RPs Underscore Importance of Sterile Technique, Prevention of Transmissible Infections

By Kelly M. Pyrek

For the first time, the Association of periOperative Registered Nurses (AORN) has issued its Perioperative Standards and Recommended Practices featuring an evidence review for all new and updated guidelines.

"The 2013 edition of the recommended practices is the first edition with our new evidence-rating system, something we are very excited about," says  Ramona Conner, MSN, RN, CNOR, manager of standards and recommended practices at AORN. "The evidence rating is at the core of all of the major changes we are making this year, and it's quite a service for our members and those who purchase the RPs. We conduct an extensive literature search and review prior to review of the documents and that has been quite a learning experience for us. It helps for us to comb through the literature for people, as we are evaluating and appraising each piece of literature, people will see noted at the end of each recommendation and individual reference, people will know what the strength and quality of the evidence is. It allows people to evaluate that evidence themselves if they choose to -- it helps the perioperative nurse articulate why we do what we do and provides the science on which these principles are based."

The evidence review involved a number of steps, according to AORN. First, a medical librarian conducted a systematic review of databases such as Medline, Cinahl 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. The lead author of the RP and the medical librarian identified and obtained relevant guidelines from government agencies, other professional organizations, and standards-setting bodies. Articles identified by the search were provided to the project team for evaluation. The team consisted of the lead author, several members of the Recommended Practices Advisory Board, and a member of the Research Committee. The literature was then 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. 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. Users will find the evidence rating noted in brackets after each intervention.

"This exercise of the evidence rating has certainly done a great deal to inform us about the evidence base of the recommended practices but it also points out where there are gaps in the literature," Conner says. "We may still make a recommendation because it makes practical sense based on what we know now, but it also indicates that we need more research in these areas. I think that's very helpful not only to the perioperative nurse but certainly to perioperative nurse researchers to identify areas where the research is lacking and requires further investigation."

AORN's rating scheme is designed to indicate the strength of the recommendations and is as follows:

- 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.
This rating is based on the following: 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; and regulatory requirements.

- Likely to Be Effective: Interventions for which the evidence is less well established than for those listed under "recommended for practice"
This rating is based on the following: 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
This rating is based on the following: 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
This rating is based on the following: 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; and 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"
This rating is based on the following: 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
This rating is based on the following: 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; and 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.

There are several RPs in the 2013 edition that are of particular interest to infection preventionists, and these include "Prevention of Transmissible Infections,"  "Sterile Technique," and "Safe Environment of Care." Let's take a closer look at each RP:

Sterile Technique
The Sterile Technique RP provides guidance for establishing and maintaining a sterile field by following the principles and implementing the processes of sterile technique. New recommendations include double gloving, changing gloves, covering the sterile field, and use of the isolation technique for bowel surgery and resection of metastatic tumors.

"Sterile technique is the foundation of everything we do in perioperative practice and so that one engendered a great deal of discussion," Conner says. "We were anxious to get that one in press and to the audience because it represents a significant revision. Our evidence review and our rating process is very evident in this revision, as it points out some long-held beliefs and practices that are not supported in the literature. Among the new recommendations is a call for double-gloving; we have recommended it previously but we have an even stronger recommendation now. What's new in this edition is we now have a recommendation to change gloves during the procedure every 90 to 150 minutes. It is based on very strong evidence in the literature."

As the Sterile Technique RP notes, "Sterile technique involves the use of 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 can directly influence patient outcomes. All individuals who are involved in operative or other invasive procedures have a responsibility to provide a safe environment for patients. Perioperative team members must be vigilant in safeguarding the sterility of the field and ensuring that the principles and processes of sterile technique are followed and implemented. Perioperative leaders can promote a culture of safety by creating an environment where perioperative personnel are encouraged to identify, question, or stop practices believed to be unsafe without fear of repercussion."

The Sterile Technique RP, authored by Sharon A. Van Wicklin, MSN, RN, CNOR, CRNFA, CPSN, PLNC, perioperative nursing specialist in the AORN Nursing Department with Ramona Conner, emphasizes the importance of cultivating and maintaining the "surgical conscience": "The perioperative registered nurse (RN) uses ethical principles to make clinical decisions and act on them. Adhering to the principles of and implementing the processes for sterile technique is a matter of individual conscience and an ethical obligation that applies to all members of the perioperative team. Perioperative team members should understand the professional responsibility to ensure that contamination of the sterile field is remedied immediately, and to make certain that any item for which sterility is in question is not used. Adhering to the principles of and implementing the processes for sterile technique and taking immediate action to protect the patient when breaks in sterile technique occur meets the maxim, 'First, do no harm.' The perioperative team serves as the protective intermediary between patients and personnel whose practices do not meet the highest standards of sterile technique. Perioperative nurses have a long-standing reputation of advocating for patients and working together with members of the healthcare team to provide a safe perioperative environment for patients undergoing operative or other invasive procedures."

