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

  • Yisihak Abraham Mehari Ethiopian Food and Drug Authority, Addis Ababa, Ethiopia.
  • Yemane Berhane 2Addis Continental Institute of Public Health; Department of Epidemiology and Biostatistics, Addis Ababa, Ethiopia
  • Heran Gerba Borta Ethiopian Food and Drug Authority, Addis Ababa, Ethiopia
  • Kidanemariam Gebre Michael Ethiopian Food and Drug Authority, Addis Ababa, Ethiopia

Abstract

Background: 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.


Methods: 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.


Results: 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.


Conclusions: 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

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References

1. Halsted LSCH. The first to use rubber gloves in the operating room. Proc Bayl Univ Med Cent. 2010 Oct;23(4):389-92.
2. Hübner N-O GoerdtA-M, Mannerow A, Pohrt U, Heidecke C-D, Kramer A. The durability of examination gloves used on intensive care units. BMC Infect Dis. 2013 May 20;13(1):226.
3. World Health Organization. Glove Use Information Leaflet. Geneve, SwitzerlandAugust; 2009.
4. European Committee for Standardization. ECF. EN 455-1 Medical gloves for single use Part 1. Belgium: Requirements and testing for freedom from holes. Brussels; 2020 May.
5. American Standards Testing Method; Standard Specification for Rubber Examination Gloves. ASTM: D3578-2015. West Conshohocken. United States; 2015.
6. U.S. Food and DrugAdministration. CFR - Code of Federal Regulations. Title 21. Silver Spring, USA; 2020 Oct 11
7. Jose Paul Meleth. An Introduction to Latex Glove. Lambert academic publishing, Germany. September 16, 2015.
8. Al-Swuailem AS. Prevalence of manufacturing defects in latex examination gloves used in selected dental practices in central Saudi Arabia. Pubmed. Jul, 2014;35(7):729-33.
9. Bekele A Makonnen N, Tesfaye L, Taye M. Incidence and patterns of surgical glove perforations: experience from Addis Ababa, Ethiopia. BMC Surgical. 2017 Mar 20;17(1):26.
10. Makama JG, Okeme IM, Makama EJ, Ameh EA. Glove Perforation Rate in Surgery: A Randomized, Controlled Study- To Evaluate the Efficacy of Double Gloving. Pubmed. 2016 Aug; 17:436-42
11. Ethiopia. CSAin Addis Ababa, Population projection of Ethiopia for Addis Ababa; 2017 Jul.
12. Addis Ababa Food Medicine Healthcare And Control Authority annual reports; 2019.
13. International Organization for Standardization (en). ISO 2859: Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection Geneva Switzerland; 2020 Nov 13.
14. American Standards Testing Method for Detection of Holes in Medical Gloves. ASTM: D5151. West Conshohocken, United States: ASTM; 2015.
15. American Standards Testing Method, for Rubber-Measurement of Dimensions. ASTM D3767: West Conshohocken, United States. ASTM; 2014.
16. European Committee for Standardization. EN 455-2 Medical gloves for single use. Part 2: Requirements and testing for physical properties. Brussels, Belgium; 2020 May.
17. Yani Pertiwi, Teguh Martianto, Ageng Priatni. Comparative study of rubber household gloves standards in Indonesia. 2020 Nov; 231-40.
18. Food and Drug Administration (FDA). Guidance for Industry and FDA Staff : Medical Glove Guidance Manual. West Conshohocken, USA; 2008 Jan 22.
19. International Organization for Standardization. ISO 11193-1. Single use medical examination gloves. Part 1: Specification for gloves made from rubber latex or rubber solution. Second edition; 2008 Apr.
20. Phalen RN, Wong WK. Integrity of Disposable Nitrile Exam Gloves Exposed to Simulated Movement. Pubmed. 2011 May;8(5):289-99.
21. Bekele A, Tadesse A.Status of hepatitis B vaccination among surgeons practicing in Ethiopia. 2014 Jul;52(3):107-12.
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How to Cite
Mehari, Y. A., Y. Berhane, H. G. Borta, and K. Gebre Michael. “Quality of Examination Gloves in Health Facilities in Addis Ababa, Ethiopia”. International Journal of Drug Regulatory Affairs, Vol. 12, no. 1, Mar. 2024, pp. 48-53, doi:10.22270/ijdra.v12i1.652.