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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 facilitys 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 facilitys 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.
ReportLinker. Medical Equipment and Supply Industry: Market Research Reports, Statistics and Analysis.
Steps in the Product Evaluation Process
The CDC's "Workbook for Designing, Implementing and Evaluating a Sharps Injury Prevention Program" offers instruction in the key steps in the product evaluation process for sharps devices that can also be applied to other supplies:
1. Organize a Product Selection and Evaluation Team
Healthcare organizations should designate a team to guide processes for the selection, evaluation, and implementation of engineered sharps injury prevention devices. Many institutions already have product evaluation committees that may be used for this purpose; others may want to assign this responsibility to a subcommittee of the prevention planning team. To ensure a successful outcome:
Assign responsibility for coordinating the process
Obtain input from persons with expertise in or perspectives on certain areas (such as from front-line workers)
Maintain ties to the prevention planning team
2. Set Priorities for Product Consideration
The team collectively determines which device types to consider.
3. Gather Information on Use of the Conventional Device
Before considering new products for evaluation, healthcare organizations must obtain information on use of the conventional device that it is replacing. Possible sources of information are purchasing and requisition requests. A survey of departments and nursing units might help identify additional issues. Key information to obtain from clinical areas includes:
Frequency of use and purchase volume of the conventional devices;
Most commonly used sizes;
Purpose(s) for which the device is used;
Other products the device is used with that might pose compatibility concerns;
Unique clinical needs that should be considered; and
Clinical expectations for device performance.
If the answers to these questions reveal areas with unique needs, representatives from these areas should be added as ad hoc members of the team.
4. Establish Criteria for Product Selection and Identify Other Issues for Consideration
Product selection is based on two types of criteria:
Design criteria that specify the physical attributes of a device, including required features for clinical needs and desired characteristics of the safety feature
Performance criteria that specify how well a device functions for its intended patient care and safety purposes
5. Obtain Information on Available Products
Potential sources of information on products with include:
Materials management staff who have information on product vendors and manufacturers and are also familiar with the service reliability of manufacturers representatives
Colleagues in other facilities who can share information on their experiences in evaluating, implementing, or rejecting certain products and devices
Websites with lists of manufacturers and products
6. Obtain Samples of Devices Under Consideration
Arrangements should be made to contact manufacturers or vendors to obtain samples of products for consideration. Once obtained, look at the devices based on the design and performance criteria and other issues that are important. Consider inviting manufacturers representatives to present information about their products to the team. Questions for the representatives might include:
Can the device be supplied in sufficient quantities to support institutional needs?
Is it available in all required sizes?
What type of training and technical support (e.g., on-site in-service training, teaching materials) will the company provide?
Will the company provide free products for a trial evaluation?
Discuss any technical questions related to the product. Based on these discussions, the team should narrow its choices to one or two products for an in-use evaluation.
7. Develop a Product Evaluation Survey Form
The form used to survey healthcare personnel who evaluate the trial device must collect information necessary to make informed decisions for final product selection. Teams should try to use readily available forms. This promotes standardization of the evaluation criteria and enhances the ability to compare responses among different healthcare organizations. If manufacturer-provided forms are used, they should be carefully screened to eliminate potential bias.
8. Develop a Product Evaluation Plan
Developing a product evaluation plan requires several additional steps, but it is necessary to ensure that the form obtains the desired information and documents the process.
Select clinical areas for evaluation. The evaluation does not need to be performed institution-wide, but should include representatives from areas with unique needs. Whenever possible, include both new and experienced staff.
Determine the duration of the evaluation. There is no formula for how long to pilot test a product, although two to four weeks is often suggested. Factors to consider include the frequency of device use and the learning curve, i.e., the length of time it takes to become comfortable using a product. It is important to balance staff interest in the product and the need for sufficient product experience. If more than one device is evaluated as the replacement for a conventional device, use the same populations and trial duration for each product. Make a defined decision on when to abort an evaluation because of unforeseen problems with a device.
Plan for staff training. Healthcare personnel participating in an evaluation must understand how to use the new device properly and what impact, if any, the integration of a safety feature will have on clinical use or technique. Training should be tailored to the audience needs and should include discussion of why the change is being proposed, how the evaluation will proceed, and what is expected of participants. It is important to provide information on the criteria used to evaluate clinical performance and to answer any questions about the interpretation of these criteria.
