on May 17, 2000; "Don’t Get Stuck with a Poor Needlestick-Prevention Policy" on July 19, 2000; and "Protecting the Privacy, Confidentiality, and Security of Electronic Medical Records" on Oct. 18, 2000.

Pamela Keating, ECRI’s director for educational programs, says, "These seminars will focus on some of the most important topics of 2000. FDA is scrutinizing reuse, many states are passing legislation concerning needlestick-prevention devices, and those close to the issue believe that handling the Health Insurance Portability and Accountability Act may be even more of a challenge than preparing for Y2K."

ECRI’s telephone seminars are similar to a call-in radio show. Participants listen to speakers on the topic then have a chance to call in during a question and answer period. All seminars are held from 1 p.m. to 2:15 p.m., EST. The registration fee, which includes participation for an entire site on one phone line, for each seminar is $199. However, ECRI is a nonprofit international health services research agency and a collaborating center of the World Health Organization.

ECRI provides information and technical assistance to the health care community to support safe and cost-effective patient care. The results of ECRI’s research and experience are available through its publications, information systems, technical assistance, laboratory services, professional seminars, conferences, and fellowships. For more information on or to register for ECRI’s Interactive Telephone Seminar Series for 2000, please contact ECRI at 5200 Butler Pike, Plymouth Meeting, PA 19462-1298. Telephone: (610) 825-6000, ext. 5888. Fax: (610) 834-1275. E-mail: info@ecri.org.


Injex needle-free use for outpatient therapy

Rosch AG Medizintechnik, a partially owned subsidiary of Equidyne Corp., has signed a contract with Acanthos GmbH for outpatient cancer therapy using the Injex needle-free injection system, which allows treatment to be administered on an outpatient basis. The Injex needle-free injector, the company says, is a compact, uncomplicated device that delivers a painless injection through the skin in a fraction of a second, and eliminates needlestick and disposal problems. For more information contact Equidyne at (603) 880-6300.


New hemodialysis access system

Creating and maintaining safe and effective vascular access is one of the most challenging and expensive components of dialysis. Dialysis-access placement, repair, and morbidity consumes over $7.5 billion worldwide each year. Vasca Inc. has submitted its 510(k) premarket notification with the Food and Drug Administration (FDA) for LifeSite Hemodialysis Access System. The FDA granted an expedited review status that is given when a device offers the potential for clinically meaningful benefit as compared to existing alternatives or when a new medical device promises to provide a revolutionary advance over currently available alternative modalities.

According to the manufacturer, the LifeSite System is the first major advance in dialysis treatment in nearly a decade and provides an alternative for vascular access in patients undergoing dialysis treatment. The device is implanted subcutaneously and can be accessed via a buttonhole technique by inserting a standard dialysis needle. The LifeSite System is designed to provide high flow rates, reduce the risk of infection, is unobtrusive, and can be used immediately following implantation. For more information, call (978) 863-4400.


Infu-Tech launches pain management on-line

Infu-Tech has signed an agreement with four leading pain management clinics in the Northeast to sell pain management products through the company’s Web site, www.Smartmeds. com. Patients from those clinics will be able to obtain information and educational materials on pain management, and can communicate with Smartmeds.com’s clinicians. They will also have the ability to follow their treatment schedules on Smartmeds’ personal health calendar. The site will be used by physicians to order pain management medications and other pharmaceutical supplies, thereby reducing costs and increasing efficiencies.

Infu-Tech provides specialty pharmaceutical and medical services to patients in their homes, ambulatory infusion sites and in long-term care facilities. With more than 15 years of clinical experience and managed care relationships with enrollees of more than 70 HMO’s, large employer groups, Medicare and Medicaid, Infu-Tech has earned a reputation for patient satisfaction and clinically proven success in delivering high levels of service to special need patients and is accredited by the Joint Commission on Accreditation of Health Care Organizations.


Nasal spray reduces pediatric anxiety

A nasal spray that contains a drug similar to Valium reduced anxiety in children undergoing painful cancer treatments in a recent study of 43 cancer-stricken Swedish children. Researchers found that subjects given midazolam in a nasal spray prior to having a needle inserted into them for intravenous treatments were calmer and more comfortable than children given a placebo.

