I am hearing this phrase with greater frequency from nurses in conversations and on various discussion forums. I have recently heard about a specific practice recommendation from a manufacturer that could increase patient risk. Although the “recommendation” was made in an effort to improve patient safety, the outcome of the recommended practice would increase product sales and could cause harm, in my opinion, and is not evidence-based. When I hear about these conversation or recommendations, my question is always, “Have you seen the same information in the printed literature supplied by the manufacturer?” This printed information is considered product labeling and must meet the guidelines from the FDA.
Most sales representatives are working to help solve your problems, but we must keep in mind that they also have other motivations for various statements – specifically their personal annual income. They have a built-in motivation for making the statements that you hear. There are sales training classes using role-playing exercises to learn key phrases and ways to explain specific aspects of a product, along with financial incentives to sell certain products. Most manufacturers have training departments that work hard to educate sales staff about what they can and cannot say, but the individual may not always adhere to their training when trying to sell a product to your facility. For anyone making a decision about any aspect of clinical practice, it is our responsibility to base product decisions on solid evidence. Where is this evidence found? First, look at published standards of practice (e.g., Infusion Nurses Society, Oncology Nursing Society, etc.) and guidelines (e.g., Centers for Disease Control, Society for Healthcare Epidemiology of America, etc.). Look at the date of publication on those documents. If those documents are aging, then you will need to go to more recent studies published in peer-reviewed journals to see if there is new information. Literature from a manufacturer is a valuable resource as well, especially the instructions or directions for use that accompanies all devices. Do the verbal statements from the sales representative match this literature? The claims allowed by the company are addressed in this literature along with other supporting white papers and sales materials. Look at the references on these pieces. How old are the quoted studies? Also, remember that a white paper is written for marketing purposes and has not been through any blinded peer-reviewed process. Do these resources quote presentations or posters from conferences? These are also lacking any type of blinded peer-review process. Relying exclusively on verbal information from a local sales representative is not adequate for product decisions or practice questions about a specific product. The sales representatives job is to sell product. While most are concerned about clinical outcomes, they do not have the same perspective as clinical decision-makers. All claims made in a conversation must be supported by sound clinical evidence. There can easily be a situation with new devices where this evidence from clinical studies is not yet available. I would recommend benchmarking your practice against what is being done in other healthcare facilities or posting a question to colleagues on an online discussion forum instead of total reliance on this verbal information from a sales situation. Confusion continues about several definitions currently being used – specifically “central line,” “CLABSI,” and “CRBSI.” Central line associated bloodstream infection or CLABSI is a term that is used only when it applies to surveillance data collection within a given facility. This data is reported to the National Healthcare Safety Network (NHSN) database at the CDC and is used for public reporting in many states. There are very specific criteria that must be met for a bloodstream infection to be counted as a CLABSI. Note this definition only applies to “central lines” and only to bloodstream infections. It does not include short peripheral or midline catheters. Catheter related bloodstream infection or CRBSI is used when making a clinical decision about the causes and management of a bloodstream infection in a specific patient. It requires diagnostic tests and appropriate treatment decisions. Note this term is not limited to central lines and encompasses all types of vascular access devices. So, what is the definition of a “central line”? Does this definition differ based on how or when it is used? The answer is a decided yes, about the differences. The NHSN is a national database tracking healthcare associated infections (HAI) from almost 15,000 healthcare facilities of all types. To learn more about NHSN, click here. For purposes of accurate and consistent HAI data collection, a “central line” is defined by NHSN as Central line: An intravascular catheter that terminates at or close to the heart or in one of the great vessels which is used for infusion, withdrawal of blood, or hemodynamic monitoring. The following are considered great vessels for the purpose of reporting central-line BSI and counting central-line days in the NHSN system:
