2022 November/December INSider

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Issue

Cheryl Campos,

NPD-BC, CEN, CPHQ, VA-BC and Andrew Haws, MBA

Hilary

Fisher, MSN, MBA, RN, CRNI®, IgCN, Andrea Owens, MSN-Ed, RN, CRNI®, VA-BC, Kori Utter, MSN, MBA, RN, CRNI®

K.

Tricia

MNSc, BSc,

PMHNP and Marlene M. Steinheiser, PhD, RN, CRNI®

by Cheryl Campos, DNP, NPD-BC, CEN, CPHQ, VA-BCTM and Andrew Haws, MBA

Note from the authors: The SuperCath 2000 is a fictitious product.

Introduction

Have you ever had an idea for a medical device that would make your workflow better or more efficient? Have you ever wondered who decides what features the products and devices you use for patient care will have? Perhaps you’ve found a specific peripheral IV catheter (PIVC) difficult to use because it’s hard to grip under certain circumstances and you wondered who can improve it. Join us as we gain insight into how new products are developed and how you can get the tools you want into your facility.

This article will provide practical steps to guide nurses on how they can collaborate with medical device companies to improve workflow and ease of use of medical devices and products and work together to improve patient care. It will include a step-by-step roadmap through the process of developing and launching a new product using a fictitious PIVC implementation case study. Finally, steps will be discussed on how nurses can effectively engage with industry partners to champion the use of a new product and increase the likelihood of successful implementation.

Product Development

When it comes to developing a new product or technology, medical device companies typically use a phase-gate approach. Each step may go by a different name or certain actions may be grouped differently, but the same basic phases in the overall process remain the same.

The five common phases are shown here. At the end of each phase of development, a decision-making step or gate is encountered before moving forward. The outcome or decision at each gate determines which route will be taken next. The company will typically decide to a) move the project forward, b) stay in the current phase and do more work, or c) halt the project all together.

To better understand this process, imagine we are developing the SuperCath 2000, the next generation of PIVC. You are about to embark on a journey through the design and development of this new device, from inception through the sideroads to get the product into your facility.

Idea Generation

A product starts with idea generation, the inception. Here the medical device company needs to figure out what the SuperCath 2000 needs to achieve. Company marketing professionals will reach out to nurses, observe their workflow, discuss cases, and learn what worked and what didn’t. Through a combination of observations, interviews, focus groups, and advisory boards, the medical device company will define what clinician needs must be addressed with the SuperCath 2000.

It’s great for nurses to be involved in the beginning of the process. Nursing knowledge gained through interviews can pave the way for successful product launch in the market. The best nurse interviews are not the ones where everyone tells the medical device company how much they like their products: the best interviews are the ones where clinicians are clear and specific about what is not working well. Your candid input is essential.

During the interviews and discussions, the medical device company will show nurses different devices and ask questions such as: Why did you choose this one over that one? Which of these safety mechanisms do you like better? What frustrates you with the tools you use in your daily work? What is causing most of your IV catheter failures and restarts?

We then translate these responses and the data into a set of product requirements. Perhaps we determine that the SuperCath 2000 needs to dwell for the entire duration of a patient stay, have a high first-attempt success rate, or allow one-handed insertion. Perhaps the device needs to be colored to indicate a specific gauge size, be power injectable, and be more kink-resistant than catheters that are currently available.

Evaluation

The next step is the evaluation phase, when the medical device company determines whether it is feasible to make the SuperCath 2000 and whether there is a market (customer base) that will lead to purchase of the device. Many innovative ideas rely on technology that is currently beyond our ability. Or perhaps it is too expensive to be feasible or it is impractical for most potential users. Defining the patient population is also part of the evaluation process. We may want to determine if a device is gender-specific, which would cut out approximately half of the patient population. Is the product only for use with neonates? That is an even smaller group of patients. We also need to evaluate product cost. For instance, making a PIVC out of platinum would cost too much and likely not provide any performance benefit. However, when making catheters for endovascular brain surgery, platinum is the best way for surgeons to see their devices under fluoroscopy while performing life-saving ischemic stroke thrombectomies. Clearly, materials and production costs must be weighed against the performance benefits and the necessity of the procedure.

During the evaluation phase the company needs to get a sense of regulatory requirements as well. Will a clinical trial be required or is the new device similar enough to an existing (predicate) device that we can assume safety and efficacy? The rigor of evaluation will vary depending on the risk. For example, adding a few gauge sizes or lengths requires less evaluation than receiving clearance for a new-to-the-world device.

Other points to consider are potential issues that may lead to the demise of a project. More than a few devices have been created to “make a procedure easier”; however, although it may make a procedure easier for a brand-new nurse, an experienced nurse may have no need for the extra assistance or modification. Now you’ve got an expensive infusion device or tool that a limited number of clinicians may use. For example, we may have designed the SuperCath 2000 with a great needle safety system; however, only a few markets have legislated safety requirements or actually enforce existing legislation. Maybe our SuperCath 2000 only makes sense in markets with a strong culture of needle safety.

The phase gate for evaluation is particularly grueling, as medical device company leaders explore the concept, consider the options, and choose between projects. The show Shark Tank can be used to understand the stakes when interacting with your coworkers working on other projects. If we want the SuperCath 2000 to become a funded project, we must be able to demonstrate that it is worth the investment.

During this phase, product development teams compete against internal peers for investment capital. Companies only have so many resources to devote and must deliver on the most valuable ideas to stay solvent.

Planning

In the planning phase, the medical device company develops a robust plan for every aspect of development. For the SuperCath 2000, we’ll finalize the product design and develop a framework for manufacturing. We will finalize our clinical evidence plan. Clinical evidence may be necessary for registration and premarketing of the device with the Food and Drug Administration (FDA 510k submission) and for us to make claims about product performance.

