Efficacy of a Novel Intraoperative Engineered Sharps Injury Prevention Device: Pilot Usability and Efficacy Trial

Abstract

Background The American College of Surgeons reports 88,320 intraoperative needlestick injuries (NSIs) per year, resulting in US $376 to US $2456 in costs per NSI. Engineered sharps injury prevention (ESIP) devices protect against NSIs. To our knowledge, no study has been published to date to demonstrate clinical effectiveness of an intraoperative ESIP device. Operative Armour is a wearable arm cuff that can be donned during surgical closure to allow surgeons to keep a suture pack and sharps protection container on their forearm. Objective We characterize Operative Armour’s ESIP device effectiveness in a tertiary hospital, hypothesizing that this device will decrease NSI risk by decreasing behaviors associated with NSIs: needle passing and handling. Methods A prospective case-control study was conducted with institutional review board quality improvement designation in which authors observed skin closures of plastic surgery procedures. To ensure accuracy, one surgeon was observed at a time. Control surgeries were purely observational; intervention cases involved surgeon use of the device during skin closure. Outcomes of interest included needle passing, needle handling, lost needles, and loaded waiting needles. Results Surgeons were observed in 50 control and 50 intervention cases. Operative Armour eliminated needle passing during skin closure. One NSI occurred in one control case; no NSIs were observed in intervention cases (P=.36). The mean number of loaded and unprotected waiting needles was also significantly decreased in the intervention group from 2.3 to 0.2 (P<.001). Furthermore, a multivariable linear regression established that Operative Armour significantly decreased the number of needle adjustments by hand per stitch observed (F4, 21.68=3.72; P=.01). In fact, needle adjustments by hand decreased overall (1 adjustment per 10 stitches vs 1 adjustment per 5 stitches, P=.004), and adjustments occurred half as frequently with use of Operative Armour in free flap reconstruction (1 adjustment per 10 stitches vs 1 adjustment per 5 stitches, P=.03) and a quarter as frequently in other breast reconstruction cases such as mastopexy (1 adjustment per 20 stitches vs 1 adjustment per 5 stitches, P=.002). Conclusions Operative Armour effectively functions as an ESIP device by decreasing intraoperative needle passing and handling. Although sample size prohibits demonstrating a decrease in NSIs during observed cases, by decreasing behaviors that drive NSI risk, we anticipate an associated decrease in NSIs with use of the device.

Preventing Perioperative Sharps Injuries

“…15 Use of innovative safety technology (eg, wearable arm cuff) that allows the surgeon to load a suture needle and return it to a storage container on the cuff can reduce needlestick injuries. 20 Surgeons and perioperative personnel may not support use of sharps safety-engineered controls. However, they should use the available safety-engineered controls when hazards cannot be eliminated or substituted.…”

“…Current sharps safety–engineered controls for use during perioperative procedures include a wearable cuff for suture needles, 20 blunt suture needles, 15 and safety covers for hypodermic needles 15 . Use of innovative safety technology (eg, wearable arm cuff) that allows the surgeon to load a suture needle and return it to a storage container on the cuff can reduce needlestick injuries 20 . Surgeons and perioperative personnel may not support use of sharps safety–engineered controls.…”

“…The OSHA recommendation 13 to use safety‐engineered sharps coincides with the third level of the hierarchy of controls—using engineering controls to isolate personnel from a hazard 14 . Current sharps safety–engineered controls for use during perioperative procedures include a wearable cuff for suture needles, 20 blunt suture needles, 15 and safety covers for hypodermic needles 15 . Use of innovative safety technology (eg, wearable arm cuff) that allows the surgeon to load a suture needle and return it to a storage container on the cuff can reduce needlestick injuries 20 .…”