Section 2.04 - Recommended Practices For Sterile Technique

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The following Recommended Practices for Sterile Technique have been approved by theAORN Recommended Practices AdvisoryBoard. They were presented as proposed recommendations for comments by members and others. Theyare effective December 15, 2012. These recommendedpractices are intended as achievable recommendations representing what is believed to be an optimallevel of practice. Policies and procedures will reflectvariations in practice settings and/or clinical situations that determine the degree to which the recommended practices can be implemented. AORN recognizes the various settings in which perioperativenurses practice, and as such, these recommendedpractices are intended as guidelines adaptable to various practice settings. These practice settings includetraditional operating rooms (ORs), ambulatory surgery centers, physicians’ offices, cardiac catheterization laboratories, endoscopy suites, radiology departments, and all other areas where surgery and otherinvasive procedures may be performed.PurposeThese recommended practices provide guidance forestablishing and maintaining a sterile field by following the principles and implementing the processes ofsterile technique. Sterile technique involves the useof specific actions and activities to prevent contamination and maintain sterility of identified areas during operative and other invasive procedures. Implementing sterile technique when preparing,performing, or assisting with surgical and other invasive procedures is the cornerstone of maintaining sterility and preventing microbial contamination.The creation and maintenance of a sterile field candirectly influence patient outcomes.1 All individualswho are involved in operative or other invasive procedures have a responsibility to provide a safe environment for patients. Perioperative team membersmust be vigilant in safeguarding the sterility of thefield and ensuring that the principles and processesof sterile technique are followed and implemented.Perioperative leaders can promote a culture of safetyby creating an environment where perioperative personnel are encouraged to identify, question, or stoppractices believed to be unsafe without fear ofrepercussion.The perioperative registered nurse (RN) uses ethical principles to make clinical decisions and act onthem.2 Adhering to the principles of and implementing the processes for sterile technique is a matter ofindividual conscience and an ethical obligation thatapplies to all members of the perioperative team.Perioperative team members should understand theprofessional responsibility to ensure that contamination of the sterile field is remedied immediately, andto make certain that any item for which sterility is inquestion is not used. Adhering to the principles ofand implementing the processes for sterile techniqueand taking immediate action to protect the patientwhen breaks in sterile technique occur meets themaxim, “first, do no harm.” The perioperative teamserves as the protective intermediary betweenpatients and personnel whose practices do not meetthe highest standards of sterile technique. Perioperative nurses have a long-standing reputation of advocating for patients and working together with members of the health care team to provide a safeperioperative environment for patients undergoingoperative or other invasive procedures.Although these recommendations include severalreferences to surgical attire (including surgicalmasks) and hand hygiene, the focus of this documentis on sterile technique. Surgical attire and handhygiene are outside the scope of these recommendations. The reader should refer to the AORN “Recommended practices for surgical attire”3 and “Recommended practices for hand hygiene in theperioperative setting”4 for additional guidance.Evidence ReviewA medical librarian conducted a systematic review ofMEDLINE , CINAHL , Scopus , and the CochraneDatabase of Systematic Reviews for meta-analyses,randomized and nonrandomized trials and studies,systematic and nonsystematic reviews, and opiniondocuments and letters. Search terms included sterilefield, sterile technique, aseptic technique, asepticpractices, surgical drapes, double-gloving, assistedgloving, closed gloving, time-related sterilization,event-related sterilization, surgical attire, protectiveclothing, sterile supplies, sterile barriers, barrier precautions, body-exhaust suits, space suits, laminar airflow, bowel technique, (glove expansion and fluids),(glove perforation and electrosurgery), strikethrough,Spaulding’s criteria, product packaging, and equipment contamination.The lead author and medical librarian identifiedand obtained relevant guidelines from governmentagencies, other professional organizations, andstandards-setting bodies. The lead author assessedadditional professional literature, including somethat initially appeared in other articles provided tothe author.The initial search was confined to 2006 to 2011,but the time restriction was not considered in subsequent searches. The librarian also established continuing alerts on the topics included in this recommended practice and provided relevant results to thelead author.Articles identified by the search were provided tothe project team for evaluation. The team consisted of2013 Perioperative Standards and Recommended PracticesLast revised: December 2012. Copyright 2013 AORN, Inc. All rights reserved.91Aseptic PracticeRecommended Practices for Sterile Technique

