Inferior vena cava filters have been around since the late 1960s, and the first FDA approved removable IVC filters were approved in 2003 and 2004. Permanent filters had already been FDA approved at that time. On average 250,000 people each year have an IVC filter implanted. According to an article in the Journal of American College of Cardiology from 2013, Accepted indications for IVCF placement include the presence of acute venous thromboembolism with inability to administer anticoagulation medication or failure of anticoagulation. Despite these clear indications, IVCF have been commonly placed in patients for primary prevention of pulmonary emboli in patients deemed to be at high risk, along with several other “soft” indications. As a result, …show more content…
Bard has been at the center of controversy due to its link to increase risk of serious medical complications after implanted. Furthermore, it has been alleged that Bard forged its FDA application for that product, and was aware of defects in the device. In 2005 Bard stopped producing the Recovery filter, but never officially recalled it. Since then Bard has manufactured other IVC filters that have been approved but are associated with medical complications as well. Additionally, 11 companies sell IVC filters. Although Bard knew about the problem with the ICV filters, the company did not disclosed this fact to the FDA. In early 2004, Bard began receiving complaints of IVC filter malfunctions with allegations that pieces of the device were prone to break off, and thus travel to other parts of the body potentially causing serious injury. Bard, worried about the complaints, contracted with litigation consultant Dr. John Lehmann, who prepared a report regarding the fracture and migration rate of the filters to previous models. The “Lehmann Report” provided legal advice to Bard about its vena cava filters and copies were distributed to a small number of employees with instructions that the report was …show more content…
In a 2014 Safety Communication Update, the FDA recommended that physicians who used retrievable IVC filters consider removing the filter as soon as the risk of pulmonary embolism had abated. They cited to a 2013 decision in the Journal of Vascular Surgery: Venous and Lymphatic Disorder, which suggested that if a patients risk for pulmonary embolism had passed, “the risk/benefit profile begin to favor removal of the IVC filter between 29 and 54 days after implantation.” Previously in 2010, the FDA published a Safety Communication about the risk of leaving a retrievable IVC filter in a patient too long., and recommended removing the filter as soon as “protection from the PE is no longer needed.” Furthermore, a study from the Journal of Vascular and Interventional Radiology, published in February 2012, found that 40% of Bard Recovery IVC filters fractured after 5.5 years. Additionally, of the 363 people who were implanted with the device, only 97 had it removed. The study evaluated cases involving filter migration into the pulmonary arteries, iliac/femoral veins, on in the right ventricle of heart, and the renal
On March 26, 2008, Hughes filed an initial grievance against Boston Scientific in the district court of Mississippi, seeking recovery of injuries allegedly caused by the HTA medical device. A summary judgment was awarded to Boston Scientific on the court’s conclusion that all claims made by Hughes are preempted under the Medical Device Amendments of 1976, 21 U.S.C. § 301 et seq. On
Vital sign assessment is important prior to discontinuing the Lactated Ringer's since the primary IV contributes to the maintenance of cardiovascular stability.
The procedure was done emergently because of the patient’s critical condition. His right IJ area was prepped in the usual fashion. It was very difficult to visualize his right IJ vein, even though his habitus should have allowed us to do so, but the patient was, I believe, severely intravascularly volume depleted, and his vein was collapsing. I have attempted to access the right internal jugular vein multiple times, both under real-time ultrasound guidance and even later on blindly. I was able to get blood return and hit the vein; however, I was not able to advance the guidewire. I was able to advance it one time and put the catheter in, and it was nonfunctioning. I had to take the catheter out and tried multiple other times on the right IJ vein without success. That procedure was terminated. Pressure was applied. There was no cervical hematoma whatsoever. The patient was uncomfortable because of the length of the procedure but did well otherwise. Hemodynamically, he was unchanged, and his oxygen saturations remained stable.I prepped the IJ vein area in the usual fashion. One percent lidocaine was used for local anesthesia. Again, the left IJ vein was collapsing. With deep inspiration, the vein could be well visualized on the real-time and ultrasound guidance, after which I could get access to the left IJ vein. A wire was advanced without difficulty while the
A. Just imagine driving home from a party after everyone had been drinking and all of a sudden there is a big crash and the next thing you know you and your friends are being taken to the hospital in an ambulance. That is what can happen when you decide to drink and drive. B. Drinking can be fun when you are with your friends but once a person makes the decision to get behind the wheel it is a completely different story.
PICCs lines have become well recognized as reliable central venous access devices (VADs), with lower potential for complications than short-term central venous catheters. PICCs first gained popularity in the 1980s, and their use has grown steadily since then. They were initially popular in many parts of the United States due to the need for venous access in home care patients. They have grown in popularity because of their reduction in potential complications and costs compared with short-term central venous catheters, and because PICCs can be inserted by registered nurses who have been trained in the procedure.
