Collaborative Leadership in Product Evaluation

334 • AORN JOURNAL • FEBRUARY 2007, VOL 85, NO 2 © AORN, Inc, 2007

Cynthia K. Halvorson, RN;Libby F. Chinnes, RN

Today, nursing leaders and infectioncontrol professionals play an in-creasingly vital role in influencing

the quality of patient care. Even thoughmembers of both professions alwayshave been advocates for patient safetyand quality care, increased public andpayer focus on health care safety andcost-effectiveness has brought a corre-sponding change in the roles of profes-sionals in these disciplines.

One area of perioperative practicethat has been affected by patient safetyand quality mandates is product selec-tion. Innovations in procedures andtechnology are drivers of perioperativepractice, and nurses in particular mustfind ways to incorporate new productsinto the perioperative setting. Theprocess of evaluating and integratingnew products into clinical practice canbe complex, and changes in routine canbe disruptive. Perioperative nurses andinfection control professionals must en-sure that during this process, the focus

on patient safety and quality health caredoes not waver.

The expertise of perioperative nursesand infection control professionals is in-valuable in selecting and implementingnew products in the surgical environ-ment. Together, health care workers inthese two disciplines can offer leadershipin product evaluation, selection, and in-troduction into clinical practice. Theyalso can integrate this process into estab-lished practices based on standards ofsafety and quality of patient care, as putforth in the culture of safety and cultureof quality mandates promoted by organ-izations such as the Joint Commission onAccreditation of Healthcare Organiza-tions (JCAHO) and the National QualityForum (NQF).1,2 By providing guidanceduring this process, these professionalscan lead other health care team membersin incorporating new products and tech-nology both efficiently and correctlywhile providing patients with the bestcare possible.

LEADERSHIP IN THEPERIOPERATIVE ENVIRONMENT

The practical value of including peri-operative nurses and infection controlprofessionals in the product evaluationprocess lies in their clinical experienceand knowledge of surgical proceduresand infection prevention protocols. Indi-viduals in both disciplines have specificknowledge of medical literature andpractice guidelines. Perioperative nursesare responsible for the knowledge anduse of evidence-based best practices, sothey are particularly capable of deter-mining whether a new product or proce-dure adheres to best practice guidelines.They also are able to offer suggestionsabout how new products might be incor-porated into standardized care routines.

Collaborative Leadershipin Product Evaluation

• NEW PRODUCT INNOVATIONS can have asignificant effect on patient safety and the qualityof patient care.

• PERIOPERATIVE NURSES and infection control professionals can collaborate during theselection of new products to ensure that productspromote patient safety and improve outcomes.

• INFECTION CONTROL PROFESSIONALSand perioperative nurses are uniquely positionedto demonstrate leadership in all phases of theproduct evaluation process. AORN J 85 (February2007) 334-352. © AORN, Inc, 2007.

ABSTRACT

336 • AORN JOURNAL

FEBRUARY 2007, VOL 85, NO 2 Halvorson — Chinnes

Infection control professionals, withtheir knowledge of best practices andcurrent guidelines, also should be in-volved in evaluating new products forinfection risks to patients and health careworkers. Furthermore, by JCAHO man-date, infection control professionalsmust be involved in the selection of anysterilization, disinfection, cleaning, ordecontamination product.3

In addition to clinical experience andknowledge, perioperative nurses and in-fection control professionals also possess

a broad range of leader-ship and communicationskills. Exercising leader-ship and communicatingeffectively requires anevolving set of new skillsbecause of changes in re-porting structures, treat-ment practices, job re-sponsibilities, and workforce composition. For ex-ample, the vertical, hier-archical flow of powerand authority from seniormanagers down to staffmembers is being replacedby horizontal, lateral inter-actions among staff mem-bers with equal powerand authority. Periopera-tive nurses and infectioncontrol professionals mayfind that they need to in-fluence behavior of other

team members over whom they have nodirect authority. This results in a need fornew communication, management, andmotivational skills. Porter-O’Grady4,5

notes several changes in the way healthcare is delivered, including new roles andskill sets demanded of leaders in an envi-ronment of more portable, less invasiveprocedures with an increased focus onclinical outcomes. There also is a greaterneed for patient education and communi-cation about self-care.

These new leadership and commu-nication roles include acting as a re-source, motivator, educator, and liaisonto other departments to encourage staffmembers to share information aboutsafety for the well-being of both pa-tients and coworkers. Nurses in partic-ular must exercise leadership in theseareas in an environment of financialconstraints, staff shortages, decreasedhospital stays, and increased reportingrequirements by payers and watchdogorganizations. All of these changes areoccurring in perioperative practicewhile technology rapidly replaces me-chanical or manual ways of providingsurgical care. Although these chal-lenges may appear overwhelming atfirst, changing paradigms provide acritical opportunity for perioperativenurses and infection control profession-als to collaborate as strategic partnersand to offer their expertise and leader-ship in the product evaluation process.

