Sofia Wareham mathiassen, Denmark
The Faculty of Health and Medical Sciences, Copenhagen University Department of Immunology and MicrobiologyPresenter of 1 Presentation
ESTABLISHMENT OF PHYSIOLOGICAL CONTAMINATION LEVELS OF INSULIN PEN INJECTORS AND MAPPING OF DIABETIC SKIN MICROBIOME THROUGH TAPE-STRIPPING, QPCR AND MALDI-TOF MS
Abstract
Background and Aims
The microbiological contamination of pen injectors during subcutaneous(SC) injections is relatively unexplored. As the industry moves toward more sustainable, integrated and automated devices, knowledge concerning device contamination and how to prevent this must be established. Contamination of the pen injector cartridge during injection has been previously documented, indicating potential transmition of various pathogens, including viruses, bacteria, and fungi. These studies, however, investigate only the drug cartridge and not needle, focusing on human cells and hemoglobin, rather than microorganisms. This paper will therefore establish the rate and nature of microbial contamination of the needle during typical SC injections. The risk of contamination will be assessed through biogeographical mapping of diabetic skin microflora through tape-stripping of abdomen and thigh of diabetic patients (type 1&2).
Methods
The microbiological identification and quantification of these specimens will be performed through microscopy and MALDI-TOF MS diagnosis. Secondly, needles and drug cartridges from used pen injectors will be collected and analyzed for contamination by microbiologic wash-outs followed by qPCR. The total number of contaminating microflora as well as viable microflora will be quantified. The identification of microorganisms will be performed using standard microbiologic assessment methods such as 16s NGS and analysis with CSLM.
Results
The relation between the microbiological distribution of the skin and the contamination of the pen injector will be calculated, motivating the establishment of minimal antimicrobial efficacy levels required by materials for future device applications.
Conclusions
This work was supported by a research grant from the Danish Diabetes Academy, which is funded by the Novo Nordisk Foundation, grant number NNF17S0031406.