Biomedical Instrumentation and Technology最新文献

{"title":"Parametric Process Control for Ethylene Oxide Sterilization: Data-Driven Release.","authors":"Brian McEvoy, Terri Guaschi Cooke, Ana Maksimovic, Daniel Howell","doi":"10.2345/0899-8205-59.1.99","DOIUrl":"10.2345/0899-8205-59.1.99","url":null,"abstract":"<p><p>In ethylene oxide (EO) sterilization processing, products can be released based on the growth responses of biological indicators or by using a parametric release (PR) process that relies on the monitoring and control of process parameters. Both methods must be used in combination with process data, in accordance with ISO 11135:2014. Process parameters can be classified as control, monitor, or both. Control parameters can be altered directly to change the readings of monitoring variables, which can't be directly controlled themselves. Currently, ISO 11135:2014 does not allow PR based on control parameters for EO concentration and humidity (calculated via pressure increment). Sterilant concentration and relative humidity (RH) can only be measured using gas analyzer probes (or similar), despite the challenges of data variance and range, calibration, redundancy, and increased sensitivity to deviations involved with use of such probes. The current article sought to experimentally determine the capacity of statistical process control to detect changes in the process, to act as an early-warning system for an out-of-specification result, and to demonstrate the use of more reliable process data for the purpose of PR. Process data from 100 routine cycles were used to trend the achieved levels of chamber RH, temperature, and EO concentration (measured by gas analyzer probes or similar), and process derived data were compared with data provided by gas analyzer probes. Process trending of routine runs was found to predict process failures, and calculating EO/water concentration via pressure increment was determined to be a viable alternative to measurement by gas analyzer probe. Further, reduced variability in key parameters enables a reduction in sterilant use.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"59 1","pages":"99-107"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12007836/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144040281","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":"Clinical Experience with Disposable Isolation Gown Selection, Strikethrough, and Reporting.","authors":"Karen Haberland, Julie Miller, Amanda Sivek, James Davis, Jeremy Suggs","doi":"10.2345/0899-8205-59.1.117","DOIUrl":"10.2345/0899-8205-59.1.117","url":null,"abstract":"<p><p><b><i>Objectives:</i></b> This study sought to investigate whether and to what extent fluid strikethrough for disposable isolation gowns is underreported and to identify areas for improving healthcare worker (HCW) understanding of gown performance. <b><i>Methods:</i></b> Researchers developed a confidential, qualitative, online disposable isolation gown user experience survey with an intended audience of HCWs with experience either wearing disposable isolation gowns or selecting them for purchase. The unrestricted survey link was distributed from February to March 2024. <b><i>Results:</i></b> A total of 211 individuals completed the survey. When asked about selection, purchasers most frequently chose to purchase level 2 isolation gowns for patient care during nonsurgical applications. More than 40% of wearers stated that they did not have a choice regarding gown protection levels when donning personal protective equipment for patient care, and 34.3% experienced fluid strikethrough (i.e., penetration of fluid through a disposable isolation gown), yet nearly one-half never reported this problem. <b><i>Discussion and Conclusion</i></b>: To enhance safety, the healthcare community must work together to improve guidance on gown performance and selection based on fluid exposure risk. Frequent, underreported strikethrough incidents highlighted confusion among HCWs regarding gown classification and appropriate usage. A need exists for a unified, task-based framework that clearly links gown performance with clinical risk. Fostering a culture that normalizes reporting issues-while minimizing staff burden-combined with targeted education and streamlined reporting mechanisms, will enable more informed decision making and reinforce infection prevention efforts.