The revised Guideline for Surgical Attire, published by the Association of periOperative Registered Nurses (AORN) in 2015, was the first to invoke operating room (OR) attire as a controllable contributing factor related to surgical site infections (SSIs).1 That guideline offered 47 recommendations, including one that called for complete coverage of the scalp, hair, and ears. At the time, these were the only recommendations on surgical attire to be issued by a national organization, and they were ultimately incorporated into the Agency for Healthcare Research and Quality’s (AHRQ) National Guideline Clearinghouse. Subsequently, national organizations, such as The Joint Commission and the Centers for Medicare & Medicaid Services, accepted these recommendations as standards for measuring patient safety in the OR.2 Enforcement of these guidelines was initially variable, but as hospitals began to receive citations for noncompliance, policies that conformed to the AORN recommendations were adopted. In numerous ORs across the country, the wearing of skullcaps, a long-held practice of the surgical profession,3 was banned, leading to a vigorous debate regarding the process for adopting a national patient safety policy.

In the U.K., a similar debate is brewing on arm coverage. In 2007, the National Health Service (NHS) launched the Bare Below the Elbows (BBE) policy, which requires short-sleeved attire and that no wristwatches, jewelry, or neckties be worn during any clinical activity. The stated goal of the BBE policy was to reduce nosocomial infections through improved handwashing practices, but physician groups argued that the real goal was to eliminate the use of the white coat,4 thereby decreasing the stature of the physician.

The AORN recommendations for OR attire and the NHS BBE policy have both been challenged for lacking a sufficient evidence base and for intruding on personal liberty.4,5 In addition, attire-related regulations were found to unintentionally distract and reduce morale among surgeons, anesthesiologists, and nurses in the OR.5 Both guidelines were developed with little physician input, leading to the perception of external overregulation, a factor that has been found to be a major contributor to burnout and decreased professional satisfaction.6,7

As the leading surgical organization in the U.S., the American College of Surgeons (ACS) published a Statement on Operating Room Attire, which outlines appropriate attire for surgeons based on professionalism, common sense, decorum, and the available evidence on this topic.3 The American Society of Anesthesiologists (ASA) also conducted a scientific review and published a statement on OR attire.8 In addition, the Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO), and other health care entities published contemporaneous guidelines on validated strategies to reduce the incidence of SSI, which minimally addressed attire-related practices. No evidence-based guidelines or position papers on OR attire published before or after the release of AORN’s recommendations supported the hypothesis that attire regulations would reduce SSI.

The ACS convened a meeting concerning recommendations for OR attire in February 2018 at its headquarters in Chicago, IL, to support a collaborative discussion and review of the entire body of evidence pertaining to OR attire with the aim of promoting perioperative policies and procedures on surgical attire through a multidisciplinary approach representing surgery, anesthesiology, nursing, and infection prevention. The following organizations participated in the summit: the AORN, the ASA, the Association for Professionals in Infection Control and Epidemiology (APIC), the Council on Surgical and Perioperative Safety (CSPS), the Association for Surgical Technologists (AST), and The Joint Commission. This article outlines the process by which this group arrived at a consensus, reviews and scores the evidence base on OR attire, and provides a framework for future recommendations for OR attire guidelines. (For scoring details, see Table 1 at the end of this post.)

The summit

Organizations participating in the summit were asked to appoint delegates and to submit a bibliography of relevant publications for discussion. The process for identifying these materials was left to the discretion of the individual societies and included works published in peer-reviewed and non-peer-reviewed scientific journals, as well as articles published by the lay media. All submitted articles were reviewed by summit attendees.

Each participant received full-text copies of each proposed article. These materials were grouped using a taxonomy that was developed to facilitate discussion and then subdivided into scientific and nonscientific sections. Some societies also provided summaries of their submissions to facilitate discussion at the in-person meeting in Chicago.

The first objective of the summit was to narrow the focus from the broad topic of OR attire to a primary area of concern. Summaries of each submitted article were discussed, and consensus regarding the interpretation of each study was reached. Articles pertaining to hospital attire laundering practices were deferred for discussion at a later date. All participants agreed upon several core concepts related to OR attire, including the need for guidelines developed in a collaborative manner, and key questions, such as particulars regarding beard coverage, were identified for further research.

