Purpose

The potential for clinically significant microbial cross transmission in the intraoperative environment poses a threat to patient safety. A growing body of literature has shown contamination in the anesthesia work area, including the anesthesia medical work cart, stopcocks, laryngeal masks and laryngoscope blades, touchscreens, and keyboards, as well as on providers’ hands, resulting in transmissions, healthcare-associated infections, and increased risk of patient mortality.

The authors acknowledge that the operating room (OR) is a challenging environment in which to affect ideal infection prevention and control practices. In addition, infection prevention and control policies specific to anesthesia care in the OR are not universal; audits of infection prevention practices are not routine; and consequently, providers may not have clarity on expected practices and behaviors. Studies have reported problematic practices by anesthesia providers, including use of multiple-dose vials for >1 patient, <100% use of gloves for airway management, failure to perform hand hygiene (HH) after removing gloves, and entry into anesthesia cart drawers without performance of HH. This guidance provides recommendations specific to the anesthesia work area to improve infection prevention through HH, environmental disinfection, and implementation of effective improvement efforts.

Furthermore, SHEA acknowledges significant challenges to implementing the array of infection prevention and control recommendations to affect OR culture in general, and the work flow of anesthesia providers in particular. Facility administrators will need to actively collaborate with anesthesia department leaders to build an implementation plan that is timely, comprehensive, and multidisciplinary, and that will allocate hospital resources to educate healthcare personnel and to acquire new infection prevention and control components (eg, single-use laryngoscopes). Facilities should consider this guidance document in revisions of their anesthesia OR policies.

This guidance builds on the foundational premise that all facilities where anesthesia services are delivered have formal infection prevention and control programs. Essential elements of these programs include, but are not limited to, policies and procedures for HH, safe preparation and delivery of intravenous medications, and environmental cleaning and disinfection. All individuals involved in these procedures require training appropriate to their tasks, as well as regular skills assessments.

Authors

The writing panel (the authors) consists of current and past members of the SHEA Guidelines Committee and representatives of organizations that partnered with SHEA to write this document: Dr. David J. Birnbach, American Society of Anesthesiologists (ASA); Dr. Richard C. Prielipp, Anesthesia Patient Safety Foundation (APSF); and Dr. Marjorie Geisz-Everson, American Association of Nurse Anesthetists (AANA). All panel members served as volunteers.

Intended Use

SHEA develops expert guidance documents (EGs) for topics of relatively narrow scope that lack the level of evidence required for a formal guideline developed using the GRADE or a similar systematic methodology but are important in provision of safe, effective healthcare. As such, systematic grading of the evidence level is not provided for individual recommendations. Each EG is based on a synthesis of limited evidence, theoretical rationale, current practices, practical considerations, writing group opinion, and consideration of potential harm where applicable.

No EG can anticipate all clinical situations, and this guidance document is not meant to be a substitute for individual clinical judgment by qualified professionals.

Guidance Statement

Which activities in anesthesia care should always result in hand hygiene (HH)?

Recommendation: HH ideally should be performed according to the WHO 5 Moments for Hand Hygiene. The authors recommend that HH be performed at the minimum before aseptic tasks (eg, inserting central venous catheters, inserting arterial catheters, drawing medications, spiking IV bags); after removing gloves; when hands are soiled or contaminated (eg, oropharyngeal secretions); before touching the contents of the anesthesia cart; and when entering and exiting the OR (even after removing gloves).

Rationale: Previous observational studies have reported that if the WHO 5 Moments for Hand Hygiene is used as the standard, the indications for HH among anesthesia providers in the OR can be as high as 54 per hour, leading to nonadherence rates of 83%.Reference Biddle and Shah ² These findings have led some investigators to conclude that applying the WHO 5 MomentsFootnote ¹ in the anesthesia work area, especially during induction, is logistically unfeasible.Reference Munoz-Price, Riley, Banks, Eber, Arheart and Lubarsky ³ Muñoz-Price et alReference Munoz-Price, Patel, Banks, Arheart, Eber and Lubarsky ⁴ showed that increasing access to ABHR led to an increase in the number of times HH was performed by anesthesiology staff during a surgical procedure.Reference Munoz-Price, Patel, Banks, Arheart, Eber and Lubarsky ⁴ Another study suggests that wearable ABHR dispensers improve HH adherence among anesthesia providers.Reference Petty ⁵ Koff et alReference Koff, Loftus and Burchman ⁶ showed that the use of a wearable ABHR dispenser capable of recording HH events decreased the contamination rate of intravenous tubing in the operating room (OR). In a multisite randomized controlled trial, Koff et alReference Koff, Brown and Marshall ⁷ also showed that providing wearable dispensers to anesthesia providers resulted in an 8-fold increase in the number of times HH was performed compared to rooms where only wall-mounted ABHR dispensers were available.

Should providers wear double gloves during airway management and discard the outer glove immediately after airway manipulation?

Recommendation: To reduce risk of contamination in the OR, providers should consider wearing double gloves during airway management and should remove the outer gloves immediately after airway manipulation. As soon as possible, providers should remove the inner gloves and perform HH.

Rationale: Anesthesia providers’ hands may become contaminated with upper-airway secretions while providing airway management and endotracheal intubation. Providers may not be able to perform HH during this time, and cross contamination of the anesthesia work area can occur. The literature search identified 2 randomized trials and 1 anecdotal report related to the strategy of using double gloves to decrease contamination in the OR.Reference Birnbach, Rosen, Fitzpatrick, Carling, Arheart and Munoz-Price ^{8 –} Reference Gadalla and Fong ¹⁰ The 2 trials found a significant decrease in OR contamination (P<.001) when double gloves were used during airway manipulation and/or intubation and the outer layer was removed after intubation. Despite the significant decrease in contamination, it was not completely eliminated; therefore, anesthesia providers should remove the inner layer of gloves as soon as possible and perform HH. Although these investigations took place in a simulated OR with anesthesia residents, the authors believe that the results can be generalized to actual ORs in hospitals.

