(I-354) Latex Sheaths for Reducing Contamination on Hand-held Surgical Instruments: Pilot Study of Usability

In low and middle-income countries (LMIC), surgical instruments are commonly reused beyond their intended life to deliver patient care [6]. This reuse requires reprocessing, which involves the cleaning and disinfection/sterilization of surgical instruments after each use to render them safe for additional use on subsequent patients. The challenge is that generalized reprocessing procedures are not suitable for all types of surgical instruments. For example, electrosurgical instruments, which convert high frequency electromagnetic energy to thermal energy to alter tissues, house electronics in unsealed compartments in the handle. Therefore, they cannot be submerged in liquid chemical solutions for cleaning or disinfection because it would damage the electronics and adversely impact instrument function. In a previous study, covering the electrosurgical instrument with a latex sheath reduced the likelihood of contamination on the instrument surface under simulated use conditions, which supports easier reprocessing without the need for liquid chemical solutions [3]. However, the impact of the latex sheath on instrument usability has not been evaluated.  The goal of this study was to test the usability of a latex sheath on electrosurgical instruments during simulated use by evaluating hand dexterity. To accomplish this goal, three tasks were completed: creating an electrosurgical ”surrogate instrument” for the usability study; designing the simulated use environment for evaluating dexterity; and completing a pilot dexterity tests for 6 participants.

The housing of an electrosurgical “bovie pen” was created by reverse engineering an actual bovie pen instrument in CAD software and then 3D printing the pen (Figure 1). A ball-point pen tip was inserted into the tip of each housing to record the instrument path during simulated use. There were 4 “bovie pen” categories: small (13 mm) and large (19.5 mm) diameter instruments; covered with sheath and uncovered.

Six participants (4 females and 2 males between 18-30 years old) completed four trials of the NTC-A dexterity test using 4 different test sheets randomized across the test conditions (24 trials in total). In each of the 4 pen categories, average completion time and total number of errors were calculated. Time to complete the hand dexterity tests and number of errors were normally distributed (Jarque-Bera goodness of fit test, p >0.2). Overall, the large covered pen required the shortest time to complete the dexterity tests and had the lowest number of errors per trial (Figure 2). Pen category was not a significant factor in the time to complete the dexterity test (ANOVA, p=0.459). Pen category was not a significant factor on the total amount of errors (ANOVA, p=0.363). The individual REBA scores ranged from 1 (no risk) to 7 (medium risk). The hand measurements were compared to anthropometric data [1] and participants were in the 27^th to 100^th percentile. There were no trends in the dexterity test results and hand size, average error count, and REBA score per participant.

Evaluating the human factors of surgical instrument designs is a key factor for assuring device safety and effectiveness in the intended use environment. In this study of six participants completing the dexterity tests, the “bovie pen” categories did not affect time of completion and the total number of errors in each test. Future work will include an expanded IRB-approved studies involving more participants, including healthcare professionals with experience using electrosurgical instruments, to further assess the impact of latex sheaths on instrument usability and their role in reducing instrument contamination and aiding patient safety.

We acknowledge support the Clemson University Creative Inquiry Program and a VentureWell BME-IDEA International Program Student Grant.

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