Biologic Material in Needles and Cartridges After Insulin Injection With a Pen in Diabetic Patients

Abstract

Our data suggest that biologic material can be trapped in the delivery system, including the cartridge, after an insulin injection with a pen-like device. Our results emphasize the strict need for individual use of insulin delivery systems, including cartridges and nonrefillable pens, especially in clinics and hospitals.

Biological contamination of insulin pens in a hospital setting

“…These problems were potentially related to similar improper technique that led to leakage and were possibly due to backflow pressure during the time the needle pathway was open to administer insulin if the pen was withdrawn too soon or too quickly. [26][27][28]33 Until 1998 there were no studies investigating possible biological contamination from backflow during medication administration. Le Floch et al 33 examined potential contamination by testing 120 insulin pens of French patients during regular ambulatory visits.…”

“…[26][27][28]33 Until 1998 there were no studies investigating possible biological contamination from backflow during medication administration. Le Floch et al 33 examined potential contamination by testing 120 insulin pens of French patients during regular ambulatory visits. The investigators found squamous cells in 30% of needles and 58% of cartridges in Omnipen, Novolet, and Novopen 3 devices.…”

Comparison of Inpatient Glycemic Control with Insulin Vials versus Insulin Pens in General Medicine Patients

“…[11][12][13] Thus, the Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) have recommended against sharing pen devices between patients due to the risk of transmitting bloodborne pathogens, even when different needles are used. 19,20 The Centers for Medicare & Medicaid Services (CMS) considers sharing of insulin pens to be equivalent to the re-use of needles or syringes in regard to citations.…”

“…Insulin pen devices can harbor biological materials in the pen cartridge, which may lead to bloodborne pathogen transmission if pens are inadvertently used on multiple patients, even if a Insulin Vials Versus Insulin Pens different needle is used. [11][12][13] Consequently, the Institute for Safe Medication Practices (ISMP) has called on hospitals to discontinue routine use of insulin pens for inpatient insulin administration. 14 In accordance with ISMP recommendations, our institution transitioned from insulin administration via patient-specific insulin lispro pen devices (Humalog KwikPens, Lilly, USA, LLC, Indianapolis, IN) to patient-specific insulin lispro 3-mL vials (Humalog 3mL vial; Lilly USA, LLC, Indianapolis, IN).…”

Facilitating the safe use of insulin pens in hospitals through a mentored quality-improvement program

“…Reports have included technique-related concerns such as improper priming, failure to "tip and roll" suspensions, use of the pen as a multiple-dose vial, incorrect injection method, misinterpretation of fluid on the skin after an injection as delivery of a partial dose, needlestick injury, and the potential for blood-borne pathogen transmission if insulin pens are used intentionally or inadvertently in more than one patient. 11,[16][17][18][19][20][21][22][23][24][25][26][27][28][29] In response to reports of insulin pen misuse in more than one patient, the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) issued communications intended to notify healthcare professionals and the public about the potential for transmission of hepatitis B and C viruses, HIV, and other blood-borne pathogens, with recommendations for mitigating the risk of misuse. 30,31 An expert consensus panel convened by the ASHP Research and Education Foundation identified 10 practical recommendations to enhance insulin-use safety throughout the medication-use process in hospitals.…”