GOALS OF PRODUCT EVALUATIONThe goals of product evaluation are to

select products and devices that• meet specific performance criteria, in-

cluding clinical and financial criteria;• are safe for patients and health care

workers;• contribute to positive patient out-

comes, such as fewer infections andinjuries; and

• are cost-effective for both the facilityand the patient.

The method established for evaluatingproducts also may provide benefits tothe facility. For example, including avalue analysis in the product evalua-tion process may demonstrate that less-expensive gloves tear more easily andultimately result in higher supply costsas well as costs associated with the in-creased risk of infection transmission topatients and staff members. The prod-uct evaluation process also encouragesstandardization of products, leading to

Perioperativenurses and

infection controlprofessionals act

as resources, motivators,

educators, andliaisons to other

health caredepartments.



• better inventory control, • more efficient use of space because

fewer products are stocked, • less training required for multiple

products, and • fewer errors because staff members

have increased product familiarity.

INFLUENCES IN THEPRODUCT EVALUATION PROCESS

There are four significant influenceson the evaluation and selection ofproducts for use in the perioperativesetting. These include practice modelsor patterns of care, business factors,

product technology andpractice innovation, andrecommended practicesand regulations.

PRACTICE MODELS OR PATTERNSOF CARE. Clinicians continu-ously strive to improvethe environment of careand patient outcomes, butin the past, these effortsoften were disconnectedand anecdotal. Efforts forimprovement often werebased on trial and error,tradition, expert opinion,limited data, or practition-er preference based on per-sonal experience. Today,

health care is practiced in a culture ofquality, which JCAHO defines as one inwhich all practitioners are involved indefining quality.6 Practice models (ie, pat-terns of care) provide a framework forimproving outcomes and defining quali-ty of care (Table 1). Despite facility differ-ences (eg, cost, availability of technology,expertise, local practice circumstances),practice models focus on the similar goalsof delivering appropriate care with lesstreatment time, reducing length of stay,and improving quality at an acceptablecost. The common goal is to ensure con-sistency by identifying and controllingvariations in care. The underlying focus is

ensuring “the right treatment at the righttime by the right provider.” In each prac-tice model, three parameters are used toevaluate health care effectiveness: cost,quality, and satisfaction.

In terms of cost, the OR often ac-counts for the largest expense in a pa-tient’s treatment. Cost per case is con-stantly challenged by payers. Forreliability, predictability, and efficien-cy, surgeons are encouraged to usestandardized products. Many periop-erative departments, therefore, re-quire a majority consensus before anew product is added to inventory.

Next, quality is assessed through pa-tient outcomes. Surgical site infections(SSIs) are an example of a high-profileoutcome. Infection control professionalstrack and analyze the occurrence of SSIs.Gruendemann6 estimates that more than75% of perioperative practice is devotedto SSI prevention. Many products fromenvironmental cleaning agents to thesterilization process and patient prep kitsare used to prevent SSIs.

Lastly, when assessing satisfaction,the patient’s satisfaction comes firstand is influenced by both outcomesand cost. The satisfaction of practition-ers also is important—products withsub-par performance are aggravatingand distracting and usually are morecostly in the long run. Today, the focushas shifted from “highest quality atlowest cost” to “best practice at an ac-ceptable cost.”

BUSINESS FACTORS. Several business fac-tors influence the product evaluationand selection process. A health care fa-cility’s purchasing process has a signifi-cant influence on the selection of prod-ucts. Group purchasing organization(GPO) agreements allow a facility to ne-gotiate the cost of product acquisitionthrough large purchase orders. The GPOmay determine bulk commodity prod-ucts, such as masks, gloves, peel packs,irrigation fluids, and surgical drapes.

Costs associatedwith the OR

often accountfor the largestportion of a

patient’streatment costs.

AORN JOURNAL • 339

Halvorson — Chinnes FEBRUARY 2007, VOL 85, NO 2

With regionalized differences in healthcare, however, a facility needs to haveflexibility for specific product choices.Some product selections for individualfacilities should be decentralized. Theterms of the GPO contract need to beconsidered when making product choic-es. The vendor may have specific vol-ume and timeframe requirements forbest pricing. The timeframe of the con-tract sometimes may be longer or short-er than preferred.

Key clinicians should determinewhether alternative products that may

be substituted by the vendor (eg, 4 x 4radiopaque sponges) would meet thefacility’s expectations. The facility’scase mix and volume also should beconsidered with the ordering quantityrequirements for contract incentives.

The type of hospital system or net-work also affects the product selectionprocess. Many facilities now are part ofnational, for-profit systems. Ambulatoryfacilities charge for cases by insuranceprocedure groups or categories of casesbased on average cost, with very few op-tions for itemized product charging.