Where should facilities locate alcohol-based hand rub (ABHR) dispensers in the OR?

Recommendation: The authors recommend that facilities locate ABHR dispensers at the entrances to ORs and near anesthesia providers inside the OR in order to promote frequent HH. Several studies have demonstrated that wearable ABHR dispensers with audible reminders increase the frequency of HH as well as the potential to decrease the incidence of HAI. While the specific wearable devices used in these studies are not currently available, the authors recommend that facilities consider suitable wearable ABHR dispensers with automatic reminders when commercially available. ABHR dispensers should be located in accordance with applicable national and local fire safety standards and codes. Additionally, the authors recommend that the facility delegate the filling of the ABHR dispensers to designated personnel and regularly ensure compliance with this practice.

Rationale: Locating ABHR dispensers at entrances to ORs facilitates the recommended practice of performing HH before entry and after exiting the room, and locating ABHR dispensers on the anesthesia machine has been associated with a modest increase in the frequency of HH.Reference Munoz-Price, Patel, Banks, Arheart, Eber and Lubarsky ⁴ Researchers in one study found that the use of a wearable ABHR dispenser with an audible reminder resulted in a significant increase in HH and reduction in anesthesia work area contamination, IV tubing contamination, and healthcare-associated infectionReference Koff, Loftus and Burchman ⁶ ; however, a subsequent similar study found an increase in the rate of HH but no effect on the rate of healthcare-associated infection.Reference Koff, Brown and Marshall ⁷

A variety of local and national fire-prevention standards and codes may restrict the placement of ABHR dispensers on top of the anesthesia machine. For example, the National Fire Protection Association (NFPA) 101: Life Safety Code ¹¹ stipulates the maximum allowable volume of an individual ABHR dispenser to be 1.2 L and requires that dispensers be separated horizontally by at least 122 cm (48 inches), and that dispensers be at least 2.5 cm (1 inch) away from an ignition source. However, the incidence of fire from ABHR dispensers appears to be extremely small.Reference Boyce and Pearson ^{12 ,} Reference Kramer and Kampf ¹³

Can the anesthesia provider apply ABHR on gloves that are being worn during a case, rather than removing the gloves, performing HH, and then replacing a new set of gloves if contaminated?

Recommendation: Changing gloves with HH between doffing and donning is the preferred method of disinfection. Current data are inadequate for the authors to either support or discourage the procedure of using ABHR on gloved hands or to determine whether application of foam or gel affects glove integrity. However, application of ABHR to gloved hands might be better than to not perform any HH when doffing and donning are not feasible.

Rationale: The clinical practice of disinfecting latex or nitrile disposable gloves with ABHR is an interesting but currently uncommon practice (supplementary Table 4). Application of foam or gel may have unknown or unintended consequences on glove integrity; however, during the Ebola outbreak in 2014, the Centers for Disease Control and Prevention (CDC) published detailed guidance (revised in 2015) recommending that ABHR be used for disinfecting the gloves at multiple times during doffing of the personal protective equipment. ¹⁴ A recent paper demonstrated that multiple ethanol-based hand-rub administrations did not show observable signs of material degradation with nitrile and latex glovesReference Gao, Horvatin, Niezgoda, Weible and Shaffer ¹⁵ ; however, the study did not test every available glove and was predominantly evaluating tensile strength and/or permeability, which may serve as an indicator of glove degradation. In addition, the authors reported that some types of glove material may become sticky to the touch after multiple administrations of ABHR, but this was not considered problematic in clinical use. In the current, predominant approach to HH, gloved hands are usually assumed to be contaminated, whereas bare hands are assumed to be clean (following appropriate washing or ABHR application). The application of ABHR to gloves could produce the unintended consequence of making the identification of clean hands more difficult (eg, “Are these gloves contaminated or was ABHR applied?”). Nevertheless, the authors believe that application of ABHR to gloves in the anesthesia workplace is worthy of consideration and further investigation. The CDC and WHO guidelines recommend removing gloves before performing HH as standard practice; however, given the frequency of HH opportunities in the perioperative setting, evaluation of the effectiveness and feasibility of application of ABHR to gloves in the anesthesia workplace as an alternative practice merits further investigation. Additionally, the authors encourage glove manufacturers to perform studies to indicate whether and how many ABHR applications can occur while still maintaining the glove’s integrity.

Should reusable laryngoscopes or video-laryngoscopes be replaced with single-use laryngoscopes/video-laryngoscopes?

Recommendation: The authors recommend that facilities ensure that standard direct laryngoscope or video-laryngoscope reusable handles and blades undergo high-level disinfection (at the minimum) or sterilization prior to use, or that reusable laryngoscopes are replaced with single-use standard direct laryngoscopes or video-laryngoscopes. Clean blades and handles should be stored in packaging appropriate for semicritical items designated for “high-level” disinfection.

Rationale: Researchers have found bacteria, blood, and lymphoid tissue contamination of laryngoscope blades and handles following low-level decontamination.Reference Lowman, Venter and Scribante ¹⁶ Infectious disease outbreaks have been associated with contaminated laryngoscopes.Reference Muscarella ¹⁷ Laryngoscopes are considered “semicritical” devices and therefore should be subjected to high-level decontamination (at the minimum) or sterilization. The Joint Commission and other regulators require that standard direct laryngoscope reusable blades be subject to high level decontamination (at the minimum) or sterilization and that blades be packaged to maintain decontamination until just prior to use. Optimal processing of laryngoscope handles has been subject to some controversy. Many reusable laryngoscope handles require disassembly prior to high-level decontamination or sterilization, making the cleaning process potentially costly.

