Infection Control Today - 07/2004: OR Topics

Medical-Product Selection is a Group Effort

By Kris Ellis

Patients in healthcare facilities expect that the many products instrumental in supporting health, preventing infection and even saving lives are reliable, safe and of high quality. Clinicians also have a vested interest in the tools they use to do their jobs, both in terms of their own safety and the efficacy of the products in treating patients. It is the job of the product evaluation committee to ensure these and other important needs and expectations are met when deciding into which products a facility will put its trust and dollars.

For most facilities, product selection works best when it is approached from a multi-disciplinary standpoint. This is one reason why todays product selection committees typically consist of members from various departments and disciplines within the facility. Although this approach may mean that all parties involved must negotiate and compromise on certain points, it does potentially ensure that all bases are covered up front and that the priorities and concerns of clinicians, administrators and purchasing managers alike are addressed during the selection process.

The Association of periOperative Registered Nurses (AORN) has recently published its Recommended Practices for Product Selection in Perioperative Practice Settings. 1 AORN advocates collaboration and a multidisciplinary approach to the selection process as a part of these practices, specifying all departments that use, purchase and select products be represented. AORN provides an exhaustive list of potential committee members, which includes surgical services, nursing services, administration, pharmacy, materials management and purchasing, anesthesia risk management and others. A dedicated infection control representative is also recommended.

The specific composition of the committee varies from one facility to the next, as does the method of representation.

You may have a physician on the committee, for example, or you may have a nurse team leader that works with the physicians as a liaison, says Carol Petersen, RN, BSN, MAOM, CNOR, a perioperative nursing specialist with AORN. There are a variety of ways to set it up as long as you get the input from multiple people, because everyone has different needs in terms of a product. But the primary concern has to be patient safety.

Some facilities establish multiple committees to handle product selection in order to accommodate different specialty areas.

There are several product committees based on specialty, with one oversight committee for the health system, says Loretta Litz Fauerbach, MS, CIC, director of infection control at Shands Hospital at the University of Florida. For example, there is a Patient Care Value Analysis Committee (VAC) and an OR Value Analysis Committee under the system-wide VAC. She also explains that the approval and implementation of most products is handled by the product committees, while the system-wide VAC is more involved with contract negotiations and trending.

Once a committee has been established, it is important to determine how each product and device will be evaluated. AORN stresses the need for objective criteria specific to a products intended function in this regard, and recommends the use of a written evaluation tool to facilitate the process. Among the criteria that may be considered are safety, quality, efficacy, ease of use, standardization, adaptability to future technology, sterilization/reprocessing parameters and more. As costs continue to rise in most areas of healthcare, the reality for many facilities is that the bottom line is often near the top of the list as well.

Standardization in particular is a concept that is prominent on many committees agendas. Standardizing involves the establishment of a reproducible model that seeks to promote uniformity and coordination throughout the facility. In terms of products, this can mean increased reliance on a certain brand or line. This effort may help some facilities to increase cost savings and efficiency by decreasing inventory and eliminating duplication. AORN suggests that when all clinical areas are involved in establishing criteria and selecting products, standardization can be increased.

With all the factors that must be scrutinized and the relative significance of each one, the importance of interdepartmental collaboration and communication is readily apparent. These cooperative efforts can be important ways to avoid pitfalls that can result from not focusing on the big picture.

You always must weigh the cost of the item against the safety of the product both for the patient and the nurse, Peterson says. Also the efficiency of use for example, its not unusual to get a product that will save a lot of money, but the packaging is so poor that when you open it, it falls on the floor and is contaminated. This is why its so important to have the end user evaluate (new products), she continues, underscoring the need for thorough and effective evaluations.

Relevant information may be available from product and device manufacturers as well.

In the process of determining these criteria, it is helpful to be educated by vendors of the product or device, to gather relevant clinical articles and/or studies and to ask if the vendor has other customers who may already have created or used product selection criteria, says Carolyn Twomey, RN, BSN, clinical nurse consultant for Regent Medical. Vendors may also be able to provide the committees with customer satisfaction data in terms of products and customer service.

Certain circumstances may warrant the consideration of a product that is new to the market or one that is new to a facility. In these cases, additional issues may factor into the decision. If it is completely different than anything else youre using, can the patient be charged for it, will insurance pay for it, and how is it going to enhance practice, says Peterson. Questions such as these can complicate the selection process and may require the input of others outside the committee.

