Editor's note: Commentary by Paul Teirstein, MD, is at the end of this article.
Compiled by Morton Kern with contributions from Eric Bates, Ann Arbor, Michigan; James Blankenship, Danville, Pennsylvania; David Cohen, Kansas City, Missouri; Mauricio Cohen, Miami, Florida; Ted Feldman, Chicago, Illinois; John Hirshfeld, Philadelphia, Pennsylvania; Allen Jeremias, Stony Brook, New York; Dean Kereiakes, Cincinnati, Ohio; Lloyd Klein, Chicago, Illinois; Mitch Krucoff, Raleigh, North Carolina; Michael Leadbetter, Cincinnati, Ohio; Jeff Moses, New York City, New York; Paul Teirstein, La Jolla, California; Peter Ver Lee, Bangor, Maine; Bonnie Weiner, Worchester, Massachusetts; Chris White, New Orleans, Louisiana.
Although the issue of appropriate attire in the cath lab was addressed in 2009 in these pages1,2, Leigh Brown, BSN, RN Clinical Manager, Electrophysiology and Cath Lab, Hermann Hospital, Houston, Texas, asks us, “What is appropriate attire in the cath lab setting? We follow the guidelines of the ACC [American College of Cardiology] and not AORN [Association of periOperative Registered Nurses]. What is coming is the requirement that everyone who enters the procedure room OR CONTROL ROOM in the cath lab must change into hospital-issue scrub attire. Requiring the staff to adhere to this new process without requiring the physicians to do the same is pointless. Our physicians are pitching a fit, and the common phrase I’m hearing is ‘We are NOT an OR! We are a cath lab!’ We adhere to AORN guidelines when we perform open procedures such as pacemakers, ICDs, or port placements, and we do this without fail.
“The burning question, of course, would be what is our infection rate on percutaneous cases? Ours is zero. Our primary System hospital in the Texas Medical Center has had one infection in five years (the patient was a homeless man). The infection rate in the other cath labs across the system is similar.
“Finally, what about STEMIs [ST-elevation myocardial infarctions]? Do we disregard what they consider ‘best practice’ if the case is emergent? I think of the delays of mere minutes, when there have been times we have hit our D2B [door-to-balloon time] in 89 minutes. What if we’d had to take the time to change out of our street clothes?
“Are there any recommendations or literature to support our position that adherence to ACC guidelines in the cath lab is appropriate? If I felt this massive change in process was going to improve outcomes, I would support it 100%. But it’s going to be difficult to improve on our already outstanding infection rates — even if the docs support it. I would like to nip this in the bud, but apparently our Infection Control experts have already researched and gathered what they consider to be compelling enough to support their position. How do other labs throughout the country practice in regard to scrub attire?”
Mort Kern: Before I pose this question to my cath lab expert colleagues, I thought it would be worthwhile to see what has changed in the last 8 years. Here are the questions that were asked in 2009:
- Do technologists and doctors wear hat and mask for preparation? Is this necessary at all?
- Do technologists and MDs wear hat and mask for the procedures?
- Do technologists wear sterile gowns to prep both patient and/or back table?
- Does anyone know the Joint Commission rule on sterile preparation?
My summary of the 2009 conversation was as follows: When in doubt, be fully sterile. I recommended prep for routine cases in hat, mask, and sterile gloves. If you think you might touch the back table because you are too short to reach over it, wear a sterile gown. For all implantable device procedures, use OR prep and full sterile technique. Shoe covers keep the hospital cleaner. At the University of California Irvine, we lost the battle to visit the lab in street clothes in one of the cath labs for hybrid work, as it comes under the OR supervision. In the other lab, the control room permits street clothes, but the cath room itself requires all personnel in scrubs.
What’s Appropriate for 2016?
Are the data to support instituting a complete 24-hour, 7 days/week sterile environment available? The answer is no, but common sense and practicality must play a large role in how we adopt sterile techniques in the lab today. The rate of infections in the cardiac cath lab ranges between 0.1% and 0.6%.3 Devices related to an increased potential for infections include intra-aortic balloon pumps, intravascular stents, atrial and ventricular septal defect and arterial closure devices, pacemakers and leads, any other implantable hardware such as the TandemHeart support systems, or other long-term, large diameter catheters. What has changed? In 2016, compared to 2009, more transcatheter aortic valve replacement (TAVR) and complex electrophysiology (EP) procedures are performed in cath and hybrid labs, with increasing attention to full sterile clothing and technique.
What Do the Guidelines, OSHA and the Joint Commission Say?
The Society for Cardiovascular Angiography and Interventions (SCAI) infection control guidelines revision of 20064 indicated that for patient preparation, aseptic technique include the use of cap, mask, sterile gowns, sterile gloves, and large sterile sheet. Skin cleaning and hair removal should occur without a shaving razor, making sure there is no breach in the skin. Antibiotics are generally not necessary. For prolonged cath lab procedures, before vascular closure device (VCD) insertion, the lab should consider a new sterile prep. The use of double gloves is optional, but may be recommended to reduce reverse contamination.
The Occupational Safety and Health Administration (OSHA) does not specify cath lab behavior but rather safety in the cath lab. Aside from infection prevention, the other purpose of using caps, gown, and mask is to reduce the reverse exposure to potential blood-borne contamination. Shoe covers are not required solely to prevent a surgical site infection, but are recommended to reduce contamination of other areas of the healthcare facility.
