Test Strip Contamination In Multi-Patient Settings

Letter to Dr. Thomas Frieden, CDC Director,Centers for Disease Control and PreventionThe purpose of this letter is to alert you to current deficiencies in guidelines surrounding the usage of glucose test strip vials in multi-patient settings, which present a significant hazard to patient safety. The CDC’s recommendations on infection prevention during blood glucose monitoring in multi-patient settings is limited to proper finger stick device use, safe insulin administration practice , proper hand hygiene with change of gloves, and consistent , effective glucose meter disinfection, These recommendations do not include glucose test strips and test strip vials as a potential source of infection.The current practice in US hospitals is to allow multiple entries into a vial (vials are packaged in quantities of 50 and sometimes 100) by providers under non sterile conditions. There are abstracts and peer reviewed publications1 which unequivocally establish that these practices are associated with strip and vial contamination with a variety of microbial species, many of which are pathogenic. Additionally, as part of the capillary blood sampling process for assisted monitoring of blood glucose (AMBG), test strip vials are handled and exposed to patient blood. Blood is present on strip vials and on strips within the vials, but may be difficult to detect visually. This creates risk for patients. For example, Hepatitis B can survive in dried blood spots for as long as a week. Unfortunately, we continue to see outbreaks due to the sharing of diabetic testing supplies, with the most recent one being a large Hepatitis B outbreak in a long term care facility in Pennsylvania (March 17, 2015).Apposition of contaminated test strips to the open wound created by capillary finger sticks is not in the best interests of patients or patient safety. Although the linkage of this practice to a specific patient infection has not been made to date, it is clear that this practice poses a risk for hospital acquired infections. According to an independent study, even the designation of a glucose strip vial to a single patient does not appear to decrease the contamination rate of the strips in acute/post-acute care settings. Therefore, the design of the conventional glucose strip vial with multiple unwrapped test strips must be assessed to allow for individual unit dispensing in multi-patient settings.The FDA and CDC have mandated glucose meter disinfection between patients. However, such disinfection is impractical, and is not part of current FDA approval for glucose test strip vials. The epidemiological investigations by State, Federal and independent investigators of Hepatitis B and C outbreaks related to AMBG have identified improper use of multi -use lancets and failure to consistently and effectively disinfect glucometers to be root causes. However, contaminated glucose test strips and glucose test strip vials in multi-patient settings have been overlooked as a source of infectious outbreaks.Our Request:

  1. Consider glucose test strip vials and test strips as potential sources of infection and blood exposure during outbreak investigations in multi-patient settings
  2. Include current scientific knowledge regarding bacterial contamination of glucose test strips and test strip vials as part of your recommendations on infection prevention during blood glucose monitoring in multi-patient settings
  3. Recommend a no-touch procedure for blood glucose monitoring whereby test strips are individually wrapped, and/or support the redesign of how test strips are dispensed and administered today in multi-patient settings

Thank you for your consideration of this important issue.Sincerely,Larry Smith Larry EllingsonPresident Vice-PresidentDLC DLCChairman ADA Chairman ADA2005-06 2004-051.Vanhaeren S, Duport C, Magneney M. Bacterial Contamination of glucose test strips: Not to be neglected. Am J Inf Control 2011; 39: 611-613; Ng R. Multicenter evaluation of bacterial contami­nation of glucose test strips. Clin Chim Acta 2012; 413: 1485-1487; Perez-Ayala M, Oliver P, Rodriguez CF. Prevalence of bacterial contamination of glucose test strips in individual single-use packets versus multiple-use vials. J Diab Tech 2013 Jul; 7(4): 854-62.