The authors recommend that handles that are not able to undergo high-level disinfection according to manufacturer’s instructions should not be used. The State of California Health and Human Services Agency Department of Health Services recommends high-level decontamination of laryngoscope handles.Footnote ² A study of laryngoscope handles cleaned with bactericidal wipes containing either 70% alcohol and 2% chlorhexidine or coco alkyl dimethyl benzyl ammonium chloride found that common bacteria were effectively eliminated; however, the authors point out that C. difficile and norovirus would not be expected to be eliminated by this treatment.Reference Howell, Thoppil, Young, Sharma, Blunt and Young ¹⁹ They recommend autoclaving laryngoscope handles at risk for the presence of C. difficile and also on a routine, monthly basis.

Single-use laryngoscopes have evolved considerably in recent years. Their performance may be comparable to reusable laryngoscopes, and their cost per use may be less than reusable laryngoscopes if the costs of high-level decontamination of reusable laryngoscopes are considered. Environmental issues pertaining to single-use laryngoscopes are addressed by some manufacturers with recycling programs for their products.

Although the authors did not conduct a literature search specific to supraglottic airway masks, they note the plausibility of residual contamination of these masks and suggest that facilities consider applying the same principles when deciding between reusable and single-use supraglottic airway masks.

Should anesthesia machines be partially or completely covered with disposable covers to prevent contamination?

Recommendation: Current data are inadequate for the authors to make recommendations regarding the use of disposable covers to prevent contamination of anesthesia machines.

Rationale: Although several studies have demonstrated the potential for contamination of anesthesia equipment and workspaces and possible transmission of a variety of microorganisms within the anesthesia environment, the authors did not identify studies that evaluated the impact of equipment covers on the level of environmental contamination or patient infection risk. However, they suggest that facilities consider using disposable covers given the plausible reduction in contamination and facilitation of cleaning and disinfection of anesthesia machines.Reference Maslyk, Nafziger, Burns and Bowers ^{20 –} Reference Loftus, Koff and Brown ²⁵

When ORs are prepared between uses, what cleaning and disinfection of the anesthesia machine and anesthesia work area should take place?

Recommendation: To reduce the bioburden of organisms and the risk of transmitting these organisms to patients, the facility should clean and disinfect high-touch surfaces on the anesthesia machine and anesthesia work area between OR uses with an EPA-approved hospital disinfectant that is compatible with the equipment and surfaces based on the manufacturers’ instruction for use. Because of challenges in consistent cleaning and disinfection between cases of the anesthesia machine and anesthesia work area, the authors suggest prioritizing high-touch surfaces. In addition, the authors suggest evaluating strategies aimed at improving the ability to clean these surfaces (eg, disposable covers, re-engineering of work surfaces).

Rationale: A number of studies have demonstrated that anesthesia machines and work areas can become contaminated with a variety of potentially pathogenic microbes, and that these organisms may be transmitted to patients through direct contact with contaminated equipment, hands of anesthesia providers, or contaminated medications.Reference Maslyk, Nafziger, Burns and Bowers ^{20 –} Reference Loftus, Koff and Brown ²⁵ However, few studies have evaluated specific cleaning and disinfection products or practices specific to the anesthesia work area.

The anesthesia work area, including the anesthesia machine, computer keyboard, monitor and mouse, reusable patient monitoring equipment, anesthesia cart, and ancillary equipment (such as ultrasound machines) are physically complex and are not primarily designed and engineered to facilitate efficient and thorough cleaning. The focus on expedited OR turnover within 10–15 minutes adds to the challenge of adequate cleaning. In the future, the authors encourage engineers and manufacturers to work with human factors experts to redesign the various components of the anesthesia work area to solve this problem. The authors suggest that anesthesia machine covers may be part of the solution, but evidence is lacking to endorse their use (see the preceding recommendation).

While awaiting evidence-based guidance, the authors recommend that the facility prioritize cleaning of the specific components that are most likely to be contaminated. Monitoring equipment such as reusable blood pressure cuffs, pulse oximeter probes, electrocardiogram (ECG) leads, twitch monitor leads and sensors, and cables that are in physical contact with patients should receive high priority for thorough cleaning (single-use monitoring sensors may be useful for reducing the cleaning burden). The anesthesia machine work surface, gas flow controls, vaporizer dials, adjustable pressure limiting valve (APL), IV stands and fluid warmers, supply cart, and computer keyboard and mouse, are also examples of components that are particularly likely to be contaminated.

Should injection ports used by anesthesia providers in the OR be covered with isopropyl alcohol-containing caps? Should injection ports—without alcohol-containing caps—used by anesthesia providers in the OR be scrubbed with alcohol before each use?

Recommendation: Anesthesia providers should only use disinfected ports for intravenous access. Ports may be disinfected either by scrubbing the port with a sterile alcohol-based disinfectant before each use immediately prior to each use or using sterile isopropyl alcohol containing caps that cover ports continuously. Prior to use, isopropyl alcohol–containing caps should cover the port for the minimum time recommended by the manufacturer. Ports should be properly disinfected prior to each individual drug injection or at the beginning of a rapid succession of injections, such as during induction of anesthesia. The authors recommend that providers consider using isopropyl alcohol containing caps, which, when in place for the recommended period, make ports immediately available for use at all times. Stopcocks should have closed injection ports installed to convert them into “closed ports,” or they should be covered with sterile caps.

