Pub Date : 2021-05-01DOI: 10.2345/0890-8205-55.2.59
A. Palmer
BACKGROUND 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. IMPLEMENTATION 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. RESULTS 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. CONCLUSION A sensor management strategy can substantially reduce the cost and medical waste commonly associated with the use of disposable, single-patient pulse oximetry sensors.
{"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":" ","pages":"59-62"},"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}
Pub Date : 2021-05-01DOI: 10.2345/0890-8205-55.2.69
Helin Räägel, Audrey P. Turley, Trevor Fish, Jeralyn J. Franson, Thor S Rollins, Sarah Campbell, Matthew R Jorgensen
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).
{"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":"55 2 1","pages":"69-84"},"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}
Pub Date : 2021-05-01DOI: 10.2345/0890-8205-55.2.63
Michelle Miller, Nicola Zaccheddu
{"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":" ","pages":"63-68"},"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}
Pub Date : 2021-05-01DOI: 10.2345/0890-8205-55.1.59
A. Palmer
BACKGROUND 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. IMPLEMENTATION 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. RESULTS 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. CONCLUSION A sensor management strategy can substantially reduce the cost and medical waste commonly associated with the use of disposable, single-patient pulse oximetry sensors.
{"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":"55 2 1","pages":"59-62"},"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}
Pub Date : 2021-01-01DOI: 10.2345/0890-8205-55.1.51
K. Giuliano, Jeannine W C Blake
OBJECTIVE The primary purpose of this research was to describe nurse and pharmacist knowledge of setup requirements for intravenous (IV) smart pumps that require head height differentials for accurate fluid flow. METHODS A secondary analysis of anonymous electronic survey data using a database of prerecruited clinicians was conducted. A survey was sent by email to 173 pharmacists and 960 nurses. The response rate for pharmacists was 58% (100 of 173), and the response rate for nurses was 52% (500 of 960). After removing respondents who did not provide direct care and who did not use a head height differential IV infusion system, the final sample for analysis was 186 nurses and 25 pharmacists. RESULTS Overall, less than one-half of respondents (40%) were aware that manufacturer guidelines for positioning the primary infusion bag relative to the infusion pump were available. Slightly more (49.5%) were aware of the required head height differentials for secondary infusion. Only five respondents selected the correct primary head height, eight respondents selected the correct secondary head height, and one respondent selected both the correct primary and secondary head heights. CONCLUSION The results of this study identify a substantial lack of knowledge among frontline clinicians regarding manufacturer recommendations for accurate IV administration of primary and secondary infusions for head height differential infusion systems. Both increased clinician education and innovative technology solutions are needed to improve IV smart pump safety and usability.
{"title":"Nurse and Pharmacist Knowledge of Intravenous Smart Pump System Setup Requirements.","authors":"K. Giuliano, Jeannine W C Blake","doi":"10.2345/0890-8205-55.1.51","DOIUrl":"https://doi.org/10.2345/0890-8205-55.1.51","url":null,"abstract":"OBJECTIVE\u0000The primary purpose of this research was to describe nurse and pharmacist knowledge of setup requirements for intravenous (IV) smart pumps that require head height differentials for accurate fluid flow.\u0000\u0000\u0000METHODS\u0000A secondary analysis of anonymous electronic survey data using a database of prerecruited clinicians was conducted. A survey was sent by email to 173 pharmacists and 960 nurses. The response rate for pharmacists was 58% (100 of 173), and the response rate for nurses was 52% (500 of 960). After removing respondents who did not provide direct care and who did not use a head height differential IV infusion system, the final sample for analysis was 186 nurses and 25 pharmacists.\u0000\u0000\u0000RESULTS\u0000Overall, less than one-half of respondents (40%) were aware that manufacturer guidelines for positioning the primary infusion bag relative to the infusion pump were available. Slightly more (49.5%) were aware of the required head height differentials for secondary infusion. Only five respondents selected the correct primary head height, eight respondents selected the correct secondary head height, and one respondent selected both the correct primary and secondary head heights.\u0000\u0000\u0000CONCLUSION\u0000The results of this study identify a substantial lack of knowledge among frontline clinicians regarding manufacturer recommendations for accurate IV administration of primary and secondary infusions for head height differential infusion systems. Both increased clinician education and innovative technology solutions are needed to improve IV smart pump safety and usability.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"55 1 1","pages":"51-58"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45528697","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}
Pub Date : 2021-01-01DOI: 10.2345/0890-8205-55.1.41
R. Naftalovich, S. Char, Andrew Iskander, D. Naftalovich
Split septum medical devices are used in tubing for intravenous (IV) fluid administration-an extremely common clinical task. These tubing caps contain a needleless, valveless system that allows fluid to flow directly through the lumen of the catheter but prevents backflow of fluid or blood when the tubing extension is not connected. We experienced complete failure of a needle-free connector extension set with a Luer-access split septum device in multiple patients due to the split septum remaining fused and essentially unsplit despite being connected on both ends. This led to an adverse event in a patient due to repeated unnecessary IV insertion attempts. This case shows how even the simplest of devices can malfunction and highlights the need for vigilance in clinical practice.
{"title":"Even the Simplest Devices May Malfunction: Split Septum Design Revisited.","authors":"R. Naftalovich, S. Char, Andrew Iskander, D. Naftalovich","doi":"10.2345/0890-8205-55.1.41","DOIUrl":"https://doi.org/10.2345/0890-8205-55.1.41","url":null,"abstract":"Split septum medical devices are used in tubing for intravenous (IV) fluid administration-an extremely common clinical task. These tubing caps contain a needleless, valveless system that allows fluid to flow directly through the lumen of the catheter but prevents backflow of fluid or blood when the tubing extension is not connected. We experienced complete failure of a needle-free connector extension set with a Luer-access split septum device in multiple patients due to the split septum remaining fused and essentially unsplit despite being connected on both ends. This led to an adverse event in a patient due to repeated unnecessary IV insertion attempts. This case shows how even the simplest of devices can malfunction and highlights the need for vigilance in clinical practice.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"55 1 1","pages":"41-43"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43279393","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}
Pub Date : 2020-06-01DOI: 10.2345/0899-8205-54.s3.3
E. Craven, Andre Tuggles, J. McLaren
{"title":"Introduction","authors":"E. Craven, Andre Tuggles, J. McLaren","doi":"10.2345/0899-8205-54.s3.3","DOIUrl":"https://doi.org/10.2345/0899-8205-54.s3.3","url":null,"abstract":"","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42571643","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}
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：