Jesson Yeh, Diana Valencia, Sue Ballek, Christopher R. Curtin, Allyson, Marshall-Hudson, Michael, Tuley, Angela, Karpf
Highlights Abstract Aim: Acceptability, usability, and overall ease of use of a safety engineered peripherally inserted intravenous catheter with blood control septum (PIVCBC) were evaluated among clinicians who frequently use peripherally inserted intravenous catheters (PIVCs). This study was conducted in healthy subjects at a Phase 1 facility. Methods: Participating clinicians were ≥18 years of age, employed in a clinical setting, and performed ≥3 PIVC insertions per week. Each clinician completed 6 PIVCBC procedures on 2 to 4 healthy human subjects. Multiple trained observers documented how many attempts it took for the clinician to get a successful stick and what vein was selected for the procedure. Clinicians responded to yes/no questions and to Likert scale statements, describing their experiences with the PIVCBC after the procedures. Video recordings were used to observe procedures. Questionnaire data was summarized by frequency and percent of responses; analyses were conducted using binomial statistics. Results: Clinician agreement ranged from 83% to 97% for: able to observe primary and secondary flashbacks, able to use their regular PIVC insertion technique, found the catheter easy to insert, able to easily remove the needle from the catheter hub, believed the catheter would protect them from blood exposure during insertion, and able to flush the catheter. Overall, 96.7% of the clinicians found the PIVCBC to be acceptable. Conclusions: Overall, the PIVCBC was acceptable, easy to use, and allowed clinicians to maintain their usual PIVC insertion technique while they felt protected from blood exposure during insertion of the catheter.
{"title":"Clinician Acceptability of a Peripheral Intravenous Passive Safety Catheter with Blood Control: Practical Use Article","authors":"Jesson Yeh, Diana Valencia, Sue Ballek, Christopher R. Curtin, Allyson, Marshall-Hudson, Michael, Tuley, Angela, Karpf","doi":"10.2309/java-d-23-00003","DOIUrl":"https://doi.org/10.2309/java-d-23-00003","url":null,"abstract":"Highlights Abstract Aim: Acceptability, usability, and overall ease of use of a safety engineered peripherally inserted intravenous catheter with blood control septum (PIVCBC) were evaluated among clinicians who frequently use peripherally inserted intravenous catheters (PIVCs). This study was conducted in healthy subjects at a Phase 1 facility. Methods: Participating clinicians were ≥18 years of age, employed in a clinical setting, and performed ≥3 PIVC insertions per week. Each clinician completed 6 PIVCBC procedures on 2 to 4 healthy human subjects. Multiple trained observers documented how many attempts it took for the clinician to get a successful stick and what vein was selected for the procedure. Clinicians responded to yes/no questions and to Likert scale statements, describing their experiences with the PIVCBC after the procedures. Video recordings were used to observe procedures. Questionnaire data was summarized by frequency and percent of responses; analyses were conducted using binomial statistics. Results: Clinician agreement ranged from 83% to 97% for: able to observe primary and secondary flashbacks, able to use their regular PIVC insertion technique, found the catheter easy to insert, able to easily remove the needle from the catheter hub, believed the catheter would protect them from blood exposure during insertion, and able to flush the catheter. Overall, 96.7% of the clinicians found the PIVCBC to be acceptable. Conclusions: Overall, the PIVCBC was acceptable, easy to use, and allowed clinicians to maintain their usual PIVC insertion technique while they felt protected from blood exposure during insertion of the catheter.","PeriodicalId":35321,"journal":{"name":"JAVA - Journal of the Association for Vascular Access","volume":"41 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134995590","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}
Gregory E. Gilbert, Lisa A. Paganotti, Ashley E. Franklin, Eric B. Bauman
An educational column by Health care professionals make a difference in patient care in many sustentative ways within the health care paradigm.1–4 Statisticians, peer reviewers, and health professions faculty contribute to anecdotal evidence which suggests that there is confusion related to misinformation concerning the methodology of quality improvement (QI) projects. Some clinicians perceive methodology as the discriminating factor that distinguishes QI projects from human subjects research (HSR). However, this distinction should be determined by the scope of the scholarly activity. The misunderstanding comes from how QI fits within the broader context of scholarly activity and the HSR model. In this article, the distinction between QI and HSR is made with the goal of explaining the differences between the two and eliminating misconceptions regarding QI.Scholarship is defined as, “… the generation, synthesis, translation, application, and dissemination of knowledge that aims to improve health and transform health care” (p. 2).5 The Oxford Learner’s Dictionary defines research as, “a careful study of a