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figuring out the needs of health suppliers and their interplay with sufferers is paramount to the position of the employees of ICU scientific which provides clinicians all over with ingenious and affordable options for scientific wants. As such, ICU medical selected to contain members of its firm within the Vascular access trade companion™ certificate software, designed to teach business authorities on the fundamental fundamentals of vascular access. VACC's software emphasizes terminology, kinds of gadgets, makes use of, issues with vascular access and the unique concerns facing special populations.
"The adventure has been useful," noted Joe Vienneau, ICU clinical's director of corporate sales working towards. "many of the people felt the modules helped their knowledge base and they are excited to have the VACC emblem companion on their enterprise card."
each of ICU scientific's revenue corporations participated in an extensive software that blanketed important care, oncology, alternate web site, renal, health center, animal fitness and corporate money owed. Vienneau pointed out the enterprise's participation in the software stemmed from a clear dedication to customer aid and repair, proposing a chance to "supply their revenue force a leg up on their rivals in a vascular entry expertise base in order that they could be a real resource for his or her shoppers."
For professional veterans like Joleen Weihs, regional revenue director for PDI, the Vascular access trade companion™ certificates program gives a wealth of assistance for those searching for a refresher. PDI provides inventive products, academic substances, practising and aid to steer clear of an infection transmission and promote health and well being. "continuing education is crucial to make sure they be mindful their clinicians' approaches and protocols," Weihs referred to. "Vascular access encompasses a big range of needs…there are loads of protocols and procedures they deserve to take note with the intention to work more quite simply with their consumers. The practicing breaks the counsel into modules that construct on every other so that you see how the entire constituents relate. it be a brilliant strategy to give tips for people new to the industry as well as greater experienced pals."
As a pacesetter, Weihs has considered advantages to her acquaintances in a few areas in that they've been in a position to be aware what the customer organization is making an attempt to achieve and support them to obtain their dreams. "they are asking better questions, really understanding the client's desires and challenges," she pointed out, including that an understanding and confidence can on no account be underestimated, above all for people in revenue dealing at once with the client. "acquaintances have more self belief because of their practising. they're capable of engage in good conversations with clinicians who've decades of adventure and gigantic expertise. ordinary, it be been a really empowering experience for them," she referred to.
Vascular entry Certification organisation
HERRIMAN, Utah, July 10, 2014 /PRNewswire-USNewswire/ -- The Vascular access Certification supplier (VACC) has issued a name to action to hospitals all the way through the country to believe encouraging authorities working within the field of vascular entry to are seeking for certification.
speakme on behalf of the VACC board of directors, Board President Hudson J. Garrett, Jr., PhD, MSN, MPH, FNP, VA- BC™, cited Memorial Sloan Kettering cancer middle as an instance for hospitals to observe. "The professionals at Memorial Sloan Kettering melanoma core are shining examples of licensed vascular entry professionals who are showing delight of their area of expertise," stated Garrett. "authorities working in the field of vascular entry can exhibit mastery of specialised expertise by using meeting standards and passing the examination offered with the aid of the Vascular entry Certification organisation, the credentialing arm of the affiliation for Vascular entry."
"We stand at the back of their specialties and that is why I inspire the team to searching for certification in vascular access," spoke of Jane Sallustro, RN, MPA, CNML, and Nurse chief at Memorial Sloan Kettering cancer center.
In VACC's call to motion, the board spoke of that as with other scientific specialties, their organization is dedicated to raising the vascular access bar via evidence based mostly follow, professionalism and advocating secure and accountable practice for sufferers and households.
Certification through VACC is multidisciplinary in scope and contains a large range of fitness care authorities actively engaged in the apply of vascular entry, together with however now not constrained to registered nurses, physicians, nurse practitioners, radiology technicians, respiratory therapists, an infection preventionists and emergency clinical functions gurus.
The Vascular entry Certification organisation (VACC), established in 2009, is an impartial non-earnings firm committed to the validation, through certification, of a really good physique of abilities for all professionals working within the container of vascular access.
supply Vascular access Certification supplier
knowing the wants of health suppliers and their interaction with patients is paramount to the position of the personnel of ICU clinical which provides clinicians around the globe with inventive and cost-effective options for medical wants. As such, ICU clinical chose to involve members of its firm within the Vascular entry business accomplice™ certificate program, designed to educate trade authorities on the basic fundamentals of vascular access. VACC's program emphasizes terminology, kinds of devices, uses, complications with vascular access and the exciting issues facing particular populations.