The reviewed studies were scored by Dr. Moalem, a coauthor of this article, using the principles published by AHRQ.9 Each group of studies was scored on limitations, directness, consistency, and precision. Groups of studies that contained relevant, valid data were summarized and tabulated for the purposes of scoring the evidence. Only scientific studies, guideline documents on SSI prevention, AORN publications on OR attire, and studies that were foundational to the AORN’s recommendations are included in this article.

In total, 110 articles were submitted by three organizations for consideration (ACS: 44; ASA: 56; AORN: 10), of which 30 were duplicates. A total of 21 articles were published before 1990, and therefore, not collectively reviewed unless an article was considered to be a landmark study or was referenced or used as a basis for a subsequent recommendation. In addition, AST provided its Guidelines for Best Practices for Laundering Scrub Attire along with supporting literature.10

The College has previously published a summary of the summit participants’ findings.11 The group unanimously agreed that the primary task of the initial meeting was to determine the effectiveness of OR hats, including the extent of hair coverage, in preventing SSI. Other aspects of OR attire guidelines were determined to be secondary considerations and were left for subsequent consideration.

The articles were subdivided into seven categories, including outcome studies (further subclassified by focus on hats/attire regulations, beards, and BBE policies), studies on porosity or effectiveness of hats, review articles, guideline statements, opinion papers, studies suggesting OR staff as a potential source of contamination, and AORN publications. Brief summaries of the most relevant scientific literature reviewed by summit participants follow.

Outcome studies

Five outcome studies evaluated the relationship between SSI and hair and scalp coverage. One concluded that omission of hats in laminar air flow ORs increased air contamination rates three- to five-fold,12 but four more recent studies on the extent of hair coverage or the type of hat worn failed to show an association with SSI. Two of these studies used validated outcome databases to determine whether enforcement of AORN recommendations decreased SSI in a combined total of 21,000 operations.13,14 Neither study revealed a significant difference, and in both a slight increase in SSI was actually noted (0.77 percent versus 0.84 percent in clean cases13 and 0.73 percent versus 0.77 percent in clean and clean-contaminated cases combined).14 A survey-based study of high-volume hernia surgeons also did not reveal an association between hat choice and SSI.15 Finally, a study attempted to relate adherence to infection control practices and SSI but found no association.16

Only two published studies evaluated the effect of facial hair on SSI. The first study used 30 subjects to demonstrate that unmasked, bearded men shed more bacteria than either clean-shaven men or women, and that wiggling the mask increased shedding in bearded men.17 A subsequent study concluded that unmasked bearded men shed similar amounts of bacteria to their shaven counterparts (9.5 versus 3.3 colony forming units [CFU], p = 0.1). The addition of a mask decreased shedding in both groups (1.6 versus 1.2 CFU).18 Both studies were limited by small sample sizes (10 in each group).

Porosity studies

A November 2017 scientific study systematically tested the permeability, particle transmission, and pore sizes of disposable bouffants, skullcaps (side and top parts), and cloth caps in a mock OR environment.19 The significant findings revealed that bouffants performed worse than disposable or cloth skullcaps in all parameters studied. Bouffants were demonstrated to have three times larger average and maximum pore sizes (89.4 and 251.8 µm) than cloth (26.1 and 89.5 µm) or the sides (31.3 and 119.8 µm) and crowns (36.2 and 110.0 µm) of disposable skullcaps. Accordingly, bouffants were found to allow for more particle-through transmission and were associated with greater bacterial shedding on settle plates (average 3 CFU versus 1 for skullcap or cloth hat). Home-laundered cloth skullcaps were associated with the least particle transmission, presumably because they have the smallest material pore size. A limitation of that study is that cloth bouffants were excluded from the comparison.

Guideline documents

Ten guideline statements on SSI prevention have been published by health care societies since 1999, when the CDC first issued guidelines for the prevention of SSI. The CDC recommended wearing face masks for the protection of the wearer, not the patient. Surgical caps also were recommended, although no comment was made regarding the type or extent of hair coverage.20 In 2017, the CDC updated its recommendations in the most comprehensive set of guidelines on SSI prevention published to date.21 In total, the CDC provided 42 statements, including 17 recommendations (8 Category 1A, 4 Category 1B, and 5 Category II), and 25 other comments on SSI prevention-related topics for which the agency could make no recommendation or considered unresolved. No mention was made of OR attire, masks, or head coverings in the CDC update. In the online supplementary materials, the CDC noted that the recommendation for head coverings remained an accepted practice.

