A growing body of research has shown that bouffants do not reduce the rate of surgical site infections compared with surgical caps. The evidence has moved experts to reconsider existing surgical attire guidelines, sparking a shift that may soon be reflected in national policies.

In February 2018, surgeons, nurses and infection control experts met to review the latest evidence on OR attire. The task force—which included representatives from the Association of periOperative Registered Nurses, the American College of Surgeons and the Joint Commission—concluded that the scientific evidence “does not demonstrate any association between the type of hat or extent of hair coverage and ssI rates,” and the “requirement for ear coverage is not supported by sufficient evidence.”

But that has not always been the case. Over the last few years, OR attire policies have generated considerable controversy, largely due to disagreement over the stringent requirements imposed on hair and skin coverage. More specifically, in 2015, AORN released surgical attire guidelines recommending that OR staff wear “a clean surgical head cover or hood that confines all hair and completely covers the ears, scalp skin, sideburns and nape of the neck.” The Centers for Medicare & Medicaid Services and the Joint Commission subsequently adopted these standards and started cracking down on OR personnel who failed to cover their hair and ears fully.

“The 2015 AORN guidelines got adopted into a clearinghouse of nationally written policies, largely because it was the only set of recommendations of its kind,” Dr. Moalem said. “Essentially overnight, the recommendations were given the status of guidelines, and before you knew it, hospitals were getting citations for failing to comply.”

To avoid being cited, hospitals across the United States started revising their OR attire guidelines to align with these standards. In Dr. Moalem’s experience, a Department of Health site visit in 2015 prompted two affiliated hospitals to mandate full coverage of all hair in the OR and ban the use of disposable surgical skullcaps that do not cover the hair completely (J Am Coll Surg2018;226[5]:804-813).

But in light of new data, efforts to revise OR attire standards are now underway. Earlier this year, AORN released a draft of updated guidelines, which reflected the task force’s consensus and, according to AORN, will be finalized and published online later this year.

The Controversy

Although the changes to OR attire policies have been attributed widely to AORN, the organization has repeatedly denied calling for a ban on surgical caps or expressing a preference for bouffant caps.

“People who say we banned the skullcaps clearly did not read the 2015 guideline,” said Lisa Spruce, RN, DNP, the director of evidence-based perioperative practice at AORN . “If skullcaps are worn appropriately, … they do an excellent job covering the hair and ears. It is when they are folded up to expose the ears that, in turn, the hair is uncovered.”

In May 2017, AORN issued a statement explaining that its 2015 guidelines do not mention bouffants or skullcaps; it simply recommends that OR staff wear headgear that confines hair and exposed skin—including the ears, scalp and nape of the neck—to limit bacteria transferred from the OR team’s skin, hair or clothing to a patient.

But many surgeons disagree that policymakers misinterpreted the 2015 AORN guidelines when banning the surgical cap.

“The 2015 guidelines may not discuss specific headgear, but every hospital interpreted the AORN guidelines as an explicit ban on the surgical cap,” said Michael Rosen, MD, the director of the Comprehensive Hernia Center at the Cleveland Clinic, in Ohio, and medical director of the Americas Hernia Society Quality Collaborative. “That’s just a fact.”

According to Kevin Gibbons, MD, and Elad Levy, MD, MBA, the language in the 2015 AORN guidelines regarding full hair and ear coverage “effectively does ban the cap” (Neurosurgery2017;81[6]:E73-E74). Dr. Moalem agreed, noting while the 2015 guidelines did not explicitly ban the skullcap, the requirement for full coverage of the sideburns and the hair on the nape of the neck forced surgeons and other members of the perioperative team to wear bouffants, and health systems to stop providing skullcaps as an alternative.

Drs. Gibbons and Levy also pointed out that AORN had published articles and recommendations prior, which called for eliminating the skullcap and using the bouffant instead (AORN J2012;95[1]:122-140; AORN Connections 2014;100[5]:C1, C9-10).

But regardless of specific headwear, some surgeons argued that the available research at the time did not support the 2015 AORN recommendations on hair and skin coverage more generally. AORN’s 2015 surgical attire guidelines cited studies, published between 1965 and 2014, that showed hair can contain bacteria such as Staphylococcus aureus, but often found little or conflicting evidence that completely covering hair reduced ssI rates. None of the studies evaluated a link between type of head covering and ssI rate.