Although the drug was tested only on children with cancer, researchers said it could be used to ease anxiety in youngsters facing infusions and procedures for other medical problems. Gustaf Ljungman, MD, lead author of the study, says, "It’s interesting for children who are very much afraid, where you otherwise would have to hold them down to carry through the procedure or immunization."

The study was published in the January issue of the journal Pediatrics. Ljungman is a pediatric cancer specialist at Uppsala University Children’s Hospital in Sweden. In the study, the spray or a placebo was given before a needle was inserted in an intravenous port, an opening left in cancer patients to avoid having to insert an IV each time doctors need to administer a drug. The main drawback to the spray seems to be that some children experience a burning sensation. The study also noted that midazolam only reduced the children’s anxiety and not the pain associated with the treatment itself.


New peripheral access system

SIMS Deltec Inc. has a new peripherally inserted central venous access system for delivery of chemotherapeutic drugs, antibiotics, pain medications, nutritional solutions, and other intravenous therapies. The P.A.S. PORT(R) Elite implantable access system is a small, low-profile portal designed for comfortable arm placement. The portal consists of a lightweight plastic exterior for patient comfort and a titanium interior floor for gouge-resistance and long-term durability. The system can be implanted in an outpatient procedure room, thereby eliminating inpatient and operating room charges. The new P.A.S. PORT(R) Elite system expands the peripheral product line available from Deltec, which includes the P.A.S. PORT(R) and P.A.S. PORT(R) T2 systems. For additional information, visit Deltec’s Web site at www.deltec.com., or call Sandra Lochen Puckett, product manager, at (651) 628-7185.


Bioject and Serono team deliver needle-free therapy

Bioject Medical Technologies, Portland, OR-based developer and manufacturer of jet injection systems for needle-free drug delivery, and the Geneva -based Serono Laboratories, have agreed to deliver Serono’s Saizen recombinant human growth hormone with a customized version of Bioject’s Vitajet 3 needle-free delivery system. The exclusive licensing agreement begins when the drug receives FDA clearance.

Patients in clinical studies evaluating the bioequivalence of Saizen when delivered with the Bioject needle-free delivery system preferred the needle-free delivery system to traditional syringes. They also indicated that the needle-free device was less painful. The Bioject device will be adapted for use in the pediatric growth market, and will be sold under the Serono brand.

Bioject’s president and CEO Jim O’Shea says, "Bioject is committed to improving patients’ lives through strategic partnerships with pharmaceutical and biotechnology companies. We have made great progress over the last year in executing our strategy. Our partners now include AngioSense, Serono, and, in a preliminary agreement, another undisclosed major biotechnology company."

Serono Laboratories is the U.S. affiliate of Ares-Serono, S.A., a biotechnology company active in growth and metabolism products headquartered in Geneva. Bioject currently markets two FDA-cleared needle-free injection systems, the Biojector 2000 and the Vitajet 3 that have already received FDA approval, and is developing a third, the Iject. A copy of the package insert for Saizen somatropin (rDNA origin) for injection, is available from Serono’s Product Information and Surveillance Group (888) 275-7376. For further information on Bioject, contact Bioject Medical Technologies at (503) 639-7221.


GWU: IPS decreasing HH access

Sixty-eight percent of all hospital discharge planners surveyed by George Washington University researchers reported increased difficulty in initially obtaining home health services for Medicare patients since the implementation of the interim payment system (IPS).

In addition, respondents to the GWU Center for Health Services Research & Policy survey show that only 22% of them reported no change in difficulty finding home health services for their Medicare patients.

The latest findings of the study were included in the second phase of the two-part study that is measuring the impact of payment changes mandated by the Balanced Budget Act of 1997.

Home health industry advocates said the results were further evidence that Medicare patients have decreased access to home health services for the sickest patients. The study’s authors shared their opinion.

"There is compelling evidence of differential treatment of sicker beneficiaries in response to financial incentives of IPS that suggest problems with access to and quality of home care services for this population, the study concluded. "These findings raise significant policy questions that should be addressed in evaluating IPS and any other payment system that may be developed."