subject, especially in order to discover new facts or information about it”.6 Melnyk and Fineout-Overholt differentiate QI from HSR as, “[QI is] identify[ing] and fix[ing] processes leading to an internal problem within the clinical setting, whereas the … human subjects research … generates new knowledge/external evidence” (p. 42).7 Thus, scholarly health care practice is characterized by both discovery and application of new discoveries in increasingly complex practice situations.QI projects improve health care function and processes. Contextually finding a better way to do something is discovery and provides novel information in the same vein as discovering new facts does. QI is research within the context of health care research even if it does not involve human subjects. When scholars use evidence-based programs or national guidelines, they should disseminate outcomes of guideline implementation for the benefit of other clinicians and ultimately patient care.QI falls under implementation science, improvement science, or translational science. “Implementation science is the study of methods to promote the systematic uptake of clinical research findings and other evidence-based practices into routine practice, and hence to improve the quality (effectiveness, reliability, safety, appropriateness, equity, efficiency) of health care”.8 Implementation science underscores rapid-cycle testing in order to learn about change and begin improvement.9 Improvement science diverts from the HSR after defining the research question. Instead of hypothesis testing, health care professionals define what is considered improvement and continue with rapid-cycle testing guided by subject matter experts.9,10 QI has a lot in common with HSR because it is dependent on the same qualitative and quantitative methods used in HSR.11Because HSR and QI share methodologies, cli
{"title":"The Difference between Quality Improvement and Human Subject Research: Foundational Support","authors":"Gregory E. Gilbert, Lisa A. Paganotti, Ashley E. Franklin, Eric B. Bauman","doi":"10.2309/java-d-230002","DOIUrl":"https://doi.org/10.2309/java-d-230002","url":null,"abstract":"An educational column by Health care professionals make a difference in patient care in many sustentative ways within the health care paradigm.1–4 Statisticians, peer reviewers, and health professions faculty contribute to anecdotal evidence which suggests that there is confusion related to misinformation concerning the methodology of quality improvement (QI) projects. Some clinicians perceive methodology as the discriminating factor that distinguishes QI projects from human subjects research (HSR). However, this distinction should be determined by the scope of the scholarly activity. The misunderstanding comes from how QI fits within the broader context of scholarly activity and the HSR model. In this article, the distinction between QI and HSR is made with the goal of explaining the differences between the two and eliminating misconceptions regarding QI.Scholarship is defined as, “… the generation, synthesis, translation, application, and dissemination of knowledge that aims to improve health and transform health care” (p. 2).5 The Oxford Learner’s Dictionary defines research as, “a careful study of a subject, especially in order to discover new facts or information about it”.6 Melnyk and Fineout-Overholt differentiate QI from HSR as, “[QI is] identify[ing] and fix[ing] processes leading to an internal problem within the clinical setting, whereas the … human subjects research … generates new knowledge/external evidence” (p. 42).7 Thus, scholarly health care practice is characterized by both discovery and application of new discoveries in increasingly complex practice situations.QI projects improve health care function and processes. Contextually finding a better way to do something is discovery and provides novel information in the same vein as discovering new facts does. QI is research within the context of health care research even if it does not involve human subjects. When scholars use evidence-based programs or national guidelines, they should disseminate outcomes of guideline implementation for the benefit of other clinicians and ultimately patient care.QI falls under implementation science, improvement science, or translational science. “Implementation science is the study of methods to promote the systematic uptake of clinical research findings and other evidence-based practices into routine practice, and hence to improve the quality (effectiveness, reliability, safety, appropriateness, equity, efficiency) of health care”.8 Implementation science underscores rapid-cycle testing in order to learn about change and begin improvement.9 Improvement science diverts from the HSR after defining the research question. Instead of hypothesis testing, health care professionals define what is considered improvement and continue with rapid-cycle testing guided by subject matter experts.9,10 QI has a lot in common with HSR because it is dependent on the same qualitative and quantitative methods used in HSR.11Because HSR and QI share methodologies, cli","PeriodicalId":35321,"journal":{"name":"JAVA - Journal of the Association for Vascular Access","volume":"41 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134995585","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 : 2023-09-01DOI: 10.2309/java-2023-28-02-00