Another important publication on SSI prevention was the product of an extensive collaborative effort by five leading health care organizations in September 2014.22 Like the CDC’s document, none of the 25 recommendations in that document related to OR attire. Similarly, the WHO recommendations on SSI prevention make no reference to attire, scrubs, hats, or hair.23

Three guideline statements from the U.K. also made no recommendations on surgical hats or masks, other than to recommend that masks should be worn for the protection of the wearer, although researchers noted that there is insignificant evidence to support the continued wearing of masks to prevent wound infection.24-26 One statement in particular, issued in a report by the Hospital Infection Society Working Party, goes on to state, “There is no need for non-scrubbed staff members of the operating team to wear disposable headgear; however, common sense dictates that hair should be kept clean and out of the way.”26

The AORN Guideline for Surgical Attire was first published in 1975 and has been revised 10 times.1 In 2015, the updated guideline included 47 specific recommendations concerning the material that should be used for scrubs, laundry and storage practices, locker room facilities, and proper wear of attire—the first time that OR attire was implicated as a cause of SSI. Recommendation 3A, “clean surgical head cover or hood that confines all hair and completely covers the ears, scalp skin, sideburns, and nape of the neck should be worn,” has been quite controversial. Other recommendations, such as “when in the restricted areas, all non-scrubbed personnel should completely cover their arms with a long-sleeved scrub top or jacket” directly contradict the BBE recommendations in the U.K. Summit participants reviewed the studies referenced in these recommendations, judging them to be of insufficient quality or relevance to support the recommendations for full hair coverage.

Partially in response to AORN’s recommendations, the ACS issued a Statement on Operating Room Attire,3 as previously noted, which was meant primarily to uphold a tradition of excellence, professionalism, trust, and respect between the surgeon and patient. In addition, the ACS and the Surgical Infection Society published a joint statement in 2016 that provided a comprehensive overview of the scope of the problem of SSI, relevant definitions, and list of proven risk factors. Following a detailed review of the evidence, the authors concluded that although questions related to surgical hat type and material and extent of coverage of skin and hair were hotly debated, no data were available to inform conclusions.27

Studies suggesting OR staff as a potential source of infection

Five experimental studies demonstrated high bacterial carriage rates among OR personnel. In one study at a large university hospital, investigators tested 238 culture specimens from 135 personnel, most of whom claimed to change uniforms daily and rated their clothing hygiene as fair to excellent.28 Pathogenic bacteria, a quarter of which were antibiotic-resistant, were isolated from at least one site from 63 percent of the study participants. In another study, each physician served as his or her own control and showed that the level and type of bacterial contamination of OR clothes increased over the course of the day, but was similar both inside and outside the OR setting, suggesting little benefit of repeated changing of clothes.29 Two studies showed that changing into clean scrubs significantly reduced airborne bacterial levels.30,31 The latter study also showed that dispersal of methicillin-resistant staphylococcus epidermidis occurred in 25 percent of women and 43 percent of men.

A small experimental study conducted in the U.K. in 2004 looked at the source of bacterial shedding in laminar flow theaters and was the sole study AORN used to develop its recommendation to cover the ears with hats.32 A total of 20 OR team members had their foreheads, eyebrows, and ears swabbed for culture. The results section of this study comprises a single sentence: “There was a significantly greater number of colonies cultured from swabs taken from the ears (p = 0.047) compared with the other two facial areas studied.”32

Several case reports of outbreaks that were attributed to bacteria carried by hospital staff were reviewed by summit participants, including studies that covered an outbreak of mycobacterium jacuzzii infections following insertion of breast implants (15 patients);33 an outbreak of group A streptococcus carried on the scalp (20 patients);34 and two reports of outbreaks of sternal SSIs caused by pseudomonas aeruginosa (16 patients)35 and rhodococcus bronchialis (7 patients).36 In each of these case reports, infections occurred despite the implicated health care professional wearing proper surgical attire. Another report detailed an outbreak of methicillin-resistant staphylococcus aureus (7 patients) that was traced to a health care worker who admitted to poor hand-washing procedures, misuse of the surgical mask, and exhibiting “non-respect” of the operating area.37 The role of that staff member during the operations involved was undisclosed.

