Docket Management
Docket: 01P-0120 - Medical Devices; Needle-Bearing Devices; Request for Comments and Information
Comment Number: EC -22

Accepted - Volume 1

Comment Record
Commentor Dr. Steve Bierman Date/Time 2002-09-18 16:25:00
Organization Venetec International, Inc.
Category Company

Comments for FDA General
Questions
1. General Comments September 18, 2002 Dockets Management Branch [HFA-305] Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, Maryland 20852 RE: Docket No. 01P-0120; Medical Devices; Needle-Bearing Devices; Request for Comments and Information To Whom It May Concern: In response to FDA's request for comments on the above-referenced matter, Venetec International requests that the agency take the following action: BAN THE USE OF SUTURE FOR CATHETER SECUREMENT, EXCEPT IN EMERGENT CIRCUMSTANCES. In support of this request, we offer the following comments: 1. Suture-securement-related needlesticks are potentially fatal for patients and clinicians. The use of suture and a suture needle to secure catheters poses a significant infection risk to both patients and clinicians. In the past, clinicians have used suture by default for securement of certain catheters (usually extended-dwell, central venous/peripherally inserted central catheters). This usage by default has occurred in the absence of a proven alternative modality, despite a growing body of evidence implicating the needlestick danger of securing with suture and suture needles. 2. Clinical Rationale. A proven alternative modality now exists. There are compelling clinical reasons to ban suture securement (except in emergent circumstances where temporary suture securement may be advisable). Peer-reviewed published clinical studies have recently documented the clinical superiority of this alternative modality -- specially designed, sutureless catheter-securement devices, also known as adhesive anchors. These studies (enclosed) include presentations to the National Patient Safety Conference in October 2000, a paper appearing in a joint publication of the National Patient Safety Foundation and Joint Commission on the Accreditation of Healthcare Organizations (Patient Safety Initiatives 2000: Spotlight on Solutions more info at http://listserv.npsf.org/SCRIPTS/WA-NPSF.EXE?A2=ind0009&L=patientsafety-l&F=P&S=&P=3147 )(1) , as well as a study published in the Journal of Vascular and Interventional Radiology http://www.jvir.org/cgi/content/abstract/13/1/77?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=StatLock&searchid=1032303625946_2&stored_search=&FIRSTINDEX=0&volume=13&issue=1&journalcode=jvascir.(2) The latter study found a clinically significant reduction in catheter-related bloodstream infections when a sutureless securement device was used instead of suture to secure peripherally inserted central venous catheters. Studies also have found a sutureless securement device to be an effective device that consistently results in fewer total complications, whose use was preferred by clinicians over suture. These studies were favorably reviewed in a recent issue of Clinical Infectious Diseases http://www.journals.uchicago.edu/CID/journal/issues/v34n10/011259/brief/011259.abstract.html.(3) More importantly, the Centers For Disease Control and Prevention recently concluded after reviewing the studies: Sutureless securement devices can be advantageous over suture in preventing catheter-related BSIs (bloodstream infections), in CDC's newly published Guidelines for the Prevention of Intravascular Catheter-Related Infections (August 2002), http://www.cdc.gov/ncidod/hip/iv/iv.htm.(4) There is substantial clinical value in reducing CRBSIs: According to published research, an estimated 16,000 patients in the U.S. develop such infections each year. These infections kill 12 percent to 25 percent of patients who get them, causing approximately 1,900 deaths to 4,000 deaths each year.(5) 3. Potentially Dangerous Needlesticks Associated with Suture. The same studies (1)have consistently documented a 2% needlestick rate among clinicians securing catheters with suture. The needlestick rate was zero percent among clinicians securing catheters with a sutureless catheter-securement device. There are at least 5 million extended-dwell catheters placed in the U.S. each year, according to carefully researched industry estimates. At a needlestick rate of 2%, the published research indicates clinicians would suffer a minimum of 500,000 suture-securement-related needlesticks per year. This figure is probably much higher, given that CDC, NIOSH and other authorities report needlesticks and other medical-sharps injuries, especially to physicians, are routinely and significantly underreported. 