Can anyone provide some insight as to whether a Tegaderm dressing is classified as a catheter securement/catheter stabilization?
According to the definition of a catheter stabilization device in the current INS standards of practice, a transparent membrane dressing does not meet that definition. 3M has added some new properties such as the cloth edges that could add to the stability question but there are no published studies supporting this yet, although they are in progress. The definition of a stabilization device is also mingled with the concept of a stabilization platform built onto the catheter (e.g. Nexivia from BD) that would combine with the special dressing to create stability. A traditional TSM dressing without any enhancements and a traditional catheter hub does not provide any level of stabilization, in my opinion and requires the addition of a manufacturered stabilization device. So the actual definition of catheter stabilization may be in flux as new outcome studies with newer products are produced. It is well designed scientific research that we should look to for these answers. Lynn
Lynn Hadaway, M.Ed., RN, BC, CRNI
Lynn Hadaway Associates, Inc.
126 Main Street, PO Box 10
Milner, GA 30257
Office Phone 770-358-7861
The new IV Advanced Securement Dressing from 3M is a securement device. It is recognized as a Class One securement device just like statlock type devices.
The FDA Class 1 is very large, and includes many things. On the 3M Tegaderm FDA 510k #K973036 it describes the class as “intravascular catheter securement devices, wound dressings, and/or protective eye coverings”. StatLock is in the same classification, as are bandages, steri-strips and eye shields for surgical patients.
To get more understanding on this issue I would then reference the INS which states in their newly released 2009 Infusion Nursing: An Evidence Based Approach on pg. 430 ‘there is no evidence that any type of dressing material can adequately stabilize a catheter’. It continues ‘the FDA defines a catheter stabilization device as a device with an adhesive backing that is placed over a needle or catheter and is used to keep the hub of the needle or catheter securely anchored to the skin. By this definition, a manufactured device must have a means to control the movement of the catheter hub rather than focusing solely on the attached administration set’….. ‘These mechanisms include a plastic cage that is snapped around the hub, posts designed to fit through the suture holes on catheter wings, or elastic bands that crisscross over the hub.”