AORN publications

In addition to the AORN recommendations, eight other AORN publications were reviewed, four of which were continuing education activities38-41 on how to implement the attire recommendations. Three studies were literature reviews that summarized some of the studies referenced earlier in this article.42-44 One study, “Surgical Head Coverings: A Literature Review,” repeatedly stated that “there is no conclusive evidence that hair covering prevents SSI.”42 Nonetheless, the author suggested that head covering may provide the best possible protection for surgical patients.

A February 2017 editorial revealed AORN’s goal in publishing the guideline was to show that “AORN was at the forefront of evidence-based approaches to perioperative nursing care when we began rating the evidence that supports our guidelines in 2011. Since that time, 17 guidelines have been accepted into the AHRQ National Guideline Clearinghouse, and five more will be submitted in 2017.”45 The author further extolled AORN as “recognized throughout the health care community, nationally and internationally, as representing the gold standard for perioperative care.”45

Conclusion

This article details the proceedings of a historic meeting between the ACS, ASA, AORN, APIC, AST, CSPS, and The Joint Commission. The ACS—dedicated to improving the care of the surgical patient and to safeguarding standards of care in an optimal and ethical practice environment—convened and organized the summit. The process was collaborative, respectful, and allowed for a multidisciplinary review of the available evidence on OR attire. Participants unanimously agreed that the summit was the optimal approach to developing guidelines that affect surgical patients, and the authors anticipate that future guidelines will continue to be developed collaboratively for the benefit of all patients and OR caregivers.

Following a careful review of the available literature, the summit participants found that the scientific evidence fails to demonstrate any association between the type of surgical hat or extent of ear and hair coverage and SSI rates. Furthermore, we concluded that one study showed the bouffant hat to be a significantly less effective barrier to the transmission of particles than either disposable or home-laundered cloth skullcaps, both of which have been banned at numerous institutions.

The summit participants emphasize the perspective that attire is the first and often most visible extension of professionalism and should therefore be defined and enforced locally. We recognize that standards for professional attire and behavior are influenced by geographic and socioeconomic factors, as well as patient acuity of illness and hospital culture. We therefore recommend that guidelines governing OR attire requirements be limited to those protocols that are sufficiently supported by evidence and can be implemented while preserving patient safety and clinician autonomy. We further recommend that outcomes, such as SSI, be carefully and continuously monitored and that attire be considered as one of numerous potential causes if discrepancies from historical or national standards are noted.

Acknowledgments

The authors would like to acknowledge and thank the following OR attire summit participants:

Representing the ACS (all MD, FACS): J. David Richardson, Fabrizio Michelassi, Adnan Alseidi, Timothy J. Eberlein, James Elsey, Enrique Hernandez, Doug Schuerer, Gary Timmerman, and Gerald B. Healy

CSPS: Roy Constantine, PA, PhD, and Joseph Charleman, MS, CST, CSFA, CRCST, LPN

AORN: Lisa Spruce, MSN, DNP, and Amber Wood, RN

APIC: Katrina Crist, MBA, CAE, Linda Greene, RN, and Janet Haas, PhD, RN, CIC, FSHEA, FAPIC

ASA: Paul Pomerantz, MD, FACS; Lois Connolly, MD; and Matthew Popovich, PhD

The Joint Commission: David Baker, MD, MPH, FACP, and Ana Pujols McKee, MD

In addition, we would like to thank Donna Coulombe, ACS Executive Services, for coordinating the summit, providing reference materials, and supporting this project.

