Biomedical Instrumentation and Technology最新文献

{"title":"Comparison of Sampling Methods for Detecting Protein in Gastrointestinal Endoscopes.","authors":"Krystina M Hopkins, Abigail G Smart, Aaron L Preston, Charesse Y James, Jill E Holdsworth, Larry A Lamb, Kari L Love, Cori L Ofstead","doi":"10.2345/0899-8205-58.3.49","DOIUrl":"10.2345/0899-8205-58.3.49","url":null,"abstract":"<p><p><b><i>Background:</i></b> Persistent microbial contamination of flexible endoscopes has been linked to infections and outbreaks. Valid and reliable sampling methods are critical for monitoring processing effectiveness in flexible endoscopes. In this study, the effectiveness of protein extraction via turbulent fluid flow (TFF) sampling was compared with flush-only sampling in manually cleaned gastrointestinal endoscopes. <b><i>Methods:</i></b> A crossover study design, in which both sampling methods were used in alternating order during each endoscope encounter, was utilized to assess protein levels after colonoscopes and gastroscopes underwent manual cleaning. Endoscope channels were sampled with 20 mL sterile water using TFF and flush-only methods. Protein levels were quantified using a spectrophotometer. <b><i>Results:</i></b> Protein samples were collected during a total of 40 encounters with 20 unique endoscopes (19 colonoscopes and 21 gastroscopes) following procedural use. More effluent was captured following TFF (20-30 mL) compared with flush-only (19-21 mL) sampling. Zero samples had detectable protein after flush-only sampling, and nine samples (22.5%; two gastroscopes and seven colonoscopes) had detectable protein following TFF sampling (range 1-4 μg/mL). Of those, four exceeded the 2 μg/mL study threshold for recleaning after the first cleaning and three of four dropped to 2 μg/mL or less after recleaning. <b><i>Conclusion:</i></b> TFF sampling of the entire suction-biopsy channel allowed the detection of residual protein in nine gastrointestinal endoscopes, whereas no protein was detected in samples obtained by manually flushing the instrument channel. More research is needed to characterize the real-world utility of using the TFF system to verify whether soil and bioburden have been effectively removed during processing. Numerous studies have documented that a majority of fully processed, patient-ready endoscopes harbor microbes.<sup>1</sup><sup>-</sup><sup>8</sup> Microbes found in endoscopes include high-concern organisms (e.g., multidrug-resistant microbes and pathogens) that have been linked to endoscopy-associated outbreaks.<sup>9</sup><sup>-</sup><sup>12</sup> In these outbreaks, visible residual soil was discovered during the outbreak investigation. Current guidelines and standards note that effectively cleaning endoscopes is critical to the success of high-level disinfection (HLD) and sterilization.<sup>13</sup><sup>,</sup><sup>14</sup> Several studies by Ofstead and colleagues<sup>6</sup><sup>,</sup><sup>15</sup><sup>,</sup><sup>16</sup> have documented high protein levels on endoscopes. A study involving colonoscopes and gastroscopes detected protein on 100% of manually cleaned endoscopes (range 3-11 μg/mL).<sup>6</sup> Other studies also found protein in 100% of manually cleaned bronchoscopes (range 2-30 μg/mL) and sterilized ureteroscopes (range 9-32 μg/mL).<sup>15</sup><sup>,</sup><sup>16</sup> These contamination ","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"58 3","pages":"49-57"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11360884/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144056857","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":"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":"Evaluation of Novel Antimicrobial Material to Prevent Biofilm Formation in Medical Devices.","authors":"Paulo Laranjeira, William H Leiva-Perez, Jorge M Zuniga","doi":"10.2345/0899-8205-58.3.43","DOIUrl":"10.2345/0899-8205-58.3.43","url":null,"abstract":"<p><p>The advancement of novel materials and manufacturing technologies offer opportunities to explore new applications in the space of medical devices. Among these advances, biobased polymers with antimicrobial activity can be used to develop prototypes by additive manufacturing, thereby enabling further exploration with benefits to time and cost. The objective of this research was to assess the effectiveness of polylactic acid (PLA) biopolymer embedded with a copper-based composite (active PLA) to reduce and prevent bacterial growth of microorganisms of concern that may lead to the formation of biofilms. The research was carried out by manufacturing coupons of active PLA using additive manufacturing to test the growth or lack thereof of microorganisms known to form biofilms in medical devices, particularly those with narrow lumens. Testing showed 99.99% antimicrobial effectiveness in reducing Pseudomonas aeruginosa (9027), Escherichia coli (8739), and Klebsiella pneumoniae (4352) growth after 24 hours of exposure. The results confirm the effectiveness of active PLA in preventing microbial growth, which opens the possibility of its use for other medical device applications. Further testing is required, particularly regarding toxicological aspects and potential concerns about the size of copper particles.