Amy Bardin-Spencer
In today’s health care landscape, vascular access teams (VATs) are often tapped to increase appropriate device utility or independently seek ways to insert various central venous access devices (CVADs) not limited to peripherally inserted central catheters (PICCs). This includes all models of VAT models (APRN, NPs, RN, RT, RRT) seeking to provide a dedicated resource when a PICC is not appropriate for the patient. This is especially important when an alternative CVAD is indicated based on medication characteristics, duration of therapies, or anatomical limitations.1 As a resource dedicated to vascular access, it is critical that you have the ability and autonomy to assess and select the most appropriate device every time.2 Equally as important is that CVAD insertion is performed by an expert, using ultrasound with appropriate training, competency, and procedural volume while utilizing best practices.1,3Many clinicians take to social media to ask how to get started and who to ask. Prior to that step, the team should have a well-documented need to justify this clinical advancement. With that, let us review the minimal required considerations. Initially, it is important to identify the gaps within your organization—there are 2 significant gaps to outline to ensure the possible advancement supports the overall organizational goals.First, identify if a gap currently exists in an underresourced care area, patient population, or delay in care. For teams that track clinical outcome data closely, this could be easily identified based on device appropriateness documentation. This requires that your organization utilizes a standardized methodology for device selection and honest recognition when an alternate CVAD is indicated. This tracking will help identify procedural volume, a significant element relevant to advancement as risk is minimized when appropriate as procedural volume supports clinician confidence and competency.Second, identify the gap related to both reported and nonreported organization quality measures. Each organization has quality metrics that drive financial reimbursement related to vascular access which include CRSBI, CLASBI, CABSI, and more recently, hospital-onset bacteremia (HOB). Quality and process improvement initiatives within health care organizations should utilize benchmarks to identify, measure, and guide the process.1,4 Below is a list of questions to get you started. Keep in mind that well-adopted and sustainable programs are guided by established process improvement efforts driven by a need to improve a desired outcome.What are the current reported infection rates?What are the types of bacteremia/pathogen and device sources?Do you have representation on the CLABSI or quality committee?What are the infection prevention goals of your organization?Much like a product change, when considering advancement, you need to fully understand the value this advancement could bring to the organization. Partnering with your infection pre
{"title":"How to Prepare for Advancement to Central Venous Access Device Insertion Beyond Peripherally Inserted Central Catheters: Socially Relevant","authors":"Amy Bardin-Spencer","doi":"10.2309/java-2023-28-02-00","DOIUrl":"https://doi.org/10.2309/java-2023-28-02-00","url":null,"abstract":"In today’s health care landscape, vascular access teams (VATs) are often tapped to increase appropriate device utility or independently seek ways to insert various central venous access devices (CVADs) not limited to peripherally inserted central catheters (PICCs). This includes all models of VAT models (APRN, NPs, RN, RT, RRT) seeking to provide a dedicated resource when a PICC is not appropriate for the patient. This is especially important when an alternative CVAD is indicated based on medication characteristics, duration of therapies, or anatomical limitations.1 As a resource dedicated to vascular access, it is critical that you have the ability and autonomy to assess and select the most appropriate device every time.2 Equally as important is that CVAD insertion is performed by an expert, using ultrasound with appropriate training, competency, and procedural volume while utilizing best practices.1,3Many clinicians take to social media to ask how to get started and who to ask. Prior to that step, the team should have a well-documented need to justify this clinical advancement. With that, let us review the minimal required considerations. Initially, it is important to identify the gaps within your organization—there are 2 significant gaps to outline to ensure the possible advancement supports the overall organizational goals.First, identify if a gap currently exists in an underresourced care area, patient population, or delay in care. For teams that track clinical outcome data closely, this could be easily identified based on device appropriateness documentation. This requires that your organization utilizes a standardized methodology for device selection and honest recognition when an alternate CVAD is