Biomedical Instrumentation and Technology最新文献

{"title":"Effect of Vaporized Hydrogen Peroxide and Nitrogen Dioxide Sterilization on Nitinol.","authors":"Patrick Anibaldi, Puneet Gill, Prabhleen Kaur, Jiann-Te Kenneth Lee, Akshaysingh Baghele, Vu L Lekate, Troy P Carter, Byron J Lambert","doi":"10.2345/0899-8205-58.1.1","DOIUrl":"10.2345/0899-8205-58.1.1","url":null,"abstract":"<p><p><b><i>Background:</i></b> Nitinol is used as the structural framework in numerous types of medical devices (e.g., guidewires, transcatheters, stents). The desire to understand the material compatibility of nitinol with vaporized hydrogen peroxide (VH₂O₂) and nitrogen dioxide (NO₂) sterilization is increasing in healthcare technology. As a result of increased regulatory pressure and capacity limitations related to ethylene oxide (EO) sterilization, the industry is seeking alternative, sustainable sterilization options. <b><i>Objective:</i></b> This study sought to characterize the corrosion resistance of nitinol metal alloy wire when exposed to varying levels of VH₂O₂ and NO₂ sterilization. <b><i>Methods:</i></b> Scanning electron microscopy (SEM) imaging and energy-dispersive X-ray spectroscopy (EDS) scans were performed to understand the effects of VH₂O₂ and NO₂ sterilization treatments on the surface morphology and chemical composition of nitinol. <b><i>Results:</i></b> From the SEM-EDS results, no notable difference was observed when comparing VH₂O₂ and NO₂ test samples with nonsterile control samples. In addition, cyclic potentiodynamic polarization measurements were performed per ASTM F2129-19a to determine corrosion susceptibility. No considerable changes were detected in the electrochemical potential after VH₂O₂ and NO₂ sterilization treatments, when compared with the nonsterile control samples. <b><i>Conclusion:</i></b> SEM-EDS and corrosion test results indicated no considerable changes in the surface properties or electrochemical potential of the sterilized samples compared with the nonsterilized control samples. Therefore, nitinol metal showed promising results for compatibility with VH₂O₂ and NO₂ sterilization.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"58 1","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10849103/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139698519","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Toward Enhanced Machine-Based Release in X-ray Sterilization.","authors":"Damien Prieels, Cody Wilson, Florent Kuntz, Josef Mittendorfer, John Logar","doi":"10.2345/0899-8205-58.1.18","DOIUrl":"10.2345/0899-8205-58.1.18","url":null,"abstract":"<p><p>Trends toward the use of irradiator parameter release (also called machine-based release) put pressure on equipment manufacturers to guarantee accuracy and reliability of monitored process parameters. In the specific case of X-ray processing, relevance of these monitored parameters is questionable due to the additional difficulty coming from the fact that the X-ray converter does not have associated parameters or a monitored feedback mechanism. To bridge this gap, this article presents a novel method to verify in real-time consistency of certain X-ray field properties. It covers the description of an X-ray flux monitor and its experimental characterization. The proposed detector can be used as a control and monitoring tool in addition to the conventional \"passive\" dosimetry per ISO 11137-1 and ISO 11137-3. It can detect photon flux deviation on the order of magnitude of 1%. Its performance would allow real-time monitoring of each pallet being processed and ensure that the correct X-ray beam is directed to the product. Further, the known response of the detector to a product can serve as a validation that the correct product is in front of the beam. Moreover, a detector of this type could contribute to moving from the current dosimetric release to irradiator parameter release. Compared with current practices, benefits would include an increased number of control points used to verify process conformity, real-time information on the radiation field (process output validation), limited manual handling of dosimeters, and verification that the product treated is the same as the performance qualification dose-mapped product.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"58 1","pages":"18-24"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10849102/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139698520","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Liability Exposure of Clinicians in Artificial Intelligence-Driven Healthcare.","authors":"Brian Lee, Rotem Naftalovich, Saad Ali, Faraz A Chaudhry, George L Tewfik","doi":"10.2345/0899-8205-58.2.39","DOIUrl":"10.2345/0899-8205-58.2.39","url":null,"abstract":"","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"58 2","pages":"39-42"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10987009/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140866572","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Borescope Inspections on Endoscope Repair Frequency and Costs.","authors":"Cori L Ofstead, Abigail G Smart, Larry A Lamb, Frank E Daniels","doi":"10.2345/0899-8205-58.4.88","DOIUrl":"10.2345/0899-8205-58.4.88","url":null,"abstract":"<p><p><b><i>Background:</i></b> Infections and injuries have been linked to endoscopes with visible damage or residue. Guidelines recommend visual inspection to identify endoscopes requiring repair or further cleaning. This study sought to evaluate the impact of routine