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By Kelly M. Pyrek
Individuals who participate in the product evaluation and purchasing process within their healthcare organization are cogs in a very large wheel that moves the U.S. healthcare industry forward. According to market research from the Freedonia Group, the disposable medical supplies market is worth $38 billion and could escalate to as much as $46 billion by 2016. MarketResearch.com reports that the U.S. durable medical equipment market reached $26 billion in 2010 and is expected to reach $31 billion by 2013 A report from ReportLinker indicates that the global medical equipment and supplies industry currently represents an estimated annual revenue of $273 billion, with predictions showing world market worth could climb to $349 billion by 2016.
Healthcare encompasses an enormous range of supplies, equipment and instruments, ranging from drug-delivery products to wound management supplies, textiles, procedure and surgical supplies, and innumerable infection prevention and control-related supplies. Well-informed product evaluation and purchasing is a significant way for hospitals to combat rising expenses in an environment of moderate reimbursements, according to Hoeksema (2011), who emphasizes that perioperative nurses play a key role in evaluating product safety, effectiveness and efficiency, environmental concerns, and cost and how these factors affect patient care.
As AORN (2010) notes, "While all team members have an opinion, "A member of the surgical team is crucial from two key vantage points:
• Being well-versed in the clinical “ins and outs” of any surgical procedure.
• Familiarity with a variety of tools, supplies, and the proper and effective use of each.
After all, as AORN points out, "With surgical procedures in particular, perioperative nurses are crucial in ascertaining that the necessary equipment, instruments, and supplies are set up and used appropriately."
Infection preventionists can join their facility's perioperative staff in the process. As AORN (2010) notes, "... increasing focus on infections and reduction of hospital-acquired infections (HAIs) has infection control practitioners (ICPs) playing a greater role in purchasing committees and they are among the first to point out that nurses are a key reference when it comes to making the case for a certain product. ICPs use data regarding cost, efficacy, and end-user clinical evaluations to support their recommendations. In many instances, the end-user is a nurse."
Information Gathering and Evaluation
While a product evaluation committee is the recommended, structured way to address purchasing issues, often nurses pick up a significant amount of information outside of a committee, through meetings with manufacturers' representatives at facilities and in conference exhibit halls.
Mary Ogg, MSN, RN, CNOR, perioperative nursing specialist for the Association of periOperative Registered Nurses (AORN), acknowledges the vast number of product choices in the marketplace today and suggests a few ways to sort through the options. "If your facility is in a preferred purchasing group, start by determining which companies are your preferred vendors. I think a good first step is to know what you have to work with and approach company A, B or C for their information. See if those companies will meet your needs first, and if they don't, then broaden your search. Speaking from personal experience, I think that exploring the exhibit floor at AORN Congress is one of the most beneficial ways to get a lot of information in a short amount of time. You are comparing companies A, B and C right there on the spot -- it's a great way to get the information in real time to take back to your facility and pursue more detailed information."
Meeting with manufacturers' reps at the facility can pay dividends, but Ogg cautions healthcare professionals to do their homework prior to the meeting to reap maximal benefits. "I recommend having access to product descriptions first so that you know the questions you should ask before the rep even comes to the facility. Know what you want from the product before you meet with the rep."
Using the revised AORN “Recommended practices for product selection in perioperative practice settings” as context, Conrardy (2012) outlines a number of recommendations to assist perioperative nurses in selecting appropriate products for use in the perioperative arena. One of the first steps is to create a multidisciplinary team to guide process improvement and product selection.
As Conrardy (2012) explains, "After the perioperative RN becomes a member of the multidisciplinary committee, he or she will work with the team to develop a process to guide product selection. The product selection process includes gathering information; establishing consistent requirements for each product under evaluation; performing a financial impact analysis; investigating a plan to standardize products across the facility; conducting an environmental impact analysis; determining whether to purchase single-use, reposable, or reusable products; determining whether to reprocess single-use devices; developing an evaluation process based on objective criteria; and developing and implementing a comprehensive plan to introduce and use new products.
Hoeksema (2011) says that cost-saving opportunities that a hospital product evaluation committee can consider include choosing less expensive but equivalent supplies, comparing the expenses associated with disposable versus reusable products, limiting the use of custom supplies, determining ways to reduce linen use, and changing practices to eliminate products that are found to have little clinical value. Adopting effective product evaluation and purchasing practices can lead to reduced costs without affecting the quality of patient care.