indicated. This tracking will help identify procedural volume, a significant element relevant to advancement as risk is minimized when appropriate as procedural volume supports clinician confidence and competency.Second, identify the gap related to both reported and nonreported organization quality measures. Each organization has quality metrics that drive financial reimbursement related to vascular access which include CRSBI, CLASBI, CABSI, and more recently, hospital-onset bacteremia (HOB). Quality and process improvement initiatives within health care organizations should utilize benchmarks to identify, measure, and guide the process.1,4 Below is a list of questions to get you started. Keep in mind that well-adopted and sustainable programs are guided by established process improvement efforts driven by a need to improve a desired outcome.What are the current reported infection rates?What are the types of bacteremia/pathogen and device sources?Do you have representation on the CLABSI or quality committee?What are the infection prevention goals of your organization?Much like a product change, when considering advancement, you need to fully understand the value this advancement could bring to the organization. Partnering with your infection pre","PeriodicalId":35321,"journal":{"name":"JAVA - Journal of the Association for Vascular Access","volume":"43 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134995591","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}
Highlights What we know about the topic: Recommendations for the use of vascular access care bundles to reduce infection are followed for different devices. The risk of arterial catheter-related infection is comparable with short-term, non-cuffed central venous catheters. There are practice concerns for clinicians inserting and caring for peripheral arterial catheters. What this paper adds: The selected studies had a theme of decreased infection after using bundled strategies for all devices. Few studies addressed use of bundles for care of peripheral arterial catheters. High quality research should be performed about using care bundles for insertion and care of arterial catheters. Abstract Introduction: A scoping review of the literature was performed. Aims/Objectives: To find information on the use of care bundles for care of arterial, central, and peripherally inserted venous catheters. Methods: Data was extracted by 2 independent researchers using standardized methodology Results: Results of 84 studies included 2 (2.4%) randomized controlled trials, 38 (45.2%) observational studies, 29 (34.5%) quality projects, and 15 (17.9%) reviews. Populations had more adults than pediatric patients. All studies had the most prominent theme of decreased infection in all devices after using bundle strategies. Discussion and Conclusions: The mapping of available evidence strongly supports the use of care bundles to reduce infection in the care of all intravascular devices. However, deficiencies regarding practice concerns about insertion and care of arterial catheters highlight areas for future research with the aim to eliminate the gap in the evidence of studies of care bundles for peripheral arterial catheters.
{"title":"Care Bundles and Peripheral Arterial Catheters: A Scoping Review","authors":"Heather Reynolds, John Gowardman, Christine Woods","doi":"10.2309/java-d-23-00009","DOIUrl":"https://doi.org/10.2309/java-d-23-00009","url":null,"abstract":"Highlights What we know about the topic: Recommendations for the use of vascular access care bundles to reduce infection are followed for different devices. The risk of arterial catheter-related infection is comparable with short-term, non-cuffed central venous catheters. There are practice concerns for clinicians inserting and caring for peripheral arterial catheters. What this paper adds: The selected studies had a theme of decreased infection after using bundled strategies for all devices. Few studies addressed use of bundles for care of peripheral arterial catheters. High quality research should be performed about using care bundles for insertion and care of arterial catheters. Abstract Introduction: A scoping review of the literature was performed. Aims/Objectives: To find information on the use of care bundles for care of arterial, central, and peripherally inserted venous catheters. Methods: Data was extracted by 2 independent researchers using standardized methodology Results: Results of 84 studies included 2 (2.4%) randomized controlled trials, 38 (45.2%) observational studies, 29 (34.5%) quality projects, and 15 (17.9%) reviews. Populations had more adults than pediatric patients. All studies had the most prominent theme of decreased infection in all devices after using bundle strategies. Discussion and Conclusions: The mapping of available evidence strongly supports the use of care bundles to reduce infection in the care of all intravascular devices. However, deficiencies regarding practice concerns about insertion and care of arterial catheters highlight areas for future research with the aim to eliminate the gap in the evidence of studies of care bundles for peripheral arterial catheters.","PeriodicalId":35321,"journal":{"name":"JAVA - Journal of the Association for Vascular Access","volume":"21 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134995584","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 : 2023-09-01DOI: 10.2309/1557-1289-28.3.1
