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Guideline Summary
Guideline Title
Recommended practices for sterile technique.
Bibliographic Source(s)
Association of periOperative Registered Nurses (AORN). Recommended practices for sterile technique. In: Perioperative standards and recommended practices. Denver (CO): Association of periOperative Registered Nurses (AORN); 2012 Dec. p. e62-90. [135 references]
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)

Any condition requiring the use of surgical and other invasive procedure–related care

Guideline Category
Prevention
Clinical Specialty
Nursing
Preventive Medicine
Surgery
Intended Users
Advanced Practice Nurses
Nurses
Physician Assistants
Guideline Objective(s)

To provide guidance for establishing and maintaining a sterile field by following the principles and implementing the processes of sterile technique

Note: Surgical attire and hand hygiene are outside the scope of these recommendations.

Target Population
  • Patients undergoing surgical and other invasive procedures
  • Perioperative healthcare personnel
Interventions and Practices Considered
  1. Implementation of practices that reduce the spread of transmissible infections (preparing or working in the operating room/invasive procedure room or performing/assisting with operative/invasive procedures)
  2. Evaluation and selection of surgical gowns, gloves, and drape products based on safety, efficacy, and cost
  3. Sterile technique for donning and wearing sterile gowns and gloves
  4. Establishment of a sterile field using sterile drapes
  5. Opening, dispensing and transferring of items introduced into the sterile field by methods that maintain the sterility and integrity of the item and the sterile field
  6. Monitoring of the sterile field
  7. Movement of personnel within or around the sterile field in a manner that prevents contamination of the sterile field
  8. Education and competency validation of perioperative team members on principles and performance of the processes for sterile technique
  9. Documentation of nursing activities related to sterile technique
  10. Development, review and revision of policies and procedures for the implementation of sterile technique
  11. Participation of perioperative personnel in a quality assurance and performance improvement activities
Major Outcomes Considered
  • Signs and symptoms of systemic, surgical site and/or wound infection
  • Risk of microbial contamination
  • Safety and efficacy of sterile technique interventions and protocols
  • Risk of infection transmission to patients and/or health care workers

Methodology

Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

Evidence Review

A medical librarian conducted a systematic review of MEDLINE®, CINAHL®, Scopus®, and the Cochrane Database of Systematic Reviews for meta-analyses, randomized and nonrandomized trials and studies, systematic and nonsystematic reviews, and opinion documents and letters. Search terms included sterile field, sterile technique, aseptic technique, aseptic practices, surgical drapes, double-gloving, assisted gloving, closed gloving, time-related sterilization, event-related sterilization, surgical attire, protective clothing, sterile supplies, sterile barriers, barrier precautions, body-exhaust suits, space suits, laminar air flow, 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 identified and obtained relevant guidelines from government agencies, other professional organizations, and standards-setting bodies. The lead author assessed additional professional literature, including some that initially appeared in other articles provided to the 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 the lead author.

Number of Source Documents

A total of 135 articles met the inclusion criteria and were included in the review.

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Not Given)
Rating Scheme for the Strength of the Evidence

Not stated

Methods Used to Analyze the Evidence
Systematic Review
Description of the Methods Used to Analyze the Evidence

Articles identified by the search were provided to the project team for evaluation. The team consisted of the lead author, two members of the Recommended Practices Advisory Board, and a member of the Research Committee. The lead author divided the search results into topics and assigned members of the team to review and critically appraise each article using the Johns Hopkins Evidence-Based Practice Model and the Research or Non-Research Evidence Appraisal Tools as appropriate. The literature was independently evaluated and appraised according to the strength and quality of the evidence. Each article was then assigned an appraisal score as agreed upon by consensus of the team. The appraisal score is noted in brackets after each reference, as applicable (see the original guideline document).

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

The collective evidence supporting each intervention within a specific recommendation was summarized and used to rate the strength of the evidence using the Oncology Nursing Society Putting Evidence into Practice (ONS PEP®) schema. Factors considered in review of the collective evidence were the quality of research, quantity of similar studies on a given topic, and consistency of results supporting a recommendation. The evidence rating is noted in brackets after each intervention in the original guideline document.

