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understanding the needs of health suppliers and their interaction with patients is paramount to the duty of the employees of ICU medical which provides clinicians around the world with ingenious and low in cost solutions for medical wants. As such, ICU scientific selected to involve contributors of its organization in the Vascular access traffic companion™ certificate application, designed to industry professionals on the simple fundamentals of vascular entry. VACC's program emphasizes terminology, types of instruments, uses, complications with vascular access and the entertaining considerations facing particular populations.
"The adventure has been constructive," talked about Joe Vienneau, ICU clinical's director of corporate revenue working towards. "most of the individuals felt the modules helped their abilities foundation and they are excited to beget the VACC logo accomplice on their company card."
each and every of ICU clinical's earnings businesses participated in an extensive program that covered censorious care, oncology, alternate website, renal, health facility, animal health and corporate accounts. Vienneau mentioned the enterprise's participation in the software stemmed from a lucid commitment to customer assist and service, offering a random to "provide their sales drive a leg up on their rivals in a vascular entry skills foundation in order that they may subsist a true aid for their clients."
For professional veterans fondness Joleen Weihs, regional earnings director for PDI, the Vascular entry industry companion™ certificates program offers a wealth of counsel for these seeking a refresher. PDI offers innovative items, tutorial elements, training and guide to uphold away from an infection transmission and promote health and wellness. "continuing training is significant to contour inevitable they esteem their clinicians' strategies and protocols," Weihs mentioned. "Vascular entry encompasses a wide sweep of wants…there are lots of protocols and strategies they deserve to uphold in intelligence to subsist able to work extra easily with their purchasers. The training breaks the counsel into modules that build on each other so you see how totality of the elements relate. it's a superb technique to give counsel for americans recent to the trade as well as extra experienced buddies."
As a leader, Weihs has considered advantages to her friends in a few areas in that they beget got been capable of beget in intelligence what the customer firm is trying to achieve and capitalize them to achieve their dreams. "they're asking more suitable questions, in fact figuring out the client's goals and challenges," she referred to, including that an figuring out and self assurance can not ever subsist underestimated, mainly for people in income dealing directly with the customer. "buddies beget greater confidence because of their practising. they're in a position to beget interaction in decent conversations with clinicians who've many years of event and tremendous skills. universal, it subsist been a very empowering event for them," she referred to.
Vascular access Certification company
understanding the needs of fitness providers and their interaction with patients is paramount to the duty of the personnel of ICU medical which provides clinicians totality over the world with innovative and not pricey options for clinical wants. As such, ICU clinical selected to involve participants of its company in the Vascular entry industry associate™ certificates software, designed to train traffic specialists on the primary fundamentals of vascular entry. VACC's software emphasizes terminology, types of contraptions, makes expend of, problems with vascular access and the piquant concerns dealing with special populations.
"The journey has been effective," stated Joe Vienneau, ICU scientific's director of corporate income practicing. "many of the individuals felt the modules helped their advantage foundation and they're excited to beget the VACC logo companion on their enterprise card."
every of ICU medical's sales groups participated in an in depth application that covered crucial care, oncology, alternate site, renal, health facility, animal health and company bills. Vienneau spoke of the company's participation in the software stemmed from a lucid commitment to consumer uphold and service, providing an opening to "provide their income force a leg up on their opponents in a vascular entry potential foundation so they can subsist a true resource for his or her shoppers."
For seasoned veterans fondness Joleen Weihs, regional revenue director for PDI, the Vascular access trade accomplice™ certificate program offers a wealth of assistance for these searching for a refresher. PDI gives imaginitive items, tutorial elements, practicing and uphold to evade an infection transmission and promote fitness and well being. "carrying on with training is significant to contour inevitable they esteem their clinicians' approaches and protocols," Weihs pointed out. "Vascular entry encompasses a wide sweep of needs…there are lots of protocols and methods they should beget in intelligence to subsist able to work extra without problems with their shoppers. The practising breaks the counsel into modules that construct on each and every different so that you see how totality the components relate. it's a superb strategy to give assistance for americans recent to the trade in addition to greater experienced acquaintances."
As a pacesetter, Weihs has considered merits to her friends in a few areas in that they've been able to entangle into account what the client company is making an attempt to achieve and aid them to achieve their dreams. "they're asking more advantageous questions, really knowing the client's goals and challenges," she talked about, including that an realizing and self credit can not ever subsist underestimated, chiefly for individuals in sales dealing at once with the consumer. "associates beget more self assurance as a result of their practising. they are able to engage in obliging conversations with clinicians who've decades of suffer and gigantic skills. ordinary, or not it's been a really empowering journey for them," she mentioned.
The Vascular entry Certification service provider (VACC), centered in 2009, is an independent non-earnings corporation committed to the validation, via certification, of a really expert carcass of expertise for totality authorities working within the box of vascular access.www.vacert.org
supply Vascular entry Certification supplier
Copyright (C) 2014 PR Newswire. totality 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 habitual kidney disease who requisite hemodialysis.
Specifically, the FDA granted marketing authorization for the expend of the Ellipsys Vascular Access System and the everlinQ endoAVF System to contour what’s called an arteriovenous (AV) fistula for patients who requisite hemodialysis access.