“The reason this sparked so much controversy is that in an era of evidence-based medicine and surgery, these guidelines appeared to mandate an infringement on one’s personal comfort and choice, without supporting evidence,” said Shanu N. Kothari, MD, FACS, FASMBS, the fellowship director of minimally invasive bariatric surgery at Gundersen Health System, in La Crosse, Wis. “To have a guideline state that coverage of all exposed skin and hair is necessary with no strong basic science evidence to support it seemed a bit far-reaching, and hence the outcry.”

Spruce disputed that the recommendations were based on weak evidence. “Our 2015 recommendations were not only based on the evidence we had at the time but also on potential risks and harms to patients,” she said, adding that “within a bundled approach for reducing risk of ssIs, covering and containing hair is a reasonable and prudent measure. There is no harm in doing so, but the benefit to all patients is a reduced risk of exposure to potentially pathogenic organisms that live on the hair, skin and facial hair of perioperative team members.”

Dr. Rosen, however, noted that there are unintended consequences of wearing bouffant caps, which when placed over the ears for long periods of time, are very uncomfortable. “Being uncomfortable, especially during lengthy operations, could put patients at risk,” he said.

New Evidence

After the Cleveland Clinic eliminated the use of surgical caps in 2016, Dr. Rosen wanted concrete data that addressed the issue of surgical caps versus bouffants. Dr. Rosen and his colleagues analyzed outcomes from more than 200 surgeons in the Americas Hernia Society Quality Collaborative and found no association between type of hat worn in the OR and ssIs (Hernia2017;21[4]:495-503).

“Due to the lack of clear evidence that surgical caps increased wound morbidity, the Cleveland Clinic reversed its ban,” Dr. Rosen said.

The analyses that followed reached similar conclusions. Three 2018 studies, which evaluated a potential link between ssIs and head covering in thousands of surgical cases, all found that bouffants do not reduce ssI rates compared with surgical caps (J Am Coll Surg 2018;227[2]:198-202; J Am Coll Surg 2018;226[5]:804-813; Neurosurgery 2018;82[4]:548-554).

The results of a 2017 study even suggested that disposable bouffants could potentially increase ssI risk. The authors found that bouffants “had greater permeability, greater particulate contamination and greater passive microbial shed” compared with skullcaps (J Am Coll Surg2017;225[4]:e29-e30).

Most recently, surgeons reported that their hospital’s requirement for OR staff to wear bouffants instead of skullcaps and long-sleeved jackets led to a substantial increase in hospital spending, although no reduction in ssIs (J Am Coll Surg 2019;228[1]:98-106). When considering the cost of long-sleeved jackets alone, the authors estimated an annual increase in hospital spending of more than $1.1 million. After factoring in all hospitals in the United States, that number jumped to $540 million per year.

“The real point here is that what we were wearing before was perfectly adequate,” said the study’s lead author Alfons Pomp, MD, FACS, FRCSC, the Leon C. Hirsch Professor and vice chairman of the Department of Surgery at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, in New York City. “If we’re going to institute a change that costs substantially more in dollars devoted to health care, then that change should improve patient outcomes.”

New OR Attire Guidelines on Horizon?

The 2018 task force marked an important step in bringing experts together to review the evidence on OR attire and ssIs.

“The meeting was incredibly collegial,” Dr. Moalem said. “Everyone was mutually respectful, and, thankfully, there was almost no disagreement over the evidence and how the evidence should be interpreted.”

In early January, AORN published a draft of updated surgical attire guidelines that incorporated the latest research. The draft recommends OR team members “cover scalp, hair, and beards when entering the semi-restricted and restricted areas,” but provides no recommendation on the “type of head or beard covers worn” or on “covering the ears in the semi-restricted and restricted areas.” The draft also provides no recommendation on wearing long sleeves in the semi-restricted and restricted areas aside from performing preoperative patient skin antisepsis. For areas with weak or no evidence, AORN recommends facilities form interdisciplinary teams to determine how best to manage them.

“The ACS discussed the recommendations, and is largely in agreement with AORN’s new draft guidelines,” Dr. Moalem said.

AORN opened the draft to public comment from Jan. 2 to Feb. 22, and said it plans to review and revise the draft guidelines accordingly. The guidelines will be published online in June and printed in its 2020 Guidelines for Perioperative Practice.

In terms of a national policy shift, Dr. Moalem explained that the Joint Commission has already retrained its site surveyors to reflect the recent data and consensus on OR attire. CMS, however, has not yet updated its OR attire policy.

“Patient safety is really what this is all about,” Dr. Moalem said. “Everyone wants what’s best for patients.”

Dr. Pomp believes medical professionals can learn from this experience. “Guidelines that will affect a multidisciplinary team should be a collaborative process,” he said. “Working together to establish guidelines could help avoid similar debates in the future.”