Rating Scheme for the Strength of the Recommendations

Recommended for Practice: Interventions for which effectiveness has been demonstrated by strong evidence from rigorously-designed studies, meta-analyses, or systematic reviews, and for which expectation of harm is small compared with the benefit.

  • Supportive evidence from at least two well-conducted randomized controlled trials that were performed at more than one institutional site, and that included a sample size of at least 100 participants
  • Evidence from a meta-analysis or systematic review of research studies that incorporated quality ratings in the analysis, and included a total of 100 patients or more in its estimate of effect size and confidence intervals
  • Recommendations from a panel of experts, that derive from an explicit literature search strategy, and include thorough analysis, quality rating, and synthesis of the evidence

Likely to Be Effective: Interventions for which the evidence is less well established than for those listed under "recommended for practice".

  • Supportive evidence from a single well conducted randomized controlled trial that included fewer than 100 patients or was conducted at one or more institutions
  • Evidence from a meta-analysis or systematic review that incorporated quality ratings in the analysis and included fewer than 100 patients, or had no estimates of effect size and confidence intervals
  • Evidence from a synthetic review of randomized trials that incorporated quality ratings in the analysis
  • Guidelines developed largely by consensus/expert opinion rather than primarily based on the evidence and published by a panel of experts, that are not supported by synthesis and quality rating of the evidence

Benefits Balanced with Harms: Interventions for which clinicians and patients should weigh up the beneficial and harmful effects according to individual circumstances and priorities.

  • Supportive evidence from one or more randomized trials, meta-analyses or systematic reviews, but where the intervention may be associated, in certain patient populations, with adverse effects that produce or potentially produce mortality, significant morbidity, functional disability, hospitalization or excess length of stay

Effectiveness Not Established: Interventions for which there are currently insufficient data or data of inadequate quality.

  • Supportive evidence from a well conducted case control study
  • Supportive evidence from a poorly controlled or uncontrolled study
  • Evidence from randomized clinical trials with one or more major or three or more minor methodological flaws that could invalidate the results
  • Evidence from non-experimental studies with high potential for bias (such as case series with comparison to historical controls)-Evidence from case series or case reports
  • Conflicting evidence, but where the preponderance of the evidence is in support of the recommendation or meta-analysis showing a trend that did not reach statistical significance

Effectiveness Unlikely: Interventions for which lack of effectiveness is less well established than for those listed under "not recommended for practice".

  • Evidence from a single well conducted randomized trial with at least 100 participants or conducted at more than one site and which showed no benefit for the intervention
  • Evidence from a well conducted case control study, a poorly controlled or uncontrolled study, a randomized trial with major methodologic flaws, or an observational study (e.g., case series with historical controls) that showed no benefit and a prominent and unacceptable pattern of adverse events and serious toxicities

Not Recommended for Practice: Interventions for which ineffectiveness or harmfulness has been demonstrated by clear evidence, or the cost or burden necessary for the intervention exceeds anticipated benefit.

  • Evidence from two or more well conducted randomized trials with at least 100 participants or conducted at more than one site and which showed no benefit for the intervention, and excessive costs or burden expected
  • Evidence from a single well conducted trial that showed a prominent and unacceptable pattern of adverse events and serious toxicities (Common Terminology Criteria for Adverse Events [CTCAE] Grade III/IV)
  • Evidence from a meta-analysis or systematic review of research studies that incorporated quality ratings in the analysis, included a total of 100 patients or more in its estimate of effect size and confidence intervals with demonstrated lack of benefit or prominent and unacceptable toxicities
  • Intervention discouraged from use by a panel of experts in the related subject, after conducting a systematic examination, quality rating and synthesis of the available evidence
Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation

Recommended Practices for Sterile Technique have been approved by the Association of periOperative Registered Nurses (AORN) Recommended Practices Advisory Board. They were presented as proposed recommendations for comments by members and others. They are effective December 15, 2012.