"The experience has been useful," mentioned Joe Vienneau, ICU scientific's director of company revenue training. "most of the individuals felt the modules helped their skills base and they are excited to have the VACC emblem partner on their company card."
each and every of ICU clinical's revenue organizations participated in an intensive application that blanketed essential care, oncology, alternate web site, renal, sanatorium, animal fitness and company accounts. Vienneau mentioned the enterprise's participation in the application stemmed from a clear commitment to client help and repair, presenting an opportunity to "provide their revenue force a leg up on their opponents in a vascular entry competencies base so they may be a real resource for his or her clients."
For seasoned veterans like Joleen Weihs, regional sales director for PDI, the Vascular access business accomplice™ certificate application provides a wealth of tips for those in the hunt for a refresher. PDI gives ingenious items, educational supplies, practising and help to steer clear of an infection transmission and promote fitness and well being. "continuing education is essential to be sure they keep in mind their clinicians' techniques and protocols," Weihs observed. "Vascular access encompasses a wide range of wants…there are a lot of protocols and processes they should have in mind so as to work extra without difficulty with their consumers. The practicing breaks the assistance into modules that build on every other so you see how all of the components relate. it's a superb technique to give suggestions for people new to the business in addition to extra experienced buddies."
As a leader, Weihs has considered advantages to her friends in a couple of areas in that they have got been in a position to take note what the client company is making an attempt to accomplish and support them to achieve their dreams. "they're asking more suitable questions, in fact figuring out the client's desires and challenges," she referred to, including that an realizing and self belief can under no circumstances be underestimated, particularly for americans in income dealing at once with the client. "buddies have extra self belief as a result of their practising. they're capable of interact in respectable conversations with clinicians who've decades of adventure and massive skills. overall, or not it's been a very empowering event for them," she said.
The Vascular entry Certification employer (VACC), centered in 2009, is an impartial non-income company dedicated to the validation, through certification, of a really good physique of knowledge for all gurus working within the box of vascular access.www.vacert.org
source Vascular access Certification company
Copyright (C) 2014 PR Newswire. All rights reserved
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Today, the U.S. Food and Drug Administration permitted marketing of two catheter-based devices designed to create a connection to veins and arteries in patients with chronic kidney disease who need hemodialysis.
Specifically, the FDA granted marketing authorization for the use of the Ellipsys Vascular Access System and the everlinQ endoAVF System to make what’s called an arteriovenous (AV) fistula for patients who need hemodialysis access.
“Dialysis is a necessary and life-saving procedure for thousands of individuals. With today’s action, there will be additional, less-invasive vascular access options for patients who will require hemodialysis,” said Bram Zuckerman, M.D., director of the Division of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health.
According to the National Institutes of Health, more than 661,000 Americans have kidney failure, of which approximately two-thirds are on hemodialysis. Hemodialysis utilizes a dialyzer, or artificial kidney, to filter a patient’s blood outside of their body. Before patients can start dialysis, however, they need to have an AV fistula created. An AV fistula is traditionally made by surgically joining an artery and a vein under the skin in the arm. After some time, the mature vein can then receive the two needles used for each hemodialysis session. Surgically created AV fistulas typically take several months to heal and for the vein to mature before being usable for hemodialysis.
The devices granted marketing authorization today are designed to create AV fistulas percutaneously (through the skin). A catheter is inserted into a blood vessel in the arm and is guided to the site of the planned AV fistula. The devices then deliver energy to form a connection between an upper forearm artery and an adjacent vein. The Ellipsys Vascular Access System uses one catheter, the everlinQ endoAVF System uses two.
For the Ellipsys Vascular Access System, the FDA reviewed data from a non-randomized, multi-center study of 103 patients. The Ellipsys Vascular Access System was used in a procedure to create an AV fistula in these patients, of which 92 patients (89.3 percent) met the criteria for a usable AV fistula within three months after the procedure. Almost all patients (96.1 percent) required an additional procedure (such as balloon angioplasty) in the first 12 months to maintain the fistula.
For the everlinQ endoAVF System, the FDA reviewed data from a non-randomized, multi-center study of 60 patients, in addition to supporting data from three other studies and clinical use of the device outside the U.S. The everlinQ endoAVF System was used in a procedure to create an AV fistula in these patients. In the main study, 52 patients (86.7 percent) met the criteria for a usable AV fistula within three months after the procedure. Almost all patients (96.7 percent) required an additional procedure at the time the fistula was created, while 28.3 percent of patients required an additional procedure (such as balloon angioplasty) in the first 12 months to maintain the fistula.