{"title":"Full Issue PDF","authors":"","doi":"10.2309/1557-1289-28.3.1","DOIUrl":"https://doi.org/10.2309/1557-1289-28.3.1","url":null,"abstract":"","PeriodicalId":35321,"journal":{"name":"JAVA - Journal of the Association for Vascular Access","volume":"28 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134995589","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 : 2023-09-01DOI: 10.2309/java-2023-28-03-president-message
Tonya Heim
I cannot believe how fast this year is going! This is my third JAVA message for the year with just one more to go. There is so much good work going on in AVA that I am excited to share.First, if you haven’t yet registered for the AVA Scientific Meeting in Portland, OR, October 14–17, there is still time. I love the Pacific Northwest, and the conference is lining up to be a great one. There are several premeeting sessions with hands-on opportunities to learn new skills. We have a wonderful keynote speaker coming to talk to us about the future of health care and lots of great breakout sessions filled with learning opportunities. We are bringing back some of your favorite elements of the Scientific Meeting and will introduce a few new things as well.In the last issue of Intravascular Quarterly, I shared some incredible social media statistics. These are some of the data points we monitor on an ongoing basis as one of our measures of success as an association. We continue to see these numbers increase, and I wanted to remind you to like, comment, and share any time you see our social media posts. When you do that, you are helping us spread the gospel of vascular access and helping us have a greater impact. Someone in your circle of friends may connect with our message, whether they are on the clinical side or a patient or patient advocate. When AVA sends out messages to our members, we are preaching to the choir. When you share those messages, you are spreading those messages to an entirely different group, many of whom will appreciate the knowledge.Your AVA Board of Directors has continued to be busy. The transition to Talley is well under way, and we are beginning to make progress on projects in response to the feedback you gave us last fall. Our Network Task Force has sent out a survey and received some great feedback. One data point that I thought was both interesting and concerning was that 60% of our Networks feel they are doing well, and 40% of them are struggling. They have added Network Leaders to the Task Force and are beginning their work in developing strategies to replicate the best practices and support our struggling networks. Our Networks are the lifeblood of our organization, and our goal is to blow up those statistics and ensure that all Networks are doing well. We believe that there will be some quick wins but that there will also be some longer-term projects.We are making some changes to our Foundation Website to better represent their work and to explain the benefit of donating to this great cause. I know that many of you included donations to the Foundation when you registered for the Scientific Meeting, and I want to sincerely thank you for doing so. It is with those donations that the Foundation carries out their mission: To prevent vascular access patient harm using a total systems approach through patient safety initiatives, multidisciplinary alliances, research, and clinician education. If you would like to author a researc
{"title":"President’s Message","authors":"Tonya Heim","doi":"10.2309/java-2023-28-03-president-message","DOIUrl":"https://doi.org/10.2309/java-2023-28-03-president-message","url":null,"abstract":"I cannot believe how fast this year is going! This is my third JAVA message for the year with just one more to go. There is so much good work going on in AVA that I am excited to share.First, if you haven’t yet registered for the AVA Scientific Meeting in Portland, OR, October 14–17, there is still time. I love the Pacific Northwest, and the conference is lining up to be a great one. There are several premeeting sessions with hands-on opportunities to learn new skills. We have a wonderful keynote speaker coming to talk to us about the future of health care and lots of great breakout sessions filled with learning opportunities. We are bringing back some of your favorite elements of the Scientific Meeting and will introduce a few new things as well.In the last issue of Intravascular Quarterly, I shared some incredible social media statistics. These are some of the data points we monitor on an ongoing basis as one of our measures of success as an association. We continue to see these numbers increase, and I wanted to remind you to like, comment, and share any time you see our social media posts. When you do that, you are helping us spread the gospel of vascular access and helping us have a greater impact. Someone in your circle of friends may connect with our message, whether they are on the clinical side or a patient or patient advocate. When AVA sends out messages