“Dialysis is a necessary and life-saving procedure for thousands of individuals. With today’s action, there will subsist 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 focus for Devices and Radiological Health.
According to the National Institutes of Health, more than 661,000 Americans beget kidney failure, of which approximately two-thirds are on hemodialysis. Hemodialysis utilizes a dialyzer, or ersatz kidney, to filter a patient’s blood outside of their body. Before patients can start dialysis, however, they requisite to beget 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 develope vein can then receive the two needles used for each hemodialysis session. Surgically created AV fistulas typically entangle several months to heal and for the vein to develope 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 contour 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 totality 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 expend 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 totality 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 subsist 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 involve blocking (occlusion) or collapse (stenosis) of the fistula, bruising and requisite 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 temper risk devices of a recent type. This action too creates a recent regulatory classification, which means that subsequent devices with the selfsame intended expend may slouch 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 too is accountable 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 recent 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 measure 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 feasible responses. Our accrediting agencies anticipate this as a measure 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 subsist time to explore beyond those bundles to examine additional approaches that may subsist beneficial.
For so long now they beget (rightly) stressed the weight of maximum infertile barrier precautions for insertion of central lines and daily re-view of line necessity to accumulate them out promptly, yet many units continue to beget central line utilization in excess of reported means. How much progress could subsist made by too looking more critically at device selection and early vascular assessment as fragment 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 accumulate if they slowed the progress to central lines or got them out even a day or two sooner while silent ensuring trustworthy access? It is accurate that many of their patients truly require a central line, but when they slouch through the motion of “daily review of line necessity” are they truly asking whether the patient silent needs the device they have? There is a inequity 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 beget 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 opening 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 region a elevated flow, power injectable midline if it is arrogate for the patient’s vascular access needs. Those lines will subsist monitored for outcomes and the repercussion 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 censorious supervision step down units; although they are not included in situation or federal reporting they depict a considerable source of morbidity (and potential mortality) for their patients and central line days exceeds what are seen in their intensive supervision units (ICUs). Recent conversations, supported by their ICU medical director will capitalize drive staff to more carefully esteem whether central lines can subsist reduced or replaced with midlines for patients with continuing requisite for therapy as they leave the ICU with medications not contraindicated for peripheral infusion. Review the available evidence to see which devices may subsist able to most safely capitalize you achieve your goals, by keeping a patient focused prevention strategy.
When you explore beyond your bundles what else outcome you see? What other trends tolerate 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 repercussion on CLABSI incidence, solving this problem became a priority. Several different strategies were used, starting with re-education on arrogate expend 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 mindful manner they did, they beget the potential to reduce excess dressing changes and the related BSI risks but too reclaim nursing time through allowing their dressings to remain in region and intact, while protecting their investment in protective strategies fondness CHG sponge dressing and advanced securement dressings.
I am fortunate to accumulate 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 repercussion that rebaselining had on many facilities’ standardized infection ratios (SIRs). I hear the pressure that Infection Prevention and Vascular Access teams are under to ameliorate their CLABSI numbers. I am frightened by some of what has been shared with me. I beget heard programs subsist actively encouraged to NOT try to reduce central line days – because leaving them elevated helps to contour rates or SIRs explore 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 subsist used… since then there could subsist no CLABSIs. That is a disturbing proposition in terms of vessel health – their veins are meant to eventual us a lifetime and must subsist treated with mindful consideration of what is infused into devices and how those devices are placed and maintained. On the flip side, I beget heard of hospitals who explore at their rates and because they are “OK” they are not pushing further to ameliorate outcomes or ameliorate compliance with the process measures that drive those outcomes. If they continue to beget patients with potentially deadly infections, how can they allow ourselves to become complacent?
Please ally with your vascular access teams or whomever has primary responsibility for those considerations in your hospital. partake the data you beget from NHSN and any process measures you ensue for totality vascular access devices; inquire them to partake the measurables they track for their productivity. Learn together how you can collaborate to capitalize contour your hospital the safest feasible region they can subsist 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 beget indicated they outcome not beget strong, open relationship with their infection preventionists. gladden gain 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 zeal 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 recent 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 stint 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: obviate 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 expend 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 reduce catheter-related bloodstream infections in the ICU. recent 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. censorious supervision 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 recent study.A recent study in The American Journal of Pathology provides information about the mechanisms underlying failure of the most common character 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 subsist associated with destitute nitric acid responsiveness.’Hemodialysis removes fritter products from the blood and establishes electrolyte and fluid poise in patients whose kidneys can no longer duty properly. There are several approaches that doctors expend to establish connections with the blood supply for hemodialysis."The arteriovenous fistula is the preferred character 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 develope (meaning the vessels outcome not enlarge enough to uphold 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 expend 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 institute 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 too institute 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 destitute 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 obviate fistula maturation failure in patients and potentially contribute to their ability to remain on hemodialysis.
"The shallow location and accessibility of the fistula contour it highly suited for application of local drug or gene therapies both during and after its surgical creation. The findings from these studies may too beget applicability to the more generic 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 focus for Clinical Epidemiology and Biostatistics at the University of Pennsylvania Perelman School of Medicine (Philadelphia).
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