TABLE 1Practice Models

Practice model type DefinitionEvidence-based Framework to apply research in the practice setting

• Treatment questions answered through research• Study data evaluated for clinical application• Findings integrated with clinical expectations and patient values1

Best practices Approaches proven effective in many organizations• Developed by health care professionals• Shared through databases and conferences

Consensus statement State-of-the-science statement synthesizing new information from medical research with implications for health care practice• Resolves an issue in clinical practice on a given intervention• Developed by independent panels of researchers, health care

providers, and public representatives• Addresses clinical efficacy, risk, and future research needs• Provides a “snapshot in time” based on available information; but

can become outdated2

Outcomes management Process linking care settings and timelines to outcomes• Focused on a defined patient population (eg, patients undergoing

total joint replacement, coronary artery bypass graft, cataract surgery)

• Multidisciplinary team critically reviews data and defines outcomes

• Integrates services, care components, and providers with the goal of collaboration

Clinical pathways Written documents defining a predictable sequence of patient care interventions for a procedure or patient group along a specified timeline• Included in the patient record are patient needs, elements of care,

nursing activities, diagnostic tests, and expected outcomes• Unique to each facility—defining best practice or current practice of

the facility and often integrates the two• Timeline can be expressed as outcomes, time, or both

1. Carlson LH, Stool SE. Evidenced based medicine: application to clinical practice. Sound Advice. 2003;1:1-7.2. National Institutes of Health. NIH Consensus Development Program. Available at: http://consensus.nih.gov/FAQs.htm. Accessed November 10, 2006.



Rural facilities may place more impor-tance on service and pay more attentionto their account with the GPO as signifi-cant influences in making their productdecisions. Academic centers also must in-tegrate the inherent costs of training sev-eral types of students into their budgets,considering factors such as • the increased costs of supplies (eg,

gloves and masks for students); • the increased use of products by

students in training labs; and • an increased use of products as a re-

sult of inadvertent contaminationwhile the student is learning.PRODUCT TECHNOLOGY AND PRACTICE INNOVATION.

Advances in technology and scientific ev-idence also have an influence on productselection and practice innovations. Forexample, improvements in implants mayrequire that a facility purchase new in-strumentation. New surgical programs ornew specialists may require additionalnew products and equipment. As scientif-ic evidence is published, recommendedpractice guidelines and new standardstypically dispel comfortable rituals andstimulate new practices, while at thesame time influencing product selection.

RECOMMENDED PRACTICES AND REGULATIONS. Pro-fessional and technical organizations suchas AORN,7 the Association for Profession-als in Infection Control and Epidemiolo-gy,3 and the American National StandardsInstitute8 provide important recommend-ed practices, guidelines, and technical re-quirements. Although compliance is con-sidered voluntary, these standards areseen as optimal levels of practice.

Reviewing and credentialing organi-zations such as JCAHO also influencenursing practice with clinical care and op-erating standards and requirements (eg,National Patient Safety Goals). Guidelinesfrom agencies such as the Centers for Dis-ease Control and Prevention on topicssuch as SSIs, hand hygiene, and artificialnails worn by surgical team members, aswell as regulations from the Occupation-

al Safety and Health Administration(OSHA) on such hazards as ethyleneoxide (EtO) and gluteraldehyde exposurelimits and monitoring have had a signifi-cant impact on clinical practice and asso-ciated products. When nursing practicestandards change, current products mustbe reevaluated to ensure compliance.

PRODUCT EVALUATION PROCESS AND STEPSAs a patient care specialty, periopera-

tive nursing is product- and technology-intensive. Coupled with the pressures oftoday’s health care market for cost con-tainment and public expectations, it is im-portant to have well-defined productevaluation processes. The process can beoutlined in eight steps:• identify the need for a new product,

technology, or practice intervention;• determine the required information;• define the roles of the committee

members;• identify the expected outcomes;• conduct the product, technology, or

practice trial;• communicate the progress and status

of the trial;• analyze the trial data; and• implement the new product, technolo-

gy, or practice, if approved.

IDENTIFY THE NEED FOR A NEW PRODUCT,TECHNOLOGY, OR PRACTICE INTERVENTION

Both clinical and nonclinical personnelcan identify a need for new products.Clinical practitioners (eg, perioperativenurses, infection control professionals,surgeons) • attend conferences; • review evidence-based and best prac-

tices literature; • review product materials; • network with colleagues for informa-

tion; and • critically evaluate clinical studies (eg,

new surgical scrubs, skin prep agents,techniques).

All of these sources provide information

Professional and technical organizations provide important recommended practices, guidelines, and technical

requirements, which are considered optimal levels of practice.



about how new products affect clinicaloutcomes. Among the nonclinical person-nel involved in the process, administra-tors often seek products and technologythat will help maintain the facility’s“state-of-the-art” status, and materialsmanagement personnel identify productneeds based on contract requirementsand the desire to optimize purchasingagreements. Existing processes and prod-

ucts may become ineffec-tive, outdated, or unneces-sary because of updatedguidelines, recommendedpractices, regulations, orstandards.