A team approach, using in-house staff and device manufacturers representatives, is one effective way to provide training. In-house staff know how products are used in a facility, including any unique applications, but manufacturers representatives understand the design and use of the safety feature. Give trainees an opportunity to handle the device and ask questions about its use, as well as an opportunity to simulate use of the device during patient care, in order to help reinforce proper use. Also consider those who might not be able to attend the training (e.g., staff on leave, new students, per diem staff) and how to implement catch-up training. One possibility is to identify persons in departments or on nursing units to serve as resources on the devices.
Determine how products will be distributed for the evaluation. Whenever possible, remove the conventional device from areas where the evaluation will take place and replace it with the device under study (128). This approach eliminates a choice of product alternatives and promotes use of the device undergoing evaluation. If the device undergoing evaluation does not meet all needs (e.g., all sizes are not available; the study device can be used for only one purpose and the conventional device has multiple purposes), it may be necessary to maintain a stock of the conventional product along with the product under study. In such instances, provide and reinforce information on the appropriate and inappropriate use of the conventional device. Precede and coordinate staff training with any switch in devices.
Determine when and how end-user feedback will be obtained. Obtain feedback on device performance in two stages. The first stage is informal and occurs shortly after the onset of pilot testing. Members of the evaluation team should visit clinical areas where the device is being piloted and engage in discussions about the device in order to get some preliminary indication of its acceptability for clinical use. These interactions can also reveal problems that might require terminating the evaluation early or providing additional training.
The second stage involves distribution of the product evaluation forms. To avoid recall bias, this should be done as soon as possible after the evaluation period is completed. An active process, such as distributing surveys during unit meetings, may be more reliable than a passive process, where forms are left in the clinical area and filled out at random, and also prevents staff from completing multiple evaluation forms for the same product.
9. Tabulate and Analyze the Evaluation Results
Compile data from the survey forms. Depending on the number of staff involved and survey forms completed, this can be done either by hand or by use of a computerized database. It is useful to score each question in addition to the overall response, particularly if evaluating two or more devices (e.g., hypodermic syringe/needle); responses to each question can be used to compare devices. In addition, categorize individual comments so they provide a better picture of the clinical experience with the device.
Consider calculating response rates by occupation and clinical area and analyzing data by these variables, if the volume of responses permits. This can help identify differences in opinion that may be influenced by variations in clinical needs.
Several factors can have a positive or negative influence on the outcome of a product evaluation. These include:
Staff experience with and preference for the conventional device;
Attitudes toward involvement in the product evaluation process;
Influence of opinion leaders;
Staff opinion of product evaluation team members and manufacturers representatives;
Perceived need for devices with safety features; and
It is possible that one or more of these factors may be influencing opinions if the response of certain groups of personnel to the product change is different from what was expected or differs from other groups in the organization. Meet with these groups to understand their issues; it might provide new insights for the evaluation team.
10. Select and Implement the Preferred Product
The evaluation team should make a product selection based on user feedback and other considerations established by the selection team. Model the process for implementing the selected device after the pilot evaluation process, and coordinate training with product replacement. It may be necessary to implement a product change over several weeks, moving by unit within the hospital.
The team should also consider a back-up plan in case the selected device is recalled or production is unable to meet current demands. Questions to ask include:
Should a less-preferred product be introduced as a replacement?
Should the conventional device be returned to stock?
If the conventional device is still being used for other purposes, should the stock be increased to meet current needs?
11. Perform Post-implementation Monitoring
Once a new device is implemented, assess continued satisfaction with the product through follow-up monitoring and respond to those issues not identified or considered during the evaluation period. In addition, some facilities may wish to assess post-implementation compliance with use of the safety feature. Each product selection team will need to consider the most effective and efficient way to perform post-implementation monitoring.
What to Ask When Evaluating Products
AORN (2010) suggests that healthcare professionals keep the following questions in mind when gathering information from manufacturers in the following product categories:
- In what instances should sterilization and high-level disinfection be used?
- What is the sterilization equipments status with the FDA, CDC, or any other regulatory group?
- Operating theory and principles?
- Ease of operation?
- What is the cost of the equipment and cost of operation?
- What is the maintenance schedule and maintenance history?
- What products/instruments/scopes does the chamber accommodate?
- How big or small a load?
- Are there any product restrictions (e.g., manufacturers not recommending)?
