By Kelly M. Pyrek
This article originally appeared in the May 2022 issue of Healthcare Hygiene magazine.
Approaching product evaluation and purchasing through the lens of infection prevention is becoming more common as healthcare value analysis professionals work to help realize clinically driven goals around optimal patient outcomes.
Premier (2020) defines value analysis as “an evidence-based process for healthcare organizations to obtain supplies, services, and equipment. Value analysis drives quality care delivery, safety and outcomes, and factors in total cost.”
This aligns with how the Association for Healthcare Value Analysis Professionals (AHVAP) defines it: “Healthcare value analysis contributes to optimal patient outcomes through an evidenced-based systematic approach to review healthcare products, equipment, technology, and services. Using recognized best practices, and in collaboration with organizational resources, value analysis evaluates appropriate utilization, clinical efficacy, and safety issues for the greatest financial value.”
Experts have previously offered descriptions for the intersection between these disciplines. For example, “Larson and Maciorowski stated that product evaluation should be based on quality, safety, cost, standardization, and service ability; Rockett stated that product evaluation involved the consideration of cost containment, cost-benefit analyses, and productivity, but the ultimate measure of product success was the impact on patient outcomes; and Elliot and Hollins viewed the product evaluation process as the interface between quality care and cost containment, with a focus on scientific and objective principles and information.” (APIC, 2015)
As the healthcare industry evolves from a cost-only driven perspective to one that embraces high-quality supply and service decisions made in a fiscally responsible manner, experts note that institutions' value analysis programs, processes, and decisions “must be structured within a framework of quality and safety,” and must “support the health system’s mission, vision and strategic goals.” Premier (2020) states further that healthcare value analysis programs must be designed to “balance issues related to quality, patient and staff safety, revenue enhancement and reimbursement optimization across the continuum of care.”
This is accomplished through appropriate standardization, pricing optimization, implementation of cost-savings initiatives, as well as identification and elimination of waste, redundancy, and inefficiency.
Some observations about the importance of healthcare value analysis have weathered the passage of time and circumstance, as Halvorson and Chinnes (2009) note, “A structured product evaluation program can have a positive effect on patient care and can contribute to the financial health of the organization. In today’s healthcare environment characterized by unprecedented financial constraints, healthcare worker shortages, shortened hospital stays, and increased reporting requirements by payers and watchdog organizations, the product selection process is increasingly important. Innovation in the medical product field is continuing to flood the marketplace with technology that rapidly replaces mechanical or manual ways of providing care. And although innovation provides an essential health benefit, the healthcare system is challenged to select and evaluate emerging technologies to ensure their cost benefit. These factors underscore the importance and need for robust product evaluation programs and collaboration across all hospital disciplines.”
Infection preventionists are no longer on the sidelines of product evaluation and purchasing decisions, as more IPs are joining their facilities’ committees for the purpose of representing the interests of HAI prevention. And as Miller and Kelly (2009) observe, “Product evaluation remains an essential function in healthcare facilities. As the healthcare environment is increasingly dominated by managed care and capitated reimbursement, constraints are placed on the amount of funding available to hospitals. At the same time, quality of care and outcome measures are beginning to be used as a basis for reimbursement. Therefore, hospitals have tremendous incentive to control costs and improve outcomes. Healthcare-associated infections (HAIs) are becoming a focus in the product market, as manufacturers develop high-cost products claiming to decrease infections. Infection preventionists must take an active part in the evaluation of products that may affect infection rates to determine whether they are efficacious and thus worth the added cost.”
Lisa Kilgore, MBA-HCM, BSBM, CIC, director of epidemiology and infection control for Scripps Health in San Diego, reminds clinicians that product/technology purchase decisions impact patient-care outcomes, and when considering a product choice, to ask themselves:
• What are the infection-related risks?
• Is there a potential for errors?
• What is the potential compatibility of devices?
• Are there special population needs?
• Are there unintended side effector complications?
Halvorson and Chinnes (2007) have suggested the goals of a product evaluation program are to select products that meet specific performance criteria, including clinical and financial criteria; are safe for patients and healthcare personnel; contribute to positive patient outcomes, such as fewer infections and injuries, and are cost-effective for the healthcare institution as well as patients.