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"59 1","pages":"117-127"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12154864/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144267451","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":"Assessing the Impact of End-of-Life Processing on Reusable Medical Devices.","authors":"Alpa N Patel, Daniel Olsen","doi":"10.2345/0899-8205-59.1.128","DOIUrl":"10.2345/0899-8205-59.1.128","url":null,"abstract":"<p><p>End-of-life (EOL) testing requirements for reusable medical devices continue to cause confusion in the medical device industry. Regulatory expectations from U.S. and European Union authorities differ, particularly regarding whether manufacturers must conduct EOL testing or if a cautionary statement in the instructions for use is sufficient. ISO 10993-1:2021 mandates biological safety evaluations for the maximum validated number of processing cycles. Similarly, ISO 17664-1:2021, regulation (EU) 2017/745, and Food and Drug Administration guidance require manufacturers to determine whether repeated processing causes degradation that could limit a device's usable life. However, these documents provide limited direction on how to perform such assessments, leaving a gap in standardized methodology. This study aimed to develop a practical and reproducible protocol for EOL evaluation, reflecting real-world clinical use and manufacturer-recommended processing instructions. The primary objective was to assess whether biological or chemical residues remained on devices after repeated use and processing. A theoretical estimate of 100 use and processing cycles was used, representing a reasonable service life based on routine clinical conditions. A simulated 100-cycle protocol, including soiling, cleaning, and sterilization testing, revealed negligible to nondetectable residual contaminants on both surrogate coupons and actual devices. These results suggest that even under worst-case conditions, devices can be processed effectively without substantial accumulation of contaminants, supporting the selected EOL threshold. This approach offers a reproducible framework for manufacturers to evaluate and validate EOL claims, addressing a critical regulatory and practical challenge.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"59 1","pages":"128-135"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12154862/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144267450","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":"Evaluating Disposable Isolation Gown Liquid Barrier Test Methods for Relevance to Healthcare.","authors":"Karen Haberland, Julie Miller, James Davis, Mukui Mutunga, Jeremy Suggs","doi":"10.2345/0899-8205-59.1.108","DOIUrl":"10.2345/0899-8205-59.1.108","url":null,"abstract":"<p><p>Healthcare staff rely on isolation gowns to provide a degree of protection against cross contamination from blood or body fluids. Gowns that meet standardized liquid barrier penetration test methods provide staff with a presumed assurance of safety. However, these test methods-namely impact penetration and resistance to hydrostatic pressure-were not drafted with personal protective equipment in mind and therefore may be inappropriate for testing products intended for use in a healthcare environment. This study found that adjusting testing parameters to better simulate clinical conditions altered the measured performance outcomes of the gowns. Specifically, increasing the temperature of the gown material's preconditioning environment or test liquid resulted in statistically significant variations in results. Further, although hydrostatic pressure resistance is measured by the appearance of a third liquid droplet on the inner surface of the gown material, the first two droplets appeared at significantly lower pressures and likely would constitute contamination of healthcare staff. The results indicated that current isolation gown test protocols and regulations should be reevaluated to more accurately reflect healthcare scenarios and improve alignment with expected barrier performance.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"59 1","pages":"108-116"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12154863/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144267452","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":"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":"&lt;p&gt;&lt;p&gt;&lt;b&gt;&lt;i&gt;Background:&lt;/i&gt;&lt;/b&gt; 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. &lt;b&gt;&lt;i&gt;Methods:&lt;/i&gt;&lt;/b&gt; 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. &lt;b&gt;&lt;i&gt;Results:&lt;/i&gt;&lt;/b&gt; 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. &lt;b&gt;&lt;i&gt;Conclusion:&lt;/i&gt;&lt;/b&gt; 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.&lt;sup&gt;1&lt;/sup&gt;&lt;sup&gt;-&lt;/sup&gt;&lt;sup&gt;8&lt;/sup&gt; Microbes found in endoscopes include high-concern organisms (e.g., multidrug-resistant microbes and pathogens) that have been linked to endoscopy-associated outbreaks.&lt;sup&gt;9&lt;/sup&gt;&lt;sup&gt;-&lt;/sup&gt;&lt;sup&gt;12&lt;/sup&gt; 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.&lt;sup&gt;13&lt;/sup&gt;&lt;sup&gt;,&lt;/sup&gt;&lt;sup&gt;14&lt;/sup&gt; Several studies by Ofstead and colleagues&lt;sup&gt;6&lt;/sup&gt;&lt;sup&gt;,&lt;/sup&gt;&lt;sup&gt;15&lt;/sup&gt;&lt;sup&gt;,&lt;/sup&gt;&lt;sup&gt;16&lt;/sup&gt; 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).&lt;sup&gt;6&lt;/sup&gt; Other studies also found protein in 100% of manually cleaned bronchoscopes (range 2-30 μg/mL) and sterilized ureteroscopes (range 9-32 μg/mL).&lt;sup&gt;15&lt;/sup&gt;&lt;sup&gt;,&lt;/sup&gt;&lt;sup&gt;16&lt;/sup&gt; 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}