Both devices are contraindicated, or should not be used, for creation of anastomoses (connections) in vessels that are less than two millimeters in diameter or too far apart (for example, in the wrist or in the hand). For both devices, complications include blocking (occlusion) or collapse (stenosis) of the fistula, bruising and need for additional procedures.
The Ellipsys Vascular Access System and everlinQ endoAVF System were reviewed through the De Novo premarket review pathway, a regulatory pathway for some low to moderate risk devices of a new type. This action also creates a new regulatory classification, which means that subsequent devices with the same intended use may go through the FDA’s 510(k) process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.
The FDA granted marketing authorization of the Ellipsys Vascular Access System to Avenu Medical.
The FDA granted marketing authorization of the everlinQ endoAVF System to TVA Medical, Inc.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of their nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
By Chellie DeVries
It has been more than 10 years since The New England Journal of Medicine published the Keystone project’s ground breaking work on reducing ICU CLABSIs using a central line insertion bundle. Since that time, this has become the absolute standard throughout healthcare settings in the United States. When it comes to completing the central line insertions checklist, many of us only accept “yes” and “yes with prompting” as possible responses. Our accrediting agencies expect this as a standard of practice.
With CMS/NHSN mandated reporting now in its seventh year, there are reports of tremendous improvements in reported central line-associated bloodstream infection (CLABSI) incidence as this and other evidence-based standards are more fully adopted. Hospitals are analyzing their data and examining contributing factors to determine where improvements are most needed. What happens when opportunities for improvement persist and bundle compliance (both insertion and maintenance) is consistently high? It may be time to look beyond those bundles to examine additional approaches that may be beneficial.
For so long now they have (rightly) stressed the importance of maximum sterile barrier precautions for insertion of central lines and daily re-view of line necessity to get them out promptly, yet many units continue to have central line utilization in excess of reported means. How much progress could be made by also looking more critically at device selection and early vascular assessment as part of a prevention strategy? MAG-IC gives us the framework for assessing the hierarchy of device options before using a central line for difficult access or peripherally compatible infusates. How much further could they get if they slowed the progress to central lines or got them out even a day or two sooner while still ensuring reliable access? It is true that many of their patients truly require a central line, but when they go through the motion of “daily review of line necessity” are they truly asking whether the patient still needs the device they have? There is a difference between needing vascular access and needing a central line.
At my organization, they are tackling this in a number of different ways – starting now in the emergency room. They have completed the first year of their midline program at the hospital (managed by their PICC team) with over 3500 midline days and tracked their outcomes closely. For their primary, power injectable line they are now at nearly 3,000 midline days with zero BSIs. Based on those successes and feedback from their medical staff leaders that there remains an opportunity for addressing lines placed in the emergency room they are now in the early phases of training interested ER nurses in ultrasound skills to allow them to assist with preventing unnecessary central line insertions (and subsequent excess central line days) by giving them (after completing competencies) the ability to place a high flow, power injectable midline if it is appropriate for the patient’s vascular access needs. Those lines will be monitored for outcomes and the impact they may contribute to the organization’s central line utilization ratios.
As they reviewed their 2016 CLABSIs there was considerable discussion about the CLABSIs that were occurring in their critical care step down units; although they are not included in state or federal reporting they represent a considerable source of morbidity (and potential mortality) for their patients and central line days exceeds what are seen in their intensive care units (ICUs). Recent conversations, supported by their ICU medical director will help drive staff to more carefully consider whether central lines can be reduced or replaced with midlines for patients with continuing need for therapy as they leave the ICU with medications not contraindicated for peripheral infusion. Review the available evidence to see which devices may be able to most safely help you achieve your goals, by keeping a patient focused prevention strategy.
When you look beyond your bundles what else do you see? What other trends bear further investigation? A review of their bloodstream infections (CLABSI and peripheral line related) for 2016 showed that 25 percent had documentation of problems with the dressing based on chart review documenting reinforced dressings or premature dressing changes. Concordant review of charts with direct observation suggested that the dressing disruption rate was even more significant. Knowing that repeated dressing changes has significant impact on CLABSI incidence, solving this problem became a priority. Several different strategies were used, starting with re-education on appropriate use of their dressings. When that was insufficient they created an intervention bundle that included a dressing in conjunction with a gum mastic based medical adhesive. Combining a securement dressing with these adhesive allowed us, in their pilot, to achieve 93 percent fully adherent dressings (without any tape reinforcement or lifted edges) and zero disrupted dressings.