We also need to plan for market-shaping activities. For example, in the tender markets in Europe, when selecting devices like PIVCs, they request bids from the companies interested in supplying the devices. Bids are then compared, and a winner is selected. They do not have a unique tender for difficult intravenous access (DiVA) specific devices. If our SuperCath 2000 is a high-tech specialty catheter designed to improve first-attempt success in DiVA patients, then it will be competing against standard PIVCs in price. It would be challenging to win a tender against a standard nonspecialty PIVC that costs $1 when our new device may cost more. We may want to work with key opinion leaders and governing bodies to see whether we can inspire the creation of a DiVA–specific device tender so our SuperCath 2000 can compete on a more even playing field.

Development

The development phase is all about execution. The medical device company now invests massive amounts of money in plastic molds, manufacturing equipment and processes, distribution logistics, and meeting regulation requirements in target markets. We may have parts coming from three different countries and final assembly and sterilization in a fourth country. Unexpected roadblocks, such as COVD-19, may arise, and companies may need to pivot their development plans.

Product packaging, also part of development, must be designed and finalized with testing to ensure it will hold up during shipping. Instructions for use must be written and validated by end-users for clarity and to meet the requirements of the FDA. Prototypes are also created, and the company starts to gain input through hands-on formative or human factors testing.

During development, the marketing department tests product messaging to make sure it speaks to our intended audience or customer. In a recent messaging poll, nurses responded negatively to the phrase “helps improve compliance.” Administrators like compliance and infection preventionists like compliance, but nurses, as patient advocates, are more likely to resonate with messages of “ease of use” or “improvement in patient care.” Thus, we may have different messages for different audiences.

Launch

Now the SuperCath 2000 is ready for prime time. The medical device company is receiving final regulatory clearance from the countries we want to sell in, training our field teams, including the company representatives and clinical specialists, and getting the final product in front of potential end-users.

During this phase, the company pays close attention to monitoring product complaint data, an important aspect of successfully marketing a device. It tracks issues reported directly to medical device company representatives, MAUDE (Manufacturer and User Facility Device Experience) or MedWatch, agencies that collect and track safety concerns and device recalls.1 Medical device companies take product complaints very seriously, as this input is critical to help us improve our devices and ensure we meet our quality commitments. We are also required to report product complaints to the FDA and other regulatory bodies.

If you are interested in this part of the process, reach out to your medical device company representatives. Tell them about your problems or give feedback or ideas for new technology. Share your suggestions for improvement or just let them know that you want to be involved. They can connect you to the product development teams, and you may be able to serve on a product advisory board. Affecting change to improve patient care can be very rewarding for nurses.

Medical device companies also send devices that don’t perform as intended back to the manufacturing facility so we can identify issues and prevent similar events in the future. For example, if you think a needle is too dull, making it difficult to pierce the skin, we will want to look at the needle under a microscope. We want to see if it was a one-off issue or if maybe a problem arose in production, requiring us to issue a product recall.

Through close collaboration between medical device companies and end-users, we can work to reduce use of substandard equipment and devices. We want to provide nurses with quality products so that you don’t have to come up with workarounds to get your job done. Even if you aren’t heavily involved, such as serving on an advisory board, we encourage you to send information to us so that we can fix an issue. Reporting can be as simple as sending a quick email to the local product representative. Take a picture of the packaging and we will have almost everything we need. We are obligated to follow up with you.

Searching for a Solution

As we continue to discuss how a vascular access device goes from inception to insertion, identification of a problem comes to the forefront. The value of inquisitive nurses advocating for implementation of evidence-based practice (EBP) to improve patient care cannot be underestimated. Multiple sources can be queried to identify where the pain points in patient care exist. Quality indicators, occurrence/event reports, sentinel events, patient surveys, staff observations, and quality councils can provide insight into potentially outdated practices and policies, and trends or issues requiring innovative solutions.2

Through this spirit of inquiry, we must ask a clinical question, identify solutions, and have a culture that supports the change process if we are to improve care.3 This requires searching for the answer to a problem or practice need using a formalized process. Nurses could do this by developing a PICO question.

PICO is an acronym for elements of a clinical question including patient population (P), intervention or issue of interest (I), comparison intervention or issue of interest (C), and outcome(s) of interest (O). This process creates a specific, well-defined question that can only be answered by searching current literature for studies comparing the identified interventions.3

The next step is to conduct a literature review, where nurses can seek assistance from a medical librarian, professional journals, and the medical device company representatives. Regardless of the source, a thorough search of the literature must be done to identify options available that may solve the problem at hand. Is there an existing product on the market that will address the problem or need? Perhaps something coming through the FDA approval process may prove beneficial. There may be an opportunity to trial a device through a performance improvement project or to conduct a clinical trial with a new device, which is another reason to establish collaborative relationships with the medical device companies that are also committed to improving patient care by providing quality products.

Once the relevant evidence is collected, it must be examined. There are a variety of resources available to nurses for appraising evidence such as the Johns Hopkins Evidence-Based Practice for Nurses and Healthcare Professionals (EBP).4 This model also provides guidance on how to implement EBP. Ultimately you want to answer the question, “Is the solution identified translatable to my workplace?” If the answer is yes, you are ready to proceed.

Successful Product Implementation Through Identifying the Key Stakeholders

Perhaps one of the biggest challenges for the medical device company is the process of getting a new product or device into the hospital setting. Identifying a great product or device requires doing the homework to determine whether it may be a viable solution. In our case, we identified the need for a new PIVC with fewer complications and longer dwell times to provide a cost-effective solution and improve patient outcomes.

It’s important to identify all the key stakeholders—anyone with a vested interest in the process or who will be affected by a product change. To be successful, implementation cannot be done in silos.5 Identification of stakeholders requires the medical device company product managers to think through each touchpoint in the process from the moment a product is considered, to when approval is obtained, to when the product arrives on-site. This includes product delivery from materials management and stocking on the unit to the point used at the bedside.