borescope inspections on repair frequency and costs. <b><i>Methods:</i></b> Retrospective analysis was performed on a database of endoscope repairs compiled for a three-year period by a large academic medical center that began performing borescope inspections for every endoscope after manual cleaning. Endpoints included total number of repairs, total repair cost, mean cost per repair, mean turnaround time per repair, and procedural usage between repairs. Subgroup analysis was performed to identify repair patterns by endoscope type. <b><i>Results:</i></b> The total cost of repairs decreased from $1,212,702 in 2022 to $724,419 in 2024. The number of repairs required annually was similar over time, but reductions occurred in the proportion of repairs classified as major (12.1% to 3.2%) and the mean cost per repair ($4,426 to $2,337; <i>P</i> < 0.001). Mean turnaround time for repairs decreased (from 24.1 to 15.5 days; <i>P</i> < 0.001). Mean number of uses between repairs increased over time (from 52.1 to 87.2; <i>P</i> < 0.001), and the facility decreased the size of the endoscope fleet from 593 to 508. <b><i>Conclusion:</i></b> Significant reductions in endoscope repair frequency and cost occurred over time in a large, centralized endoscope processing department that performed borescope inspections of every endoscope after manual cleaning.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"58 4","pages":"88-98"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11584169/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144050450","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advantages and Limitations of Physical and Virtual Dose Mapping.","authors":"Nick Brydon","doi":"10.2345/0899-8205-58.2.34","DOIUrl":"10.2345/0899-8205-58.2.34","url":null,"abstract":"","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"58 2","pages":"34-38"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10987008/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140852614","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Unveiling the Potential of Enzymatic Detergents to Deactivate Infectious Prions.","authors":"Marcia Frieze, Pablo Rivera","doi":"10.2345/0899-8205-58.4.58","DOIUrl":"10.2345/0899-8205-58.4.58","url":null,"abstract":"<p><p>When infectious misfolded proteins self-propagate, they cause transmissible spongiform encephalopathies (TSEs) or prion diseases. TSEs are rare, progressive neurodegenerative diseases with long incubation times and are always fatal. Iatrogenic transmission of these diseases is a major concern for human health, and existing methods of decontamination are either ineffective or require caustic chemical treatment followed by extended steam sterilization cycles. Research was undertaken to explore using enzymatic detergents to decontaminate prion-laden surgical devices, equipment, and stainless-steel tools using existing healthcare facility protocols, including cleaning followed by steam or low-temperature sterilization. Several formulations of enzymatic detergents were used to clean stainless steel wires contaminated with infected hamster brain homogenate. Buffering the solutions to achieve a final pH between 8.5 and 9 when diluted, followed by sonication at 45 to 60°C, was effective in rendering prions undetectable in Western blot images. Subsequent sterilization in an autoclave improved the results, causing further prion degradation. Protein misfolding cyclic amplification showed that adding a four-minute prevacuum auto-clave cycle produced a less than 5-log to 6-log reduction in infectious prion proteins using a multienzymatic detergent and a 6-log reduction using a protease enzyme detergent. Increasing the autoclave cycle to 18 minutes generated a consistent 6-log reduction for both formulations, which is the accepted benchmark for effective sterilization.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"58 4","pages":"58-66"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11457920/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144004543","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Influence of Water Temperature in Vacuum Pumps Used for Air Removal in Steam Sterilizer.","authors":"Sandoval Barbosa Rodrigues, Lucas Gabriel Correa, Rafael Queiroz de Souza","doi":"10.2345/0899-8205-58.4.81","DOIUrl":"10.2345/0899-8205-58.4.81","url":null,"abstract":"<p><p>The temperature of the water used in vacuum pumps of steam sterilizers has the potential to cause failures in sterilization processes due to reduced efficiency and compromised vacuum levels. This study measured the impact of water temperature on a liquid ring vacuum pump (monobloc design) in a steam sterilizer. A sterilizer with a 566-L chamber was used for the tests. The water temperatures tested were 10°C, 20°C, 30°C, 40°C, and 50°C, and the following outcomes were analyzed: vacuum depth achieved in the drying phase (mbar), total cycle time (min), vacuum rate in the conditioning phase (mbar/s), and water consumption (L). Water temperature influenced the performance of the vacuum pump in all outcomes analyzed. Considering total cycle times, the performance with water at 10°C can be up to 50% better compared with performance with water at 50°C. The highest vacuum rates were obtained with water between 10°C and 20°C (up to 13 and 20.24 mbar/s, respectively). In cycles performed at 10°C, average water consumption was 33.3 L. In contrast, for cycles carried out at 50°C, the average water consumption increased to 94.2 L. The temperature of the water used in vacuum pumps influences the efficiency of sterilization cycles, which can result in longer cycles and higher water consumption.