DETERMINE THE REQUIREDINFORMATION

The product evalua-tion committee must ga-ther necessary informa-tion to consider a productfor evaluation. This stepallows for screening orprequalifying of a prod-uct for clinical acceptanceto avoid unnecessary useof an organization’s re-sources or clinicians’ time.Examples of required in-

formation include the product indica-tion, clinical advantages and disad-vantages, and whether the productcomplies with existing standards, regu-lations, and recommendations.

DEFINE THE ROLESOF COMMITTEE MEMBERS

New products are selected by a prod-uct evaluation committee, sometimescalled the value analysis committee.Committee members collaborate to ad-dress facility-wide needs (eg, cost con-tainment, quality enhancement, stan-dardization, contract negotiations). Alldepartments and services that will useor be influenced by a product shouldbe represented on the committee. The

most significant contribution by nurseson this committee is determining aproduct’s clinical acceptability.9 A peri-operative nurse must be a member ofthis committee because the OR uses amajority of products in a facility (ie, anaverage of 4,000 line items10). Infectioncontrol professionals also assess prod-uct safety for staff members and pa-tients in addition to considering thecost and potential infection risks of aproduct. Staff members from materialsmanagement work with vendors forproduct information; provide a costanalysis; suggest comparable, compet-itive products; and assist clinical lead-ers in establishing par levels, reorder-ing thresholds, and storage needs.Biomedical engineering personnel val-idate that the product performs to themanufacturer’s specifications beforeuse. Clinical specialists and educatorscoordinate with the vendor for educa-tional materials, inservice training, andon-site support. Administrative repre-sentation on the committee keeps thefacility’s overall vision in focus andprovides authority to the committee.

The committee also may include fo-cused subcommittees for more specificdepartment or specialty service needs.Lead physicians may be asked to pro-vide supporting information about theclinical need and relevance of a prod-uct. The product vendor plays an im-portant role by working with clinical,materials management personnel, andeducation leaders. In addition, bothperioperative nurses and infectioncontrol professionals are uniquelyqualified to assess the risks and costsof new products and technology, particularly as they affect infectionoutcomes and patient safety. Table 2highlights these qualifications. Collab-orative leadership between these spe-cialists ensures strong patient advoca-cy and supports the best possiblepatient outcomes.

Perioperativenurses and

infection controlprofessionals are

essentialmembers of the

new product evaluation committee.



IDENTIFYEXPECTED OUTCOMES

The product evalua-tion committee identifiesthe outcomes expectedfrom introducing a newproduct and then devel-ops a project plan. Typi-cal outcomes include • reducing or replacing

existing inventory, • meeting purchasing

agreement require-ments,

• updating or enhanc-ing technology, and

• providing surgeonswith preferred prod-ucts and technology.

The project plan shouldlist the process steps,timeline, individual mem-ber responsibilities, andall key checkpoints forprogress reports.

At this stage, collaboration betweenthe vendor and clinical, materials man-agement, and education leaders is vital.The vendor may be asked to present tothe committee and provide inservicetraining before the product evaluationbegins. The committee also should dis-cuss with the vendor the level of prod-uct support and service that will be pro-vided after purchase. It is important todetermine whether• clinical support will be provided by

the sales representatives or clinicalsupport staff members;

• support for the item is available lo-cally or regionally, which is signifi-cant to smaller facilities in less urbanareas because of potentially in-creased wait times for service; and

• the support telephone line is easy toaccess and helpful for troubleshoot-ing, even during a surgical procedure.

The vendor also must be willing to in-teract with everyone involved in the

decision-making process—the physi-cian, materials management personnel,nurses, and other clinicians.

CONDUCT THE PRODUCT TRIALDuring the product trial, criteria for

product acceptance are evaluated. Thesecriteria should be objective, evaluatingperformance needs versus wants. Crite-ria outlined in AORN’s “Recommendedpractices for product selection in periop-erative practice settings” include clinical,financial, administrative, and materialsmanagement considerations.7 Severalareas within the facility will be affected,so collaboration among the various de-partments in evaluating these criteria isimportant.

CLINICAL CRITERIA. The first clinical cri-terion is the product’s indication. Ifthe indication is appropriate for ex-pected use, the next consideration isusability. When considering the easeof use of a product, a good question to

TABLE 2Collaborative Leadership in

Product Evaluation and Patient AdvocacyWhat do perioperative nurses bring to the product eval-uation process?• Clinical expertise and intimate knowledge of perioperative clinical

needs• Knowledge of nursing and perioperative literature• Experience applying recommended and best practices• A focus on patient care, both for patient safety and infection

prevention• Ability to prioritize patient needs, surgeon preferences, costs, and

inventory control• Representation to achieve consensus within the surgical team• A “surgical conscience”