Many health care organizations have a products review or value analysis committee responsible for the evaluation of new products and devices. Stakeholders on this committee typically include an interprofessional group of direct and indirect clinician end-users with support from a strong nursing leader, such as the chief nursing officer (CNO). Infection preventionists, biomedical engineers, information technologists, or pharmacists may also be involved.5 The Needlestick Safety and Prevention Act, signed into law November 6, 2000, mandates involvement of nonmanagerial health care workers in evaluating and choosing devices.6 Nurses who have witnessed what happens at the bedside must therefore drive the change for improvement, including front line nurses who will use the new PIVC (end-users), not only department directors or managers. End-users are often the only ones who truly understand the impact of a substandard device, or the impact that a lack of needed products has on patient care.

Other stakeholders who can testify at the committee may include a member of materials management, who can provide valuable insights, such as financial impact, supply chain shortages, and availability of hospital contracts with medical device companies; a patient who may be affected by the device or product; employee health nurses who are knowledgeable about needlestick rates (if relevant to the product or process being evaluated); an infection prevention coordinator that can speak to current central line or catheter-related blood stream infection rates; unit practice council members who represent nursing departments that will utilize the new product; and/or a physician champion who may be able to speak to poor patient outcomes because of the poor quality of the PIVCs currently being used and drive home the need for a better solution.

Unfortunately, not all stakeholders will understand the true cost or impact of their decisions for product purchase, which is often based solely on the initial cost of a product. Getting a device approved is not only a matter of recognizing the value. We have a complicated road ahead.

Approval for Product Trial

In our scenario we have found a possible solution to our identified problem. Next, we need to determine the process to get the desired device or product on the agenda of the products committee. Then, the medical device company, the nurse, or the person championing the new product or device can reach out to materials management for assistance, and we can build a strategy to negotiate the next steps of the journey to get the SuperCath 2000 approved for trial. By conducting a product trial, we can determine whether the solution identified in literature review can be translated to our health care setting.

At the day of the products committee meeting, the champion needs to convey the value added and importance of bringing in a product that can improve first-time attempt success rates, decrease the number of catheters used, and shorten time to insert, thereby lessening patient pain, suffering, and dissatisfaction. Furthermore, the device can limit delays in treatment and improve hospital throughput.

If you are the nurse championing the new device to the products committee, your goal is to convey a powerful message to the team. If your organization allows, have the medical device company representative present to showcase the product and help answer questions. Presenting evidence of improved outcomes and a comprehensive cost analysis is recommended. Medical device companies can provide health care economic outcomes models that can aid in decision making regarding feasibility of implementing a product. Despite its high quality, if the device or product is too expensive, it may never be approved.

Using actual numbers from your organization and plugging them into a health economic model will help the committee better understand the return on investment of a potential new product.

The Impact of Using an Economic Model

To further explore the importance of evaluating the true cost of patient care, it is important to recognize the volume of the product. Since we know that between 60% to 90% of hospitalized patients require a PIVC during their hospital stay, the financial impact of a product change cannot be taken lightly.7 An economic model that outlines all costs associated with product use can help identify the true cost and return on investment with a product change. The stakeholders then understand the soft and hard costs as they begin to recognize the cost of poor quality.

In our scenario, a standard PIVC is currently used. We can compare this to the SuperCath 2000 which we are proposing to trial as an example of how an economic model can be applied. Partnering with the medical device company and obtaining product purchase prices from materials management, we input numbers to demonstrate value added/cost savings and economic benefit of converting to the SuperCath 2000. At a minimum, overall cost should be evaluated based upon price of device, number of device(s) used per hospital stay, and impact (cost) of nurse time.

In Table 1, the information used to demonstrate the value of switching to the SuperCath 2000 is portrayed. The catheter cost ($), average dwell time (days) and number of PIVC starts and restarts were input in the economic model using an average length of stay (LOS) of 4.8 days. The cost of the SuperCath 2000 is $3. The average dwell time is 5.2 days; therefore, only one successful PIVC placement would be needed per patient stay. The number of catheters per start was based on the number of attempts for successful placement. For the SuperCath 2000 this was 1.02. Therefore, the cost of the SuperCath per patient visit is $3.06 ($3 x 1.02 catheters).

Conversely, the cost of the standard PIVC is $1. The average dwell time is 1.4 days. Therefore 3.4 starts/restarts are needed for a PIVC to last the LOS. The number of catheters per start was based on the number of attempts for successful placement (1.9). Thus, for the standard PIVC the number of catheters per patient stay was 6.5 (3.4 x 1.9). The cost of the standard PIVC for the patient visit is $6.50 ($1 x 6.5 catheters).

Table 1

Taking the scenario a step further, we can look at nurse time to start/restart a PIVC. In our example, we used start times in minutes from a known study comparing a specialty catheter to a standard PIVC.8 Collection of actual times at your own hospital can be done for a more accurate estimate. The SuperCath 2000 averaged 5.6 minutes to insert compared with

12.5 minutes with the standard PIVC. The cost for nursing time per insertion was based on an hourly pay rate of $60 or a dollar a minute. Nursing cost for placement of the SuperCath 2000 was $5.60 versus the cost for insertion for the standard PIVC of $42.50.

The final step is to calculate overall cost comparison between the two catheters. This is based upon price of the catheter, number used per hospital stay, and cost of nurse time for insertion.

In our example, the SuperCath 2000 ends up being $8.66 per patient visit and the standard PIVC is $49. This presents a very different scenario than just comparing the cost of the PIVCs. If the materials management team understands more than the hard costs (number of vascular access devices and supplies used), we have a better chance of influencing purchasing decisions. The hospital will still have to pay the nurses for the same amount of time on duty (soft cost), but nurses can instead devote time to other value-added and critical duties by avoiding the time spent starting and restarting PIVCs.