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"58 4","pages":"81-87"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11493151/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143989244","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Improving Protein Assay Methods to More Accurately Assess Medical Device Cleanliness.","authors":"Terra A Kremer, Allan Kimble, Christopher Ratanski","doi":"10.2345/0899-8205-57.4.122","DOIUrl":"10.2345/0899-8205-57.4.122","url":null,"abstract":"<p><p>Protein assays commonly used to evaluate reusable device cleanliness do not always accurately measure the low concentrations of protein that are expected on reusable medical devices after processing. Methods often are adapted to provide an estimation of protein concentration; however, sensitivity issues in the portion of standard curves at the acceptance criteria of 6.4 μg/cm² protein have been reported. Using analytical validation criteria, method improvements for the micro-bicinchoninic acid assay for protein residuals are demonstrated by incorporating a standard addition method, increasing the well volume, and changing the working reagent ratio. These improvements increased method sensitivity and accuracy in the reliable detection of protein levels for device cleaning validations.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"57 4","pages":"122-128"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10764063/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139088869","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Detection of Superheated Steam during Sterilization Using Biological Indicators.","authors":"Brian Kirk, Paulo Laranjeira","doi":"10.2345/0899-8205-57.4.106","DOIUrl":"10.2345/0899-8205-57.4.106","url":null,"abstract":"<p><p>Saturated steam (SS) is used for sterilizing many medical devices. Exposure to SS for appropriate temperature/time combinations creates a microbicidal environment that renders product sterile. Superheated steam (SHS) has been heated beyond its saturation point and is less microbicidal, compromising process efficacy. Sterilization monitoring systems should detect SHS. One method is to use biological indicators (BIs; e.g., rapid-readout self-contained BIs [RRSCBIs]). The purpose of this study was to determine if RRSCBIs can detect SHS. Pressurizing the boiler to 4,700 mB, manifold to 4,000 mB, and chamber jacket to 3,600 mB and heating the viewing window to 150°C in a 10-L BI evaluation resistometer vessel allowed approximately 12°C and 4.5°C of superheat in a nominal 121.75 ± 0.25°C and 132.5 ± 0.25°C cycle, respectively, to be reproducibly achieved. Replicate tests using multiple RRSCBIs from different batches were exposed vertically (cap up), inverted (cap down), and horizontally to SS and SHS. RRSCBI viability was determined using a fluorescent readout method. RRSCBIs exposed to SS at 121.75 ± 0.25°C for 7 or 14 minutes were negative. A total of 135 type A RRSCBIs were exposed to SHS (12°C) at 121.75 ± 0.25°C for 14 minutes. Zero of 45 RRSCBIs mounted vertically showed a positive fluorescent result, 26 of 45 mounted inverted were positive, and 45 of 45 mounted horizontally were positive. A total of 135 type B RRSCBIs were exposed to SHS (12°C) at 121.75 ± 0.25°C for 7 minutes. Twenty-four of 45 mounted vertically were positive, 41 of 45 mounted inverted were positive, and 45 of 45 mounted horizontally were positive. RRSCBIs detected SHS, but this was orientation dependent. Further work is required to establish the application of these findings in healthcare facility settings.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"57 4","pages":"106-116"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10634659/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72015570","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Affinity and Inactivation of Bacterial Endotoxins for Medical Device Materials.","authors":"Allan Kimble, James Hauschild, Gerald McDonnell","doi":"10.2345/0899-8205-57.4.153","DOIUrl":"10.2345/0899-8205-57.4.153","url":null,"abstract":"<p><p>Endotoxins are high-molecular-weight complexes that contain lipopolysaccharide, protein, and phospholipid originating from the outer membrane of gram-negative bacteria. As gram-negative bacteria are naturally present in a variety of sources, endotoxins are commonly identified as contaminants in manufacturing environments. In industrial applications, endotoxin often is considered difficult to inactivate and to have a strong affinity with surfaces resulting from its hydrophobic chemical structure. This article describes the investigation of the true affinity of endotoxin, from various microbial sources in solution, for medical device material surfaces. In addition, endotoxin reduction was investigated with commonly used sterilization methods such as those based on ionizing radiation, dry and moist heat, and ethylene oxide sterilization. Endotoxin activity was found to be reduced following exposure to a range of sterilization modalities with the degree of activity reduction related to the source of endotoxin and the substrate material upon which it was present.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"57 4","pages":"153-162"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10764065/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139088867","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}