Rationale: Peripheral intravenous tubing stopcocks and injection ports that are used for medication administration frequently become contaminated with potentially pathogenic bacteria during intraoperative use. Lower rates of provider HH, higher numbers of intravenous medications, and greater numbers of hub interactions increase the probability of injection port contamination. Although the literature does not provide direct evidence of clinical benefit in anesthesia practice, moderate- to high-quality evidence exists that disinfecting catheter hubs, needleless connectors, and injection ports with a sterile alcohol-containing disinfectant reduces the risk of central-line–associated bloodstream infection (CLABSI).Reference Yokoe, Anderson and Berenholtz ²⁶ Optimally, the authors recommend disinfection of injection ports to be performed before each medication injection, consistent with recommendations in other patient care settings; however, published studies do not address the optimal frequency of injection port disinfection and the comparative effectiveness of alcohol-containing caps and alcohol wipes in anesthesia practice, and the authors acknowledge that the act of disinfecting injection ports for 10–15 seconds followed by a drying time can be challenging in anesthesia practice, particularly during induction and emergence of anesthesia.Reference Moureau and Flynn ²⁷ For this reason, compared to alcohol wipes, passive disinfection using sterile alcohol-containing caps offers visual assurance of hub disinfection and may assist facilities in improving and monitoring compliance with this best practice.Reference Moureau and Flynn ²⁷

When anesthesia drugs are drawn at the point of care should vials be scrubbed with alcohol prior to puncture?

Recommendation: Anesthesia providers should wipe medication vials’ rubber stoppers and necks of ampules with 70% alcohol prior to vial access and medication withdrawal.

Rationale: The caps of anesthesia medications are not sterile; therefore, it should be standard practice to disinfect the rubber stoppers and neck of ampules prior to each use. ²⁸ A study in New Zealand observed 10 anesthesia teams during 20 simulated cases.Reference Gargiulo, Sheridan and Webster ²⁹ None of the anesthesiologists disinfected the vial septa prior to drawing intravascular solutions, and the anesthesia teams said they believed this procedure was in compliance with infection prevention and control practices. These researchers isolated microorganisms from 5 of 38 collection bags (13%), 6 of 17 needles (35%), and 10 of 197 syringes (5%). ^{28 –} Reference Hemingway, Malhotra, Almeida, Azadian and Yentis ³⁰

Which intravenous catheters should be placed with full barrier precautions?

Recommendation: All central venous catheters (CVCs) and axillary and femoral arterial lines should be placed with full maximal sterile barrier precautions. Full maximal sterile barrier precautions include wearing mask, cap, sterile gown, and sterile gloves and using a large sterile drape during insertion. Peripheral arterial lines (eg, radial, brachial, or dorsalis pedis arterial lines) should be placed with a minimum of a cap, mask, sterile gloves, and a small sterile fenestrated drape.

Rationale: The authors based this recommendation on the Compendium of Strategies to Prevent Bloodstream Infections in Acute Care Hospitals Reference Yokoe, Anderson and Berenholtz ²⁶ and the 2011 Healthcare Infection Control Practices Advisory Committee (HICPAC) guideline,Reference O’Grady, Alexander and Burns ³¹ which identify the following maximal sterile barrier precautions for CVC and axillary and femoral arterial line insertion:

1. 1. All healthcare personnel involved in the catheter insertion procedure should wear mask, cap, sterile gown, and sterile gloves.

2. 2. The provider should cover the patient with a large (“full body”) sterile drape during catheter insertion.

The provider should also follow these measures when exchanging a catheter over a guidewire. Placement of other arterial lines should follow the HICPAC recommendations to use a minimum of a cover, mask, sterile gloves, and a small sterile fenestrated drape.Reference O’Grady, Alexander and Burns ³¹ As with other standard-of-care practices, in emergency situations providers should weigh other safety considerations.

Should providers always recap a medication syringe after giving a portion of the syringe contents to the patient if the syringe and medication may be used again on that patient?

Recommendation: To reduce the risk of bacterial contamination of the syringe and syringe contents, the authors recommend that anesthesia providers cap needleless syringes that will be used to administer multiple doses of a drug to the same patient after each administered dose. Needleless syringes should be capped with a sterile cap that completely covers the Luer connector on the syringe.

Rationale: Bacterial contamination of medication syringes can occur during anesthesia practice, most commonly with skin microorganisms.Reference Matlow, Wray and Richardson ²⁹ Higher rates of medication contamination have been associated with emergency procedures, compared to elective surgical procedures. Low provider HH, lack of injection port disinfection, and contact with nonsterile equipment may increase the risk of intraoperative contamination of syringe contents when used to administer multiple doses of medication to the same patient. Although research has not assessed the effectiveness of capping medication syringes on reducing rates of medication contamination, it is plausible that capping medication syringes will reduce the risk of inadvertent contamination of the syringe and contents from the hands or work space of the anesthesia provider. The authors do not recommend recapping needles, which is highly discouraged due to the associated occupational hazards.

What measures should be taken to protect clean supplies in the anesthesia cart from contamination? Should the anesthesia supply cart be cleaned between cases?

Recommendation: The anesthesia supply cart should have its accessible outer surfaces wiped clean between cases. To prevent contamination of communal supplies, anesthesia providers should always perform HH before opening the drawers or bins of the cart and handling the contents of the drawers or bins. Storage of supplies on the top surface of the cart should be avoided as much as possible and any supply items on the cart top surface should be removed between cases to facilitate cleaning. The interior of the supply cart should be cleaned on a periodic basis. Future innovation and re-engineering of the storage, dispensing, and restocking of supplies in the anesthesia work area is needed to decrease the potential for bacterial cross contamination between cases.