4. Compliance with OSHA Directive and the Needlestick Safety and Prevention Act. Implementing the Needlestick Safety and Prevention Act, OSHA's revised Compliance Directive states: Where engineering controls will reduce employee exposure either by removing, eliminating or isolating the hazard, they must be used. In view of this rigorous standard -- and the availability of a clinically documented engineering control that eliminates suture-related needlestick hazards, there is a clear legal rationale to ban suture for catheter securement, and such a ban would further the aims of the Needlestick Safety and Prevention Act. 5. Legal Recognition of Catheter Securement Devices. OSHA and the congressional authors of the Needlestick Safety and Prevention Act clearly recognized the utility of catheter securement devices in helping clinicians to meet the requirements of the law. The authors' Joint Statement of Legislative Intent on HR 5178 states in part: It is not the intent of this legislation to disturb OSHA's existing determination that to the extent that specific types of devices, such as catheter securement devices or sharps destruction devices can reduce the risk of needlestick injuries, such devices could be appropriate components of an employer's comprehensive exposure plan. 6. Market Availability of a Proven Alternative. The catheter securement devices that were the subject of the above-referenced clinical presentations and published studies (StatLock devices, manufactured by Venetec International) are today part of the standard catheter-securement protocol at hundreds of U.S. medical facilities. These readily available, sterile, sutureless devices range in cost from $2 per unit to $10 per unit, with the average selling price being approximately $5 -- providing a practicable, affordable alternative to suture for catheter securement. StatLock devices are already included in more than 75 percent of trays/kits containing extended-dwell central venous catheters in the U.S. 7. Compliance with Legal Standards for Banning a Device. FDA has substantial reasons to implement the requested ban on suture securement of catheters, as set out in Section 516 of the Act (21 U.S.C. 360f). The agency may ban a device if it presents a substantial deception or an unreasonable and substantial risk of illness or injury. The use of suture for catheter securement presents both an unreasonable and substantial risk of illness or injury. Suture is commonly used, for example, to secure central venous catheters in patients with HIV, Hepatitis C, and other infectious diseases. When securing these catheters with suture and the required suture needles, clinicians face the danger of contracting a potentially fatal disease. Given that this risk drops to zero and is completely eliminated by use of a sutureless securement device, it is unreasonable to continue to ask clinicians to face the needlestick risk associated with suture securement of catheters. Moreover, in view of the documented needlestick rate associated with suture securement, this risk is clearly substantial. Absent such a ban, thousands of patients will continue to endure unnecessary and potentially fatal CRBSIs. Additionally, hundreds of thousands of clinicians will encounter an unreasonable and substantial risk of needlesticks related to suture securement. Thank you for your consideration of this evidence and our request. Please contact me should you have any additional questions or comments regarding this matter. Sincerely yours, STEVE BIERMAN, M.D. Medical Director and CEO Venetec International 12555 High Bluff Drive, #170 San Diego, CA 92130 __________________________________________________________ (1) Patient Safety Initiative 2000: Spotlight on Solutions: Compendium of Successful Practices, Volume 1, Published by the National Patient Safety Foundation and the Joint Commission on Accreditation of Healthcare Organizations. (2) Yamamoto AJ, et al. Sutureless Securement Device Reduces Complications of Peripherally Inserted Central Venous Catheters; Journal of Vascular and Interventional Radiology, Volume 13, Number One, Jan. 2002, pp. 77-81. (3) Crnich CJ, Maki DG, The promise of novel technology for the prevention of intravascular device-related bloodstream infection. II. Long-term devices. Clinical Infectious Diseases. 2002;34:1362-1368 (4) Centers For Disease Control And Prevention, Morbidity and Mortality Weekly Report, Recommendations and Reports, Volume 51, RR-10, August 2002 (5) Mermel LA, Prevention of intravascular catheter-related infections. Ann Intern Med 2000; 132:391-402.




EC -22