While this is a simplified scenario, a deeper dive into the true cost savings through reduction in complications, shorter hospital LOS, and potential reduction of morbidity and mortality could occur. An even broader assessment could include the impact on patient satisfaction, hospital reputation, and trust in health care overall.

Collecting Baseline Data for Comparison

The nurses were able to convince the key stakeholders and decision makers at the committee to trial the SuperCath 2000. But we cannot rest on our laurels. An implementation plan and team must be established and baseline data must be collected that reflects the current state of PIVC insertion and associated complication rates.

Table 2 has an example of documentation in the EMR that reflects some of the data that can be pulled into a report. The SuperCath was added to the type of peripheral line inserted. Length of PIVCs is also included to track which size was used. A place to document the use of vascular visualization technology (e.g., near infrared, ultrasound) should also be included in the EMR. This can help identify if a patient is a DiVA and lend information for patient care during hospitalization.2

By working with the programmer/system analyst, data analytics can be abstracted from the EMR. This will set the implementation team up for success as we can then abstract data related to the SuperCath 2000 and validate what we have known all along, that the standard PIVC is wrought with complications and that the SuperCath 2000 may be the answer!

Table 2

Education and Training

Another important training piece is to identify any nurses that will be documenting the type of VAD used in the EMR to ensure they recognize the new catheter and document correctly. The medical device company’s implementation team and hospital champions carefully plan to determine the best areas of the hospital to trial the SuperCath 2000 and which nurses will be the superusers. Knowing that most patients admitted through the emergency department (ED) will receive a PIVC, the ED nurses are often a great choice to train and pilot a new device. They might also train your vascular access specialist team if one exists in the hospital. Regardless of which areas, all nurses and clinicians that will encounter the SuperCath 2000 must be educated about the new product and informed of any required change(s) in practice. Remember we do not want to function in silos.

Another important training piece is to identify any nurses that will be documenting the type of VAD used in the EMR to ensure they recognize the new catheter and document correctly. At this time, the implementation team partners with hospital educators to provide hospital-wide nursing education regarding the importance of documenting the accurate number of insertion attempts.

Where does the nurse document that multiple attempts occurred? Does each nurse who made an attempt document this in the EMR? Without this forethought, the implementation team won’t have valid data. Table 3 has an example of documentation in an EMR that captures the number of unsuccessful attempts and actions taken post attempt.

Table 3

Many companies have clinical educators and representatives that can offer free training and support during the product conversion period, including online learning modules, didactic courses, and hands-on training.2

In addition to providing any prerequisite insertion training, medical device company educators can help answer questions and assist nurses as needed in the first few days of implementation. Unit champions and superusers are also crucial to provide ongoing support, address issues that may arise, and provide updates as the staff progress through the process. They can also remind nurses to complete product evaluations, which are available from the medical device company representatives, so that the end-user input is captured and used in the final decisions on product use.

Comparative Data

The medical device company and the nurses have both committed a great deal of time, energy, and resources to this project. Now it is time to check results and determine the answer to the PICO questions: In adult hospitalized patients, how does the use of a specialty PIVC affect first-time attempt success rates, catheter dwell times, complication rates, and resource use compared to a standard PIVC? Did the intervention result in a clinically significant improvement? Did the SuperCath 2000 perform as anticipated? Has the intervention made a positive change and reduced complications compared to the standard PIVC? Has there been a reduction in PIVC use as hoped?

Because you had a clear understanding of the entire process and did the prework, you are now positioned to measure the outcomes or check the results of the intervention. You can look at the outcome measures and compare baseline data to the current data associated with the new product.5 A report can be pulled from the EMR to identify the number of attempts made to successfully place a PIVC, the dwell time, and the reason for removal (when clinically indicated due to complications or completion of therapy).2 Catheter use can also be obtained from materials management to determine whether a reduction in quantity purchased/used occurred. Keep in mind that there may be an initial increase in product use during the learning phase of implementation.

Through data analysis, you have established that the change worked. Do you and the medical device company need to revisit the process, modify use or training, or test the product further?7 Is there sufficient favorable data to recommend the use of the SuperCath 2000 hospital wide? Due to the well-thought-out plan, inclusion of key stakeholders in the early stages of the project, having end-user engagement throughout the entire process, and a thorough initial evidence collection and review, the decision is to adopt the use of the SuperCath 2000 hospital-wide.

Formal Implementation Hospital Wide and Ongoing Training

Now the implementation team can continue to provide education, support, and training, and hardwire the use of the new PIVC. The team and nurses can monitor the data from the reports created from the EMR. If issues arise or modifications are needed, you can continue to improve processes. Remember, any change in practice should be updated in the organization policies, procedures, and/or practice guidelines.

Training additional nurses in the use of the SuperCath 2000 can continue through the superusers established during the pilot program and again by partnering with medical device company representatives. Once nurses start to see the improvement brought about by the SuperCath 2000, they will often come forward and request to be in the next cohort to be trained.

Conclusion

Nurses are uniquely qualified to identify patient care issues related to inferior medical devices or lack of product availability.

is

be at the head.

2. Gorski LA, Hadaway L, Hagle ME, et al. Infusion therapy standards of practice. J Infus Nurs. 2021; 44(suppl 1):S1-S224. doi:10.1097/NAN.0000000000000396

3. Stillwell, S, Fineout-Overholt, E, Melnyk, BM, Williamson, K. RN evidence-based practice, step by step: asking the clinical question. Am J Nurs. 2010; 110(3)58-61.

4.

5.

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8. Idemoto,

Guest Feature: An Interview with Michael Ferrara

What is the mission of your company?

At BD, our mission is “Advancing the World of Health.” Our division provides solutions to optimize the medication delivery process with a specific area of focus around vascular access management. We strive to improve the clinical and economic outcomes associated with the end-to-end vascular access management process.

What is your role within the company?

Vice president of worldwide marketing for BD Medication Delivery Solutions.

What types of products do you develop?