What do infection control professionals bring to the prod-uct evaluation process• Clinical expertise on infection risk, control, and prevention• Knowledge of infection control and prevention literature• Experience of compliance with policies, procedures, and accepted

practices• A focus on patient and health care worker safety, identifying infec-

tion safety risks both to patients and staff members with an empha-sis on control and prevention

• An understanding of compliance with the regulations of the Occu-pational Safety and Health Administration, the US Food and DrugAdministration, and the Centers for Disease Control and Prevention

• Ability to apply national guidelines in a cost-effective manner• A “facility conscience”



ask is, “Is it an engineering marvel butan operational nightmare?” For exam-ple, consider the ease of configuringand balancing a microscope or the dif-ficulty of setting up and calibratingfluid management systems for hys-teroscopy. The requirements for han-dling and storage, packaging andopening, and dispensing onto the ster-ile field also influence ease of use.Many vendors label the assembly andset-up sequence to facilitate clinicaluse (eg, for chest drainage systems orphacoemulsification units). Productswith clear, easy-to-follow instructionsare easier to use, can increase healthcare worker’s comfort level, decreaseintraoperative time, and promote saferpatient care.

Additional considerations includewhether the product• is compatible with existing items;• fits with existing instruments and sys-

tems, such as• new endoscopy equipment with

existing light cords, trocars, andtubing or

• new grounding pads with existingelectrosurgical units;

• is reusable, disposable, or intendedfor single-use;

• has a mechanism to track the num-ber of uses and to determine that theproduct still functions according tooriginal manufacturer’s specifica-tions; and

• can stand alone or requires additionalcomponents.

Finally, if a product is not sterile as sup-plied or if it is reusable, it is essential todetermine the best method for process-ing and sterilizing and whether this iscompatible with the existing sterilizationmethods in the facility. In some in-stances, it may be necessary for a healthcare facility to invest in additional pack-aging or sterilization systems.

FINANCIAL CRITERIA. Three areas of finan-cial consideration are cost/value analy-

sis, compliance with the GPO, and reim-bursement potential. In considering anew product, the product evaluationcommittee must determine how much itwill cost; whether it is on contract; and,as a charge item, whether it will be reim-bursed or not.

The direct cost of a product is basedon the terms of the contract. Indirectcosts include variables such as time andsteps for maintaining inventory (eg, re-ordering, restocking); inservice pro-grams; and competency validation. Ster-ilization and reprocessing also areaddressed from a clinical point of view,but it is important to consider the oper-ational expenses of staffing, sterilizationprocess and products, and maintenance.The item may have a higher cost, but thecost/value analysis may show im-proved cost-effectiveness as a wholewith improved efficiencies and out-comes (eg, reduced infection rates).

Contract or GPO questions focus onthe preferred product contract status.The product may be so new that it isnot yet on contract, or it may be specif-ic to a particular patient population orprocedure group that can provide jus-tification for recommending its accept-ance. If the product is on contract, thefacility’s actual or projected volumemay not satisfy contractual require-ments for best pricing.

The question of reimbursement re-flects a concern of every health caremanager. It is critical to determine the fi-nancial impact of a new procedure orproduct to the cost per case. It also is es-sential to determine how reimbursementis obtained. Will an item be included inthe case charge or will it need to be a sep-arate charge item? When a new proce-dure or new product is introduced, oftenthe vendor has done considerable up-front work identifying billing codes andreimbursement strategies, which canprovide substantial assistance in an-swering these questions.

When considering a new product, the product evaluation committee should determine the financial effect the product willhave on the cost per case and how the cost will be reimbursed.



MATERIALS MANAGEMENT CRITERIA. Materialsmanagement personnel provide essentialsupport to the product evaluationprocess. Members of this departmentwork with the vendor for cost analysisand ordering quantities. A key questionthey should ask is whether the new prod-uct will replace or reduce existing inven-

tory. Clinical services orspecialty area usage also isimportant to determine.Not only can standardiza-tion be achieved amongphysicians in one servicegroup, but similar servicesalso may be able to consol-idate inventory. For exam-ple, open-heart, peripheralvascular, and transplantservices use many of thesame products, and openurology, general surgery,and gynecological sur-gery also may use manysimilar products. Identify-ing the projected utiliza-tion of a product by thevarious departments as-sists materials manage-ment personnel with con-tract negotiations.

ADMINISTRATIVE CRITERIA.Administrative personnelwill request verificationthat the product will help

meet the strategic goals of the organiza-tion, such as the launch of a new clinicalservice or procedure. Risk managers re-quire assurance that the product will beused in accordance with the manufactur-er’s labeled instructions and not for off-label uses. The vendor should providedocumentation that verifies a product’scompatibility with equipment fromother manufacturers. Components oftenare mixed and matched in a health caresetting, both intentionally and uninten-tionally; therefore, it is important duringthe evaluation of a new product to re-

view its function and compatibilitywith other equipment. For example, ifnew electrosurgical units (ESUs), ESUgrounding pads, and ESU pencils arenot standardized to existing units, thismight create surgical delays and poten-tially could put patients at risk. Stan-dardization is an obvious and easy risk-management strategy that also helpsensure annual competency validation ofhealth care professionals.