In the RP, AORN makes the following recommendations:*
- Recommendation I: Perioperative personnel should implement practices that reduce the spread of transmissible infections when preparing or working in the OR or invasive procedure room and when performing or assisting with operative or other invasive procedures.
- Recommendation II: 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.
- Recommendation III: Perioperative personnel should use sterile technique when donning and wearing sterile gowns and gloves.
- Recommendation IV: Sterile drapes should be used to establish a sterile field.
- Recommendation V: A sterile field should be prepared for patients undergoing surgical or other invasive procedures.
- Recommendation VI: 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.
- Recommendation VII: Sterile fields should be constantly monitored.
- Recommendation VIII: All personnel moving within or around a sterile field should do so in a manner that prevents contamination of the sterile field.
- Recommendation IX: 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.
- Recommendation X: 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.
- Recommendation XI: Policies and procedures for the implementation of sterile technique should be developed, reviewed periodically, revised as necessary, and readily available in the practice setting.
- Recommendation XII: Perioperative personnel should participate in a variety of quality assurance and performance improvement activities that are consistent with the healthcare organizations plan to improve understanding of and compliance with the principles and processes of sterile technique.
* Adapted with permission from Perioperative Standards and Recommended Practices. Copyright © 2013, AORN, Inc, 2170 S. Parker Road, Suite 400, Denver, CO 80231. All rights reserved.

Because sterile technique  is at the heart of everything that perioperative professionals do, perhaps that is why it can stir up debate. As Conner acknowledges, "There are so many confounding factors in the operating room that upholding sterile technique can be very challenging. It can take a long time for research to be implemented into practice. Many of the practices related to sterile technique are ingrained through training from long ago and it's very difficult to change these long-held beliefs and habits. For example, in the Sterile Technique RP, the really big news that will engender great debate is related to draping. People have long believed that you should never cover the sterile field; based on our literature review, we are now saying you can, and in some cases, should cover the sterile field. That challenges a principle that was hammered into people's brains decades ago. This new evidence review process challenges some of my long-held beliefs as well."

Conner emphasizes that AORN continues to provide numerous educational products and tools to help perioperative professionals transition to these new recommendations and implement them into their practice. "When we publish a recommended practice, we also develop additional resources to assist with implementation," Conner says. "We also incorporate the information into Perioperative 101, which is our education program. We also offer videos and other training modules and tools shortly after the recommendations are developed to help people absorb the information. Additionally, we publish an article in AORN Journal article to help the membership in both inpatient care and ambulatory care with changes in the recommended practices."

Prevention of Transmissible Infections
The Prevention of Transmissible Infections RP guides perioperative RNs in implementing standard precautions and transmission-based precautions (i.e., contact, droplet, airborne) to prevent infection in the perioperative practice setting. Additional guidance is provided for topics such as  bloodborne pathogens; personal protective equipment (PPE); healthcare-associated infections and multidrug-resistant organisms (MDROs); immunization; and activities of healthcare workers with infections.

"The Prevention of Transmissable Infections RP has a firm foundation in infection prevention for perioperative services," says Conner. "It's a major update and review and reflects all of the current literature and it too is evidence-rated. One section that was expanded was immunizations for healthcare personnel. We also added a new wound classification decision tree, because we get that question all the time. We also expanded and clarified some recommendations related to MDROs because that is such a huge, emerging concern."

