Background on the Design of the Perifix

In the Labor & Delivery suite, one of the needlestick risks faced by the anesthesia provider involves the procedural needle used for giving epidural anesthesia.

Unlike ordinary hypodermic needles, the epidural needle has a unique shape designed to facilitate locating the epidural space and introducing a thin, plastic catheter tube to deliver

anesthetics that relieve labor pain. It is important to keep in mind that the anesthesia provider cannot see the tip of the epidural needle as it is directed towards the central nervous system of the patient. The anesthesia provider has to rely on the tactile sensations or “feel” transmitted back through the special needle as it is slowly advanced through tissue in your lower back to the epidural space target. Over a period of time, anesthesia providers develop an intimate “feel” for their particular epidural procedural needle.

Thus, manufacturers face a challenge of how to design needlestick safety into this procedural needle without disturbing the acquired “feel”.

B. Braun Medical Inc. is a global market leader in regional anesthesia trays and devices. Here in the U.S., they supply over 50% of the epidural trays used by hospitals [IMS Data, 2002].

“We realized early in the design process that hinged needle guards and sliding protective sleeves wouldn’t work for the epidural needle,” says Brad Lane, Director Pain Control for B. Braun Medical Inc. “These types of safety attachments were too bulky to add to the epidural needle. They would definitely interfere with the anesthesia providers’ finger placement and inhibit the critical sensations they perceive through the needle.”

To solve the problem B. Braun looked inward to the effectiveness of the safety clip design concept used by the highly successful Introcan® Safety™ IV Catheter. The Introcan® Safety™ IV Catheter safety clip resides in the hub of the IV catheter.It automatically covers the tip of the IV catheter stylet sharp hazard as the nurse or physician removes the stylet from the IV catheter. The end-user is not required to change his/her technique while using its passive safety design.

“Although the needle is larger, the safety clip concept easily transferred to the epidural needle,” says Lane. “We placed the safety clip back by the hub of the epidural needle within a small, unobtrusive deployment shroud. Otherwise, the needle design is essentially the same so that we achieve our goal of preserving the critical ‘feel’ of the needle.”

When the anesthesia provider has completed their epidural procedure, the needle is withdrawn from the patient’s back. At this point, the anesthesia provider advances the deployment shroud containing the safety clip towards the tip of the epidural needle. The clip engages over the tip of the epidural needle and locks into place neutralizing the sharps hazard. Then the entire assembly is disposed of in a nearby sharps container.

“The Perifix Safety Epidural Needle will be a key component in our forthcoming line of safety regional anesthesia trays,” Lane continued. “We anticipate launching these products here in the Perifix in Safety Activated Mode U.S. in the second quarter of 2003. Providing these trays and devices will help B. Braun address the risk concerns faced by hospitals as they strive to have their anesthesia departments comply with the 2000 Needlestick Safety and Prevention Act [H.R. 5178], new JCAHO accreditation standards, and local healthcare worker safety legislation.”

Perifix® Safety Epidural Needle