RP: Sterile Techniquethe lead author, two members of the RecommendedPractices Advisory Board, and a member of theResearch Committee. The lead author divided thesearch results into topics and assigned members of theteam to review and critically appraise each articleusing the Johns Hopkins Evidence-Based PracticeModel and the Research or Non-Research EvidenceAppraisal Tools as appropriate. The literature wasindependently evaluated and appraised according tothe strength and quality of the evidence. Each articlewas then assigned an appraisal score as agreed uponby consensus of the team. The appraisal score is notedin brackets after each reference, as applicable.The collective evidence supporting each intervention within a specific recommendation was summarized and used to rate the strength of the evidenceusing the Oncology Nursing Society Putting Evidenceinto Practice (ONS PEP ) schema. Factors consideredin review of the collective evidence were the quality ofresearch, quantity of similar studies on a given topic,and consistency of results supporting a recommendation. The evidence rating is noted in brackets aftereach intervention.Editor’s note: MEDLINE is a registered trademark ofthe US National Library of Medicine’s Medical Literature Analysis and Retrieval System, Bethesda, MD.CINAHL, Cumulative Index to Nursing and AlliedHealth Literature, is a registered trademark of EBSCOIndustries, Birmingham, AL. Scopus is a registeredtrademark of Elsevier B.V., Amsterdam, Netherlands.ONS PEP is a registered trademark of the OncologyNursing Society, Pittsburgh, PA.Recommendation IPerioperative personnel should implement practices thatreduce the spread of transmissible infections when preparingor working in the OR or invasive procedure room and when performing or assisting with operative or other invasiveprocedures.Aseptic PracticeProtecting patients and safeguarding health care providers from potentially infectious agent transmissionis a key focus of perioperative nurses.5 Hand hygienehas been recognized as a primary method of decreasing health care-associated infections.4,6 Surgical attireand personal protective equipment (PPE) are worn tosupport cleanliness and hygiene, promote patient andhealth care provider safety, and aid in preserving theintegrity of the sterile field within the perioperativeenvironment.3,5I.a.Perioperative personnel entering the OR orinvasive procedure room for any reason (eg,stocking supplies, bringing procedural suppliesand equipment into clean rooms) should wearcleanscrub attire,1 including a freshly laundered orsingle-use, long-sleeved jacket snappedclosed with the cuffs down to the wrists, andsurgical head covers or hoods that cover allhair and scalp skin, including facial hair,92sideburns, and the hair at the nape of theneck.1[Recommended for Practice]Surgical attire helps contain bacterial shedding and promotes environmental cleanliness.1,3Head coverings and hoods minimize microbialdispersal by containing hair and scalp skin.1,3I.b.Perioperative personnel should perform handhygiene before entering the OR or invasive procedure room and areas where sterile supplieshave been opened. [Recommended for Practice]Following regular hand hygiene practiceshelps prevent transmission of infection andreduces health care-associated infections forpatients and health care personnel.4,6Prevention of health care-associated infections is a priority of all health care providers.Health care-associated infections can result inuntoward outcomes such as increased morbidity and mortality, longer length of stay,increased pain and suffering, and escalatingcost of care.7 Hand hygiene, hand washing, andsurgical hand scrubs are the most effective wayto prevent and control infections and representthe least expensive means of achieving both.4I.c.Perioperative personnel should wear a cleansurgical mask that covers the mouth and noseand is secured in a manner to prevent ventingwhen open sterile supplies are present1 andwhen preparing, performing, or assisting withsurgery and other invasive procedures,includingcentral venous catheter (CVC) insertion,peripherally inserted central catheters(PICCs), and guidewire exchange8-10;regional anesthesia procedures11; orhigh-risk spinal canal procedures (eg, myelogram, lumbar puncture, spinalanesthesia).10,12-20[Recommended for Practice]A clean surgical mask helps protect thepatient and procedure site from microbial contamination by organisms carried in the provider’s mouth or nose.1,3,10,21Researchers