Pennington and DeRienzo (2010) say that in today's economy, it is imperative that nurses exhibit stewardship for their organization's resources and help ensure that purchasing decisions are sound. Regardless of the decision-making method chosen, a formal, consistent review process that evaluates cost, compares products, examines implications, analyzes risk, uses evidence, and includes safety and outcome measures is vital to success. Clinical Quality Value Analysis (CQVA) is a product evaluation platform that can be used to determine whether a proposed product or service will add value to the organization as well as improve patient outcomes. Using CQVA for a proposed product or service is a five-step process: assess, plan, design, implement and measure/sustain.
Garcia (undated) encourages healthcare professionals to ponder the following questions when evaluating a product:
• Will the product improve the satisfaction of the patient or the product user?
• Will the treatment outcome of the patient be changed by using the product?
• Will the product alter practice or have an impact on clinical decisions related to patient care?
Garcia (undated) adds that good value analysis requires accurate estimates of total costs, including not only the purchase price, but also the cost of labor, utilities, maintenance and other factors. He explains that if a product is more expensive than one currently used, a thorough value analysis assists in determining the incremental cost of the product versus the expected benefit to the patient. He emphasizes a focus on procedures rather than products to get the best evaluation and purchasing outcomes.
AORN (2010) emphasizes the use of an evaluation tool that is simple to follow and easy to complete. It should include product-specific criteria, including safety, performance, quality, efficiency, and ease of use, among other characteristics. As AORN (2010) notes, "Having a well-defined multidisciplinary team will help ensure all of the technical questions about cost, usability, and safety are answered before the evaluation tool is developed. This assists the team members in creating an effective, streamlined tool based on objective criteria. As clinical experts and end users of the products, perioperative RNs have valuable input regarding what questions to ask when evaluating a product. Overall documentation of the selection and evaluation process must occur because it can provide additional information to justify procuring the equipment or products or for negating the purchase as well. Documentation must remain objective and factual and not contain any opinions that may mar the data about specific products. This is a reason for the requirement of having an evaluation tool that is strictly objective in nature."
Clinician or surgeon preference is often one of the biggest obstacles to the standardization of medical/surgical supplies and equipment, yet many facilities are finding ways to balance this preference against other factors. A study conducted by VHA, Inc. of more than 1,200 Veterans Health Administration (VHA) hospitals ranked decision criteria for clinical managers as follows: product superiority, standardization, price, and finally, physician preference. (AORN, 2010)
"It's always been a balancing act of providing quality through the product as well as being a good conservator of our resources," says Ogg. "You are always looking for the best outcome for your patients, what will be safest for them as well as for healthcare workers and the facility. It's always been decreasing resources, get highest quality and best return on investment -- it's a constant balancing act."
According to Garcia (undated) product standardization can achieve a number of important goals, including eliminating duplication, reducing inventory, encouraging a procedure standard among staff, and reducing educational needs for staff.
"Standardizing your inventory can reduce costs, improve inventory control, and improve storage space," Ogg confirms. "One of the big advantages of standardization is that it decreases the amount of end user training that is needed so errors related to staff's unfamiliarity with the product should decrease. Instead of learning two or three different types of instruments, they only train on one. If you take minimally invasive instrumentation such as trocars as an example, there are two major manufacturers in the marketplace and one surgeon likes company A and the other surgeon likes company B -- these devices have different quirks to them and so if you only have one, then your staff knows how to use that one well. I think that will help decrease errors in the long run."
Conrardy (2012) notes, "When looking to procure new technology or products, the product selection team should consider standardization, which can reduce costs and may improve inventory control and use of storage space. When referring to product evaluation, standardization can loosely be defined as a procurement agreement within a geographical region or between various groups within a facility pertaining to a certain product or product line. In the example of surgical gloves, there are many companies that provide this product. However, if there is a particular brand that a facility provides for surgeons, there may be other facilities within the same network that stock the brand. This opens up the opportunity to standardize acquisition of the same brand at all of the local network facilities. When proposing a product evaluation for multi-brand products (e.g., gloves, cleaning supplies, dressings, tape), a standardization effort can work to the facility’s benefit. This principle also applies to purchasing a product within the facility. If the gloves are used by the OR personnel and not the radiology department personnel, there is a potential to benefit the facility if staff members in both departments agree to use the same gloves."
