Infection Control Today - 07/2004: OR Topics

July 1, 2004

Medical-Product Selection is a Group Effort

Medical-Product Selection is a Group Effort

By Kris Ellis

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

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

The Association of periOperative Registered Nurses (AORN) hasrecently published its Recommended Practices for Product Selection inPerioperative Practice Settings. 1 AORN advocates collaboration and amultidisciplinary approach to the selection process as a part of thesepractices, specifying all departments that use, purchase and select products berepresented. 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. Adedicated infection control representative is also recommended.

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

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

Some facilities establish multiple committees to handleproduct 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 LitzFauerbach, MS, CIC, director of infection control at Shands Hospital at theUniversity of Florida. For example, there is a Patient Care Value AnalysisCommittee (VAC) and an OR Value Analysis Committee under the system-wide VAC.She also explains that the approval and implementation of most products ishandled by the product committees, while the system-wide VAC is more involvedwith contract negotiations and trending.

Once a committee has been established, it is important todetermine how each product and device will be evaluated. AORN stresses the needfor objective criteria specific to a products intended function in thisregard, and recommends the use of a written evaluation tool to facilitate theprocess. 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 inmost areas of healthcare, the reality for many facilities is that the bottomline is often near the top of the list as well.

Standardization in particular is a concept that is prominenton many committees agendas. Standardizing involves the establishment of areproducible model that seeks to promote uniformity and coordination throughoutthe facility. In terms of products, this can mean increased reliance on acertain brand or line. This effort may help some facilities to increase costsavings and efficiency by decreasing inventory and eliminating duplication. AORNsuggests that when all clinical areas are involved in establishing criteria andselecting products, standardization can be increased.

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

You always must weigh the cost of the item against thesafety of the product both for the patient and the nurse, Peterson says. Also the efficiency of use for example, its notunusual to get a product that will save a lot of money, but the packaging is sopoor that when you open it, it falls on the floor and is contaminated. This iswhy its so important to have the end user evaluate (new products), she continues, underscoring the need for thorough andeffective evaluations.

Relevant information may be available from product and devicemanufacturers as well.

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

Certain circumstances may warrant the consideration of aproduct that is new to the market or one that is new to a facility. In thesecases, additional issues may factor into the decision. If it is completelydifferent 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, saysPeterson. Questions such as these can complicate the selection process and mayrequire the input of others outside the committee.

If a new or unfamiliar product is up for consideration, somefacilities may initiate a clinical evaluation or trial. This can be a useful wayto ensure the product meets the expectations of the committee and of prospectiveusers. Trials are also a potential safeguard against ordering a product of poorquality.

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

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

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

Analysis based on set criteria established by the committeeallows all parties involved to gauge products in relation to their own needs anddecide upon a recommendation. The method by which a final decision is made canvary depending on the facility, but may be as simple as a vote by committeemembers. If users have the opportunity to give products a trial run, their inputcould be key in helping the committee to make a decision based on theiropinions.

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

For vendors, it is crucial to design and market products thatare compatible with the needs and criteria of facilities product selectioncommittees and users. To this end, many vendors actively seek to identify andincorporate input from clinicians when developing a product. Each vendor has itsown methods, which may include focus groups, market research, questionnaires andsite visits, among other things.

At Regent Medical, the commercial department works closelywith R&D personnel to integrate ideas from customers and healthcare contactsinto product development and product improvements, according to Virginia James, medical glove product manager atRegent Medical.

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

Our approach is always to come into a healthcare facilityand work directly with the end user whether it is the physician, nurse, orsupport 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 tomanaging infection control and ultimately improving patient outcomes.

Clinician involvement and input from the start can be a toolin itself for vendors that want to be sure committees are aware of theirproducts.

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

The prominence of group purchasing organizations (GPOs) alsofactors heavily into vendors efforts to present their products. Partneringwith GPOs provides vendors with a potential tool to greatly increasedistribution and market share. This is a valuable asset to companies that areable to secure this kind of partnership, and sometimes can be a thorn in theside of those that are not. Whatever the case may be, there is no denying thatworking with GPOs is a fundamental reality for vendors and many facilities aswell. As Parks says, The bottom line is that GPOs are currently an integralpart of the go-to-market strategy for most manufacturers.

Opinions and perspectives on GPOs also vary among cliniciansand staff at different healthcare facilities. It is generally acknowledged thatGPO membership can save money and simplify purchasing in many instances, but maybe limiting in others. Sometimes, depending on the product, they (GPOs) maynot have something that is acceptable to you, but I think thats probably morerare. The bottom line is most GPOs do a good job of giving you some variety, says Barnard, describing GPO product availability. Because GPOmembership creates a unique situation for each facility, it is important thatcommittee members as well as end users understand the implications of theirspecific GPO contracts. This will allow a facility to reap the maximum benefitsof GPO membership while being cognizant of when other options may exist.

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