Vascular access devices for the proper selection, placement, care and maintenance across a full range of IV catheters—basically everything required for the end-to-end practice of vascular access from the patient to IV line to infusion pumps.

How do you receive the impetus for a product?

We focus on industry challenges and complications associated with clinical practice. We try to do a lot of customer insights and understand the clinical practice. We work with customers, clinicians, and caregivers to optimize successful medication delivery. Through observation, human factor research, and/or market studies, we identify unmet needs, such as a patient or practice challenge or a challenge with the products clinicians are using.

What are the stages of medical device product development?

We identify a specific area of interest or a clinical practice around a department or a patient condition. Once we’ve identified an area, we do an analysis to understand the customer needs and issues we are trying to solve. What new value can we create that will address these key needs? We create a proposal, which is internally reviewed and compared to other proposals. The concept project also has to be validated externally from customers and market research. We need to detail the benefits for the customer, the patient, and BD. We need to be very clear and specific on the unmet need: what is the real issue we are looking to address? Once approved, the project gets funding and the core team organizes to go through product and concept development.

How are nurses involved in your work?

We have a team of clinicians and subject matter experts on our staff as well as a network of customer champions as part of the advisory board, and we are always soliciting feedback from our customers. Marketing, medical, and engineering are the key components of the overall process.

What are the current challenges in the medical device industry?

Broadly the same as in the medical field. Inflationary pressures, increasing costs of raw materials, transportation, manufacturing, etc.

What do you see as the future of the medical device industry?

I see continued innovation through newer technologies applied to the industry. We want to provide full solutions to address the challenges associated with vascular access and IV therapy. We are constantly looking for new opportunities for better clinical efficiency and to improve the workflow of nurses.

We see opportunities to transform data into information and provide more analytics. We want to provide more actionable insights to our customers.

I think it’s an exciting time to be in the medical device field.

Hilary Chandler, MSN, RN, OCN, CRNI®

Hilary Chandler has been a nurse since 2009 and has worked in infusion therapy since 2011. She currently serves as the nurse manager of Cancer Services at Kelsey-Seybold Clinic in Houston, Texas. In this role, she oversees the daily clinical operations for the cancer center including a 27-chair infusion department. In addition to cancer treatments, the department provides other infusion therapies such as biologics, iron, antibiotics, IVIG, and hydration

In 2020, Hilary launched the vascular access program for her organization to insource PICC and midline catheter insertions. She also developed a negativepressure isolation unit to provide monoclonal antibody treatments to patients with COVID-19. Kelsey-Seybold Clinic was one of the first centers in the Houston area to provide this treatment option to the community.

In addition to clinical interests, Hilary is passionate about nursing education, having created educational programming for her organization and a Staff Education Committee for the Cancer Center. Hilary received her CRNI in 2019® and is excited for the opportunity to serve on the National Council on Education (NCOE) committee. She is looking forward to working collaboratively with speakers to develop fresh and engaging educational content for the annual meeting.

Kori Utter, MSN, MBA, RN, CRNI®

As a member of INS and the INS National Council on Education, Kori Utter is able to pursue her passion for nurse education in the infusion specialty. Kori has been an infusion nurse for 10 years, and is currently a nurse manager for a specialty pharmacy in Massachusetts. Some of Kori’s past experience includes working as a vascular access team member for a large teaching hospital, being an infusion nurse and director of nursing for an infusion company, and working in home health nursing. She earned her master’s in nursing and master’s in business administration with a focus on leadership and administration from the University of Mary in 2022.

When Kori is not working, she enjoys spending time with her rescue dogs, hiking in the New Hampshire mountains, watching Boston sports, and spending time with her family. She also enjoys going to concerts, traveling to new places, and working out with virtual exercise classes.

INS is pleased to welcome four new members to the National Council on Education. You can read about their backgrounds and interests below.

Christie Fisher, MSN, MBA, RN, CRNI®, IgCN

Christie Fisher is the director of nursing at CarepathRx MSO, an innovative pharmacy solutions company and a clinically advanced pharmacy. Fisher serves as the pharmacy’s nursing ambassador, drawing on her professional knowledge and background to improve the overall patient experience and clinical education.

Christie earned her RN diploma from Ohio Valley General Hospital School of Nursing in 1998, her BSN from the University of Pittsburgh, a dual MBA and MSN in nursing education and leadership from Carlow University, as well as the prestigious CRNI® and IgCN certifications.

Christie's career includes critical care, oncology, cardiology, international, infusion, and diagnostic nursing as well as hospital capacity management. She began her career with home infusion with Chartwell PA in 2017 (now CarepathRX), developing a wide array of experience in all aspects of home infusion.

Through her work with the INS NCOE, Christie desires to collaborate with a team of infusion nurse experts to ensure best-practice recommendations reach nurses in a way that they can learn and incorporate into their daily practices.

Christie enjoys spending time with her family, encouraging others to live to their full potential, and challenging herself to reach new heights.

Andrea Owens, MSN-Ed, RN, CRNI®, VA-BC

Andrea’s four decades as a nursing professional include strong foundations in adult critical care, infusion therapy, vascular access, leadership, clinical education, and, since 2014, academia. She has served in a variety of leadership roles in her professional career as a clinician and an academic.

In her current role as an assistant professor of nursing, she has found a love for teaching foundational skills and knowledge while setting a solid foundation for the next generation of nursing professionals and future nurse leaders. One of her treasured honors has been the Marian University’s 2020 Thomas J. and Sherri D. Enneking Excellence in Teaching Award.

Andrea is pairing her experience in curriculum development and design with her knowledge, skills, and expertise in the field of vascular access to champion change in prelicensure nursing curricula. As the 2018 president of the Association for Vascular Access, Andrea is committed in her efforts to increasing the awareness of the need for a standardized vascular access curriculum. In addition to her continued efforts toward changing the paradigm of PIV education and training in schools of nursing, her research interests include studying effective learning outcomes in student nurses and course collaborative unfolding case studies.

