Biomedical Instrumentation and Technology最新文献

{"title":"Light for a Potentially Cloudy Situation: Approach to Validating Cloud Computing Tools.","authors":"Michelle Miller, Nicola Zaccheddu","doi":"10.2345/0890-8205-55.1.63","DOIUrl":"https://doi.org/10.2345/0890-8205-55.1.63","url":null,"abstract":"","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43325420","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Innovative Pulse Oximeter Sensor Management Strategy.","authors":"Allan G Palmer","doi":"10.2345/0899-8205-55.2.59","DOIUrl":"https://doi.org/10.2345/0899-8205-55.2.59","url":null,"abstract":"<p><strong>Background: </strong>Following a merger of two children's hospitals, leadership discovered a considerable utilization volume of single-use sensors that was associated with declining hospital reimbursements. This discovery resulted in the establishment of a new sensor management strategy, the goal of which was to decrease costs and waste associated with disposable pulse oximetry sensors.</p><p><strong>Implementation: </strong>The sensor management strategy involved using replacement tapes with single-patient-use pulse oximeter sensors instead of the current practice of reprobing with a new sensor. A 60% utilization goal was set, with the focus shifted from sensors used per patient to replacement tapes per sensor.</p><p><strong>Results: </strong>The implementation of a new sensor management strategy between the years 2006 and 2019 in a hospital system decreased sensor volume by more than 780,000 sensors and realized a cost avoidance of more than 7 million dollars.</p><p><strong>Conclusion: </strong>A sensor management strategy can substantially reduce the cost and medical waste commonly associated with the use of disposable, single-patient pulse oximetry sensors.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8641413/pdf/i0899-8205-55-2-59.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39005999","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 Innovative Pulse Oximeter Sensor Management Strategy.","authors":"A. Palmer","doi":"10.2345/0890-8205-55.2.59","DOIUrl":"https://doi.org/10.2345/0890-8205-55.2.59","url":null,"abstract":"BACKGROUND\u0000Following a merger of two children's hospitals, leadership discovered a considerable utilization volume of single-use sensors that was associated with declining hospital reimbursements. This discovery resulted in the establishment of a new sensor management strategy, the goal of which was to decrease costs and waste associated with disposable pulse oximetry sensors.\u0000\u0000\u0000IMPLEMENTATION\u0000The sensor management strategy involved using replacement tapes with single-patient-use pulse oximeter sensors instead of the current practice of reprobing with a new sensor. A 60% utilization goal was set, with the focus shifted from sensors used per patient to replacement tapes per sensor.\u0000\u0000\u0000RESULTS\u0000The implementation of a new sensor management strategy between the years 2006 and 2019 in a hospital system decreased sensor volume by more than 780,000 sensors and realized a cost avoidance of more than 7 million dollars.\u0000\u0000\u0000CONCLUSION\u0000A sensor management strategy can substantially reduce the cost and medical waste commonly associated with the use of disposable, single-patient pulse oximetry sensors.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47013970","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Medical Device Industry Approaches for Addressing Sources of Failing Cytotoxicity Scores.","authors":"Helin Räägel, Audrey P. Turley, Trevor Fish, Jeralyn J. Franson, Thor S Rollins, Sarah Campbell, Matthew R Jorgensen","doi":"10.2345/0890-8205-55.2.69","DOIUrl":"https://doi.org/10.2345/0890-8205-55.2.69","url":null,"abstract":"To ensure patient safety, medical device manufacturers are required by the Food and Drug Administration and other regulatory bodies to perform biocompatibility evaluations on their devices per standards, such as the AAMI-approved ISO 10993-1:2018 (ANSI/AAMI/ISO 10993-1:2018).However, some of these biological tests (e.g., systemic toxicity studies) have long lead times and are costly, which may hinder the release of new medical devices. In recent years, an alternative method using a risk-based approach for evaluating the toxicity (or biocompatibility) profile of chemicals and materials used in medical devices has become more mainstream. This approach is used as a complement to or substitute for traditional testing methods (e.g., systemic toxicity endpoints). Regardless of the approach, the one test still used routinely in initial screening is the cytotoxicity test, which is based on an in vitro cell culture system to evaluate potential biocompatibility effects of the final finished form of a medical device. However, it is known that this sensitive test is not always compatible with specific materials and can lead to failing cytotoxicity scores and an incorrect assumption of potential biological or toxicological adverse effects. This article discusses the common culprits of in vitro cytotoxicity failures, as well as describes the regulatory-approved methodology for cytotoxicity testing and the approach of using toxicological risk assessment to address clinical relevance of cytotoxicity failures for medical devices. Further, discrepancies among test results from in vitro tests, use of published half-maximal inhibitory concentration data, and the derivation of their relationship to tolerable exposure limits, reference doses, or no observed adverse effect levels are highlighted to demonstrate that although cytotoxicity tests in general are regarded as a useful sensitive screening assays, specific medical device materials are not compatible with these cellular/in vitro systems. For these cases, the results should be analyzed using more clinically relevant approaches (e.g., through chemical analysis or written risk assessment).","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43377618","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Light for a Potentially Cloudy Situation: Approach to Validating Cloud Computing Tools.","authors":"Michelle Miller, Nicola Zaccheddu","doi":"10.2345/0890-8205-55.2.63","DOIUrl":"https://doi.org/10.2345/0890-8205-55.2.63","url":null,"abstract":"","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44040968","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Medical Device Industry Approaches for Addressing Sources of Failing Cytotoxicity