Some products make it easier to com-ply with updates in standards and regu-lations such as JCAHO’s National Pa-tient Safety Goals. As an example, newproducts have been developed for med-ication labeling and identification on thesterile field, and sharps containers andsafe-zone products have been devel-oped to decrease health care workers’risk of exposure to bloodborne infec-tions. An excellent example of how stan-dards and regulations affect product se-lection occurred in response to theOSHA requirement that health care or-ganizations limit employees’ exposureto EtO and glutaraldehyde and monitorthe safe use of these products. The resultof this requirement was a dramatic shiftto the use of peracetic acid and gas plas-ma sterilization methods.

Product evaluation is most effectivewhen it is conducted in the intendedareas of use. Depending on the size of thesurgical department, product evaluationshould be conducted with specific select-ed specialties to provide an optimal sam-pling of staff members and procedures.The proposed product will likely replacea current product during the trial phase,so the vendor needs to be available toprovide critical support. It will be impor-tant, therefore, to clarify with the vendorwhat additional support (eg, additionalsales representatives, clinical supportspecialists) will be assigned or availableon-site for assistance with clinicalquestions. Perioperative staff membersshould focus on evaluating the product

Product vendorsshould document

a product’s compatibility

with equipmentfrom other vendors.

Incompatibleproducts

potentiallycould put

patients at risk.



and should not be put in a position ofselling the product to other decisionmakers. Clinical support leaders must bepresent and visible during the clinicalevaluation to help with questions thatarise and the logistics of implementingthe new product or procedure.

An evaluation tool should be devel-oped to capture the need-to-know infor-mation and constructive comments. Thetool will help keep everyone focused onproduct evaluation during the clinicaltrial phase (Figure 1). A careful selectionof criteria for product acceptance ensuresthe validity of the results and eliminatesnonessential or subjective feedback. Theevaluation tool should be used to trackthe progress of the trial for an adequatenumber of procedures and to ensure thatkey physicians have had an opportunityto use the product.

COMMUNICATE THE PROGRESSAND STATUS OF THE TRIAL

Throughout the product trial, commu-nication is vital to the success of the eval-uation. Questions regarding product useshould be addressed immediately. Any-thing that impedes a proper evaluationmust be identified and corrected as soonas possible. Timelines may need to be ad-justed to give key physicians an opportu-nity to work with the product and to en-sure adequate procedure sampling.

ANALYZE THE TRIAL DATADuring the product trial, first-hand

information is collected and analyzedby committee members to determinewhether the product will be approved.This information must be recorded ina language that is useful to decisionmakers, whether it is narrative, nu-meric data, or a combination of thetwo. For example, administrators willwant financial and strategic informa-tion, whereas clinicians will wantquality clinical information. Data col-lated from the evaluation tool will in-

dicate the extent to which clinical cri-teria were met. Key considerationswill include• how well the product actually fit into

the desired setting,• whether procedural steps were

eliminated,• if the product reduced procedural

time,• whether inventory was substantially

reduced, and• what the real effect of the product was

on the cost per case.The three parameters ofcost, quality, and satisfac-tion used in the practicemodels must underliedata analysis. Committeemembers should deter-mine how well the prod-uct meets the cost crite-ria, established qualityoutcomes, and end-userexpectations.

IMPLEMENT THE NEWPRODUCT, TECHNOLOGY,

OR PRACTICEAfter the product has

been approved, clinicalleaders and materialsmanagement personnelshould mutually agreeon the timeline for prod-uct rollout. As in the prod-uct trial phase, clinicalleaders should oversee product conver-sion and implementation. The vendormust continue to provide high-level sup-port during product implementation.Additional inservice sessions and train-ing for all staff members should bescheduled to coordinate with productimplementation. Materials managementpersonnel will coordinate with the ven-dor and service leader for par levels andreordering thresholds, which should bemonitored for fluctuations in volume aswell as usage if the number of physicians

An evaluationtool is useful in

capturingessential

information andhelps staff

members focus on the product

evaluationprocess.



using the product increases.Some logistical considerations will

ease the facility’s transition to the newproduct. Preference cards should be up-dated to include descriptive notes withthe most current information. A sur-geon may change his or her preferenceof skin prep to a one-step agent, for ex-ample, but an outdated preference cardmay still reflect an older, multiple-stepproduct and technique. Another stagein the transition to a new product will

be to revise pick lists and charging in-formation. The decision to use a newproduct must be communicated to allstaff members and include the time-frame in which to expect the new prod-uct on the shelf and in case carts. Final-ly, it is important that vendors followup periodically to ensure that a productis being used appropriately and to clar-ify any misunderstandings or compli-cations encountered with implementa-tion of the product.