Understanding Moral Distress: An Article and A Survey

Infusion nurses face many challenges while caring for a wide variety of patients including those in acute and critical care units, those being treated intermittently in outpatient settings, and those receiving long-term care. While providing treatment, they often witness patients and families suffering, and the nature of this work puts them at risk for experiencing moral distress, ethical dilemmas, compassion fatigue, and burnout syndrome. These important concepts are all interrelated, and are defined below; however, the main focus of this article and its accompanying survey is on moral distress.

Moral distress is the experience of painful feelings and psychological disequilibrium that takes place when clinicians are aware of a morally proper decision that needs to be made without being able to make it, usually as a result of various barriers including, but not limited to institution policy, lack of resources, protocols, staffing, time limits, workplace incivility, bullying, sabotage, retaliation, lateral violence, and disruptive patient behavior.

Ethical dilemma is a situation that is difficult to problem-solve because there are at least two (or more) morally justifiable actions to take but neither/none of these solutions is completely satisfactory to all involved. Ethical dilemmas can lead to moral distress. (This article and its accompanying survey will not be addressing ethical dilemmas in-depth, but the authors note the importance of attention to this in practice.)

Compassion fatigue, also referred to as secondary traumatic stress disorder or vicarious traumatization, occurs as clinicians expend more energy and compassion than they receive, which manifests as physical, emotional, psychological, and spiritual exhaustion. Compassion fatigue may result from moral distress.

Components

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as if one’s

attrition, and physical

mental health problems

and/or worry about one’s own or a loved one’s well-being

by K. Murphy-Ende, PhD, PsyD, PMHNP and Marlene M. Steinheiser, PhD, RN, CRNI®

Burnout syndrome is an imbalance of personal characteristics of the employee and work systems or employer. It leads to decreased quality of care, poor patient satisfaction, absenteeism, and attrition.

Moral distress in particular arises when the clinician feels conflicted between ethical stances and values and an obligation to perform an action that goes against these beliefs—for example, providing what is perceived as inappropriate or futile care. These experiences pose a threat to one’s moral integrity because the clinician knows the correct ethical action to take but is unable to do so.

Decisions that may lead to moral distress:

• Setting priorities for care for patients

•

time

• Trying to allocate scant resources equally

• Realistically maintaining their own physical and mental health care needs

• Needing to tend to responsibilities outside of work, such as family, friends, and personal responsibilities

• Providing technical care and patient education that might be difficult while not knowing what the patient has been told and what they understand about their illness and treatment goals

• Setting boundaries with patients who may require more emotional and supportive counseling than time allows

• Deciding when to refer a patient or family member to a mental health professional

• Assessing and addressing a psychiatric emergency for a patient with suicidal ideation or one who is mentally distressed/mentally ill

• Sending a patient home who does not have a safe home environment or appropriate resources

• Providing care for severely ill patients with limited or inadequate resources

• Deciding whether to get involved in quality improvement and how to best communicate the concerns about patient care, staff competency, and staff well-being.

• Finding time to participate in continuing education

Negative

such as emotional distancing

depersonalize and dehumanize care, leading to undigni

care

Moral distress interventions that need to be addressed at personal, interpersonal, and organizational levels:

• Resiliency building

• Stress reduction through self-care

• Balance between bearing witness to patient suffering with the recognition that it is not possible to connect deeply with all patients

• Education about interventions to manage moral distress

• Narrative writing

• Staff ethics huddle

• Utilizing mental health professionals (psychologists/psychiatrist/social worker)

• Team building and nurturing a climate of mutual team support

• Opportunities to debrief with each other

• Formal clinical mentoring

• Ethics support through a formal hospital ethics committee consult or ethics interprofessional rounds

• Open and direct communication with the patients’ prescribing provider (nurse practitioner or physician)

• Interdisciplinary rounds and opportunities for clinicians to share information regarding patient’s and family’s values and preferences

• Qualitative research that continues to describe the climates that lead to moral distress and interventions that are helpful

Administrators’ and middle manager’s responsibilities include asking about moral distress, affirming the issues, assessing the issues, and taking action. Leaders need to obtain training on moral distress and be accountable to staff. It is vital for managers to make changes to minimize moral distress and to prevent staff from leaving the organization.

Most nursing professionals, regardless of specialty or role, face stressful situations at work, and are at risk for developing stress-related symptoms. Moral distress in particular arises when a person feels conflicted between their ethical stances and values and their obligation to perform an action that goes against these beliefs. Symptoms can be psychological, physical, or emotional. One may feel depressed, emotionally exhausted, or fatigued; develop headaches or muscle aches; and/or feel isolated, frustrated, angry, or guilty. Infusion nurses might feel moral distress from a specific patient scenario, institutional policies and procedures, legal issues, time constraints, power differential, and/or supervisor or coworker dynamics.

INS is conducting a survey on moral distress. You can access the survey here. We sent it to you yesterday by email. Please consider taking the survey by November 23, 2022. Your confidential input will help us better understand what nurses are experiencing so we can plan an educational session about moral distress.

American Association of Critical-Care Nurses. Moral distress in nursing: What you need to know. https://www.aacn.org/clinical-resources/moral-distress. Accessed September 27, 2022.

Epstein, EG, Delgado, S. Understanding and addressing moral distress. Online J Issues Nurs. 2010; 15 (3): Manuscript 1.

Murphy-Ende, K Workplace stress. In: Current Trends in Oncology Nursing. 2nd ed. Payne/ Murphy-Ende. Oncology Nursing Society; 2019.

Steinheiser MM, Crist JD, Shea KD. Compassion fatigue among registered nurses working in skilled nursing facilities. Res Gerontol Nurs. 2020; 13 (6): 320-328.