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"58 3","pages":"43-48"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11205206/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144004375","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":"Finding the Waste: Parts Inventory Analysis Using Lean Methodology.","authors":"Marie-Ange Janvier, Andrew A M Ibey, Kajal Madhusudan, Ishtar Al-Tahir, Mark R Asbil, Kim Greenwood","doi":"10.2345/0899-8205-58.4.72","DOIUrl":"10.2345/0899-8205-58.4.72","url":null,"abstract":"<p><p>During a 12-year period (2011-23), the number of staff in the Clinical Engineering (CE) Department at the Children's Hospital of Eastern Ontario (CHEO) increased from five to more than 20 biomedical equipment technicians/technologists. However, despite this increase in staff, processes did not evolve and procedures that used modern technological and shipping advances were not implemented. The absence of standardized procurement and inventory processes for parts created discrepancies between on-hand inventory and the computerized maintenance management system (CMMS). Owing to inaccurate CMMS information and unsystematic parts documentation, time and money were wasted. This situation led to a lack of confidence in CMMS data, causing staff disengagement, loss of accountability, and limited parts tracking. The current article describes a project that used Lean methodologies and use of the define, measure, analyze, improve, and control structure, including tools such as interviews, a survey, process mapping, and Gemba walks, to create a list of prioritized problems. A total of 16 problems were formulated, four of which were identified as prerequisites to be implemented regardless of prioritization. The four prerequisites described the scope of each problem and potential solutions. The goal of this process was to create a workflow that could save time and money while improving the morale of stakeholders involved in the parts procurement and inventory process.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"58 4","pages":"72-80"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11493152/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144032449","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":"Health Technology Assessment in U.S. Hospitals: A Qualitative Study.","authors":"Scott Skinner","doi":"10.2345/0899-8205-58.4.67","DOIUrl":"10.2345/0899-8205-58.4.67","url":null,"abstract":"<p><p><b><i>Objective:</i></b> The processes of evaluating and selecting health technologies in hospitals have been extensively explored. However, few studies have been specific to U.S. hospitals, and none has approached the subject from the perspective of clinical engineering (CE)/healthcare technology management (HTM) professionals. This study specifically explored the intraorganizational phenomenon of how electronic medical equipment (EME) is evaluated and selected in U.S. hospitals from the perspective of CE/HTM professionals. <b><i>Methods:</i></b> The study was qualitative, incorporating semistructured interviews conducted with 10 CE/HTM professionals. Interviews were carried out via Internet conferencing and recorded. The recordings were transcribed and the transcripts analyzed using the constant comparative method and grounded theory. <b><i>Results:</i></b> Participants were able to describe details of the intraorganizational processes used to evaluate and select EME within their hospitals. Themes that emerged included coronavirus disease 2019 impact, growing influence over time, multidisciplinary committees, negative outcomes, organizational factors, and process definition/exceptions. <b><i>Conclusion:</i></b> This study found a variety of recurring themes associated with the evaluation and selection processes for EME from the perspective of CE/HTM professionals in U.S. hospitals. Participants had varying degrees of power and influence with the processes. The themes may inform CE/HTM professionals seeking to grow their involvement with such processes.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"58 4","pages":"67-71"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11482723/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144050438","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":"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}