However, some categories of products pose a greater challenge than others in terms of evaluation, and require discernment on the part of clinicians.
“One of the most challenging categories to evaluate are medical devices,” confirms Kilgore. “Especially if they are specialty devices. For instance, per the Food and Drug Administration (FDA), ‘Fixed endcap duodenoscopes, are no longer marketed in the U.S. The FDA has cleared seven duodenoscopes with disposable components that facilitate reprocessing or are fully disposable, and some manufacturers are offering replacement programs to upgrade to a model with a disposable component at no cost. Facilities should complete their transition to newer models that have disposable components or are fully disposable, which emerging data suggest can lower infection risks.’ (See: Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication, April 5, 2022; available at: https://www.fda.gov/medical-devices/safety-communications/use-duodenoscopes-innovative-designs-enhance-safety-fda-safety-communication) There are some clinicians who do not happy about using disposable scopes or tips as a personal preference. By providing them with the proper education and the regulatory reasoning behind the ‘why’ makes the transition more seamless. This also provide hospitals with an opportunity to reduce hospital acquired infections and to be in compliance with the FDA.”
Kilgore says it is important for clinicians and infection preventionists to have informed opinions to assist their institutions in effectively evaluating products and devices.
“The clinician or IP should consider using the Healthcare Infection Control Practices Advisory Committee (HICPAC) Infection Prevention Product Assessment Algorithm,” she suggests. “This tool can assist when formulating product-specific recommendations. By doing this, it eliminates bias.”
The CDC’s product assessment guide walks clinicians through critical considerations when evaluating medical devices, products and technologies. Important product considerations include:
• Does the product have the necessary regulatory approvals if required?
• Does the product have the specific indications for the intended clinical usage?
• Is the product compliant with established evidence-based clinical guidelines or regulatory requirements?
• Is the product on your GPO contract?
• What is the overall cost per usage of the product?
• What product implementation product is available from the supplier?
In terms of assessing a product or technology’s claims, experts suggest the following considerations:
• Review the product/technology’s full regulatory approval document
• Assess the product/technology’s technical data bulletin if available
• Review published product reports or clinical studies in peer-reviewed literature
• Review the FDA’s MAUDE Reports to assess potential risk for adverse events, especially for medical devices
• Validate supplier materials with independent sources
• Assess for compliance with appropriate clinical guidelines and recommendations
Premier (2020) suggests that evaluators gather information from a variety of sources, including:
• Key clinical and non-clinical stakeholders
• Clinical requirements, areas of use and current outcomes
• Product specifications, such as product and current utilization amounts and practices
• Associated policies, procedures and guidelines, including internal, professional associations and regulatory
• Evidence-based literature
• Annual spend and supplier proposed pricing, value adds and key terms and conditions
• Benchmarking data – price, cost, quality, safety, labor, and outcomes as applicable
• Reimbursement information
• Supplier capacity – historic, projected and disaster recovery plans
When information has been secured, Premier (2020) recommends that healthcare value analysis projects follow five key processes:
1. Identify. Pinpoint the opportunities to address.
2. Gather Information. Determine and gather the requisite data, content and information to evaluate the opportunity.
3. Analyze. Weigh all the evidence gathered to make the right decision for your organization and the impacted stakeholders.
4. Implement. Efficiently implement the decision.
5. Monitor. Measure and report on decision sustainability and value over time.
Premier (2020) makes a critical observation, in that sometimes a process improvement is needed, rather than purchasing a new product or technology: “It is not uncommon to gravitate toward a solution before thoroughly examining the problem that needs to be solved. Solutions can seem easy, obvious and speedy. Problems, on the other hand, are more difficult to discuss, can appear nebulous and can raise questions that challenge our assumptions. Although that solution-first mindset feels comfortable, it may not provide the best odds for success. It may set teams on a direction that might not deliver the value we expect, and we may miss other paths leading to a result that more accurately solves the problem. When evaluating new requests, value analysis teams can implement process steps to assist them in identifying or confirming the problem the requestor is trying to solve.”