In the RP, AORN makes the following recommendations: *
- Recommendation I: Healthcare workers should use standard precautions when caring for all patients in the perioperative setting.
- Recommendation II: Contact precautions should be used when providing care to patients who are known or suspected to be infected or colonized with microorganisms that are transmitted by direct contact or indirect contact.
- Recommendation III: Droplet precautions should be used throughout the perioperative environment (i.e., preoperative, intraoperative, postoperative) when providing care to patients who are known or suspected to be infected with microorganisms that can be transmitted by large droplets.
- Recommendation IV: Airborne precautions should be used when providing care to patients who are known or suspected to be infected with microorganisms that can be transmitted by the airborne route.
Recommendation V: Healthcare personnel must follow the OSHA bloodborne pathogens standard when there is a risk of exposure to blood or other potentially infectious materials.
- Recommendation VI: Perioperative personnel must wear PPE when exposure to blood or other potentially infectious materials is anticipated.
- Recommendation VII: Perioperative personnel should take action to prevent the transmission of healthcare-acquired infections.
- Recommendation VIII: Healthcare personnel should be immunized against vaccine-preventable diseases.
- Recommendation IX: Activities of healthcare personnel with infections, exudative lesions, and nonintact skin should be restricted when these activities pose a risk of transmission of infection to patients and other healthcare providers. State, federal, and professional guidelines and strategies should be followed to determine the need for work restrictions for healthcare personnel with bloodborne infections.
- Recommendation X: Perioperative personnel should receive initial and ongoing education and competency validation of their understanding of the principles of infection prevention and the performance of standard, contact, droplet, and airborne precautions for prevention of transmissible infections and MDROs.
- Recommendation XI: Documentation should reflect activities related to infection prevention.
- Recommendation XII: Policies and procedures for the prevention and control of transmissible infections and MDROs should be developed, reviewed periodically, revised as necessary, and readily available within the practice setting.
Recommendation XIII: Perioperative team members should participate in a variety of quality assurance and performance improvement activities to monitor and improve the prevention of infections and MDROs.
*Adapted with permission from Perioperative Standards and Recommended Practices. Copyright © 2013, AORN, Inc, 2170 S. Parker Road, Suite 400, Denver, CO 80231. All rights reserved.

Safe Environment of Care
The Safe Environment of Care RP provides guidance on maintaining a safe environment of care related to patients and perioperative personnel and the equipment used in the perioperative environment. They include information on musculoskeletal injury, fire safety, electrical equipment, clinical and alert alarms, blanket- and solution-warming cabinets, medical gas cylinders, waste anesthesia gases, latex, chemicals including methyl methacrylate bone cement, and hazardous waste.

"The Safe Environment of Care RP was last updated in 2009," says Conner. "Generally we review and update the RPs on a five-year cycle. In this case we brought that into the review process earlier than planned because the latex guidelines was due for review this year and so we incorporated recommendations for latex safety into the Safe Environment of Care RP. While we were at it, we did the full evidence review and rating on everything we had already recommended, the good news is, not a lot has changed. Safe Environment of Care addresses a lot of regulatory requirements -- they are automatically recommended for practice, of course, we always recommend that people comply with them. There is some new information and enhancement to fire safety section, included a sample fire safety assessment form, the fire safety triangle figures are included as well."

In the RP, AORN makes the following recommendations:*
- Recommendation I: Precautions should be taken to mitigate the risk of occupational injuries that may result in death, days lost from work, work restrictions, medical treatment beyond first aid, and loss of consciousness.
- Recommendation II: Potential hazards associated with fire safety in the practice setting should be identified, and safe practices for communication, prevention, suppression, and evacuation should be established and followed.
- Recommendation III: Precautions should be taken to mitigate the risk of injury associated with the use of electrical equipment.
- Recommendation IV: Precautions should be taken to mitigate hazards associated with non-functioning clinical and alert alarms or with personnel failing to hear or failing to act on alarms.
- Recommendation V: Precautions should be taken to avoid thermal injuries related to warming solutions, blankets, and patient linens in blanket- and solution-warming cabinets.
- Recommendation VI: Precautions should be taken to mitigate risks associated with handling, storage, and use of compressed medical gas cylinders and liquid oxygen containers.
- Recommendation VII: Precautions should be taken to mitigate hazards related to waste anesthesia gases.
- Recommendation VIII: A protocol to establish a natural rubber latexsafe environment should be developed and implemented.
- Recommendation IX: Precautions must be taken to mitigate the risks associated with the use of chemicals in the perioperative setting (eg, methyl methacrylate, glutaraldehyde, formalin, ethylene oxide).
- Recommendation X: Precautions should be taken to avoid hazards associated with handling waste.
- Recommendation XI: Perioperative personnel should receive initial and ongoing education and competency validation and assessment for establishing a safe environment of care.
- Recommendation XII: Documentation reflecting activities related to providing a safe environment of care should be recorded in a manner consistent with the healthcare organizations policies and procedures.
- Recommendation XIII: Policies and procedures for the provision of a safe environment of care should be developed, reviewed periodically, revised as necessary, and readily available in the practice setting.
- Recommendation XIV: Perioperative personnel should participate in a variety of quality assurance and performance improvement activities that are consistent with the healthcare organizations plan to improve understanding of and compliance with the principles and processes of maintaining a safe environment of care.
* Adapted with permission from Perioperative Standards and Recommended Practices. Copyright © 2013, AORN, Inc, 2170 S. Parker Road, Suite 400, Denver, CO 80231. All rights reserved.