Steinheiser, M. Compassion fatigue among nurses in skilled nursing facilities: Discoveries and challenges of a conceptual model in research. Appl Nurs Res. 2018; 44: 97-99.

Chair: Barb Nickel, APRN-CNS, CRNI®, CCRN

Co-Chair: Lisa Gorski, MS, RN, HHCNS-BC, CRNI®, FAAN

Peter Carr, PhD, MMedSc, BSc, RN

Simon Clare, MRes, BA, RGN

Rachael Crickman, DNP, ARNP-CNS, RN, AOCNS, OCN® Michelle DeVries, MPH, CIC, VA-BC

Samantha Keogh, PhD, RN, BSc(Hons)

Tricia Kleidon, MNSc, BNSc, RN

Amy Kyes, MSN, RN, CRNI®, CVRN-BC, APRN, AGCNS-BC

Britt Meyer, PhD, RN, CRNI®, VA-BC, NE-BC

Jennie Ong, PharmD

Mary Jo Sarver, MSN, ARNP, AOCN®, CRNI®, LNC, VA-BC

The March/April 2022 INSider highlighted the Infusion Therapy Standards of Practice Committee kickoff meeting and throughout 2022, we’ve featured several members of the Infusion Therapy Standards of Practice Committee. You can listen to Lisa Gorski, MS, HHCNS-BC, CRNI® , FAAN and Barb Nickel, APRN-CNS, CCRN, CRNI® in the May/June issue, Michelle DeVries, MPH, CIC, VA-BC and Amy Kyes, MSN, RN, CRNI® , CVRNBC, APRN, AGCNS-BC in the July/August issue, and Rachael Crickman, DNP, ARNP-CNS, AOCNS, OCN, RN in the September/October issue. Our final featured member is Tricia Kleidon, MNSc, BSc, RN.

Tricia Kleidon, MNSc, BSc, RN

Tricia is a nurse practitioner in pediatric vascular assessment and management at Queensland Children’s Hospital and a research fellow at University of Queensland. Tricia is part of a dynamic clinical and research team that prides itself on achieving positive outcomes for patients and minimizing vascular access related complications. She is currently enrolled in a PhD program of research entitled “Techniques and Technologies to Improve PIVC First-Time Insertion Success and Reduce Complications and Failure.”

Right now, the committee is working hard on revising the Standards. A draft of the Standards will go out for public comment in mid-2023, and will be published in 2024.

AWARD:

TONIA AIKEN , JD, BSN, RN

James Aiken, MD, FACEP, MHA, the medical director at SafePush, LLC, nominated Tonia Aiken, JD, BSN, RN, the CEO of SafePush, LLC. Tonia is a nurse and attorney who has taught and presented nationwide on legal and ethical issues for nursing. She is a past president of the American Association of Nurse Attorneys and a past president of the New Orleans District Nurses Association.

How do you know the nominee?

I am the medical director and cofounder of SafePush. I have worked with Tonia from the inception of SafePush when she brought the problem of IV push injections to me. She had a client who had lost the use of an arm and hand because a health care provider injected an IV push too rapidly. As an emergency medicine physician, I confirmed that I saw this problem frequently when nurses or doctors administered critical care medications. We both felt that there was a need for an innovative tool for providers.

How long have you known the nominee?

Tonia is my wife. We have known each for 39 years. She is dedicated, hardworking, and has a passion to provide an innovative tool to make administering IV pushes safer for patients and to take the guesswork out of it for health care providers.

Describe an innovative process or outcome the nominee has implemented at the organization that is new or a value add to the health care industry.

Tonia has been the driving force in finding the right team and engineer with a fluid dynamics background to develop the SafePush device. SafePush attaches to the tip of a syringe and the IV line, is disposable and color-coded for rates, requires no electricity and minimal training, and prevents human error. SafePush can replace the current practice of watching a clock or watch and estimating/guessing at the rate of delivery of IV push injections of critical care medications.

What was the catalyst behind the innovation?

Tonia had a client, a patient in a hospital, who received an IV push that was given too rapidly. The patient developed Reflex Sympathetic Dystrophy and lost the use of the hand and arm. When she discussed the issue with me, I told her that this is a problem in the emergency room. I work at a level 1 trauma center as an ER physician. Health care providers do not use small volume infusion pumps—they take too much time to find and to set up and have many human and technical errors.

How did the innovative idea impact the customer?

SafePush is going through the FDA process and has been granted an abbreviated 510K path based on the Safer Technology route. SafePush is patented technology. We have done focus groups and surveys of nurses and doctors who find that SafePush is an easy-to-use, safe, and practical tool that takes the guesswork and worry out of administering potentially dangerous drugs to patients. We have numerous letters of support from health care providers and associations.

As an infusion specialist, was there an infusion-related workflow that the nominee developed or changed in response to providing excellent care?

Proposed workflow changes include the pairing of a prefilled syringe with the SafePush device in a kit that would be sent from a pharmacy—with the proper device for the rate of 1cc, 2cc, or 5cc per minute. The other proposed change is that SafePush would be indicated or a drawer would open with the device when a medication is pulled that requires an IV push at a specific rate. The device will allow health care providers to keep their eyes on the patient and not the syringe.

Was there a process or outdated institutional practice that was updated to current standards influenced by the nominee?

As discussed above, this would replace what is recommended by the Institute for Safe Medical Practices (ISMP)—using a clock to estimate the rate. We have informed ISMP of our device and that there is an alternative to what they recommended in their 2015 publication.

Is there a method to evaluate the effectiveness of the innovative idea that was implemented?

We have been approved for a pre-FDA study by the Louisiana State Surgery and Research Committee at University Medical Center in New Orleans. We are working with the Medical Technology Enterprise Consortium and the Military and Health Research Foundation to do studies with the Department of Defense. We have performed focus groups and surveys and continue to perform more focus groups until we are out of FDA.

Summarize why you feel this nominee should receive the Innovation Award?