studied the effectiveness of surgical masks in reducing the dispersal of bacterial contamination from the upper airways of 25volunteers. The volunteers were asked to speakdirectly at an agar plate for five minutes. A surgical mask was applied and the volunteers wereinstructed to speak at the agar plate for threeadditional periods of five minutes each. Theresults showed a marked reduction in the bacterial contamination of the agar plates while thevolunteers were wearing surgical masks.21In a study investigating the possibility thatsurgical masks increase vertical shedding of bacteria from the face during facial movement, volunteers were asked to speak for 20 minuteswhile moving their heads from side to sidewithout a surgical mask for the first five minutes

and then with a surgical mask for three additional five-minute periods. A blood agar platewas positioned 30 cm below the volunteers’faces. The results showed a statistically significant reduction in the number of colony formingunits on the agar plate when the volunteerswere wearing surgical masks. The researchersrecommended wearing a surgical mask, particularly when the perioperative team member’s faceis in close proximity to the procedural site andwhen the need for speaking during the procedure is anticipated.22In a prospective, randomized, controlled trialof 221 patients, researchers assessed the needfor surgical masks during cataract surgery.Patients were randomly assigned to group A, inwhich the surgeon wore a clean surgical mask,or group B, in which the surgeon did not wear asurgical mask. A settle plate was secured adjacent to the patient’s head on the operative sidewithin the sterile field during all procedures.The results showed a significant reduction ofbacterial organisms falling on the operative sidewhen the surgeon wore a surgical mask.23In a study exploring the relationship betweenthe use and position of a surgical mask during30 cardiac catheterization procedures, researchers obtained bacterial samples within thedraped, operative site adjacent to the femoralartery. Surgical masks were either not worn byperioperative team members, or worn in positions above and below the nose. The number ofbacterial colonies recovered when no mask wasworn was significantly greater than when a surgical mask was worn. Mask placement belowthe nose also was associated with a higher colony count than when the mask was worn abovethe nose. The researchers voluntarily discontinued the study after 30 patients in the interest ofpatient safety because of the high bacterialcount associated with not wearing surgicalmasks.24Surgical masks are effective in limiting thedispersal of oropharyngeal droplets21,25 and arerecommended by the Centers for Disease Control and Prevention (CDC) for the placement ofCVCs, PICCs, and guidewire exchange.8-10The American Society of Regional Anesthesia and Pain Medicine recommends the use ofsurgical masks during regional anesthesia as amethod to reduce the likelihood of site contamination from microorganisms that may be present in the upper airway of providers.11Oropharyngeal flora was found to be thesource of contamination in a number ofreported cases of bacterial meningitis after lumbar puncture, spinal and epidural anesthesia,and intrathecal chemotherapy.12-19In 2004, the CDC investigated eight instancesin which patients contracted meningitis afterprocedures that involved placing a catheter orinjecting material into the spinal canal or epi-dural space. The cases involved blood or cerebrospinal fluid contaminated with streptococcalspecies or other pathogens consistent with oropharyngeal fluid. None of the clinicians woresurgical masks during the procedures. Equipment and products used during these procedures were excluded as sources of contamination.10 In June 2007, the Healthcare InfectionControl Practices Advisory Committee reviewedthe cases and determined there was sufficientevidence to warrant the wearing of a surgicalmask by the individual placing a catheter orinjecting material into the spinal or epiduralspace.10In September 2008, three cases of bacterialmeningitis in postpartum women were reportedto the New York State Department of Health.Two additional cases of meningitis werereported to the Ohio Department of Health inMay 2009. All of the patients had receivedintrapartum spinal anesthesia. The investigatorsconcluded that the New York incidents wereassociated with a single anesthesiologist. Theanesthesiologist reported wearing a surgicalmask; however, personnel reported that thepresence of unmasked visitors in the procedurearea was common. The Ohio incidents werefound to be associated with a second anesthesiologist who did not wear a surgical mask. Thefindings underscore the need for adhering toaseptic practices and wearing surgical masksduring spinal procedures.20Recommendation IISurgical gowns, gloves, and drape products for use in the perioperative setting should be evaluated and selected for safety,efficacy, and cost before purchase or use.The safety and efficacy of