It can also occur during blood transfusion or during dressing change. The insertion of central catheters can occur in the Interventional Radiology or sometimes at the bedside. Regardless of the where the insertion process occur, a sterile field must always be maintained and sterile techniques must always be employed to prevent any organisms from being introduced to the central line into the patient. According to The Joint Commission (2013), many organizations such as Michigan Keystone Intensive Care Unit Project and Institute for Healthcare Improvement are actually adhering to insertion bundles to reduce the CLABSI rates. The bundles include hand hygiene, maximal barrier precautions, chlorhexidine skin preparation, avoidance of femoral vein, and prompt removal of central catheter. Furuya et al. (2011) studied the effectiveness of the insertion bundle and how it impacts the bloodstream infections for patients in the Intensive Care Unit. As a result, lesser infection have occurred when the compliance is high. As mentioned, the site of the catheter also needs to be considered in the insertion process. Avoiding areas such as the groin to access the femoral artery is recommended because this area can be easily contaminated with urine or feces. In addition, after the insertion of a new central line, all the used IV tubing
Over the past 20 years there has been many high profile cases both with children and with adults that has resulted in Enquiries and Serious Case Reviews Some of these cases have received heavy media attention and have shaped quality assurance, policy, regulation and inspection is completed and conducted.
According to a study conducted in 2011 by the government, approximately 80% of urinary tract infections associated with indwelling catheters, increase the hospital length of stay by one to three days, and according to the Centers for Medicare & Medicaid Services (CMS), have an annual cost of
Unfortunately, “VTE comprised of DVT and/or PE represent a serious public health challenge, affecting up to 600,000 Americans annually. The consequences can be deadly; VTE has been identified as the most common cause of preventable mortality in hospitalized patients, accounting for up to 10% of hospital deaths” (Shermock et al., 2013, p. 1) It is imperative that all patients admitted to the ICU should be assessed for VTE. The assessment should be done frequently. It is important to assess both subjective and objective data. Past medical history is very important. It is essential to find out if the patient has any predisposition to a VTE including any trauma to veins, any varicosities, obesity, COPD, HF. Certain medications can also put a patient at risk for VTE such as oral contraceptives, hormone therapy, tamoxifen, or raloxifene. Also, any recent surgeries such as orthopedic, gynecologic, gastric, or urologic and past surgeries involving veins or a central venous catheter can put a patient at risk. Objective data includes fear, anxiety, and pain. Monitor vital signs frequently. Check the integumentary system for symmetry; taut, shiny, warm skin, erythematous, tender to palpation. Not every patient
Only when it is absolutely necessary should a catheter be inserted into a patient. Every patient is assessed for the need for a Foley catheter. If the Foley is inserted, assessments are also then done daily to see if the need is still valid. If the reason is not justifiable the catheter must be removed from the patient (Joint Commission releases new NPSG for CAUTI, 2011). Nurses must follow guidelines while inserting indwelling catheters as well. Aseptic technique is critical to maintain during this process. The use of sterile equipment and a sterile procedure helps to reduce the risk of CAUTI. If in any way the catheter becomes contaminated during the process of insertion, the nurse should discard of the entire catheter and start with a new, sterile kit. Proper hand hygiene is very important before and after contact with indwelling catheters to decrease risk of infection. Maintenance of a close drainage is system is also important that way bacteria are not able to get in and cause infection (Revello & Gallo, 2013). Decreasing the number of times Foleys are inserted and how long they stay in for can help reduce the risk of CAUTI since the longer a Foley stays in, the higher the risk of infection becomes. Nurses must keep the catheter line patent, with no kinks to allow urine to flow freely through into the collection bag. When a urine sample must be obtained it must be done in a sterile
Wrong site, wrong procedure, and wrong patient errors are avoidable safety issues. Nearly 1.9 trillion dollars are spent on medical errors each year in the United States (Catalano & Fickenscher, 2008). Between 1995 and 2007, 691 wrong-site surgeries have been reported to The Joint Commission's Sentinel Event data repository (AHC Media LLC, 2008). In 2003 in response to the outcry for better patient safety The Joint Commission
Brusch says, “Once a indwelling catheter is placed, the daily incidence of bacteriuria can be between 3-10%.” Another large problem that results CAUTI’s is that at times, catheters are left in a patient longer than necessary. Prolonged use of
This course has provided a new perspective on exercise and behavior adoption for many reasons. The first and prominent realization I had was during the behavior change project. This assignment allowed me to take a step back, and assess where I stand physically and mentally. I noticed that I lacked discipline in my diet and exercise routines. That being said, I did exercise periodically prior to this moment, but I knew that I was capable of accomplishing more and using my time more wisely. The fact that this assignment allowed me to directly apply what we learned in class in my life is appealing to me. There have been many theories and terms that we have covered, but items such as the self-determination theory, social support, and the stimulus-response theory stood out, probably due to incorporating them in my behavior change.
It considers threats and impacts associated with climate change could be reduced and handled through mitigation and adaptation. The report evaluates resilience, choices, opportunities, constraints, needs, limits, as well as other features connected with adaptation. Climate change requires shifting probabilities of impacts that are varied with complicated interactions. A focus on danger, which will be not old in this report, complements other aspects of the report and supports decision. Societies and individuals may view or rate possible gains and hazards otherwise, given aims and varied values. All-inclusive evaluation has been eased by increased works across a more comprehensive group of issues and sectors, with increased coverage of the ocean, variation, as well as human systems. (IPCC, 2014)
1) Summary of Article: A review of literature shows the length of time a catheter remains in the body is directly associated with CAUTI.