Residual Biomarkers in Medical Device Cleaning Validation : A Review of Current Methods and Biological Justification
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Authors
Kloosterman, Steven M.
Issue Date
2023-09-01
Type
Thesis
Language
en_US
Keywords
Alternative Title
Abstract
Modern reusable medical devices require extensive biochemical analysis to ensure devices are not only compliant with regulatory bodies and industry standards, but also that devices pose minimal risk to patients— especially when reusable medical devices come into contact with sterile tissues. Current industry standards identify five residual analytes to be tested when medical devices undergo simulated use cleaning tests. The specific residual analytes that can be measured are protein, hemoglobin, carbohydrates, total organic carbon, and adenosine triphosphate. The residual presence of any of these analytes is often indicative of microorganismal contamination or ineffective cleaning procedures on medical devices and can indicate the presence of bioactive molecules, such as pyrogens, and endotoxins. For each analyte being tested, it is necessary to examine the reason for its testing, the various ways in which the analytes can be quantitively analyzed in vitro, and whether evidence exists to justify the industry standard’s allowable tolerances of the various analytes. To the best of our knowledge, substantial research into the cytotoxic and immune-reactivity characteristics of each residual analyte in the future is necessary to ensure patient and provider safety, and ultimately reducing the incidence of iatrogenic infections as a result of contaminated medical devices.
Description
iii, 17p.
Citation
Publisher
Kalamazoo College
License
U.S. copyright laws protect this material. Commercial use or distribution of this material is not permitted without prior written permission of the copyright holder.