References

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Medscape Survey Lifestyle Report 2016: Bias and Burnout. 2016. Available at: www.medscape.com/features/slideshow/lifestyle/2016/general-surgery#page=1. Accessed March 12, 2019. American College of Surgeons. Stop Overregulating My OR! Available at: facs.org/advocacy/regulatory/somo. Accessed March 12, 2019. American Society of Anesthesiologists. Statement on developing policy for infection prevention related to surgical attire. 2017. Available at: www.asahq.org/quality-and-practice-management/standards-guidelines-and-related-resources/statement-on-developing-policy-for-infection-prevention-related-to-surgical-attire. Accessed July 10, 2018. Berkman ND, Lohr KN, Ansari M, et al. Grading the strength of a body of evidence when assessing health care interventions: An EPC update. J Clin Epidemiol. 2015;68(11):1312-1324. AST Guidelines for Best Practices for Laundering Scrub Attire. 2017. 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Farach SM, Kelly KN, Farkas RL, et al. Have recent modifications of operating room attire policies decreased surgical site infections? An American College of Surgeons NSQIP review of 6,517 patients. J Am Coll Surg. 2018;226(5):804-813. Haskins I, Prabhu A, Krpata D, et al. Is there an association between surgeon hat type and 30-day wound events following ventral hernia repair? Hernia. 2017;21(4):495-503. Davis CH, Kao LS, Fleming JB, et al. Multi-institution analysis of infection control practices identifies the subset associated with best surgical site infection performance: A Texas Alliance for Surgical Quality Collaborative Project. J Am Coll Surg. 2017;225(4):455-464. McLure H, Talboys C, Yentis S, Azadian B. Surgical face masks and downward dispersal of bacteria. Anaesthesia. 1998;53(7):624-626. Parry JA, Karau MJ, Aho JM, Taunton M, Patel R. To beard or not to beard? Bacterial shedding among surgeons. Orthopedics. 2016;39(2):e290-e294. Markel TA, Gormley T, Greeley D, et al. Hats off: A study of different operating room headgear assessed by environmental quality indicators. J Am Coll Surg. 2017;225(5):573-581. Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Cont. 1999;27(2):97-134. Berríos-Torres SI, Umscheid CA, Bratzler DW, et al. Centers for Disease Control and Prevention guideline for the prevention of surgical site infection, 2017. JAMA Surg. 2017;152(8):784-791. Anderson DJ, Podgorny K, Berríos-Torres SI, et al. Strategies to prevent surgical site infections in acute care hospitals: 2014 update. Infect Cont & Hosp Epidem. 2014;35(S2):S66-S88. Allegranzi B, Zayed B, Bischoff P, et al. New WHO recommendations on intraoperative and postoperative measures for surgical site infection prevention: An evidence-based global perspective. 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Nursing and physician attire as possible source of nosocomial infections. Am J Infect Control. 2011;39(7):555-559. Sivanandan I, Bowker KE, Bannister GC, Soar J. Reducing the risk of surgical site infection: A case-controlled study of contamination of theatre clothing. J Periop Prac. 2011;21(2):69-72. Bischoff WE, Tucker BK, Wallis ML, et al. Preventing the airborne spread of Staphylococcus aureus by persons with the common cold: Effect of surgical scrubs, gowns, and masks. Infect Cont & Hosp Epidem. 2007;28(10):1148-1154. Tammelin A, Domicel P, Hambraeus A, Ståhle E. Dispersal of methicillin-resistant Staphylococcus epidermidis by staff in an operating suite for thoracic and cardiovascular surgery: Relation to skin carriage and clothing. J Hosp Infect. 2000;44(2):119-126. Owers K, James E, Bannister G. Source of bacterial shedding in laminar flow theatres. J Hosp Infect. 2004;58(3):230-232. Rahav G, Pitlik S, Amitai Z, et al. An outbreak of Mycobacterium jacuzzii infection following insertion of breast implants. Clin Infect Dis. 2006;43(7):823-830. Mastro TD, Farley TA, Elliott JA, et al. An outbreak of surgical-wound infections due to group A streptococcus carried on the scalp. New Eng J Med. 1990;323(14):968-972. McNeil SA, Nordstrom-Lerner L, Malani PN, Zervos M, Kauffman CA. Outbreak of sternal surgical site infections due to Pseudomonas aeruginosa traced to a scrub nurse with onychomycosis. Clin Infect Dis. 2001;33(3):317-323. Richet HM, Craven PC, Brown JM, et al. A cluster of Rhodococcus (Gordona) bronchialis sternal-wound infections after coronary-artery bypass surgery. New Eng J Med. 1991;324(2):104-109. Faibis F, Laporte C, Fiacre A, et al. An outbreak of methicillin-resistant Staphylococcus aureus surgical-site infections initiated by a healthcare worker with chronic sinusitis. Infect Cont & Hosp Epidem. 2005;26(2):213-215. Cowperthwaite L, Holm RL. Guideline implementation: Surgical attire. 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Table 1. Categorization and appraisal of evidence related to OR attire

Table References