Setting Acceptance Criteria for a National Flocked Swab for Biological Specimens during the COVID-19 Pandemic

Abstract

Swab sticks are a means of sampling a person by swabbing the nasopharyngeal pathway. This tool is at a critical point, where domestic availability in Indonesia is lacking because it is purely dependent on foreign supplies during the coronavirus disease 2019 (COVID-19) pandemic. The procurement process takes weeks or even months. Therefore, a collaboration of national companies with different industrial backgrounds and the Research Center for Biomedical Engineering, Universitas Indonesia, addressed this scarcity by developing and producing a national swab stick. Since there was no swab stick manufacturer in Indonesia, the production was arranged in such a way from four different industries, following ISO 13485:2016, Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes’. The companies contributing have strong experience in resin production, plastic processing, flocking technology, and medical packaging. However, it is important to ensure that the quality of the product developed meets the quality of existing products. This manuscript summarizes the quality assurance of the swab stick design, prototype, and production. Here, we propose a series of measurements; namely, geometrical, tensile, peel, surface, flock adsorption, and residue testing. The conclusion shows that the developed swab stick has stiffness around 400 MPa, deflected at 15N, a density of 1.5–2.5 Dtex, water contact angle at 78 degrees, and adsorbs around 25–35mL of liquid water. Moreover, there was no solvent or any toxic substance around the flocked swab during the residue testing. These qualities shall be developed further into a national product with nearly 100% local content in order to increase availability of the national medical device and fight COVID-19 in Indonesia. The product was formally registered under the trade name Sterilized Nasopharynx Swab Stick HS 19.

Keywords

• covid-19 pandemic
• iso 13485
• national swab stick
• quality assurance
• 100% local content