Rationale: The anesthesia work area is contaminated with potential pathogens and poses a threat for clinically significant bacterial cross transmission. HallReference Hall ³² confirmed the presence of blood contamination on 33% of surfaces, including surfaces in direct contact with the patient, for example, blood pressure cuffs and pulse oximeter probes after visual inspection of anesthesia work area surfaces.Reference Hall ³² Research has found significant anesthesia work area bioburden with both commensal and pathogenic bacteria, including coagulase-negative staphylococci, Bacillus spp, streptococci, Staphylococcus aureus, Acinetobacter spp, and other gram-negative rods.Reference Maslyk, Nafziger, Burns and Bowers ²⁰ Loftus et alReference Loftus, Brown and Koff ³³ studied the impact of bacterial contamination of patients, providers’ hands, and stopcocks in the OR. They found that providers’ hands and the surrounding environment were drivers of stopcock cross transmission, which was associated with increased patient 30-day mortality. Bacterial transmission in the anesthesia work area of the OR was associated with 30-day postoperative infections, which impact as many as 16% of patients undergoing surgery.Reference Loftus, Koff and Birnbach ³⁴ Other studies have linked anesthesia provider hand contamination as a proximal source of both enterococcal and staphylococcal transmission in the anesthesia work area.Reference Loftus, Koff and Brown ^{23 ,} Reference Loftus, Koff and Brown ²⁵

Although studies quantifying the impact of contamination of anesthesia supply carts and work areas on surgical site infection (SSI) risks are lacking, a growing body of literature suggests potential contamination.Reference Maslyk, Nafziger, Burns and Bowers ^{20 ,} Reference Loftus, Brown and Koff ^{33 ,} Reference Fukada, Iwakiri and Ozaki ^{35 ,} Reference Link, Kleiner, Mancuso, Dziadkowiec and Halverson-Carpenter ³⁶ Given the threat of bacterial cross transmission from the anesthesia work area, including the anesthesia machine and supply cart, the facility should take measures to minimize bioburden between all cases.

What is the expiration time for sterile injectable drugs and intravenous solutions prepared by anesthesia providers?

Recommendation: Provider-prepared sterile injectable drugs (eg, a drug drawn from a vial into a syringe) are more likely to be subject to contamination than drugs prepared in an ISO Class 5 setting, such as a pharmacy; therefore, provider-prepared sterile injectable drugs should be used as soon as practicable following preparation. The package inserts for propofol that contain a preservative typically specify that the use of propofol should commence within 12 hours of preparation. At the time of this publication, United States Pharmacopeia (USP) Chapter 797 recommends that the use of provider-prepared sterile injectable drugs commence within 1 hour of preparation; however, a draft revision of USP General Chapter 797 suggests that a drug from a single dose vial punctured or entered in environments with air less clean than ISO class 5 may be used until the end of a case. ³⁷ If available, commercially prefilled syringes or syringes prepared by the hospital pharmacy in an ISO class 5 setting have a relatively long “beyond use date.”

Rationale: The USP 797 generally is considered the applicable authority for the compounding of sterile injectable solutions and drugs. At the time of this publication, USP 797 states that the use of compounded sterile provider-prepared products outside of an ISO class 5 setting (eg, a pharmacy IV room) be for “immediate use” only, commencing within 1 hour of preparation and interprets “compounding” as including drawing medications from vials into syringes. ²⁸ Scientific literature is sparse pertaining to a 1-hour limit on the advance preparation of sterile drugs for injection in an “immediate use” setting. To the best of our knowledge, the “1-hour limit” from USP 797 is based on the underlying principle that drugs prepared outside of a properly regulated pharmacy IV “clean room” are more likely to become contaminated, and bacterial counts may increase over time.Reference Fukada and Ozaki ³⁸ Austin et alReference Austin, Hand and Elia ³⁹ performed a systematic review of the literature and found a significantly higher frequency of contamination of doses prepared in clinical than in 10 pharmaceutical environments (3.7% vs 0.5%; P=.007).Reference Austin, Hand and Elia ³⁹ A draft of the revision of USP Chapter 797 released in July 2018 contains language suggesting that provider prepared drugs could be used until “the end of a case.” ³⁷ This draft is subject to change and will not be finalized until late in 2019.

Because no reliable method exists for knowing with certainty whether the drugs or solutions have been used, the authors suggest designated healthcare personnel discard provider-prepared sterile injectable drugs and intravenous solutions at the end of each case, whether used or not. If the drugs or solutions have been used, they may be contaminated and subsequent use for another patient may result in transmission of organisms to that patient. The facility may consider returning to stock unused commercial prefilled syringes, which have not passed their “beyond use” date, have intact security locking caps, and have been present in the anesthesia work area during a case; however, consideration should be given to the possibility that the external surface of such syringes may become contaminated during a case and pose an infection risk if reused for another case.

In addition to USP 797, the facility may consider the advice of other authorities, which may be at variance with the 1-hour limit recommended by USP 797. For example, The Joint Commission’s recommendations for syringe labeling do not require labeling provider-prepared injectable drugs for “immediate use” with a date and time of expiration unless the expiration occurs within 24 hours of preparation, suggesting that “immediate use” may extend beyond 1 hour. The Food and Drug Administration (FDA) “package insert” for propofol states that propofol has a 12-hour expiration time after being drawn up into a syringe; formulations of propofol without preservative may have a 6-hour expiration time after being drawn up into a syringe.Reference Jelacic, Bowdle, Nair, Kusulos, Bower and Togashi ⁴⁰

How long can IV bags be spiked in advance of commencing use?

Recommendation: Anesthesia practitioners should minimize the time between spiking IV bags and patient administration; nevertheless, certain emergent or urgent circumstances may require advanced set-up of IV fluids and anesthesia providers should comply with their hospital protocols.

Following spiking of an IV bag, administration should commence as soon as possible. No specific time limit has been identified in the literature for advance preparation of IV bags.

Rationale: Facilities should determine whether local regulatory authorities (eg, state boards of health or pharmacy) have rules regarding spiking of IV bags. Scientific literature pertaining to spiking IV bags is sparse. Haas et alReference Haas, Beitz and Reed ⁴¹ found no bacterial growth up to 8 hours in 80 bags of lactated Ringer’s solution spiked by a single provider following proper HH, but they did not address whether these results are replicable across multiple providers, in other settings, and with other types of IV solutions.