To read the entire document, “Bloodstream Infection Event (Central Line-Associated Bloodstream Infection and Non-central line associated Bloodstream Infection) click here. Please take notice of the fact that this definition is specifically for the purpose of reporting CLABSI and counting central line days. It does not differentiate between insertion sites and tip location. Clinicians who are deeply involved with vascular access devices have fought an uphill battle for many years about the most appropriate tip location. Some may be concerned about this definition doing harm to those efforts. I do not think this definition can or should alter or harm our efforts. Recommendations for appropriate central vascular access device (CVAD) tip location is based on clinical evidence that the best outcomes are achieved when the catheter tip is positioned in the lower third of the superior vena cava (SVC) at or near the cavaatrial junction (CAJ). If veins from the lower extremity are used, tip location with better outcomes are seen when the tip is located in the inferior vena cava (IVC) above the level of the diaphragm. We also recognize several facts about CVADs:
Given these circumstances, I interpret the NHSN list of veins to provide instructions that all of these catheters must be counted as central lines for purposes of reporting CLABSI to this system. I do not interpret this to mean that the NHSN is making a statement that all of these tip locations are acceptable or desirable or appropriate. As professionals involved with infusion and vascular access, we must remain current on the evidence about tip location, continue to educate and advocate for CVAD tip location in the CAJ. However, I do not think these NHSN definitions are harmful to our work. My answer is a definite Yes---No --- and Maybe! Seriously, there is no single answer for this question. The literature on informed consent does not spell out specific procedures that require informed consent. Instead, the language in these published resources is “invasive procedures or treatments”. Therefore, your facility must make this decision. First, let us discuss what is and is not “informed consent”. This is definitely a shared decision-making process. It begins with educating the patient and family about the procedure and ends with a signature on a piece of paper. Please do not think that the signed piece of paper alone is the informed consent. The education comes from the professional performing the procedure because that individual is the most knowledgeable about that procedure. This education should not be delegated to others. This education should include a description of the procedure, the reason for it being recommended, the risks and benefits associated with the procedure, and the alternatives to treatment if the recommended procedure is rejected. Use learning methods and educational materials (written, video, etc) that are most appropriate for each patient and their needs. Confirm that the patient comprehends this information by using “teach back” methods. After confirmation that the patient comprehends all information given, a signature is obtained on a piece of paper. That is the complete process of informed consent. Each facility must follow state laws or regulations, if present, about informed consent. Collaborate with the risk manager in your facility to discuss these laws or regulations and gain their thoughts on the need for informed consent for a midline catheter insertion. Some will say it falls under the general consent signed on hospital admission because it is a peripheral catheter. Other will say it is intended for a longer dwell time than a traditional short peripheral catheter and requires strict sterile technique for insertion and therefore requires “informed consent.” Alternative settings may have additional considerations for or against the need for informed consent. In my opinion, everything that we do to all patients requires their informed consent. We cannot omit this educational process but that does not always require that the patient or family and a witness sign a document labeled as “informed consent” and listing the specific procedure. Another approach is to document what was taught, how it was taught, the level of the patient/family comprehension, and how this was confirmed. This education is then documented on a specific form. This process provides an alternative when the “informed consent” document is not required. It could also be helpful to use such an educational documentation tool even with the “informed consent’ document. Wow, the first half of this year simply disappeared due to a very hectic schedule! Now is time to celebrate the birth of our great country. We would like to wish everyone a happy and safe holiday weekend. We are very sorry that we have neglected our blog over the past few months, however work and family caused this to slip in priority. Fortunately, Lynn’s schedule is getting lighter with no summer business travel and other projects ending. So, watch for our blog message to begin next week. Enjoy your holiday and we look forward to hearing your responses and questions to our blog, and Facebook and Linkedin. |
Author: Lynn HadawayLynn Hadaway is an international thought leader in infusion therapy and vascular access, having been in this practice for more than 40 years. Her experience comes from hospital-based infusion teams, device manufacturers, and continuing education services. Her journal and textbook publications are extensive. She also maintains board certification in infusion nursing (CRNI) and nursing professional development (RN-BC). Categories
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May 2019
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