surgical gowns, gloves, anddrape products depends on the design of the item andthe materials from which they are made.26Quality, patient and worker safety, and cost containment are primary concerns for perioperative RNs whenthey participate in evaluating and selecting medicaldevices and products for use in practice settings.27II.a.Surgical gowns, gloves, and drape productsshould be evaluated and selected for use in theperioperative setting according toproduct-specific requirements27,28;procedure-related requirements27;end-user requirements and preferences27,28;patient-related requirements27;environmental considerations29;compliance with federal, state, and local regulatory agencies5,30,31; andcompliance with standards-setting bodies.32[Likely to be Effective]Product-specific requirements include contractual agreements, compatibility with existingproducts, and implementation of new productsof differing material or construction.27,2893Aseptic PracticeRP: Sterile Technique

Aseptic PracticeRP: Sterile TechniqueProcedure-related requirements define whatis necessary for the procedure where the surgical gowns, gloves, and drape products will beused, such as resistance to penetration by bloodand other body fluids, or the presence of adhesive apertures.27End-user requirements, such as the degree ofprotection from blood, body fluids, and otherpotentially infectious materials, and preferences, such as comfort, vary depending on howthe surgical gowns, gloves, and drape productsare used.27Patient-related requirements define the ability of the product to meet the needs of the individual patient, such as being appropriatelysized or able to conform to patient contours.27Environmental considerations, such as thepotential for recycling or reprocessing, mayreduce waste, conserve resources, and decreasecosts without compromising quality of care.29Mandatory Occupational Safety and HealthAdministration regulations require that personal protective equipment such as surgicalgowns and gloves do not permit blood or otherpotentially infectious material to “pass throughto or reach the employee’s work clothes, streetclothes, undergarments, skin, eyes, mouth, orother mucous membranes under normal conditions of use and for the duration of time whichthe protective equipment will beused.”30(1910.1030(d)(3)(i))Surgical gowns and drape products are surgical devices, and as such are regulated by the USFood and Drug Administration (FDA).31 Failureof these devices is subject to medical devicereporting requirements according to the SafeMedical Devices Act of 1990 as amended inMarch 200033 and MedWatch: The FDA SafetyInformation and Adverse Event ReportingProgram.34The American National Standards Instituteand Association for the Advancement of Medical Instrumentation standard PB70:2012, “Liquid barrier performance and classification ofprotective apparel and drapes intended for usein health care facilities,” establishes a commonsystem of classification and specifies labelingrequirements for manufacturers of protectiveapparel and drapes used in health care facilities. 32 The classification system is based onstandardized test methods for determining liquid barrier performance and compliance. Theimplementation of consistent classification andlabeling requirements by the manufacturer aidsin evaluation and selection of the most appropriate protective products for the health careorganization.32II.a.1.94Surgical gowns, gloves, and drape productsused during operative and other invasiveprocedures must provide a barrier1,30,32 andshould be resistant to tears, punctures, andabrasions.28Tears, punctures, and abrasions mayallow for the passage of microorganisms,particulates, and fluids between sterile andunsterile areas and expose patients andperioperative personnel to microbial contamination and bloodborne pathogens.Abrasions may adversely affect barrierproperties by weakening the material andcausing it to tear or generate lint.26In a study evaluating bacterial penetration of disposable, non-woven drapes usedduring total hip arthroplasty, six brands ofdrapes were tested after 30 and 90 minutes.The results showed that bacterial penetration was time dependent. Most of thedrapes remained impenetrable or allowedpassage of fewer than 100 colony formingunits at 90 minutes; however, none of thedrapes tested were completely impenetrable, and certain brands were more resistantto bacterial penetration than others.35In another study considering the effectsof moisture and physical stress on surgicaldraping materials, researchers found thatmaterials differ dramatically in the abilityto resist bacterial penetration.36II.a.2.Seams and points of attachment of surgicalgowns should minimize liquid penetrationand passage of potential contaminants.1,32Wicking or pressure on a seam or pointof attachment may cause liquid transferbetween sterile and unsterile surfaces, andone or both sides of the gown may becomecontaminated.II.a.3.Surgical gowns, gloves, and drape pr

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