to our members, we are preaching to the choir. When you share those messages, you are spreading those messages to an entirely different group, many of whom will appreciate the knowledge.Your AVA Board of Directors has continued to be busy. The transition to Talley is well under way, and we are beginning to make progress on projects in response to the feedback you gave us last fall. Our Network Task Force has sent out a survey and received some great feedback. One data point that I thought was both interesting and concerning was that 60% of our Networks feel they are doing well, and 40% of them are struggling. They have added Network Leaders to the Task Force and are beginning their work in developing strategies to replicate the best practices and support our struggling networks. Our Networks are the lifeblood of our organization, and our goal is to blow up those statistics and ensure that all Networks are doing well. We believe that there will be some quick wins but that there will also be some longer-term projects.We are making some changes to our Foundation Website to better represent their work and to explain the benefit of donating to this great cause. I know that many of you included donations to the Foundation when you registered for the Scientific Meeting, and I want to sincerely thank you for doing so. It is with those donations that the Foundation carries out their mission: To prevent vascular access patient harm using a total systems approach through patient safety initiatives, multidisciplinary alliances, research, and clinician education. If you would like to author a researc","PeriodicalId":35321,"journal":{"name":"JAVA - Journal of the Association for Vascular Access","volume":"179 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134995587","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 : 2023-09-01DOI: 10.2309/java-2023-28-03-editorial
Michelle L. Hawes
This is part 2 of a 3-part series on sutures used as an improvised securement for external devices. After finishing this article, the reader will be able to: Discuss the Needle Stick Prevention Act (NSPA).Describe the components of the exposure control plan in the NSPA.Explain acceptable off-label use of devices.Recognize an action that can be taken to remove sutures as a securement option for vascular access devices (VADs).Sutures are excellent for wound closure but are not intended to secure external devices.1 All sutures used as improvised securement for VADs are labeled for wound closure and general soft tissue approximation and/or ligation.1According to the US Food and Drug Administration (FDA):If a device has been labeled for a certain clinical purpose, that means it has passed safety and efficacy standards for that purpose only.Engineered securement devices (ESDs) have achieved FDA labeling because they have passed safety and efficacy standards for the securement of external devices. The understanding of an FDA-labeled product is important because it defines the product’s use and confirms its safety within the boundaries of that use.2Sutures are not labeled as an ESD. The question is, could suture manufacturers seek an additional application of sutures as an ESD? The answer would be a definite no. There are 2 basic questions the FDA would pose around patient safety before the process of additional labeling could begin.2First, does the device pose unnecessary risk? The risk of needle stick exposure is not a part of current ESDs, which would categorize sutures as an unnecessary risk. Next, does the device pose unnecessary harm? Considering the damage caused by additional punctures in the patient’s skin, sutures used to secure VADs would cause 4–8 of these injuries. Current ESDs do not increase the number of punctures in the patient’s skin.How did sutures ever become the standard securement for CVADs? In the 1960s, when lifesaving CVADs were introduced, sutures were considered the best way to secure the new technology. This practice was still off-label but acceptable because of the lack of other options.3There is a place for off-label use. It is critical to the advancement of medicine and the creation of new devices. No one would have expected CVADs to be withheld until the 1990s, when the first ESD would become available. Physicians have the right to practice medicine when the patient’s need requires adaptation of available products.According to the FDA, here are the boundaries of off-label device utilization:Through tradition, convenience, and ignorance of options, sutures have been used continuously as a securement device as if the off-label practice was still necessary and the FDA’s guidelines do not apply.As part of the NSPA, a facility’s risk manager must perform an annual review that considers options to eliminate the unnecessary risk of sharps exposure.4 The NSPA states:Notice that it does not consider limiting the number of needle st