FIGURE 1Items Comprising a New Product Evaluation Tool

General items to include• clinical area or service• name of evaluator• surgical procedure • name of physician using product (if applicable)

Specific criteria Evaluation criteria should be tailored to the type product and its function or use in the practicesetting. Evaluation of the product may include criteria in the following categories.

Patient and health care worker safetyThe item or product• reduces potential injury;• reduces potential exposures;• increases protection (eg, minimizes patients’

or staff members’ risk of infection); and• is of equal or improved reliability.

Ease of useThe item or product• operates simply,• functions intuitively,• has clear instructions, and• requires a minimal learning curve.

Quality of trainingThe manufacturer• provides pretrial inservice training and• provides support during the procedural

evaluation.

Vendor supportThe product vendor• provides support during pretrial and inser-

vice training,• provides on-site support during clinical

evaluation,• provides continued support during the

implementation phase, and• provides ongoing support.

Clinical performanceThe item or product• performs to manufacturer’s specification,• performs to clinical expectations,• is available in different sizes, and• is available in the quantities desired.

EfficiencyThe item or product• reduces operational steps,• reduces set up time, and• reduces procedural time.

CostThe item or product• reduces inventory and• reduces case cost.

Compatibility and standardizationThe item or product• is compatible with existing equipment, com-

ponents, and supplies;• is compatible with equipment from other de-

partments or associated facilities within thehealth care system or network;

• is compatible with reprocessing and sterili-zation processes;

• may or may not require special storage; and• may or may not require special disposal.



SUCCESSFUL TRANSITION TONEW PRODUCTS

Many steps are involved in theproduct evaluation process, and sev-eral factors influence the successfultransition to new products or clinicalprocesses. A multidisciplinary ap-proach helps ensure that knowledge-able health care professionals will haveappropriate input into the decision-making process, from consideration ofbest clinical practices to the financialoutcomes. Both perioperative nursesand infection control professionals arein a unique position to provide leader-ship in the product evaluation process.In order to be accountable and to meetpatient safety and quality standards,perioperative nurses can be most effec-tive in the product evaluation processby forming an alliance with infectioncontrol professionals. Together, theycan become architects of change inproduct evaluation, ensuring the bestpatient outcomes as they lead their fa-cilities into the future. ❖

Cynthia K. Halvorson, RN, MSN,CNOR, is an independent periopera-tive clinical specialist, consultant, andeducator from the United States, cur-rently living in Zurich, Switzerland.

Elizabeth F. Chinnes, RN, BSN, CIC,is an independent infection controlconsultant with IC Solutions, LLC, MtPleasant, SC.

The authors acknowledge Catherine Jarrell,MA, scientific writer, St Charles, Mo; andKaren S. Whitson, MBA, KS WhitsonCommunications, Shawnee, Kan, for theirassistance in preparing and submittingthis manuscript for publication.

Editor’s Note: The authors received unrestricted grants from Enturia, Inc,Leawood, Kan.

REFERENCES1. O’Leary D. Patient safety: instilling hospi-tals with a culture of continuous improve-ment. June 11, 2003. Available at: http://www.jointcommission.org/newsroom/room/oncapitolhill/testimony_061104.htm.Accessed November 1, 2006.2. Weber V, Joshi MS. Effecting and leadingchange in health care organizations. JtComm J Qual Improv. 2000;26:388-399.3. Zelenka VR, Haberstich NJ. Productevaluation. In: APIC Text of Infection Controland Epidemiology. Washington, DC: Associ-ation for Professionals in Infection Controland Epidemiology; 2005:34-1–34-8.4. Porter-O’Grady T. A different age forleadership, part 1: new context, new con-tent. J Nurs Adm. 2003;33:105-110.5. Porter-O’Grady T. A different age forleadership, part 2: new rules, new roles. JNurs Adm. 2003;33:173-178.6. Gruendemann BJ. Collaboration betweeninfection control and perioperative profes-sionals. Am J Infect Control. 2004;32:55-56.7. Recommended practices for product se-lection in perioperative practice settings.In: Standards, Recommended Practices, andGuidelines. Denver: AORN, Inc; 2006:593-596.8. American National Standards Institute.ANSI/AAMI ST46-2002 Steam Sterilization andSterility Assurance in Healthcare Facilities.Washington, DC: American National Stan-dards Institute; 2002.9. Routledge JD, Henderson LJ. Testingprototype products in the operating room.AORN J. 1996;63:450-451.10. Barlow RD. GPO or go it alone?There’s a third way. OR Manager. 2002;18:11-13.

RESOURCESAnton WR, Canfield J. Balancing costs

and technology through a new product entryprogram. Surg Serv Manag. 2000;6:20-27.

Arriaga MA, Gorum M, Kennedy A.Clinical pathways in acoustic tumor man-agement. Laryngoscope. 1997;107:602-606.