- What is the equipments footprint how much space will it take?
- New construction or remodeling?
- What are the goals/objectives of the new construction or remodeling?
- How much space is needed for the desired equipment, and is there enough room without contaminating the sterile field?
- Is there a footprint of what the room will look like fully equipped (e.g. CAD-CAM, other 3D rendition)?
- What are special considerations (e.g., shielding for MRI)?
- If the construction is a remodeling project, what special precautions should be taken to segregate rooms that are in use from the remodeling area? Have infection control procedures been established?
- Will any equipment be hung from booms? If so, will reinforcement of the ceiling be required?
- What considerations will be taken regarding traffic flow in the remodel or new construction space?
- If the construction project is a hybrid room, what is the size and configuration of the imaging equipment? Does the floor need to be reinforced?
- Who is responsible for coordination with clinical staff members, architects and equipment manufacturers?
3. Greening of the OR
- Have clear and measurable objectives been identified?
- Will there be a focus on energy consumption, waste or both?
- What will be the process to evaluate reusable versus disposable items?
- What will and will not be considered for reprocessing?
- How to balance against patient/staff safety (e.g., double gloving for sharps safety)?
- When is it feasible to refurbish equipment rather than replace it?
- Are there surgical items that are disposed of but never used and are there ways to reduce that waste?
- What steps are taken to segregate noninfectious from infectious waste? Could this process be improved?
- Are inventory processes optimized to reduce obsolescence?
- With new construction or remodeling, has the facility taken steps to achieve energy efficiency?
4. Orthopedic/cardiac surgery
- Is the orthopedic service current on minimally invasive techniques?
- Does the facility set clear expectations with its orthopedic suppliers for delivery of instrument sets, allowing plenty of time for sterile processing?
- Are cardiac service staff members current on minimally invasive and other new cardiac techniques?
- Have clear expectations been set for cardiac suppliers, including valve inventories, pacemaker and implantable defi brillator assistance?
- Are perioperative staff members in sync with imaging teams for both orthopedic and cardiac imaging-assisted procedures?
- Is equipment current and staff members trained for tourniquet usage, bone cement, and blood transfusions?
- Are preference cards current for cardiac and orthopedic services?
- Are communications optimal between nursing and surgeon team members in these specialties?
- Do you ensure that a complaint is filed on a returned product which is immediately replaced during a procedure?
5. Infection prevention
- Does the facility have an infection surveillance process in place?
- Does the facility conduct risk assessments to identify infection-susceptible patients?
- Does the facility have clear policies and procedures for prep solutions?
- Does the facility perform terminal cleaning of the ORs on a regular and consistent basis?
- Per AORNs recommended practices, does the facility prohibit homelaundering scrubs?
- What is the facilitys policy related to external OR personnel wearing scrubs from a different facility? And if it is prohibited, how is the policy enforced?
- Does the facility track and meet SCIP requirements for antimicrobial prophylaxis?
- Does the facility have clear policies related to steam sterilization for immediate use, and where is high-level disinfection appropriate or inappropriate?
- Are wrapped sterile trays inspected to ensure integrity?
- Are traffic patterns controlled within the OR areas to minimize air flow toward the operative site?
- Do perioperative staff members maintain good aseptic technique?
- Do perioperative staff members wear protective equipment to reduce the risk of staff members becoming contaminated by bloodborne pathogens?
- Do staff members at the surgical site double glove to reduce the likelihood of needlesticks and other sharps injuries?
- Has the facility evaluated blunt needles and established neutral zones to improve sharps safety?
6. Patient and staff safety
- Are staff members well-trained in performing counts and does the facility enlist the use of adjunct technologies to reduce the likelihood of retained surgical items?
- Are staff members vigilant about positioning, repositioning and padding for patients who are susceptible to pressure ulcers?
- Are policies and procedures in place to ensure blood compatibility for blood transfusions?
- Is the universal protocol implemented?
- Are checklists used to reduce the likelihood (and ultimately eliminate) wrong-site or wrong-patient errors?
- Are steps taken to reduce smoke in the surgical environment?
- What equipment and devices are used to protect staff members from bloodborne pathogens and ergonomic injuries?
- What steps have been taken to establish a culture of safety?
Source: AORN. Product Selection: Key Considerations; The Vital Relationship Between Industry and the Perioperative Nurse.