Recommendations

Major Recommendations

Note from the Association of periOperative Nurses (AORN): Although these recommendations include several references to surgical attire (including surgical masks) and hand hygiene, the focus of the recommendations is on sterile technique. Surgical attire and hand hygiene are outside the scope of these recommendations. The reader should refer to the AORN "Recommended practices for surgical attire" and "Recommended practices for hand hygiene in the perioperative setting" for additional guidance.

  1. Perioperative personnel should implement practices that reduce the spread of transmissible infections when preparing or working in the operating room or invasive procedure room and when performing or assisting with operative or other invasive procedures.
  2. Surgical 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.
  3. Perioperative personnel should use sterile technique when donning and wearing sterile gowns and gloves.
  4. Sterile drapes should be used to establish a sterile field.
  5. A sterile field should be prepared for patients undergoing surgical or other invasive procedures.
  6. Items introduced to the sterile field should be opened, dispensed, and transferred by methods that maintain the sterility and integrity of the item and the sterile field.
  7. Sterile fields should be constantly monitored.
  8. All personnel moving within or around a sterile field should do so in a manner that prevents contamination of the sterile field.
  9. Perioperative team members should receive initial and ongoing education and competency validation on their understanding of the principles of and performance of the processes for sterile technique.
  10. Nursing activities related to sterile technique should be documented in a manner consistent with health care organization policies and procedures and regulatory and accrediting agency requirements.
  11. Policies and procedures for the implementation of sterile technique should be developed, reviewed periodically, revised as necessary, and readily available in the practice setting.
  12. Perioperative personnel should participate in a variety of quality assurance and performance improvement activities that are consistent with the health care organization's plan to improve understanding of and compliance with the principles and processes of sterile technique.
Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see the "Major Recommendations" field). See the full guideline document for systematic review and discussion of evidence.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Prevention of patient and health care worker injury

Potential Harms

Not stated

Qualifying Statements

Qualifying Statements
  • These recommended practices represent the Association's official position on questions regarding optimal perioperative nursing practice.
  • No attempt has been made to gain consensus among users, manufacturers, and consumers of any material or product.
  • Compliance with the Association of periOperative Registered Nurses (AORN) recommended practices is voluntary.
  • AORN's recommended practices are intended as achievable and represent what is believed to be an optimal level of patient care within surgical and invasive procedure settings.
  • Although they are considered to represent the optimal level of practice, variations in practice settings and clinical situations may limit the degree to which each recommendation can be implemented.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Resources
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Staying Healthy
IOM Domain
Safety

Identifying Information and Availability

Bibliographic Source(s)
Association of periOperative Registered Nurses (AORN). Recommended practices for sterile technique. In: Perioperative standards and recommended practices. Denver (CO): Association of periOperative Registered Nurses (AORN); 2012 Dec. p. e62-90. [135 references]
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2012 Dec
Guideline Developer(s)
Association of periOperative Registered Nurses - Professional Association
Source(s) of Funding

Association of periOperative Registered Nurses (AORN)

Guideline Committee

Association of periOperative Registered Nurses (AORN) Recommended Practices Advisory Board

Composition of Group That Authored the Guideline

Lead Author: Sharon A. Van Wicklin, MSN, RN, CNOR, CRNFA, CPSN, PLNC

Contributing Author: Ramona Conner, MSN, RN, CNOR

Team Members: Antonia B. Hughes, MA, BSN, RN, CNOR; Paula J. Morton, MS, RN, CNOR; Christine Anderson, PhD, RN; Annette Wasielewski, BSN, RN, CNOR

Financial Disclosures/Conflicts of Interest

No financial relationships relevant to the content of this guideline have been disclosed by the authors, planners, peer reviewers, or staff.

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Not available at this time.

Print copies: Available from the Association of periOperative Registered Nurses (AORN) Web site External Web Site Policy.

Availability of Companion Documents

The following is available:

Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on April 16, 2013. The information was verified by the guideline developer on May 21, 2013.

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

Disclaimer

NGC Disclaimer

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

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