If a new or unfamiliar product is up for consideration, some facilities may initiate a clinical evaluation or trial. This can be a useful way to ensure the product meets the expectations of the committee and of prospective users. Trials are also a potential safeguard against ordering a product of poor quality.

For example, if youre changing glove manufacturers and the cost looks great but they tear easier, you only find that out through a trial, says Peterson.

There are a number of ways in which a new product may be brought up for consideration. Typically, we will start with a trial in a specific area to evaluate the product. The information is usually brought to the hospital from staff or MD attendance at a conference or a best practice publication, according to Janet Frain, RN, CIC, CPHQ, CPHRM.

Users may also generate a new product request based on their needs, or an evaluation may be requested by a different department or committee member based on product cost or availability. In general, acceptance of new technology is often driven by a leading medical or nursing (including infection control, risk management and occupational medicine practitioners) practitioner who pushes a facility to consider innovation and change in practice, says Twomey.

Analysis based on set criteria established by the committee allows all parties involved to gauge products in relation to their own needs and decide upon a recommendation. The method by which a final decision is made can vary depending on the facility, but may be as simple as a vote by committee members. If users have the opportunity to give products a trial run, their input could be key in helping the committee to make a decision based on their opinions.

Usually if the staff have a (good) feeling about something, well go with it unless there is a serious cost concern, says Bonnie Barnard, MPH, CIC, infection control professional at St. Peters Hospital in Helena, Mont. In the cases where cost and preference do not coincide favorably, the committee must exercise its ability to negotiate and compromise, which makes skilled and effective communication among committee members very important.

For vendors, it is crucial to design and market products that are compatible with the needs and criteria of facilities product selection committees and users. To this end, many vendors actively seek to identify and incorporate input from clinicians when developing a product. Each vendor has its own methods, which may include focus groups, market research, questionnaires and site visits, among other things.

At Regent Medical, the commercial department works closely with R&D personnel to integrate ideas from customers and healthcare contacts into product development and product improvements, according to Virginia James, medical glove product manager at Regent Medical.

The next step vendors must take is to make sure their products are among those evaluated by the appropriate committees. This effort can involve several components and strategies including sales representatives, consultants, educational programs and clinical data.

Our approach is always to come into a healthcare facility and work directly with the end user whether it is the physician, nurse, or support staff to assess their unique set of needs, says David Parks, general manager of Kimberly-Clark Health Cares infection control business. We then determine which of our products can best meet those needs relative to managing infection control and ultimately improving patient outcomes.

Clinician involvement and input from the start can be a tool in itself for vendors that want to be sure committees are aware of their products.

As part of our philosophy, everything we do as a company has to meet customer needs and help them fulfill their mission of caring for patients. To that end, we place a high value on involving clinicians in the products development process, says Greg Groenke, vice president of product development for medical specialties at Cardinal Health, Inc. We have learned that if there is a true need for a product, it will be considered by these committees. Thats why it is so important to work closely with clinicians to determine the needs.

The prominence of group purchasing organizations (GPOs) also factors heavily into vendors efforts to present their products. Partnering with GPOs provides vendors with a potential tool to greatly increase distribution and market share. This is a valuable asset to companies that are able to secure this kind of partnership, and sometimes can be a thorn in the side of those that are not. Whatever the case may be, there is no denying that working with GPOs is a fundamental reality for vendors and many facilities as well. As Parks says, The bottom line is that GPOs are currently an integral part of the go-to-market strategy for most manufacturers.

Opinions and perspectives on GPOs also vary among clinicians and staff at different healthcare facilities. It is generally acknowledged that GPO membership can save money and simplify purchasing in many instances, but may be limiting in others. Sometimes, depending on the product, they (GPOs) may not have something that is acceptable to you, but I think thats probably more rare. The bottom line is most GPOs do a good job of giving you some variety, says Barnard, describing GPO product availability. Because GPO membership creates a unique situation for each facility, it is important that committee members as well as end users understand the implications of their specific GPO contracts. This will allow a facility to reap the maximum benefits of GPO membership while being cognizant of when other options may exist.

The goal of consistently getting a quality product at a good price is universal. For healthcare facilities, the knowledge and cooperation of many are required to meet this objective. The diversity found in all facets of different facilities dictates that each one must find its own method of product evaluation and selection that is effective and reliable.

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