title: Use of synthetic single-stranded oligonucleotides as artificial test soiling for validation of surgical instrument cleaning processes.
abstract: Surgical instruments are often strongly contaminated with patients' blood and tissues, possibly containing pathogens. The reuse of contaminated instruments without adequate cleaning and sterilization can cause postoperative inflammation and the transmission of infectious diseases from one patient to another. Thus, based on the stringent sterility requirements, the development of highly efficient, validated cleaning processes is necessary. Here, we use for the first time synthetic single-stranded DNA (ssDNA_ODN), which does not appear in nature, as a test soiling to evaluate the cleaning efficiency of routine washing processes. Stainless steel test objects were coated with a certain amount of ssDNA_ODN. After cleaning, the amount of residual ssDNA_ODN on the test objects was determined using quantitative real-time PCR. The established method is highly specific and sensitive, with a detection limit of 20 fg, and enables the determination of the cleaning efficiency of medical cleaning processes under different conditions to obtain optimal settings for the effective cleaning and sterilization of instruments. The use of this highly sensitive method for the validation of cleaning processes can prevent, to a significant extent, the insufficient cleaning of surgical instruments and thus the transmission of pathogens to patients.
authors.affiliation: Department of Thoracic, Cardiac, and Vascular Surgery, University Hospital Tuebingen, Calwerstraße 7/1, 72076 Tuebingen, Germany.
authors.forename: Nadja
authors.initials: N
authors.lastname: Wilhelm
authors.affiliation: Department of Thoracic, Cardiac, and Vascular Surgery, University Hospital Tuebingen, Calwerstraße 7/1, 72076 Tuebingen, Germany.
authors.forename: Nadja
authors.initials: N
authors.lastname: Perle
authors.affiliation: 3mach GmbH, Ringstraße 11, 72414 Rangendingen, Germany.
authors.forename: Robert
authors.initials: R
authors.lastname: Simmoteit
authors.affiliation: Department of Thoracic, Cardiac, and Vascular Surgery, University Hospital Tuebingen, Calwerstraße 7/1, 72076 Tuebingen, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Schlensak
authors.affiliation: Department of Thoracic, Cardiac, and Vascular Surgery, University Hospital Tuebingen, Calwerstraße 7/1, 72076 Tuebingen, Germany.
authors.forename: Hans P
authors.initials: HP
authors.lastname: Wendel
authors.affiliation: Department of Thoracic, Cardiac, and Vascular Surgery, University Hospital Tuebingen, Calwerstraße 7/1, 72076 Tuebingen, Germany.
authors.forename: Meltem
authors.initials: M
authors.lastname: Avci-Adali
mesh_terms: D000818:Animals; D002498:Centrifugation; D017931:DNA Primers / Q000378:metabolism; D004277:DNA, Single-Stranded / Q000302:isolation & purification*; D016678:Genome / Q000235:genetics; D006801:Humans; D057230:Limit of Detection; D009841:Oligonucleotides / Q000302:isolation & purification*; D060888:Real-Time Polymerase Chain Reaction; D015203:Reproducibility of Results; D013242:Sterilization / Q000379:methods*; D013525:Surgical Instruments; D014508:Urea
chemical_list: D017931:DNA Primers; D004277:DNA, Single-Stranded; D009841:Oligonucleotides; D014508:Urea