{"title":"Unsafe: Sutures as an Unnecessary Risk for Clinicians and Patients: Editor’s Message","authors":"Michelle L. Hawes","doi":"10.2309/java-2023-28-03-editorial","DOIUrl":"https://doi.org/10.2309/java-2023-28-03-editorial","url":null,"abstract":"This is part 2 of a 3-part series on sutures used as an improvised securement for external devices. After finishing this article, the reader will be able to: Discuss the Needle Stick Prevention Act (NSPA).Describe the components of the exposure control plan in the NSPA.Explain acceptable off-label use of devices.Recognize an action that can be taken to remove sutures as a securement option for vascular access devices (VADs).Sutures are excellent for wound closure but are not intended to secure external devices.1 All sutures used as improvised securement for VADs are labeled for wound closure and general soft tissue approximation and/or ligation.1According to the US Food and Drug Administration (FDA):If a device has been labeled for a certain clinical purpose, that means it has passed safety and efficacy standards for that purpose only.Engineered securement devices (ESDs) have achieved FDA labeling because they have passed safety and efficacy standards for the securement of external devices. The understanding of an FDA-labeled product is important because it defines the product’s use and confirms its safety within the boundaries of that use.2Sutures are not labeled as an ESD. The question is, could suture manufacturers seek an additional application of sutures as an ESD? The answer would be a definite no. There are 2 basic questions the FDA would pose around patient safety before the process of additional labeling could begin.2First, does the device pose unnecessary risk? The risk of needle stick exposure is not a part of current ESDs, which would categorize sutures as an unnecessary risk. Next, does the device pose unnecessary harm? Considering the damage caused by additional punctures in the patient’s skin, sutures used to secure VADs would cause 4–8 of these injuries. Current ESDs do not increase the number of punctures in the patient’s skin.How did sutures ever become the standard securement for CVADs? In the 1960s, when lifesaving CVADs were introduced, sutures were considered the best way to secure the new technology. This practice was still off-label but acceptable because of the lack of other options.3There is a place for off-label use. It is critical to the advancement of medicine and the creation of new devices. No one would have expected CVADs to be withheld until the 1990s, when the first ESD would become available. Physicians have the right to practice medicine when the patient’s need requires adaptation of available products.According to the FDA, here are the boundaries of off-label device utilization:Through tradition, convenience, and ignorance of options, sutures have been used continuously as a securement device as if the off-label practice was still necessary and the FDA’s guidelines do not apply.As part of the NSPA, a facility’s risk manager must perform an annual review that considers options to eliminate the unnecessary risk of sharps exposure.4 The NSPA states:Notice that it does not consider limiting the number of needle st","PeriodicalId":35321,"journal":{"name":"JAVA - Journal of the Association for Vascular Access","volume":"24 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134995586","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}
Background: Left ventricular assist devices are connected to an external power source via a tunneled subcutaneous driveline. The risk of infection increases each time a compromised dressing is changed. Our goal was to increase dressing durability to 7 days, reduce risk of infection, and promote greater patient satisfaction. Methods: For this quality improvement project of 20 patients with a left ventricular assist device, the control group (n = 10) used a standard dressing kit but extended changes from 2 times a week to 1 time every 7 days. For the intervention group’s kit, we added gum mastic liquid adhesive and liquid adhesive remover and had 2 days of live training. Patients reported weekly. Results: In our project we observed an improvement in dressing integrity at 14 weeks in the intervention group versus control group: intact dressings—96% vs. 44%; edges lifting—4% vs. 48%; detachments—0% vs. 8%. Exit site skin condition was comparable, except bleeding—0% in intervention group vs. 12% in control group. Overall, 98% of intervention group reached 7-day goal (avg dressing durability = 7.01 days) vs. 32% of control group (avg = 4.9 days). Fewer dressing changes extrapolates to potential cost savings of $599.56 per patient annually. Patient understanding of the bundled procedure improved quickly: 80% of dressings were assessed as intact week 1, rising to 96% in weeks 2 to 15. Patients also commented on improved satisfaction. Conclusion: In our quality improvement project with gum mastic liquid adhesive and liquid adhesive remover, we observed favorable results with improved dressing integrity, fewer dressing changes, improved patient satisfaction, and reduced costs.
背景:左心室辅助装置通过隧道式皮下传动系统连接到外部电源。每次更换破损的敷料，感染的风险都会增加。我们的目标是将敷料耐久度提高到7天，降低感染风险，提高患者满意度。方法:对20例使用左室辅助装置患者的质量改善项目，对照组(n = 10)使用标准敷料包，但将更换次数从每周2次延长至每7天1次。对于干预组的工具包，我们添加了胶浆液体粘合剂和液体去胶剂，并进行了2天的现场培训。患者每周报告一次。结果:在我们的项目中，我们观察到干预组与对照组在14周时敷料完整性的改善:完整敷料- 96%对44%;优势提升:4% vs. 48%;分遣队- 0% vs. 8%除出血外，出口部位皮肤状况具有可比性-干预组为0%，对照组为12%。总体而言，98%的干预组达到了7天的目标(平均敷料持续时间= 7.01天)，而对照组为32%(平均敷料持续时间= 4.9天)。减少换药次数可以为每位患者每年节省599.56美元的潜在成本。患者对包扎过程的理解迅速提高:80%的敷料在第1周被评估为完好无损，在第2至15周上升到96%。患者还对满意度的提高进行了评价。结论:我们采用胶浆液体粘合剂和液体去胶剂进行质量改进项目，改善了敷料完整性，减少了敷料更换，提高了患者满意度，降低了成本。
