Biomedical Instrumentation and Technology最新文献

{"title":"Beyond Endoscopes: Pilot Study of Surgical Instrument Lumen Inspection.","authors":"Krystina M Hopkins, Steven J Adams, Larry A Lamb, Abigail G Smart, Cori L Ofstead","doi":"10.2345/0899-8205-58.1.25","DOIUrl":"10.2345/0899-8205-58.1.25","url":null,"abstract":"<p><p><b><i>Objective:</i></b> Borescope examinations of endoscope channels are commonly described in literature, but no studies on surgical instrument lumen inspection have been published recently. Inadequately processed surgical instruments have been implicated in patient infections. This study assessed the utility of borescopes for inspecting surgical instruments. <b><i>Methods:</i></b> The study team inspected and photographed sterilized, patient-ready arthroscopic shaver handpieces and suction tips using a tablet camera and borescopes to characterize internal anatomy, defects found in lumens, and the impact of recleaning on debris or residues. <b><i>Results:</i></b> Ten suctions and eight shavers were inspected. All suctions had internal ridges and suction holes that were perpendicular to the lumen. All shavers had visible ridges, elbows, and lever mechanisms inside lumens. Of the 18 instruments, 16 (88%) had internal features that appeared rough or jagged and 17 (94%) had visible debris or discoloration in the lumens. Recleaning efforts generally were effective for suctions, but multiple rounds of recleaning with enhanced steps were less effective for shavers, which were replaced. Researchers documented retained soil and brush bristles in several new shavers despite following manufacturer instructions for cleaning and found visible damage and discoloration within five uses. <b><i>Discussion:</i></b> This study demonstrated the value of borescope examinations for surgical instrument lumens. Visual inspections identified anatomical features that could influence cleaning effectiveness and detected residual soil, discoloration, and debris in most instruments. The findings suggested that manufacturer cleaning instructions were insufficient and additional cleaning was not always effective. In response, the site's multidisciplinary team strengthened risk assessment protocols and enhanced their cleaning practices.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"58 1","pages":"25-33"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10878677/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139913594","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":"Effect of Gamma and X-ray Irradiation on Polymers Commonly Used in Healthcare Products.","authors":"Philip Roxby, Hervé Michel, Céline Huart, Samuel Dorey","doi":"10.2345/0899-8205-58.1.7","DOIUrl":"10.2345/0899-8205-58.1.7","url":null,"abstract":"<p><p>Synthetic organic polymers commonly are used in the construction of healthcare product and medical device components. Medical devices often are sterilized to ensure that they are free from viable microorganisms. A common technique to achieve this is using ionizing radiation, usually gamma. A trend exists in industrial sterilization to supplement gamma with alternative accelerator technologies (e.g., X-ray). In the current work, studies were performed to characterize polymer modifications caused by gamma and X-ray sterilization processes and to assess the comparative equivalency. The studies were developed to evaluate two key process parameters: dose and dose rate. Three commonly used polymers were selected: high-density polyethylene, low-density polyethylene, and polypropylene. Four grades of each family were chosen. The dose assessment involved sample exposures to both gamma and X-ray irradiation at two dose levels (30 and 55 kGy). All other processing conditions, including dose rate, were controlled at standard processing levels akin to each sterilization technology. The dose rate assessment expanded on each dose level by introducing two additional dose rate parameters. Subsequent laboratory testing used techniques to characterize physico-chemical properties of the polymers to ascertain equivalency across test groups. Initial results indicated positive levels of equivalency between gamma and X-ray irradiation.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"58 1","pages":"7-17"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10849104/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139698518","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":"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":"https://doi.org/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":"Advantages and Limitations of Physical and Virtual Dose Mapping.","authors":"Nick Brydon","doi":"10.2345/0899-8205-58.2.34","DOIUrl":"https://doi.org/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":"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}

{"title":"Effects of Electron Beam Sterilization on Polytetrafluoroethylene: Design of Experiments Study.","authors":"Rishabh Jain","doi":"10.2345/0899-8205-57.4.117","DOIUrl":"10.2345/0899-8205-57.4.117","url":null,"abstract":"<p><p>Polytetrafluoroethylene (PTFE) is a common polymer used in medical devices due to its exceptional properties (e.g., biocompatibility, inertness, chemical stability, low coefficient of friction). However, as a result of molecular weight reduction caused by the process of chain scission, it is known to be susceptible to radiation exposure and can rapidly lose strength and integrity. In this design of experiments study, the goal was to determine whether an operating window of conditions exist for electron beam (E-beam) radiation sterilization in which the degradation of PTFE is acceptably low. PTFE was tested for yield stress after exposure to radiation under different parameters (total dose [15-60 kGy], packaging atmosphere [air/nitrogen], and poststerilization accelerated aging [real-time equivalent of 1 and 3 years]). The results showed that total dose and packaging atmosphere were significant factors and indicated that the use of modified atmosphere packaging (vacuum sealing with nitrogen gas purge) can be a useful approach in increasing the stability of PTFE toward E-beam sterilization.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"57 4","pages":"117-121"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10764064/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139088868","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}