Making the Business Case
AORN (2010) recommends an evidence-based approach to product evaluation and purchasing, especially when evaluating the data: "If you are proposing a change in product that may be more expensive, but provides clinical value, you must show that product will achieve the desired results (e.g., reduce infections, reduce the incidence of pressure ulcers, produce a better outcome). That is, you should be able to show that the increased expenditure is more than off set by clinical benefits or cost reductions. Costs often quoted in articles are general costs to society (costs that include all costs, such as productive days lost from work for the patient). These costs are important, but ideally a cost/benefit analysis should include your facility’s actual costs and revenues. For example, the difference between reimbursement for patients and the actual hospital costs associated with patients is their contribution margin. If the product being evaluated is aimed at reducing SSIs, for example, then to truly understand the economic impact of a reduction in SSIs, one should compare the contribution margin for those patients with SSIs versus those without. That difference or delta provides hard data on actual costs and this can be compared with clinical data (and your own goal setting) to determine whether change (i.e., adding the new product) is warranted."
Ogg cautions that cost does not always equal price, as there are other factors that must be taken into consideration. "A prime example is if the product or device is going to prevent a surgical site infection; it may be a little more expensive but if you take into the cost of what an SSI would be, it far outweighs the actual price. To take an example from sharps safety, sometimes the safety-engineered devices are pricier than the more traditional models but you have to weigh into all of those costs whether or not there was an occupational injury -- will there be treatment for the injury, plus follow-up treatment and testing, time lost from work, etc. And heaven forbid the healthcare worker acquires an infection and then incurs thousands and thousands of dollars for prophylaxis -- you must take all of these things into consideration and not just focus on the fact that syringe A costs 15 cents more than syringe B."
AORN (2010) emphasizes that factors other than return on investment (ROI) play a role in the product selection process: "As you analyze the clinical data that support the use of a product, critically evaluate the source of any research and whether the same results can be expected at your facility. For example, do you have the staffing resources available to use the new product or operate the new system? Will the supplier provide sufficient support, training, and education to ensure that the product is used properly within your facility? What metrics do you have in place to ascertain whether the goals of product conversion have been met (e.g., how will you measure the reduction in hospital-acquired conditions or adverse events, if that is the goal?)? The key to successful new product implementation is to have a plan and follow that plan."
Drawing from current studies in the literature is one of the most common ways that practitioners determine the efficacy of a product or a technique, but a common complaint is that the literature isn't keeping pace with product innovations in the marketplace. While that may be an unresolved issue, Ogg says that practitioners can find the most reliable evidence in AORN's recommended practices (RPs), which now are evidence-based. "For every recommenced practice, when we conduct our literature review we also weigh and appraise our evidence, and once it has been appraised, we rank the interventions based on the strength of that evidence," Ogg explains. "So that is one great way for our members and all perioperative nurses to be able to consult an RP and see the evidence that says, for example, double-gloving does reduce needlestick injuries by a certain percentage and the evidence will be there. Rating our evidence can also indicate where we need further research and identify research opportunities for nurses getting their doctorate degrees."
AORN. Product Selection: Key Considerations; The Vital Relationship Between Industry and the Perioperative Nurse. 2010.
AORN. Recommended Practices for Product Selection in Perioperative Practice Settings. 2012.
Conrardy JA. Implementing AORN Recommended Practices for Product Selection. AORN J. Vol. 95, No. 6. June 2012
Freedonia Group. Disposable Medical Supplies to 2016 - Demand and Sales Forecasts, Market Share, Market Size, Market Lead-ers. March 2012.
Garcia R. Linking Infection Control and Product Evaluation. Webber Training teleclass.
Hoeksema J. Taking steps to control costs in the OR. AORN J. 2011 Dec;94(6 Suppl):S79-84.
MarketResearch.com. Durable Medical Equipment: U.S. Market Size, Segments, Growth and Trends. April 2011.
Pennington C and DeRienzo NR. An effective process for making decisions about major operating room purchases. AORN J. 2010 Mar;91(3):341-9.
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