{"title":"A Look at PPE-Related Challenges and Perceptions from the Frontlines of the COVID-19 Crisis.","authors":"Jacqueline Daley","doi":"10.2345/0899-8205-57.s1.1","DOIUrl":"10.2345/0899-8205-57.s1.1","url":null,"abstract":"","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10512994/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9421990","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}
Meena Andiappan, Lucas Dufour, Senthujan Senkaiahliyan
{"title":"Addressing Burnout among Healthcare Technology Management Professionals.","authors":"Meena Andiappan, Lucas Dufour, Senthujan Senkaiahliyan","doi":"10.2345/0899-8205-57.3.75","DOIUrl":"10.2345/0899-8205-57.3.75","url":null,"abstract":"<p><p>This article suggests ways in which healthcare delivery organizations (HDOs) may address and mitigate burnout among healthcare technology management (HTM) professionals. Burnout is defined as a state of emotional and physical exhaustion resulting from workplace stressors. Although not intended to be a fully comprehensive empirical analysis of causes of burnout, this article discusses four likely causes for burnout that are particularly relevant to HTM professionals in HDOs: (1) gaps in developing a trained and sustainable workforce, (2) growing demand for HTM expertise across knowledge domains, (3) increasing occupational stressors related to patient safety, and (4) perceived lack of understanding of employee needs. Next, based on existing literature, the article proposes four possible solutions in response to each of these issues: (1) developing human resource planning and mentoring to ensure adequate transfer of skills and knowledge, (2) implementing ways to accomplish knowledge filtering, (3) integrating HTM workers in quality improvement initiatives, and (4) implementing employee voice practices. The article concludes by discussing the possible benefits that may be derived from implementing these solutions.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10508863/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10081139","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}
Terra A Kremer, Allan Kimble, Christopher Ratanski
{"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/cm<sup>2</sup> 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":null,"pages":null},"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":"Endotoxin Is Inactivated by Ethylene Oxide, Gamma, Electron Beam, and Steam Sterilization.","authors":"Nick Brydon","doi":"10.2345/0899-8205-57.3.98","DOIUrl":"10.2345/0899-8205-57.3.98","url":null,"abstract":"<p><p>The effect of sterilization on bacterial endotoxin is receiving greater attention within the medical device industry. Contributing factors to this increased attention include the growing popularity of transferring devices among sterilization modalities and the focus on aspects of microbiological quality other than sterilization. This systematic review examined the effects of sterilization on bacterial endotoxin, with attention drawn to industry standards and regulations to elucidate whether such documents are aligned with published data. In summary, numerous experiments have shown a reduction in pyrogenicity and/or limulus amebocyte lysate reactivity of endotoxin following sterilization, whereas a number of publications and industry standards have claimed (without data or references) that sterilization does not inactivate endotoxin. The results of this review would be useful for device manufacturers when selecting a sterilization modality or deciding whether to test for endotoxin pre- vs poststerilization, as well as for standards developers and regulators in aligning standards and regulations with peer-reviewed data.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10512995/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10121546","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}
George Tewfik, Rotem Naftalovich, Jasvir Kaila, Adejuyigbe Adaralegbe
{"title":"ChatGPT and Its Potential Implications for Clinical Practice: An Anesthesiology Perspective.","authors":"George Tewfik, Rotem Naftalovich, Jasvir Kaila, Adejuyigbe Adaralegbe","doi":"10.2345/0899-8205-57.1.26","DOIUrl":"10.2345/0899-8205-57.1.26","url":null,"abstract":"","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10508852/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9838362","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}
Trabue D Bryans, Cathy Leckwart, Hudson Barco Dos Santos
{"title":"Bioburden Method Suitability: A Practical Solution to Screening for Inhibition.","authors":"Trabue D Bryans, Cathy Leckwart, Hudson Barco Dos Santos","doi":"10.2345/0899-8205-57.3.81","DOIUrl":"10.2345/0899-8205-57.3.81","url":null,"abstract":"<p><p>ANSI/AAMI/ISO 11737-1:2018 addresses validation of the method for determination of bioburden. Clause 7 states that validation shall consist of four items, one of which is \"assessment of test method suitability to demonstrate lack of inhibition of growth.\" Information must be provided, either through a rationale or via testing, showing that no inhibitory properties from the product exist in the specified bioburden test. However, the standard has no guidance on specific test methods for this particular purpose. Therefore, a simple bioburden suitability screening presented here could be used to quickly assess whether a product that is tested for bioburden has inhibitory substances that would be manifested in the bioburden test. The screening procedure uses a vegetative microorganism, <i>Staphylococcus aureus</i>, inoculated onto the product or into the extract solution, followed by the bioburden test procedure. A recovery of 70% or greater is recommended as acceptable for confirming the bioburden test Suitability.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10512993/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10081138","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 Time, Temperature, and Humidity on Soil Drying on Medical Devices.","authors":"Terra A Kremer, Christopher Carfaro, Sue Klacik","doi":"10.2345/0899-8205-57.2.58","DOIUrl":"10.2345/0899-8205-57.2.58","url":null,"abstract":"<p><p>In the healthcare environment, delays can occur that prevent reusable devices from being processed within the specified time outlined in manufacturers' instructions for use. It has been suggested in the literature and industry standards that residual soil components, such as proteins, may undergo a chemical change when they are exposed to heat or experience prolonged drying times under ambient conditions. However, little experimental data are available in the literature to document this change or how is may be addressed for cleaning efficacy. This study presents the effects of time and environmental conditions on contaminated instrumentation from the point of use until the cleaning process begins. It demonstrates that soil drying after a period of eight hours changes the solubility of the soil complex, with a significant change occurring after 72 hours. Temperature also contributes to chemical changes in protein. Although no significant difference occurred between 4°C and 22°C, temperatures greater than 22°C demonstrated a decrease in soil solubility in water. An increase in humidity prevented the soil from completely drying and prevented the chemical changes affecting solubility from occurring.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10512989/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10050253","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":null,"pages":null},"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":"What's on the Horizon for HDO Sterilization Guidance? WG 40 Co-chairs Weigh In.","authors":"Sarah Friedberg, Susan G Klacik","doi":"10.2345/0899-8205-57.s1.18","DOIUrl":"10.2345/0899-8205-57.s1.18","url":null,"abstract":"","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10508854/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9421988","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":"Endoscope Processing FAQs.","authors":"Garland-Rhea Grisby, Petra M Richards","doi":"10.2345/0899-8205-57.s1.20","DOIUrl":"10.2345/0899-8205-57.s1.20","url":null,"abstract":"","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10512979/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9504003","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}