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지역 EMS의 현장검사 혈당측정기 사용에 대한 실태조사

Survey of Point-of-Care Testing Devices for Pre-hospital EMS Equipment of Glucometer on Local Area

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Objective: glucometer is one of POCT(point-of-care testing) devices used by EMS. Accurate measurement value is important for patient decision making. Quality control is necessary for this, but most EMS are still using glucometer without quality control it. Therefore, management status and quality control status of glucometers used by 119 paramedics waswere investigated. Methods: 6 and 8 of glucometers and blood glucose test strips were submitted from 4 safety centers in 2010 and 8 safety centers in 2012, respectively. Glucometers submitted by local safety centers were analyzed in 2010 and 2012. The control glucometer, which was well managed at A University Hospital, was assumed to be accurate for at blood glucose measurement. Glucose values of various quality control materials control solutions were measured and analyzed using linear regression and Pearson’s correlation test. Error rates were obtained via error tolerance range required by the 2011 ISO(International Organization for Standardization) guideline. For statistics, Excel and MedCalC programs were used. Results: mong 14 safety centers in the region, 4 centers(28.5%) in 2010 and 8 centers(57.1%) in 2012 submitted 6 and 8 glucometers. In the first evaluation in 2010, 2 out of 6(33.3%) glucometers were untestable due to error, and 45 out of 6(66.683.3%) blood glucose test strips' validity were expired. In the second evaluation in 2012, 1 out of 8(13.5%) glucometers were untestable due to lack of battery, and 2 out of 8(25%) blood glucose test strips' validity were expired. All correlation coefficients were above 0.989 in 2010 and above 0.997 in 2012. Error rates were generally high when using expired blood glucose test strips. Conclusion: Among 119 paramedics’ guideline, quantity and operation status of POCT devices are well managed, but quality control is not. Therefore, it is necessary to add management status and quality control status of POCT devices to the EMS’ field work guideline.

Abstract

Objective: glucometer is one of POCT(point-of-care testing) devices used by EMS. Accurate measurement value is important for patient decision making. Quality control is necessary for this, but most EMS are still using glucometer without quality control it. Therefore, management status and quality control status of glucometers used by 119 paramedics waswere investigated. Methods: 6 and 8 of glucometers and blood glucose test strips were submitted from 4 safety centers in 2010 and 8 safety centers in 2012, respectively. Glucometers submitted by local safety centers were analyzed in 2010 and 2012. The control glucometer, which was well managed at A University Hospital, was assumed to be accurate for at blood glucose measurement. Glucose values of various quality control materials control solutions were measured and analyzed using linear regression and Pearson’s correlation test. Error rates were obtained via error tolerance range required by the 2011 ISO(International Organization for Standardization) guideline. For statistics, Excel and MedCalC programs were used. Results: mong 14 safety centers in the region, 4 centers(28.5%) in 2010 and 8 centers(57.1%) in 2012 submitted 6 and 8 glucometers. In the first evaluation in 2010, 2 out of 6(33.3%) glucometers were untestable due to error, and 45 out of 6(66.683.3%) blood glucose test strips' validity were expired. In the second evaluation in 2012, 1 out of 8(13.5%) glucometers were untestable due to lack of battery, and 2 out of 8(25%) blood glucose test strips' validity were expired. All correlation coefficients were above 0.989 in 2010 and above 0.997 in 2012. Error rates were generally high when using expired blood glucose test strips. Conclusion: Among 119 paramedics’ guideline, quantity and operation status of POCT devices are well managed, but quality control is not. Therefore, it is necessary to add management status and quality control status of POCT devices to the EMS’ field work guideline.

참고문헌 (9)

  1. National Fire Agency, "National Fire Agency Statistical Years Book", National Fire Agency, ~ (2021)
  2. The International Organization for Standardization, "In vitro diagnostic test systems-Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus", ISO 15197, ~ (2011)
  3. American Diabetes Association, "Standards of medical care in diabetes--2012", Diabetes Care, 35(Suppl_1), pp.S11~63 (2012)
  4. "2013 Consumer Guide: Diabetes Forecast Magazine" (2013)[URL]
  5. 안동희, "ISO15197에 따른 혈당측정기의 분석적 수행능 평가", Annals of Laboratory Medicine, 29(5), pp.423~429 (2009), 대한진단검사의학회
  6. Seo JA, "Clinical evaluation of SD CHECK GOLD as point-of-care glucose meter", J Lab Med Qual Assur, 31, pp.261~267 (2009)
  7. Kim KS, "The effects of diabetes care education on the accuracy and the error of self-monitoring of blood glucose in elderly diabetes patient", pp.2013
  8. Bergenstal RM, "Evaluating the accuracy of modern glucose meters", Insulin, 3, pp.5~14 (2008)

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