JMIR Publications

ABSTRACT

Background:

The American College of Surgeons report 88,320 intraoperative needlestick injuries (NSIs) per year, resulting in $376-$2456 in costs per NSI. Engineered sharps injury prevention (ESIP) devices protect against NSIs. To date, no study has been published to demonstrate clinical effectiveness of an intraoperative ESIP device. Operative Armour (OA) is a wearable arm cuff that allows surgeons to keep a suture pack and a sharps protection container on their forearm.

Objective:

Our objectives were to characterize OA’s ESIP 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 IRB 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 OA 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. OA eliminated needle passing during skin closure. Needle adjustments by hand occurred half as frequently with use of OA in free flap reconstruction (1/10 vs. 1/5, P =0.03) and a quarter as frequently in other breast cases such as mastopexy (1/20 vs. 1/5, P =0.002). The mean number of loaded and unprotected waiting needles was also significantly decreased in the intervention group from 2.3 to 0.2 (P =0.001), but the number of lost needles was not significantly different (P =0.18).

Conclusions:

OA 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.