Evaluation of Surgical Glove Integrity: Does an African Country Receive Inferior Quality?

Authors

  • Abebe Bekele Addis Ababa University
  • Barnabas Alayande
  • Mesikir Abate
  • Nardos Mekonnen
  • Dieudonne Hakizimana
  • Daniel Zemenfes

Keywords:

Glove perforation, surgical quality, occupational injury

Abstract

In a 2017 study, the incidence of glove perforation in Addis Ababa was found higher than most other publications. This poses a significant threat to both patients and the surgical workforce. We hypothesized that poor surgical glove quality may have contributed to the high incidence. Hence, we tested the integrity of six  brands of sterile gloves. The assumption was the perforation rate in these gloves would be higher than the standard acceptable quality level (AQL).

From the 1,200 single gloves evaluated, 59 (4.9%) gloves had perforations. Brand 1 (13.5%) and Brand 5 (10%) had the highest rate of perforations, followed by Brand 3 (3.0%) Brand 6 (2.0%), Brand 2 (1.0%) and Brand 4, which had 0 perforations. Compared to the standard AQL 1.5 for surgical gloves at the time of the study, Brand 1 and Brand 5 had a significantly higher perforation rate (13.5%, CI=8.8%-18.2%, p=0.000) and (10.0%, CI=5.8%-14.2%, p=0.000), respectively.

Our study results showed unacceptably high rates of perforation for 2 glove brands. The implications of this are staggering for surgical staff.  In Ethiopia, choice of surgical glove brand may be a determinant of surgical safety.

In view of our findings of a large proportion of glove perforations prior to use, we recommend, at minimum, that surgeons visually inspect gloves before and after donning. Relevant government institutions, contractors, importers, hospital administrators, and surgical teams must take collective responsibility for ensuring appropriate quality of gloves. Quality enforcement must be strengthened, and local production must be considered.

References

Misteli H, Weber WP, Reck S, Rosenthal R, Zwahlen M, Fueglistaler P, Bolli MK, Oertli D, Widmer AF, Marti WR. Surgical glove perforation and the risk of surgical site infection. Arch Surg. 2009 Jun;144(6):553-8; discussion 558. doi: 10.1001/archsurg.2009.60. PMID: 19528389.

Esteban JI, Gómez J, Martell M, Cabot B, Quer J, Camps J, González A, Otero T, Moya A, Esteban R, et al. Transmission of hepatitis C virus by a cardiac surgeon. N Engl J Med. 1996 Feb 29;334(9):555-60. doi: 10.1056/NEJM199602293340902. PMID: 8569822.

Harpaz R, Von Seidlein L, Averhoff FM, Tormey MP, Sinha SD, Kotsopoulou K, Lambert SB, Robertson BH, Cherry JD, Shapiro CN. Transmission of hepatitis B virus to multiple patients from a surgeon without evidence of inadequate infection control. N Engl J Med. 1996 Feb 29;334(9):549-54. doi: 10.1056/NEJM199602293340901. PMID: 8569821.

Kobayashi M, Tsujimoto H, Takahata R, Einama T, Okamoto K, Kajiwara Y, Shinto E, Kishi Y, Hase K, Ueno H. Association Between the Frequency of Glove Change and the Risk of Blood and Body Fluid Exposure in Gastrointestinal Surgery. World J Surg. 2020 Nov;44(11):3695-3701. doi: 10.1007/s00268-020-05681-1. Epub 2020 Jul 13. PMID: 32661693.

McKinney WP, Young MJ. The cumulative probability of occupationally-acquired HIV infection: the risks of repeated exposures during a surgical career. Infect Control Hosp Epidemiol. 1990 May;11(5):243-7. doi: 10.1086/646161. PMID: 2351810.

Kiyosawa K, Sodeyama T, Tanaka E, Nakano Y, Furuta S, Nishioka K, Purcell RH, Alter HJ. Hepatitis C in hospital employees with needlestick injuries. Annals of internal medicine 1991, 115 (5), 367-369.

Shapiro CN. Occupational risk of infection with hepatitis B and hepatitis C virus. Surg Clin North Am. 1995 Dec;75(6):1047-56. doi: 10.1016/s0039-6109(16)46776-9. PMID: 7482133.

Palmer JD, Rickett JW. The mechanisms and risks of surgical glove perforation. J Hosp Infect. 1992 Dec;22(4):279-86. doi: 10.1016/0195-6701(92)90013-c. PMID: 1363107.

Tlili MA, Belgacem A, Sridi H, Akouri M, Aouicha W, Soussi S, Dabbebi F, Ben Dhiab M. Evaluation of surgical glove integrity and factors associated with glove defect. Am J Infect Control. 2018 Jan;46(1):30-33. doi: 10.1016/j.ajic.2017.07.016. Epub 2017 Sep 20. PMID: 28893444.

Thanni LO, Yinusa W. Incidence of glove failure during orthopedic operations and the protective effect of double gloves. J Natl Med Assoc. 2003 Dec;95(12):1184-8. PMID: 14717474; PMCID: PMC2594859.

Bekele A, Makonnen N, Tesfaye L, Taye M. Incidence and patterns of surgical glove

perforations: experience from Addis Ababa, Ethiopia. BMC Surg. 2017; 17:26.

Zaatreh S, Enz A, Klinder A, König T, Mittelmeier L, Kundt G, Mittelmeier W. Prospective data collection and analysis of perforations and tears of latex surgical gloves during primary endoprosthetic surgeries. GMS Hyg Infect Control. 2016 Dec 20;11:Doc25. doi: 10.3205/dgkh000285. PMID: 28066701; PMCID: PMC5175006.

Tanner J, Parkinson H. Double gloving to reduce surgical crossâ€infection. Cochrane Database of Systematic Reviews 2006, Issue 3. Art. No.: CD003087. DOI: 10.1002/14651858.CD003087.pub2. Accessed 12 March 2021

Food and Drug Administration, HHS. Medical devices; patient examination and surgeons' gloves; test procedures and acceptance criteria. Final rule. Fed Regist. 2006 Dec 19;71(243):75865-79. PMID: 17294550.

CEN -European Committee for Standardization (2001) CEN 455–1:2000 Medical gloves for single use—Part 1: Requirements and testing for freedom from holes

CEN - European Committee for Standardization (2020) CEN EN455–1:2020—Medical gloves for single use—Part 1: Requirements and testing for freedom from holes

Medhioub F, Jaber E, Hamrouni A, Gharbi L. Unnoticed surgical gloves intraoperative perforation: A multicentric study of the leading factors. Jr. med. res. 2020;

Hwang KL, Kou SJ, Lu YM, Yang NC. Evaluation of the quality of surgical gloves among four different manufactures. Annals of Occupational Hygiene. 1999 May;43(4):275-81. PMID: 10432871.

Albin MS, Bunegin L, Duke ES, Ritter RR, Page CP. Anatomy of a defective barrier: sequential glove leak detection in a surgical and dental environment. Critical Care Medicine 1992; 20(2): 170-184.

Department of Health and Human Services, Food and Drug Administration, Medical Devices: Patient Examination and Surgeon’s Gloves; Adulteration. Federal Register, Vol 54, No.223, Tuesday, Nov 21, 1989, Proposed Rules, 48218

International Trade Centre. Trade Map. Available from https://www.trademap.org/ [Accessed 10th March, 2021]

Tchantchaleishvili V, Myers PO. Left-handedness--a handicap for training in surgery? Journal of Surgical Education. 2010 Jul-Aug;67(4):233-236. DOI: 10.1016/j.jsurg.2010.06.001.

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Published

2021-09-24

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