Anesthesia providers occasionally spike IV fluids in advance, especially in preoperative holding areas and in ORs that are reserved for emergencies. Providers should weigh the risks versus benefits of spiking IV bags that are not intended for immediate use. The authors encourage facilities to conduct a risk assessment in collaboration with their Infection Prevention and Control Departments.

Should syringes and medication vials be reused?

Recommendation: Single-dose medication vials and flushes should be used whenever possible. If multiple-dose medication vials must be used, they should be used for only 1 patient and should only be accessed with a new sterile syringe and new sterile needle for each entry. Syringes and needles are single patient devices and syringes should never be reused for another patient, even if the needle is changed.

Rationale: The CDC established safe injection practices as part of its 2007 Guidelines for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings.Reference Siegel, Rhinehart, Jackson and Chiarello ^{42 , 43} Numerous authorities and organizations, including the Association for Professionals in Infection Control and Epidemiology (APIC), AANA, ASA, and the Joint Commission have issued guidelines and/or recommendations concerning injection safety and have referenced CDC safe injection practices.Reference Dolan, Felizardo and Barnes ^{44 –} Reference Stackhouse, Beers and Brown ⁴⁷ The Association of Anaesthetists of Great Britain and Ireland has also issued safe injection practices that mirror those of the CDC. ⁴⁸ The CDC recommendations are based on reports of outbreaks of preventable healthcare-acquired viral and bacterial infections resulting from improper injection safety practices.Reference Siegel, Rhinehart, Jackson and Chiarello ⁴² Improper injection safety practices include: use of single-dose medication vials for multiple patients,Reference Greeley, Semple and Thompson ^{49 –} Reference Branch-Elliman, Robillard, McCarthy and Gupta ⁵⁴ improper use of multiple-dose vials, ^{50 ,} Reference Germain, Carbonne and Thiers ^{55 ,} Reference Katzenstein, Jørgensen and Permin ⁵⁶ and use of a single syringe or needle to administer intravenous medication to multiple patients.Reference Siegel, Rhinehart, Jackson and Chiarello ^{42 ,} Reference Dolan, Felizardo and Barnes ^{44 ,} Reference Gutelius, Perz, Parker, Hallack, Stricof and Clement ^{53 ,} Reference Samandari, Malakmadze and Balter ⁵⁷ Several groups of researchers have reported outbreaks of preventable healthcare-acquired viral and bacterial infections in inpatient operating suites, adult and pediatric medical-surgical wards, and outpatient endoscopy, surgery, infusion, myocardial perfusion testing, and pain centers.Reference Greeley, Semple and Thompson ^{49 –} Reference Gutelius, Perz, Parker, Hallack, Stricof and Clement ^{53 ,} Reference Germain, Carbonne and Thiers ^{55 –} Reference Krause, Trepka, Whisenhunt, Katz, Nainan and Wiersma ⁶⁰

How should keyboards and touch screens in the anesthesia work area be cleaned and protected from contamination?

Recommendation: Facilities should require cleaning and disinfection of computer keyboards and touchscreen computer monitors after each anesthesia case using a hospital-approved disinfectant consistent with manufacturers’ recommendations. Additionally, cleaning and disinfection should also occur every time there is obvious soiling or contamination of anesthesia work surfaces. Facilities should consider use of commercial plastic keyboard shields, sealed medical keyboards, or washable keyboards and touchscreens to facilitate thorough disinfection.

Rationale: The problem of bacterial contamination of clinical and OR equipment is well documented as a host of bacteria such as coagulase-negative staphylococci, Bacillus spp, and even MRSA inhabit anesthesia surfaces, such as workspace computer touchscreens and keyboards.Reference Fukada, Iwakiri and Ozaki ³⁵ Research has identified the anesthesia computer mouse as one of the most contaminated surfaces in the OR, followed by the OR bed, nurse computer station mouse, the OR door, and the surfaces of the anesthesia medical work cart.Reference Link, Kleiner, Mancuso, Dziadkowiec and Halverson-Carpenter ³⁶ Moist surfaces, such as damp gloves or computer keyboards, increase the risk of transmitting Staphylococcus epidermidis from one surface to another.Reference Hodgson and Ruis-Frutos ⁶¹ Additional areas of concern include semi-sealed parts of anesthesia equipment, where bacteria may chronically colonize surfaces in areas not readily subject to cleaning procedures and where microbe growth may go undetected.Reference Hodgson and Ruis-Frutos ⁶¹

What infection prevention and control modifications should be made, if any, for patients in contact isolation?

Recommendation: Anesthesia providers should follow all institution-specific guidelines when caring for patients on contact isolation in the OR, including performing HH and using appropriate personal protective equipment (PPE). Environmental disinfection should follow recommendations regarding cleaning between cases, irrespective of an individual patient’s multidrug-resistant organism status.

Rationale: Data demonstrate that microorganisms, including multidrug-resistant organisms, can be spread via anesthesia providers in the OR. Research has shown contaminated hands of anesthesia providers contaminate the anesthesia work area, including the anesthesia machine, anesthesia cart, supplies on the cart, stopcocks and keyboards.Reference Loftus, Koff and Brown ^{23 ,} Reference Loftus, Koff and Birnbach ^{34 ,} Reference Rowlands, Yeager, Beach, Patel, Huysman and Loftus ^{62 ,} Reference Birnbach, Rosen, Fitzpatrick, Carling and Munoz-Price ⁶³ In addition, up to 30% of organism transfer occurred between cases and was linked to an anesthesia work area that was not completely decontaminated with routine cleaning.Reference Loftus, Koff and Birnbach ³⁴ The highest risk of contamination of the anesthesia work area occurs during induction and emergence of anesthesia.Reference Loftus, Koff and Birnbach ^{34 ,} Reference Rowlands, Yeager, Beach, Patel, Huysman and Loftus ⁶² HH, contact precautions, and environmental disinfection recommendations to decrease transmission of pathogenic organisms outside of the OR also apply to providers in the OR environment.