Sterilization
Another notable RP from AORN is the Recommended Practices for Sterilization, authored by Cynthia Spry, MA, MS, RN, CNOR, CSIT, and a number of collaborators, which has been accepted by the National Guidelines Clearinghouse.

"The big changes in the sterilization RP in particular, include the fact that flash sterilization is now referred to as immediate-use steam sterilization," says Conner. "In addition, we now have tables to help people determine what quality monitoring is required, and we discuss chemical indicators, biological indicators and what is to be used when for this testing of sterilization loads. We also discuss new science around loaner instrumentation -- I think people will appreciate that guidance because it's a big challenge for everyone. Perioperative personnel need to work very closely with sterile processing personnel because loaner instrumentation can create conflict. Everyone, from the surgeon, to SPD personnel, to OR personnel -- need to collaborate to make the lending of instruments more practical and more successful."

In the RP, AORN makes the following recommendations: *
- Recommendation I: Patient care items should be processed for reuse based on the intended use of the item.
- Recommendation II: Devices labeled as single-use should not be reprocessed unless the U.S. Food and Drug Administration (FDA) guidelines for reprocessing of single-use devices can be met.
- Recommendation III: Items to be sterilized should be cleaned, decontaminated, inspected, packaged, sterilized, and stored in a controlled environment and in accordance with the Association of periOperative Registered Nurses (AORN) "Recommended practices for cleaning and care of surgical instruments and powered equipment" and the device manufacturer's validated and written instructions for use.
- Recommendation IV: Items to be sterilized should be inspected for cleanliness and proper function in accordance with AORN's "Recommended practices for cleaning and care of surgical instruments and powered equipment" (AORN, 2011).
- Recommendation V: Items to be sterilized should be packaged in a manner that promotes successful sterilization. Items should be packaged in accordance with AORN's "Recommended practices for selection and use of packaging systems for sterilization" (AORN, 2011).
- Recommendation VI: Saturated steam under pressure should be used to sterilize heat- and moisture-stable items unless otherwise indicated by the device manufacturer.
- Recommendation VII: Immediate-use steam sterilization (IUSS) should be kept to a minimum and should be used only in selected clinical situations and in a controlled manner.
- Recommendation VIII: Ethylene oxide sterilization is a low-temperature process that may be used for moisture- and heat-sensitive surgical items and when indicated by the device manufacturer.
- Recommendation IX: Low-temperature hydrogen peroxide gas plasma sterilization methods should be used to sterilize moisture- and heat-sensitive items and when indicated by the device manufacturer.
- Recommendation X: Low-temperature hydrogen peroxide vapor sterilization methods should be used for moisture- and heat-sensitive items and when indicated by the device manufacturer.
- Recommendation XI: Sterilization systems using ozone should be used for moisture- and heat-sensitive items when indicated by the device manufacturer.
- Recommendation XII: Dry-heat sterilization should be used only for materials that are impenetrable to moist heat. Dry heat may be used to sterilize anhydrous (i.e., waterless) items that can withstand high temperatures and when indicated by the device manufacturer.
- Recommendation XIII: Liquid chemical sterilant instrument processing systems that use peracetic acid as a low-temperature sterilant should be used for devices that are heat-sensitive, can be immersed, are approved for this process by the device manufacturer, and cannot be sterilized using terminal sterilization methods.
- Recommendation XIV: A formalized program between the healthcare organization and healthcare industry representatives should be established for the receipt and use of loaned instrumentation.
- Recommendation XV: Sterilized materials should be labeled and stored in a manner to ensure sterility, and each item should be marked with the sterilization date.
- Recommendation XVI: Transportation of sterile items should be controlled.
- Recommendation XVII: Personnel should receive initial and ongoing education and competency validation for sterilization practices.
- Recommendation XVIII: Documentation should reflect activities related to sterilization.
- Recommendation XIX: Policies and procedures for sterilization and sterilization-related processes and practices should be developed, reviewed periodically, revised as necessary, and readily available in the practice setting.
- Recommendation XX: A quality assurance and performance improvement process should be in place to measure patient, process, and system outcome indicators.
*Adapted with permission from Perioperative Standards and Recommended Practices. Copyright © 2013, AORN, Inc, 2170 S. Parker Road, Suite 400, Denver, CO 80231. All rights reserved.