{"title":"Quality Improvement Project to Assess the Effect of Gum Mastic Liquid Adhesive on the Integrity and Durability of Driveline Dressings, Risk of Infection, and Patient Satisfaction","authors":"Abigail Vowels","doi":"10.2309/java-d-23-00006","DOIUrl":"https://doi.org/10.2309/java-d-23-00006","url":null,"abstract":"\u0000 \u0000 \u0000 \u0000 \u0000 Background: Left ventricular assist devices are connected to an external power source via a tunneled subcutaneous driveline. The risk of infection increases each time a compromised dressing is changed. Our goal was to increase dressing durability to 7 days, reduce risk of infection, and promote greater patient satisfaction. Methods: For this quality improvement project of 20 patients with a left ventricular assist device, the control group (n = 10) used a standard dressing kit but extended changes from 2 times a week to 1 time every 7 days. For the intervention group’s kit, we added gum mastic liquid adhesive and liquid adhesive remover and had 2 days of live training. Patients reported weekly.\u0000 Results: In our project we observed an improvement in dressing integrity at 14 weeks in the intervention group versus control group: intact dressings—96% vs. 44%; edges lifting—4% vs. 48%; detachments—0% vs. 8%. Exit site skin condition was comparable, except bleeding—0% in intervention group vs. 12% in control group. Overall, 98% of intervention group reached 7-day goal (avg dressing durability = 7.01 days) vs. 32% of control group (avg = 4.9 days). Fewer dressing changes extrapolates to potential cost savings of $599.56 per patient annually. Patient understanding of the bundled procedure improved quickly: 80% of dressings were assessed as intact week 1, rising to 96% in weeks 2 to 15. Patients also commented on improved satisfaction.\u0000 Conclusion: In our quality improvement project with gum mastic liquid adhesive and liquid adhesive remover, we observed favorable results with improved dressing integrity, fewer dressing changes, improved patient satisfaction, and reduced costs.\u0000","PeriodicalId":35321,"journal":{"name":"JAVA - Journal of the Association for Vascular Access","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43162491","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 : 2023-06-15DOI: 10.1177/11297298231179064
Andreia Pinelo, Paulo Almeida, Luís Loureiro, Duarte Rego, Sérgio Teixeira, Daniel Mendes, Carlos Veterano, Henrique Rocha, João Castro, Henrique Almeida, Miguel Queirós, N. Matos, Jesse Garcia, Francisco Lim, Daniel Kong, Gabriel Jabbour, Faris Hakki, Medstar Washington Hospital, M. Napoli, W. Morale, M. Lodi, F. Galli, G. Bonforte, D. Bonucchi, G. Brunori, L. Buzzi, L. Carbonari, G. Forneris, M. Gallieni, C. Lomonte, S. Mandolfo, A. Marciello, M. Meola, D. Patanè, N. Pirozzi, P. Quaretti, D. Savio, C. Sessa, M. Spina, L. Tazza, M. Taurisano, P. Ria, S. Barbarini, Andrea Mancini, A. Pascalis, N. A. White, K.E.A. van der Bogt, T. Horeman, J. Rotmans, SL Laboyrie, Djm Peters, R. Bijkerk, MR de Vries, Thiago Almeida Barroso, Adriano Martins Galhardo, Leonardo de Oliveira Harduin, Julia Bandeira Guerra, Leonardo Cortizo, Márcio Gomes Filippo, Edson Ferreira, Gonçalves Júnior, L. Soliveri, M. Bozzetto, P. Brambilla, A. Caroli, A. Remuzzi, Edson Gonçalves, Ferreira Junior, Larissa de, Melo Freire, Gouveia Silv
2022. 43 BCA and 40 ePTFE were grafts connected to the HeRO grafts.
2022. 43例BCA和40例ePTFE与HeRO移植物连接。
{"title":"Abstracts to 13th Congress of the Vascular Access Society, 27th - 29th April 2023, Porto, Portugal","authors":"Andreia Pinelo, Paulo Almeida, Luís Loureiro, Duarte Rego, Sérgio Teixeira, Daniel Mendes, Carlos Veterano, Henrique Rocha, João Castro, Henrique Almeida, Miguel Queirós, N. Matos, Jesse Garcia, Francisco Lim, Daniel Kong, Gabriel Jabbour, Faris Hakki, Medstar Washington Hospital, M. Napoli, W. Morale, M. Lodi, F. Galli, G. Bonforte, D. Bonucchi, G. Brunori, L. Buzzi, L. Carbonari, G. Forneris, M. Gallieni, C. Lomonte, S. Mandolfo, A. Marciello, M. Meola, D. Patanè, N. Pirozzi, P. Quaretti, D. Savio, C. Sessa, M. Spina, L. Tazza, M. Taurisano, P. Ria, S. Barbarini, Andrea Mancini, A. Pascalis, N. A. White, K.E.A. van der Bogt, T. Horeman, J. Rotmans, SL Laboyrie, Djm Peters, R. Bijkerk, MR de Vries, Thiago Almeida Barroso, Adriano Martins Galhardo, Leonardo de Oliveira Harduin, Julia Bandeira Guerra, Leonardo Cortizo, Márcio Gomes Filippo, Edson Ferreira, Gonçalves Júnior, L. Soliveri, M. Bozzetto, P. Brambilla, A. Caroli, A. Remuzzi, Edson Gonçalves, Ferreira Junior, Larissa de, Melo Freire, Gouveia Silv","doi":"10.1177/11297298231179064","DOIUrl":"https://doi.org/10.1177/11297298231179064","url":null,"abstract":"2022. 43 BCA and 40 ePTFE were grafts connected to the HeRO grafts.","PeriodicalId":35321,"journal":{"name":"JAVA - Journal of the Association for Vascular Access","volume":"53 1","pages":"NP1 - NP47"},"PeriodicalIF":0.0,"publicationDate":"2023-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90812340","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}
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