Which techniques should be used to improve infection prevention practices by anesthesia providers?

Recommendation: Facilities should conduct regular monitoring and evaluation of infection prevention practices. To promote adherence, improvement efforts should be collaborative and should include input from frontline anesthesia personnel and local champions. Hospital and physician leadership should identify clear expectations and goals, should ensure data transparency, and should facilitate use of process measures to improve performance.

Rationale: Although the authors did not identify studies that specifically addressed the efficacy of interventions to improve infection control among anesthesia providers, studies in anesthesia and elsewhere can inform an approach to implementing and sustaining improvements.

Improvement efforts should involve monitoring, evaluation, and feedback. Timely collection, analysis, and provision of data to providers are important, but they can be cumbersome and time consuming because collecting adherence data most often involves human observers. Overt observation of behaviors can improve practice,Reference Borer, Gilad and Meydan ⁶⁴ but it may be subject to the Hawthorne effect, in which the awareness of being observed changes one’s behavior.Reference Chen, Vander Weg, Hofmann and Reisinger ^{65 ,} Reference Srigley, Furness, Baker and Gardam ⁶⁶ Covert observations have been successful using video observation of anesthesia practicesReference Rampersad, Martin, Geiduschek, Weiss and Bates ^{67 ,} Reference Martin, Rampersad, Geiduschek, Zerr and Weiss ⁶⁸ and procedural technique.Reference Friedman, Katznelson, Devito, Siddiqui and Chan ⁶⁹ Video recordings allow evaluation during all shifts and in many areas without overextending observing staff.Reference Rampersad, Martin, Geiduschek, Weiss and Bates ⁶⁷ Healthcare worker volunteersReference Pan, Dolcetti and Barosi ⁵² and nonprovider volunteersReference Linam, Margolis, Atherton and Connelly ⁷⁰ have assessed HH practices on inpatient units.

Facilities providing feedback should focus on ways to improve adherence rather than place blame. Researchers have found that providers fail to adhere to infection prevention practices not out of malice or indifference but due to a complex combination of beliefs, work environment, technology, information load, and conditioning.Reference Weinger and Englund ^{71 –} Reference Carthey, Walker, Deelchand, Vincent and Griffiths ⁷⁵ Audit and feedback programs have been shown to be effective when designed using both theory and evidence.Reference Hysong, Kell, Petersen, Campbell and Trautner ⁷⁶ Institutions should be mindful that the hierarchical nature of team organization in the anesthesia work area could hinder honest communication and feedback.Reference Dolan, Heath, Potter-Bynoe and Stackhouse ⁷⁷ Fostering psychological safety and comfort in taking interpersonal risk may help workplace team learning and improvement.Reference Derickson, Fishman, Osatuke, Teclaw and Ramsel ⁷⁸

Clarity of expected behaviors in the context of a provider’s role can help focus educational activities.Reference Gurses, Seidl and Vaidya ⁷⁹ Interventions such as reminder cards or checklists have been utilized to improve adherence to transmission-based precautions,Reference Russell, Young, Leung and Morris ^{80 ,} Reference Denton, Topping and Humphreys ⁸¹ as has simulation for education and evaluation of different aspects of anesthesia practice.Reference Gargiulo, Sheridan and Webster ^{29 ,} Reference Lim, Krohner, Metro, Rosario, Jeong and Sakai ^{82 –} Reference Burtscher, Manser and Kolbe ⁸⁴ A Children’s Hospital Association working group developed an evaluation tool for infection prevention in anesthesia practice. While not validated empirically, facilities may consider use of this tool to initiate discussions among anesthesia providers and infection preventionists to identify areas of importance and in need of improvement.Reference Dolan, Heath, Potter-Bynoe and Stackhouse ⁷⁷

Leadership support helps to define goals, remove barriers, and hold practitioners accountable for their performance.Reference Edwards ⁸⁵ One institution demonstrated sustained improvements in HH adherence following a ‘stand-down’ event following a HH summit attended by hospital leaders. This involved a hospital-wide 15-minute period when all nonessential activity was stopped, plans to improve HH were discussed, and written action plans were submitted. Improvement efforts were supported by frequent covert observation and direct discussions of performance with institutional leaders.Reference Cunningham, Brilli, McClead and Davis ⁸⁶ Although they are important to improving practices, institutions should be careful to not allow standards, monitoring, and incentives to have a negative effect on culture, learning, and interpersonal relationships.Reference Brewster, Tarrant and Dixon-Woods ⁸⁷

What is the impact of providing measurement and feedback data on HH?

Recommendation: Facilities should monitor providers’ HH performance and give them feedback as part of a comprehensive program to improve and maintain adherence. Insufficient data exist to recommend the routine use of automated, electronic, or video monitoring and feedback, although examples in the literature demonstrate efficacy of such technology.

Rationale: Facilities have used various types of monitoring and feedback to increase providers’ adherence to HH. Because of the expense and the likelihood that measuring HH adherence through direct observation only provides a small sample of provider behavior, facilities’ interest in automated measurements has increased, including video surveillanceReference Armellino, Hussain and Schilling ⁸⁸ and a variety of electronic devices that detect and record providers’ use of ABHR, to include such features as delivering real time reminders to perform HH. Systematic reviews of studies conducted outside of the OR concluded that insufficient information exists to recommend the use of automated monitoring and feedback,Reference Ford, Birmingham, King, Lim and Ansermino ^{89 ,} Reference Srigley, Gardam, Fernie, Lightfoot, Lebovic and Muller ⁹⁰ although a study of personal, wearable ABHR dispensers that emitted an audible alarm 6 minutes after the previous activation of the dispensers reported a 27-fold increase in HH compared to standard fixed ABHR dispensers.Reference Koff, Loftus and Burchman ⁶ An intermittent reminder to perform HH displayed on a video screen in the anesthesia work area increased the hourly frequency of HH by approximately 10-fold.Reference Rodriguez-Aldrete, Sivanesan and Banks ⁹¹

What is the impact of providing measurement and feedback data on environmental disinfection?