As an example, the value analysis team at a multi-hospital healthcare system received a product request from a medical/surgical nursing unit that wanted silver-coated urinary catheters. Their rationale for securing this technology was that it could address an increase in catheter-associated urinary tract infections (CAUTIs). The healthcare system’s value analysis team noted that while some studies suggest that silver-coated urinary catheters may reduce the risk of infections, clinical trials have yielded mixed results; they also observed a variance in CAUTI rates among hospitals and nursing units within the system. Further review revealed variances in the nursing protocol/policy for aseptic insertion of indwelling catheters. As Premier (2020) explains, “With the help of the value analysis team and clinical education staff, the health system elected to standardize the nursing protocol/practice and provide enhanced education to staff in lieu of purchasing a more expensive product. They were able to decrease the CAUTI rate and sustain it. In this example, a change in process addressed the problem. Because the value analysis team and clinical education staff revealed a better solution, purchasing a new product was no longer the only or best option.”
Kilgore recommends that before recommending a product or medical device, the clinician should look consider the following:
1. What is the quality of the product compared to what is already in use at your facility or is this a completely new product/device?
2. Does this address the greatest threat of real harm to the patients?
3. Are there potential unintended side effects/complication of using this product or device?
4. Is there an FDA-approved indication?
5. Have there been any review recalls and FDA citations?
6. Does the product or device require EPA registration?
7. Is the vendor a part of your group purchasing organization (GPO)?
8. What is the cost to make this change?
9. How difficult is it to educate staff to use safely on patients?
Adding to this list may be the need to keep in mind current pandemic- and healthcare supply chain-related challenges. “During the pandemic, hospitals experienced a severe shortage of personal protective equipment (N95s, surgical/procedure masks, gloves, isolation gowns), disinfectant products and other critical devices (ventilators, tubing etc.),” Kilgore reminds clinicians. “A way to increase visibility is to always have greater transparency between supply chain and stakeholders/end-users. Another recommendation would be to not limit yourself to only one vendor in your institution’s GPO for products.”
When evaluating new purchasing requests, Premier (2020) says value analysis teams can use the following guiding questions to assess the problem and potentially offer alternate solutions:
• What problem are we trying to solve? Is there a problem to solve?
• What possible root causes exist? Is there a process/practice element that contributes to the problem?
• Is the problem’s existence or severity variable across our facilities/departments?
• Is clinical practice standardized across our facilities/departments?
• What outcome is measured, or can be measured, to monitor improvement?
According to Premier (2020), “The goal of this exercise is to explore the problem and shape the best response (process and/or product). This exploration will lead the team to more questions, followed by more research to refine the opportunity and its value. Expanded exploration allows the team to collect different perspectives from various stakeholders, test assumptions and answer outstanding questions. The end output will be a solution that focuses on a validated problem.”
Halvorson and Chinnes (2009) concur, noting, “As economic pressures in healthcare increase, the philosophy of product selection must continue to be objective, scientific, and need-based. Because many elements must be considered when products are being selected for use in the healthcare setting, it is likely that the product evaluation committee will continue to play an important role in improving patient outcomes, promoting employee safety, and affecting the organization’s bottom line. The infection preventionist brings a unique and vital perspective to the product selection process by mediating pressure on resource utilization (e.g., reuse of medical devices), evaluating and reducing infection risks associated with product change, ensuring patient safety, and providing expertise in clinical literature review.”
References:
Centers for Disease Control and Prevention (CDC). A Process for Assessing Products for Infection Prevention in Healthcare Settings: a framework from HICPAC. July 2019. Accessible at: https://www.cdc.gov/hicpac/workgroup/product-assessment.html
Miller BE and Kelly RE. Product Evaluation. APIC Text of Infection Control & Epidemiology, 3rd edition, 2009.
Halvorson CK and Chinnes LF. Collaborative Leadership in Product Evaluation. AORN J 2007;85(2):334-352.
Premier. Value Analysis Guide. Fourth Edition, 2020.