Tonia has a passion for helping people and making a difference in the world—whether as a nurse in the hospital or a nurse attorney representing the injured or nurses whose job was on the line for licensure issues. She truly cares.

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Announcing Maureen Fertitta’s Retirement

With great difficulty and lots of smiles, big hugs, and well-wishes, we announce Maureen Fertitta's well-deserved retirement as of November 15, 2022. For the past 8 years, you have probably come to rely on Maureen’s expertise, either knowingly or unknowingly. If you ever had a problem with your CRNI® certification and reached out for help via phone, email, or chat, Maureen was the one who helped you. But perhaps you have never had an issue with your certification—and that can be attributed to Maureen as well, as she was the brains behind the certification software module.

Maureen has been not only the cornerstone of INCC for the past 8 years, but the anchor in the INS Member Services Department as well. She assured that the day-to-day processes and procedures were well-organized and run efficiently with the appropriate staff members assigned and accountable to their deadlines. And she accomplished all of this with an easy manner and perfect mix of friendship and collegiality, and was always there for any INS/INCC staff member, behind supporting, beside helping, or in front leading.

In retirement, Maureen plans to spend more time with her husband and 4 daughters and their spouses, but mostly with her 7 grandchildren (and more on the way). The entire staff will miss Maureen tremendously—not only her exceptional knowledge of every software platform but also her contagious smile and laugh, her welcoming attitude, and her ability to make everyone in the office feel like they can accomplish anything. Maureen, as we begrudgingly watch you leave for your retired life, we wish you all the best. Please don’t forget us because we will never forget you and all you have done for INS and INCC.

Maureen Fertitta, Senior Certification and Member Services Associate

END OF YEAR REVIEW

INFUSION NURSES SOCIETY

The Infusion Nurses Society has enjoyed hosting both in-person and virtual meetings in 2022. In March, INS hosted a virtual conference on infusion therapy related complications. In June, 333 members convened in-person at the Rosen Shingle Creek Resort in Orlando, Florida for INS 2022—and 262 members joined the meeting virtually. INS rounded out our meetings in October with a virtual symposium on infusion medication safety: perspectives on preventing patient and clinical harm.

We said both hellos and goodbyes to staff members this year. Darlene Leuschke, who is responsible for the INCC test development and administration activities, started in May.

Maureen Fertitta, who has served as a staff member at INCC for 8 years, will retire in November 2022, and Mary Alexander, who has been the CEO of INS and INCC for 25 years, will retire in April 2023.

The Standards of Practice Committee met for their kickoff meeting in January in the Norwood, Massachusetts office. Throughout 2022, we’ve featured videos from members of the committee where they reflect on their research and the current revision process. A Standards draft will go out for public comment in mid-2023, and the 9th edition of the Infusion Therapy Standards of Practice will be published in 2024.

The INSider has begun to include more creative pieces. Throughout 2022, members of the Diversity, Equity, and Inclusion Task Force have shared their personal stories through INSider videos. We’ve also published poems, an essay from the family member of a patient, an essay from a nurse about the pandemic, an interview with a children’s book author, and more.

This summer, we conducted a survey in which we asked members what sections of the INSider were of interest to them and what else they’d like to see in the INSider, and we are planning future issues based on that feedback.

In September/October, we started a new feature, to highlight members’ updates and accomplishments, and we’ll continue that new feature in the New Year. If you have anything you’d like to share, please email Rachel King at rachel.king@in1.org. We can’t wait to hear your updates and accomplishments in 2023!

Michael Miller, managing editor at INS, passed away unexpectedly on October 8, 2022, at the age of 36. Michael now rests in the comfort of his Heavenly Father, surrounded by the serene bliss and peace he searched for on earth. Michael is survived by his loving husband, Anthony; his dog, Charlie and cat, Bette; his mother, Merri; his grandparents Florence and John Hoijer and grandmother Arliss Miller; his brother Luke Miller and sister Tiffany Scherbing; and his seven nieces and nephews: Cody, Annika, Sam, Connor, Vincent, Alfie, and Luisa.

Michael was born in Waconia, Minnesota, to Merri Beth Miller (nee Hoijer) on Saturday, February 8, 1986. He graduated with a Master of Arts in English in 2011 at Syracuse University and a Masters of Business Administration in 2016 at Metropolitan State University. On April 29, 2015, at the age of 29, Michael married his soulmate, Anthony Moran, then 27, at the Minnesota Landscape Arboretum in Chanhassen, Minnesota.

Michael was a devoted husband and son and loved his family and friends so deeply. Michael's favorite places were the Minnesota Landscape Arboretum in Chanhassen, Minnesota; Hobart, Australia, where he met Anthony; the Upper Peninsula of Michigan, where he spent many summer vacations with cousins; and Boston, Massachusetts. Michael enjoyed antiquing in Stillwater, Minnesota, lunching and dining with Anthony, and exploring new foods and cuisines—as well as enjoying his staples of sweet tea and Australian sweets. Michael was an avid reader of history and politics; a much-loved colleague and professor of writing at Metropolitan State University; and a highly respected and sought-after editor at various medical journals.

Michael joined the Infusion Nurses Society as associate managing editor last winter and worked primarily with the Journal of Infusion Nursing. He collaborated with the INS publications department, authors, researchers, peer reviewers, and others while managing the editorial processes of the journal. Michael enjoyed working with professionals in the medical field and readily supported those in the publication process. His forte was untangling complex concepts and writing into succinct and scholarly prose while respecting the voice of the author.

“Michael was exceptionally talented as an editor and writer, and we are honored that he shared his giftings and abilities with INS,” Dawn Berndt, director of publications and educational design, wrote. “More importantly, Michael was a kind, gentle man who treated colleagues and authors with great respect. I admired his thoughtfulness and thorough commitment to any request or work-related task. It is difficult for me to describe the void that his passing leaves in the publications department and in my heart as well.”