Date Approved

5-21-2021

Embargo Period

5-24-2021

Document Type

Thesis

Degree Name

M.S. Biomedical Engineering

Department

Biomedical Engineering

College

Henry M. Rowan College of Engineering

Advisor

Brewer, Erik C.

Committee Member 1

Staehle, Mary

Committee Member 2

Tremoulet, Patrice

Committee Member 3

Caputo, Gregory

Keywords

Disinfection, Human Factors, Infections, Multi-Dose Vials, Usability, Vial Cap

Subject(s)

Drug delivery devices--Sterilization

Disciplines

Biomedical Engineering and Bioengineering

Abstract

Recently, multi-dose vials (MDVs) have demonstrated significant bioburden, with randomized studies revealing bacterial contamination rates up to 27%. When the proper protocol of disinfecting the vial diaphragm with a pre-saturated wipe is followed, MDV bioburden is eliminated. However, when this sterilization protocol is neglected, the susceptibility of MDV to house potential nosocomial pathogens intensifies. In this work, the usability and effectiveness of a novel device, referred to as the Vial Cap, are investigated to gauge the feasibility and acceptability of this device as a method of MDV disinfection. The usability of the Vial Cap was evaluated using principle human factors engineering (HFE) techniques to quantify the device's ease of use, efficiency, and user acceptance. The Vial Cap was observed to be highly accepted by the intended users as represented by a high System Usability Scale (SUS) score. The Vial Cap was significantly more efficient in simulated timed-based studies and the users were able to easily to operate the device. Specific elements of the Vial Cap were evaluated to determine their individual impact on disinfection efficacy. The minimum disinfection time, applied force, and estimated usage were evaluated to determine improvements to the Vial Cap design. Implementation of design recommendations from this research can produce a Vial Cap that can enhance MDV disinfection practices and increase patient safety.

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