International Journal Of Drug Regulatory Affairs

  • Year: 2024
  • Volume: 12
  • Issue: 1

Quality of examination gloves in health facilities in Addis Ababa, Ethiopia

  • Author:
  • Yisihak Abraham Mehari1, Yemane Berhane2, Heran Gerba Borta1, Kidanemariam Gebre Michael1
  • Total Page Count: 6
  • Page Number: 48 to 53

1Ethiopian Food and Drug Authority, Addis Ababa, Ethiopia

2Addis Continental Institute of Public Health, Department of Epidemiology and Biostatistics, Addis Ababa, Ethiopia

Abstract

Examination gloves are used in health facilities to protect health professionals and patients from the risk of infection and reduce opportunities for cross-transmission of infectious microorganisms. Poor-quality examination gloves can expose health professionals to infectious diseases such as Covid-19, Hepatitis, HIV/AIDS, and other contagious diseases. Hence, this study aimed to assess the quality of examination gloves in health facilities in Addis Ababa.

A cross-sectional study design was employed. The examination gloves were collected from randomly selected health facilities in Addis Ababa. The gloves were examined following standard procedure in the Ethiopian Food and Drug Authority. Holes in the examination gloves were detected using the watertight (leakage test) and geometrical dimensions such as thickness, width, and length were measured.

A total of 2500 selected examination gloves were collected between Feb 10 and Feb 20, 2021. The gloves were sampled from health facilities in Addis Ababa. From the total samples collected, only 2280 examination gloves of five different brands were tested, which makes the response rate 91.2%. The proportion of gloves with holes detected ranged from 5.7% to 21.9%. Overall, only 0.17% and 3.2% of the gloves had width and length below standard, respectively. None of the gloves tested in this study had a thickness below the standard.

All brands of examination gloves tested had a higher hole (leakage) rate than the acceptable quality limit. This implies there is a substantial risk of infectious disease transmission to health professionals and patients in healthcare settings. Hence, regulatory enforcements need to be strengthened across the life cycle of the product.

Keywords

Examination glove, Rubber gloves, Addis Ababa, Ethiopian Food and Drug Authority (EFDA), US Food and Drug Administration, Acceptance quality limit (AQL), Glove Visual Leak Tester (VLT), ISO 2859