Recommendation: Facilities should utilize measures to assess the appropriateness and adequacy of environmental disinfection, track the measures, and share the results with stakeholders to optimize adherence to recommended disinfection practices.

Rationale: Measurement and feedback improve thoroughness of cleaning in inpatient settingsReference Branch-Elliman, Robillard, McCarthy and Gupta ^{54 ,} Reference Eckstein, Adams and Eckstein ^{92 –} Reference Kundrapu, Sunkesula, Sitzlar, Fertelli, Deshpande and Donskey ¹⁰⁰ via use of checklists of areas to clean,Reference Carling and Huang ¹⁰¹ improvements to the cleaning methodology, including the cleanser used,Reference Sitzlar, Deshpande, Fertelli, Kundrapu, Sethi and Donskey ⁹⁷ and the use of visual indicators, such as ultraviolet visible markersReference Goodman, Platt, Bass, Onderdonk, Yokoe and Huang ^{93 –} Reference Sitzlar, Deshpande, Fertelli, Kundrapu, Sethi and Donskey ^{97 ,} Reference Trajtman, Manickam, Macrae, Bruning and Alfa ^{99 ,} Reference Kundrapu, Sunkesula, Sitzlar, Fertelli, Deshpande and Donskey ¹⁰⁰ and ATP bioluminescence.Reference Branch-Elliman, Robillard, McCarthy and Gupta ^{54 ,} Reference Sitzlar, Deshpande, Fertelli, Kundrapu, Sethi and Donskey ⁹⁷ A study that focused on cross contamination of the work area by anesthesia providers reported improvements in anesthesia providers’ adherence following engagement by coaching, as viewed through remote video observation.Reference Martin, Rampersad, Geiduschek, Zerr and Weiss ⁶⁸ Multiple studies have demonstrated improved cleaning after sharing monitoring data with environmental service (EVS) staff, along with education, observation, and collaboration between infection prevention and EVS personnel.Reference Branch-Elliman, Robillard, McCarthy and Gupta ^{54 ,} Reference Eckstein, Adams and Eckstein ^{92 –} Reference Kundrapu, Sunkesula, Sitzlar, Fertelli, Deshpande and Donskey ¹⁰⁰ Some facilities improved adherence through capital investment in EVS, most often through the creation of a dedicated environmental disinfection team.Reference Carling, Parry and Rupp ^{94 ,} Reference Sitzlar, Deshpande, Fertelli, Kundrapu, Sethi and Donskey ^{97 ,} Reference Kundrapu, Sunkesula, Sitzlar, Fertelli, Deshpande and Donskey ¹⁰⁰

The authors recognize that these short-term responses may not be sustainable or generalizable to all contexts, and we did not identify studies that measured how feedback alone affects environmental disinfection. Nonetheless, the literature suggests improvements to adherence derive from the belief among environmental services personnel that adequate cleaning protects the health of patients and families, is expected, and is supported by the facility.Reference Matlow, Wray and Richardson ¹⁰²

Background

Evidence for Infection Prevention Measures in the Anesthesia Work Area

Future Directions

The authors identified several unique elements of anesthesia practice that pose unsolved problems for infection prevention. These include the anesthesia machine, the anesthesia cart, and provider prepared drugs and IV infusion bags.

Numerous challenges exist for thorough cleaning of the anesthesia machine between cases. The anesthesia machine is a complicated apparatus with an irregular and complex external surface. Many anesthesia machines also have drawers to store supplies. Anesthesia machines were designed at a time when the importance of infection prevention in the anesthesia workplace was not well understood, and since then, the fundamental design has not changed greatly. The anesthesia machine may need to undergo fundamental redesign that allows for quick and effective cleaning of the external surfaces.

The anesthesia supply cart presents similar challenges and cleaning the anesthesia cart between cases can be extremely challenging depending upon the particular design of the cart. Anesthesia carts have many variations, which also can have a complex exterior surface due to attachment of electrical components such as a defibrillator or cardiac output monitor, sharps collection containers, waste bins, and discarded drug collection containers. Supplies and materials may be stored in cart drawers but also in bins on the top of the cart. Typical anesthesia carts contain supplies and materials intended to be used for numerous cases. Contamination of supplies can occur if providers do not remove soiled exam gloves and apply ABHR prior to obtaining supplies and materials from storage. Few examples exist of practices that have attempted to include the anesthesia cart in a “clean zone,” where only clean hands are allowed. Although some success has been documented with this approach, maintaining the desired provider behavior presents challenges.

Anesthesia providers are frequently engaged in preparing sterile drugs for injection by bolus and infusion. Provider prepared drugs are not prepared using the same stringent methods as pharmacies and commercial compounders, increasing the possibility for contamination. Because bacteria may multiply over time, common sense suggests that providers should commence administration of provider prepared drugs promptly; however, little evidence exists concerning the length of time that is safe. Minimizing the use of provider-prepared drugs by using drugs that are prepared in a pharmacy or by a commercial compounder is a possible or partial solution. Some of the recommendations provided in this guidance might need to be reinterpreted if a new version of USP 797 ²⁸ is available (scheduled for release in late 2019).

The authors encourage investment in research to better understand the infection prevention and control problems posed by the anesthesia work station and to develop design improvements that reduce the risk of infection.