We are in the process of expanding the study across multiple other devices in their organization to find the bundle that works best for us. By studying this in the careful manner they did, they have the potential to decrease excess dressing changes and the related BSI risks but also save nursing time through allowing their dressings to remain in place and intact, while protecting their investment in protective strategies like CHG sponge dressing and advanced securement dressings.
I am fortunate to get to talk with colleagues in vascular access and infection control across the country on a weekly basis. I hear the struggles they are facing with the implications of Value-Based Purchasing and most recently the impact that rebaselining had on many facilities’ standardized infection ratios (SIRs). I hear the pressure that Infection Prevention and Vascular Access teams are under to improve their CLABSI numbers. I am frightened by some of what has been shared with me. I have heard programs be actively encouraged to NOT try to decrease central line days – because leaving them high helps to make rates or SIRs look better. Rather than focusing on decreasing the risk by ensuring optimal compliance with prevention strategies, this leaves their patients at unacceptable risk by potentially leaving in a device that is not actually necessary for care. I am equally concerned with hospitals who are suggesting that central lines should not be used… since then there could be no CLABSIs. That is a disturbing proposition in terms of vessel health – their veins are meant to last us a lifetime and must be treated with careful consideration of what is infused into devices and how those devices are placed and maintained. On the flip side, I have heard of hospitals who look at their rates and because they are “OK” they are not pushing further to improve outcomes or improve compliance with the process measures that drive those outcomes. If they continue to have patients with potentially fatal infections, how can they allow ourselves to become complacent?
Please partner with your vascular access teams or whomever has primary responsibility for those considerations in your hospital. Share the data you have from NHSN and any process measures you follow for all vascular access devices; ask them to share the measurables they track for their productivity. Learn together how you can collaborate to help make your hospital the safest possible place they can be for their patients. In September, I am teaching a “Power Hour” at the National Association for Vascular Access conference focusing on NHSN surveillance and how to leverage that data for vascular access teams. That came about because so many of these professionals have indicated they do not have strong, open relationship with their infection preventionists. Please reach out and collaborate – you truly will not find better allies in the organization for achieving their mutual goals.
Chellie DeVries has been involved in infection control and hospital epidemiology with a passion for vascular access considerations for more than 20 years. She was a reviewer for the 2016 Infusion Therapy Standards of Practice, wrote the Infection Prevention and Control Chapter for the forthcoming new edition of Infusion Nursing: An Evidence Based Approach and the chapter on Vascular Access Device Associated Infections for the International Federation of Infection Control text book.. She volunteers as an advisor for AVA's Patient Advocacy Committee and a member of their PIV task force and serves as a director-at-large with the Vascular Access Certification Corporation (VACC).
References:Chopra V, Flanders SA and Saint S. (Sept. 15, 2015). The Michigan Appropriateness Guide for Intravenous Catheters (MAGIC): Results fro a Multispecialty Panel Using the RAND/UCLA Appropriateness Method. Annals of Internal Medicine, 163(163), S1-S39.
Chopra V, Ratz D and Kuhn L. (April 2014). PICC-associated bloodstream infections: prevalence, patterns, and predictors. American Journal of Medicine, 127(4), 319-28. http://dx.doi.org/10.1016/j.amjmed.2014.01.001
Fabiani A, Dreas L and Samson G. (January-February 2017). Ultrasound-guided deep-arm veins insertion of long peripheral catheters in pa-tients with difficult venous access after cardiac surgery. Heart and Lung, 46(1), 46-53. http://dx.doi.org/http://dx.doi.org/10.1016/j.hrtlng.2016.09.003
Institute for Healthcare Improvement. (2012). How-to Guide: Prevent Central Line-Associated Bloodstream Infections. Retrieved from http://www.ihi.org/resources/Pages/Tools/HowtoGuidePreventCentralLineAssociatedBloodstreamInfection.aspx
Kim JS, Holton P and Vigon C. (2011). Reduction of catheter-related bloodstream infections through the use of a central venous line bundle: Epidemiologic and economic consequences. American Journal of Infection Control, 39, 640-6.
