Business Wire - October 15, 2002
Doctors and nurses who secure catheters with suture needles are unnecessarily exposed to potentially deadly viruses such as Hepatitis C and HIV, the documents state. Venetec's letter pointed to the widespread availability of safer alternatives, in the form of sutureless catheter-securement devices such as StatLock, which are proven to completely eliminate the risk of an accidental needlestick and subsequent infection.
Last year, the Service Employees International Union (SEIU) and Public Citizen's Health Research Group (HRG) petitioned the FDA to ban certain medical devices, including intravenous catheters and related infusion equipment that does not use needleless technology or recessed needles.
The FDA subsequently requested public comment on the SEIU/HRG petition, including suggestions for any additional actions the agency should take to protect healthcare workers from needlestick injuries. The comments from Venetec's medical director and CEO Steve Bierman, M.D., came in response to the FDA request.
An estimated 800,000 American doctors and nurses suffer needlesticks and other medical-sharps injuries each year, meaning they face a high risk of infection and disease.
Suture needles are often used to secure short central-venous catheters and peripherally inserted central catheters, which are used to administer antibiotics and other kinds of critical-care IV therapy. Citing well-documented industry research, Dr. Bierman's letter notes there are at least 5 million central-venous catheters placed in the U.S. each year.
Two recently published studies document a 2% needlestick rate among clinicians who secure catheters with suture -- meaning clinicians suffer an estimated 500,000 suture-securement-related needlesticks per year, most of them not reported. When a catheter-securement device is used instead, this needlestick risk drops to zero and is completely eliminated.
"In earlier days, there was no other method than suture to secure central venous catheters. Today, strong data affirm the safety and efficacy of sutureless securement devices. Renowned medical experts advocate these devices, and state-of-the-art hospitals are requiring sutureless securement devices. It's time for the FDA to ban suture for securing catheters, and protect doctors and nurses from the silent epidemic of suture needlesticks," said Dr. Bierman.
Venetec's request notes several other reasons for the FDA ban on suture securement:
1. Clinicians have used suture in the past only by default, in the absence of a proven alternative technology.
2. A proven alternative now exists, in the form of sutureless securement devices -- needleless devices that are also sometimes called adhesive anchors. Several published, peer-reviewed studies document the ability of a sutureless catheter-securement device (StatLock, Venetec International, San Diego, Calif.) to eliminate suture-related needlesticks during catheter securement. The studies have consistently concluded StatLock also results in fewer total complications for patients.
Recent guidelines from the Centers For Disease Control and Prevention conclude: "Sutureless securement devices can be advantageous over suture in preventing catheter-related bloodstream infections." These infections are especially dangerous, killing an estimated 12 percent to 25 percent of patients who contract them.
3. Sutureless securement devices comply with the federal Needlestick Safety and Prevention Act, as well as regulations issued by the Occupational Safety and Health Administration. The OSHA Compliance Directive states: "Where engineering controls (i.e. products) will reduce employee exposure either by removing, eliminating or isolating the hazard, they must be used."
4. Sutureless securement devices have been specifically recognized by the congressional authors of the Needlestick Safety and Prevention Act.
5. These needleless securement devices are widely available and used in hundreds of U.S. healthcare institutions.
6. The FDA has legal authority to ban a device if it presents "an unreasonable and substantial risk of illness or injury." Said Dr. Bierman, "That description clearly applies to suture and suture needles used for securement, in view of the new clinical research and published studies."
Dr. Bierman's letter to the FDA asserts the ban should apply in all instances accept medical emergencies, where temporary, short-term use of suture may be appropriate.
The FDA is expected to rule in the coming months on Venetec's request and the initial proposal from SEIU and HRG.
About Venetec International: The world leader in safety securement devices, Venetec International manufactures and markets StatLock, which replaces tape and suture to secure virtually all kinds of catheters and medical tubes. The custom-designed, adhesive-backed pad has an integrated, precision-molded anchor for connecting the pad to the catheter assembly.
Venetec International holds an intellectual property portfolio of more than 50 patents and has nearly as many patents-pending. The company has agreements with many healthcare organizations, including Premier, Inc. and the Veterans Health Administration.
StatLock devices are included in the catheter systems of B. Braun, Baxter Healthcare, BD (Becton Dickinson), C.R. Bard, Cook, Inc., Kendall/Tyco, Arrow International, Medical Components, Inc. (Medcomp), HDC Corp., SIMS Deltec, Inc., and others. StatLock is used in hundreds of healthcare facilities, including Memorial Sloan-Kettering Cancer Center, Beth Israel Deaconess Medical Center, and the Cleveland Clinic. For more information, call (800) 833-3895 or access www.StatLock.com.
CONTACT: Dowling & Dennis Public Relations
Liz Dowling, 760/942-2544
LizDowling@aol.com
SOURCE: Venetec International
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