Cause of Device-Related Incident
Device factors; Support system failures; User errors

Clinical Specialty or Hospital Department
CCU / ICU / NICU; Clinical Laboratory; Clinical/Biomedical Engineering; Emergency Medicine; Nursing

Device Factors
Improper maintenance, testing, repair, or lack or failure of incoming inspection; Manufacturing error

Document Type
Hazard Reports

External Factors
*Not stated

Support System Failures
Error in hospital policy; Failure to train and / or credential

Tampering and/or Sabotage
*Not stated

User Errors
Failure to read label; Incorrect clinical use

UMDNS
Blood Glucose Monitors, Portable [16-488]; Reagents, Strip, Glucose [17-419]

Errors in Using Blood Glucose Monitors in Hospitals



Hazard [Health Devices Apr 1996;25(4):150]

Problem

Between 1994 and 1996, the U.S. Food and Drug Administration (FDA) has received more than 400 medical device reports on blood glucose monitors (BGMs), and ECRI continues to receive reports of errors involving the use of these units in hospitals. The most common errors include the following:

  • Incorrect quality control (QC) or proficiency testing procedures (e.g., not following manufacturer recommendations, incorrectly performing procedures)
  • Improper technique (e.g., fingerstick, timing, wiping)
  • Incorrect match between monitor calibration and test-strip calibration (e.g., using the wrong calibration code for a lot of test strips)
  • Inadequate cleaning
  • Inappropriate procedures for comparing BGM results with laboratory results

These errors can lead to inaccurate blood glucose readings that, if not detected, may result in inappropriate patient therapy (e.g., unnecessary insulin injection).

Discussion

BGMs, which are used to measure blood glucose concentrations, play a critical role in diabetes management. On most BGMs, a drop of whole blood is placed on a blood glucose test strip (compatible with the BGM) before or after the strip is inserted into the monitor to determine the blood glucose concentration. On some units, the user must manually wipe excess blood from the test strip before inserting it in the BGM; on others, this step is unnecessary.

Hospitals have guidelines and policies in place for using BGMs. However, errors can increase when many different people use the units and when many different BGM brands are used. Effective BGM testing requires coordination of the procedures of several different hospital departments (e.g., clinical laboratory, nursing, emergency, biomedical engineering) to ensure that the devices are properly used, calibrated, and maintained. Frequent in-service training is required for hospital personnel and should help to minimize problems in using BGMs.

Recommendations

Our recommendations are adapted from our Evaluation of blood glucose monitors (Health Devices 23[3], March 1994). Hospitals should ensure that all staff using these units follow our recommendations, which cover four basic areas:

1.  Training and education.

  • Alert all department managers and the laboratory manager to any problems involving BGM use and have them ensure that the staff is adequately trained to prevent such problems.
  • Properly train all BGM users, preferably through one-on-one or classroom education. Training should include any instructional information provided with the BGM, including audiotapes and videotapes. Periodically monitor user performance to determine if additional training is needed.
  • When a new BGM model is first introduced into the hospital, ensure that users practice with a control solution compatible with that BGM until they obtain consistent results (within 10%).
  • Provide training on appropriate fingerstick sampling techniques. Ensure that a clean, dry puncture site is used to avoid alcohol contamination in the blood sample.
  • Follow appropriate QC and proficiency testing procedures specified by the manufacturer and established by your hospital.

2.  Use of test strips and control solutions.

  • Use only those test strips and control solutions intended for use with the model or type of BGM you are using.
  • Use only test strips or control solutions that are current (i.e., within the manufacturer-stated expiration date) and document the date on which a new lot of strips goes into use.
  • Use only test strips for which a calibration code or chip has been entered into the monitor, if the unit is so designed.
  • Store test strips in their container with the cap tightly closed. Reclose the cap immediately after removing a strip. Store strips only at temperatures specified by the manufacturer.
  • Use the test strips immediately after removing them from the container. If they have been refrigerated, allow them to reach room temperature before opening the package. Minimize the strips' exposure to moisture and bright light (especially sunlight).
  • Apply enough blood to adequately fill or cover the reagent area. Touch the drop of blood to the pad; do not smear it, unless the manufacturer's instructions say to do so.
  • If using a BGM that requires manual wiping of the test strip, be sure that the correct technique and wiping material are used for the BGM in question.
  • Because QC solutions or check strips may have a wide blood glucose range, consider developing your own ranges. (New ranges can be developed by the ancillary testing coordinator or the laboratory manager.)

3.  Cleaning and infection control.

  • Clean the monitor at intervals recommended by the manufacturer, or more frequently if needed.
  • Follow appropriate infection control procedures as recommended by the manufacturer for the lancing device and monitor.

4.  Comparing BGM and laboratory results.

  • Periodically compare the monitor's results with the clinical laboratory's results. Be aware, however, that a discrepancy is possible between results on your BGM and those from the lab. For example, whole blood is sometimes used on the BGM while plasma is used in the laboratory testing; this can produce differences of as much as 11%. Other factors contributing to discrepancies can include the type of blood (e.g., capillary versus venous sample) collected for the laboratory, whether a fasting or nonfasting specimen is used, how and when blood is collected, the time elapsed between blood draw and blood analysis in the laboratory, and the type of blood preservative used in the blood collection tube.
  • Periodically review the entire quality assurance process that is used to compare BGM results with laboratory results, including the factors listed in previous item. (The process can be reviewed by the ancillary testing coordinator or the laboratory manager.)
  • Check BGM results against laboratory results for patients with known or suspected interfering substances (e.g., hematocrit, uric acid, bilirubin, high medication dose, abnormal PO2).

Additional References

Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Accreditation manual for pathology and clinical laboratory services. PA-101. 1996.

National Committee for Clinical Laboratory Standards (NCCLS). Ancillary (bedside) blood glucose testing in acute and chronic care facilities [Approved guideline]. C30-A. 1994.

UMDNS Terms

  • Blood Glucose Monitors, Portable [16-488]
  • Reagents, Strip, Glucose [17-419]

Cause of Device-Related Incident

Device factors: Improper maintenance, testing, repair, or lack or failure of incoming inspection; Manufacturing error

User errors: Failure to read label; Incorrect clinical use

Support system failures: Error in hospital policy; Failure to train and/or credential

Mechanism of Injury or Death

Failure to deliver therapy; Overdose; Underdose


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