Moureau N, Siegl G and Hill M. (2015). How to Establish an Effective Midline Program: A Case Study of 2 Hospital. Journal of the Association for Vascular Access, 20, 179-88. http://dx.doi.org/http://dx.doi.org/10.1016/j.java.2015.05.001
Pathak R, Patel A and Ennui H. (May 2015). The incidence of central line-associated bacteremia after the introduction of midline catheters in a ventilator unit population. Infectious Diseases in Clinical Practice, 23(3), 131-34.
Provonost P, Needham D and Berenholtz S. (2006, December 28). An intervention to decrease catheter-related bloodstream infections in the ICU. New England Journal of Medicine, 355(26), 2725-32.
Scoppettuolo G, Pittiruti M and Pitoni S. (2016). ORIGINAL RESEARCH Open Access Ultrasound-guided “short” midline catheters for difficult venous access in the emergency department: a retrospective analysis. International Journal of Emergency Medicine, 9(3), 1-7. http://dx.doi.org/10.1186/s12245-016-0100-0
Timsit JF, Bouadma L and Ruckly S. (June 2012). Dressing disruption is a major risk factor for catheter-related infections. Critical Care Medi-cine, 40(16), 1707-14. http://dx.doi.org/10.1097/CCM.0b013e31824e0d46
Patients with end-stage renal disease rely on hemodialysis to survive. About 500,000 Americans are in the end-stage renal disease and are being treated with hemodialysis, which requires repeated access to the blood. Failure to maintain adequate access to the vasculature can cause death for these patients, reveals a new study.A new study in The American Journal of Pathology provides information about the mechanisms underlying failure of the most common type of hemodialysis vascular access, the arteriovenous fistula. Despite being the preferred approach, there is currently limited understanding of the mechanisms involved in fistula maturation failure.
‘Kidney failure and cardiovascular disease may be associated with poor nitric acid responsiveness.’Hemodialysis removes waste products from the blood and establishes electrolyte and fluid balance in patients whose kidneys can no longer function properly. There are several approaches that doctors use to establish connections with the blood supply for hemodialysis."The arteriovenous fistula is the preferred type of vascular access because of lower complication rates compared with synthetic arteriovenous grafts or central venous catheters. However, up to 60% of newly created fistulas never become usable for dialysis because they fail to mature (meaning the vessels do not enlarge enough to support the dialysis blood circuit)," explained lead investigator Xiaoyong Tong, MD, PhD, of the Innovative Drug Research Centre, Chongqing University, Chongqing (China).
This study examined vein tissue obtained at the time 19 patients underwent surgical creation of arteriovenous fistulas at Boston University. Success was defined as the ability to use the fistula for 75% of hemodialysis sessions during the fifth month after fistula creation.
The investigators focused in on the ability of smooth muscle cells to respond to nitric acid, a vasodilator derived from the inner-most cells of blood vessels. When smooth muscle cells from the vein segments were grown in culture, the investigators found that nitric oxide-induced inhibition of smooth muscle cell migration, but not proliferation, was significantly greater in cells from patients with subsequent fistula maturation success than from those with subsequent fistula maturation failure (17% inhibition versus 5.7% inhibition). They also found that overexpression of the calcium regulatory protein, sarcoplasmic/endoplasmic reticulum calcium ATPase (SERCA), or down-regulation of Nox4, a major source of reactive oxygen species in blood vessels, significantly improved nitric oxide responsiveness of smooth muscle cells from poor nitric oxide responders.
These findings suggest that impairment in responsiveness to nitric oxide that occurs in some patients with end-stage renal disease may result in hyperplasia (excessive growth) of the innermost layer of the blood vessels or reduced ability of the vessels to dilate. Either abnormality can limit the maturation and viability of the arteriovenous fistula.
This research raises the possibility that therapeutic restoration of nitric oxide responsiveness through manipulation of local mediators may prevent fistula maturation failure in patients and potentially contribute to their ability to remain on hemodialysis.
"The superficial location and accessibility of the fistula make it highly suited for application of local drug or gene therapies both during and after its surgical creation. The findings from these studies may also have applicability to the more general problem of impaired nitric oxide responsiveness associated with kidney failure and cardiovascular disease," commented co-investigator Laura M. Dember, MD, of the Renal, Electrolyte and Hypertension Division and Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania Perelman School of Medicine (Philadelphia).
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