Scores.","authors":"Helin Räägel,&nbsp;Audrey Turley,&nbsp;Trevor Fish,&nbsp;Jeralyn Franson,&nbsp;Thor Rollins,&nbsp;Sarah Campbell,&nbsp;Matthew R Jorgensen","doi":"10.2345/0899-8205-55.2.69","DOIUrl":"https://doi.org/10.2345/0899-8205-55.2.69","url":null,"abstract":"<p><p>To ensure patient safety, medical device manufacturers are required by the Food and Drug Administration and other regulatory bodies to perform biocompatibility evaluations on their devices per standards, such as the AAMI-approved ISO 10993-1:2018 (ANSI/AAMI/ISO 10993-1:2018).However, some of these biological tests (e.g., systemic toxicity studies) have long lead times and are costly, which may hinder the release of new medical devices. In recent years, an alternative method using a risk-based approach for evaluating the toxicity (or biocompatibility) profile of chemicals and materials used in medical devices has become more mainstream. This approach is used as a complement to or substitute for traditional testing methods (e.g., systemic toxicity endpoints). Regardless of the approach, the one test still used routinely in initial screening is the cytotoxicity test, which is based on an in vitro cell culture system to evaluate potential biocompatibility effects of the final finished form of a medical device. However, it is known that this sensitive test is not always compatible with specific materials and can lead to failing cytotoxicity scores and an incorrect assumption of potential biological or toxicological adverse effects. This article discusses the common culprits of in vitro cytotoxicity failures, as well as describes the regulatory-approved methodology for cytotoxicity testing and the approach of using toxicological risk assessment to address clinical relevance of cytotoxicity failures for medical devices. Further, discrepancies among test results from in vitro tests, use of published half-maximal inhibitory concentration data, and the derivation of their relationship to tolerable exposure limits, reference doses, or no observed adverse effect levels are highlighted to demonstrate that although cytotoxicity tests in general are regarded as a useful sensitive screening assays, specific medical device materials are not compatible with these cellular/in vitro systems. For these cases, the results should be analyzed using more clinically relevant approaches (e.g., through chemical analysis or written risk assessment).</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8641414/pdf/i0899-8205-55-2-69.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38942926","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 Innovative Pulse Oximeter Sensor Management Strategy.","authors":"A. Palmer","doi":"10.2345/0890-8205-55.1.59","DOIUrl":"https://doi.org/10.2345/0890-8205-55.1.59","url":null,"abstract":"BACKGROUND\u0000Following a merger of two children's hospitals, leadership discovered a considerable utilization volume of single-use sensors that was associated with declining hospital reimbursements. This discovery resulted in the establishment of a new sensor management strategy, the goal of which was to decrease costs and waste associated with disposable pulse oximetry sensors.\u0000\u0000\u0000IMPLEMENTATION\u0000The sensor management strategy involved using replacement tapes with single-patient-use pulse oximeter sensors instead of the current practice of reprobing with a new sensor. A 60% utilization goal was set, with the focus shifted from sensors used per patient to replacement tapes per sensor.\u0000\u0000\u0000RESULTS\u0000The implementation of a new sensor management strategy between the years 2006 and 2019 in a hospital system decreased sensor volume by more than 780,000 sensors and realized a cost avoidance of more than 7 million dollars.\u0000\u0000\u0000CONCLUSION\u0000A sensor management strategy can substantially reduce the cost and medical waste commonly associated with the use of disposable, single-patient pulse oximetry sensors.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43101507","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Light for a Potentially Cloudy Situation: Approach to Validating Cloud Computing Tools.","authors":"Michelle Miller, Nicola Zaccheddu","doi":"10.2345/0899-8205-55.2.63","DOIUrl":"10.2345/0899-8205-55.2.63","url":null,"abstract":"","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8641412/pdf/i0899-8205-55-2-63.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39005998","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":"Connecting Across Competencies: Leveraging Best Practices for Processing.","authors":"Terra A Kremer,&nbsp;Kaumudi Kulkarni,&nbsp;Christopher Ratanski,&nbsp;Lorraine Floyd,&nbsp;Christopher Anderson","doi":"10.2345/0899-8205-55.s3.6","DOIUrl":"https://doi.org/10.2345/0899-8205-55.s3.6","url":null,"abstract":"<p><p>The AAMI working group ST/WG 93 is finalizing a standard (AAMI ST98) for the cleaning validation of reusable medical devices based on guidance from the technical information report AAMI TIR30:2011/(R)2016. A number of analytical best practices are being considered for this new standard. Test method suitability for processing cleaning validations historically has been established using one positive control and performing an extraction efficiency. The new cleaning validation standard is proposed to require a change from only one replicate test sample to three when performing method suitability. This change will affect manufacturers; therefore, the value of and consideration for performing these additional replicates requires explanation. This article discusses how variation of validation parameters can affect the accuracy and precision during method suitability testing. Multiple replicates are needed to understand the variability of method extraction and impact on cleaning validations of reusable medical devices.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8655702/pdf/i0899-8205-55-s3-6.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39253187","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":"Industrial Sterilization: Challenging the Status Quo, Driving for Continuous Improvement.","authors":"Emily Craven,&nbsp;Joyce M Hansen","doi":"10.2345/0899-8205-55.s3.3","DOIUrl":"https://doi.org/10.2345/0899-8205-55.s3.3","url":null,"abstract":"","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8655704/pdf/i0899-8205-55-s3-3.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39259648","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}