Bartels JE, Bednash G. Answering thecall for quality nursing care and patientsafety: a new model for nursing education.Nurs Admin Q. 2005;29:5-13.

Beyea SC. Evidence-based practice inperioperative nursing. Am J Infect Control.2004;32:97-100.

Brown BJ. Patient and staff safety. NursAdmin Q. 2005;29:1-2.

Chazaro R, Knowles VM. Innovationsand change: Glove standardization. Surg



Serv Manag. 1999;5:46-48.Contino DS. Leadership competencies:

knowledge, skills, and aptitudes nursesneed to lead organizations effectively. CritCare Nurse. 2004;24:52-64.

Davis JL, Knief S. A strategic approach tothe introduction of new technology. SSM.2003;9:26-29.

Ellis K. Medical-product selection is agroup effort. Infect Control Today. 2004;8:12-16.

Gallagher RM, Rowell PA. Claimingthe future of nursing through nursing-sensitive quality indicators. Nurs AdminQ. 2003;27:273-284.

Gantz NR, Sorenson L, Howard RL. Acollaborative perspective on nursing lead-ership in quality improvement. The foun-dation for outcomes management and patient/staff safety in health care environ-ments. Nurs Admin Q. 2003;27:324-329.

Gershon RRM, Qureshi KA, Grimes MJ,McKenzie J. Evaluating and selecting prod-ucts that have infection control implications.In Mayhall CG, ed. Hospital Epidemiology andInfection Control. Philadelphia: LippincottWilliams & Wilkins; 2004:1747-1753.

Guerra SR. Partnering with industry.SSM. 2002;8:41-50.

Halvorson C. Microsurgery team’s rolein surgical site infection prevention. InfectControl Today. 2000;4:20-27.

Ham C. Improving the performance ofhealth services: the role of clinical leader-ship. Lancet. 2003;361:1978-1980.

Hamer BA. Uncovering three hiddensupply costs. In Outpatient Surgery 2003-2004 Surgical Supply Buying Guide. Malvern,Pa: Herrin Publishing Partners; 2003:18-19.

Karr D. Standardization and cost sav-ings. Surg Serv Manag. 1999;5:32-38.

Kurtzman ET, Kizer KW. Evaluating theperformance and contribution of nurses toachieve an environment of safety. NursAdmin Q. 2005;29:14-23.

Lambert VA, Nugent KE. Leadership stylefor facilitating the integration of culturallyappropriate health care. Semin Nurse Manag.1999;7:172-178.

Luther KM, Maguire L, Mazabob J, Sex-ton JB, Helmreich RL, Thomas E. Engagingnurses in patient safety. Crit Care Nurs ClinNorth Am. 2002;14:341-346.

Marsh SE. Productivity-effectiveness:Incorporating the human component intoequipment cost analysis. Surg Serv Manag.1999;5:44-47.

Rick C, Kobs AE. Guest editorial. NursAdmin Q. 2005;29:3-4.

Rupert C, Kitzman S. The clinical voicein product selection and implementation.SSM. 2002;8:24-26.

Sanford KD, Bradley C. Guest editorial.Nurs Admin Q. 2005;29:113-114.

Sherman RO. Growing our future nurs-ing leaders. Nurs Admin Q. 2005;29:125-132.

Urden LD. Tools and systems for im-proved outcomes: Leading and succeedingin outcomes management. Outcomes Manag.2004;8:2-4.

Wallace CJ. Applying Senge’s concepts oforganizational learning to clinical outcomesresearch and practice. Semin Nurse Manag.1998;6:161-168.

Waters VL. Cultivate corporate cultureand diversity. J Nurs Manag. 2004;35:36-37,50.

Wesorick B. 21st century leadershipchallenge: creating and sustaining healthy,healing work cultures and integrated serv-ice at the point of care. Nurs Admin Q.2002;26:18-32.

The AORN Journal will join more than 120 presti-gious science journals to participate in the

Council of Science Editors’ Global Theme Issue onPoverty and Human Development in November2007. The purpose of this international collabora-tion is to raise awareness worldwide and stimulateinterest and research into poverty and human de-velopment. Some journals will dedicate an entireissue to this subject; others will publish a few arti-cles or an editorial on the subject.

The AORN Journal is soliciting articles pertain-ing to perioperative nursing and poverty (eg, sur-

gery for uninsured patients, working with disadvan-taged populations in the United States, medicalmissions). If you are a perioperative nurse whoworks with impoverished populations, we want tohear from you. The deadline to submit manuscriptsis March 31, 2007.

For more information, send an e-mail toLinda DeLia, manuscript solicitation editor, [email protected] or call (800) 755-2676 x 249. First-time or hesitant writers who would like help witharticle development or the submission process alsoare welcome to contact DeLia.

Call for Papers on Poverty and Human Development Topics

Documents

Collaborative Leadership in Product Evaluation