Date of Award

5-2019

Document Type

Thesis

Degree Name

Master of Science (MS)

Department

Bioengineering

Committee Member

Melinda K Harman, Committee Chair

Committee Member

Donna Weinbrenner

Committee Member

Delphine Dean

Abstract

The World Health Organization acknowledges that single-use medical devices (SUDs) are commonly reprocessed and reused beyond their intended life to deliver patient care in low-resource settings. SUDs originally intended for use on one patient for one procedure are “reprocessed” in such cases, which involves cleaning, disinfection or sterilization, and functional testing before they are reused in hospitals. Studies have shown that reuse of SUDs in countries where reprocessing is unregulated can be safe if stringent standard operating procedures are followed.

The broad objective of this thesis was to validate a reprocessing protocol for the bag-valve-mask (BVM), a single-use device commonly reused in low- and middle-income countries. This device is critical for supporting neonatal resuscitation in low- and middle-income countries, where neonatal mortality due to failure to establish breathing has a prevalence of roughly 19%. This was accomplished by documenting reprocessing practices in a tiered healthcare system in Tanzania and assessing cleaning markers and functional performance parameters for BVM exposed to a bleach-based reprocessing protocol under simulated worst-case conditions and by defining human factors affecting BVM reprocessing.

Tanzanian hospital personnel interviews revealed variations in reprocessing practices and demonstrated a need for validated reprocessing protocols and screening methods for single-use devices. The bleach-based protocol was validated to meet disinfection targets established by the FDA, and its efficacy was unaffected by simulated worst-case conditions including high organic load, low hypochlorous acid presence (pH ~11), and prolonged drying of bioburden following simulated use. The BVM met performance targets even after multiple reprocessing cycles and simulated abrasive wear. Finally, the usability study defined human factors relevant to user compliance with the validated bleach-based protocol. This body of work ultimately provides a comprehensive framework for validating reprocessing protocols for single-use medical devices such as the BVM. The approaches outlined in this thesis support the safe reuse of medical devices through reprocessing validation using protocols that are suitable for clinical or laboratory settings.

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