Closure Overview

There are approximately 40M open surgeries per year in the U.S. The vast majority of the incisions are closed with an interrupted stitch technique where each stitch is independently knotted, as opposed to a running suturing technique that uses a single uninterrupted suture for all stitches. Sutures are dispensed from off-the-shelf sterilized suture packs and are typically pre-attached to suture needles. Sutures used for interrupted stitching are either “swaged-on” sutures (permanently attached to the needle and cut between stitches), or “pop-off” sutures that can be released from their needles without cutting. When using pop-off sutures, the interrupted stitch technique employs a new suture and needle for each stitch; when the stitch is made, a knot is tied and the needle is “popped off” the suture with a tug by the surgeon, who then exchanges the contaminated needle for a new needle and suture. The number of stitches required to close an incision varies from five to several hundred, with an average number estimated to be about twenty-five. This implies that on an annual basis up to 800M needles are used and must be accounted for in the U.S. alone.

Workflow and Safety Challenges

An OR scrub tech is traditionally responsible for pre-loading suture needles into needle drivers and then presenting the needle driver to the surgeon on demand. After each needle has been used, the surgeon passes the contaminated needle (in the driver) back to the scrub tech. Passing each needle back and forth is inherently inefficient – two people are required to do a single person’s job. This process also introduces several other problems:

  • Passing contaminated needles to the scrub tech introduces a needle stick safety hazard of potential high severity; in fact, the problem is so significant that in the year 2000 the U.S. Congress passed the Needle Stick Prevention Act requiring that all labs and Hospitals develop a plan to minimize exposure to bloodborne pathogens and to evaluate any new technology developed to further that goal. Hospitals are increasingly focused on the high cost of employee injuries and have implemented extensive injury minimization policies and procedures.
  • A dropped needle must always be found to ensure that it is not retained in the patient. Dropped needles may occur during the needle pass, because the needle driver is not always securely clamped when the surgeon releases it, or may occur as a result of being dislodged when the surgeon returns the needle driver to a designated “safe-zone” on the Mayo stand. The closure is suspended while locating a dropped needle, sometimes requiring that an x-ray machine must be brought into the OR, resulting in significant procedural delays.
  • The scrub tech is simultaneously engaged in other activities during incision closure and is frequently unprepared to present a new pre-loaded needle driver to the surgeon on demand when it is needed. Additional suture packs often need to be retrieved from outside the OR. This results in wasted OR time and stress between the surgeon and scrub tech.
  • The scrub tech is also responsible to account for each needle that is used during the closure to minimize the potential for a retained foreign object. Counting of individual used needles is inherently error prone and requires redundant counting by two persons to ensure an accurate number resulting in wasted OR time.