What Do the Cath Lab Experts Think About Cath Lab Fashion in 2016?
Mauricio Cohen, Miami, Fl.: Our hospital has become very strict and follows Joint Commission rules. We do devices, percutaneous valves, and vascular surgery in our cath lab. No one is allowed to wear anything but scrubs beyond the gate to the lab, very similar to the OR. Arms have to be covered with a silly “paper” jacket because human skin sheds. Cotton shirts to cover the arms are not allowed. Only bouffants (head covers, see below) are allowed to cover the head in any area of the cath lab. Beards are covered as well. Masks are required in the rooms. I did not like these regulations, especially the bouffant, but I found out that this is the recommendation.
The answer to your questions:
- Do technologists and doctors wear hat and mask for preparation? Yes.
- Is this necessary at all? I don’t really know.
- Do technologists and MDs wear a hat and mask for the procedures? Yes.
- Do technologists wear sterile gowns to prep both patient and/or back table? YES for the one that will stay and assist with the case. NO for the others assisting in prepping the patient. The table is prepped by a gowned tech.
- Does anyone know the Joint Commission rule on sterile preparation? It’s available online. It is a boring document that I could barely read.
Bonnie Weiner, Worchester, Mass.: Sorry you are subject to the same idiocy. The Accreditation for Cardiovascular Excellence (ACE) standards talk about “cath lab-specific” infection control policies. The issue is that even if we have them, our hospitals frequently won’t let us use them for all of the reasons already mentioned.
Eric Bates, Ann Arbor, Mich.: This is not a clinical guideline issue since evidence is required to make recommendations. The relative ACC/SCAI documents are Bashore et al5 (page 2266) and Naidu et al6 (page 460). Both support hand washing, gowns, gloves, masks, and hats. Is the enemy the Joint Commission or us?
Jim Blankenship, Danville, Penn.: When we started doing TAVRs in the cath lab, anesthesiologists and surgeons pressured us to increase sterile procedure measures throughout the cath suite. Then the Pennsylvania Department of Health visited our lab and decreed that we needed to treat the entire cath suite with the same precautions as the OR: bunny suits, hats/masks/gloves/shoe covers. The most recent Joint Commission visit last month led to a new requirement to “cover all facial hair”, which means caps were taken out of the lab and only bouffant caps are allowable (we have not been required to shave or cover our eyebrows). As with Bonnie’s lab, EMTs [emergency medical technicians] can transport STEMI patients directly into the cath room from the outside because this is considered an emergency.
John Hirshfeld, Philadelphia, Penn.: While I agree that there is little evidence base for an attire standard for facilities that do diagnostic catheterization and coronary interventions only, it is worth pointing out one important benefit of an attire standard — that it keeps the riffraff out of the suite. While I am working in the lab, I prefer not to need to deal with distractions caused by people who are not actively working in the suite. Like many other slippery slopes, if there is not an obstacle to outsiders entering the suite, before long, the corridor outside the procedure rooms can become a social center.
Jeff Moses, New York City, New York: Just to add to the absurdity, I work at two places with recent Joint Commission reviews. 1) At Columbia, it’s full-bore OR (because of some absurd lapses in the actual OR, not us, witnessed by a reviewer) with bouffant hats, ears covered, masks, etc. No bunny suits, as the hospital overshot because of some poor practices elsewhere. 2) At St. Francis in Long Island, they actually BACKED OFF masks after Joint Commission when they were told the masks, etc., were not mandatory. I love evidenced-based medicine. Without hats/masks, we had 20k consecutive procedures with no infections. The only problems were with 2 TAVRs, where full OR garb is the rule.
Time for a Change?
Paul Teirstein, La Jolla, Calif.: Obviously these rules are ridiculous and not evidence based. Why do we simply do what these inconsistent, non-evidence-based autocrats say? Jim (Blankenship, past president SCAI), it’s time for you to push back. Perhaps you can organize a multicenter, randomized trial of hats and masks vs no hats and masks for percutaneous coronary intervention (PCI).
Chris White, New Orleans, Louisiana: I have to agree with Paul. SCAI could be seen as the champion against this very unpopular issue for our members… lead from the front, and then use the data to support our members in the trenches (cath labs). Could be done inexpensively with registry data, or more expensively with a controlled trial sponsored by our industry partners.
Mort Kern, Long Beach, Calif.: Paul, you led the charge against nonsensical ABIM MOC and now this. These rules imposed on the cath lab from the OR czars are without rationale or factual support. I agree a movement by SCAI to set the rules for us is the way to go. Mr. SCAI President, do I hear a call to action?
Peter Ver Lee, Bangor, Maine: What about a STEMI patient brought directly to the lab in street clothes by paramedics wearing uniforms? Are we supposed to transfer that patient to a stretcher outside the lab, then transfer to the cath lab table? This will result in negligible reduction in risk of infection, but will increase D2B time.
Lloyd Klein, Chicago, Ill.: I think we should build a wall against all of the germs. This is all the revenge of the C student.
Ted Feldman, Chicago, Ill.: There is a broad issue with the hospitals and the American Hospital Association not being willing to push back at the Joint Commission. This could be an important effort, beyond hats and masks, if other large organizations (AMA, American Hospital Association) are involved.
Allen Jeremias, Stony Brook, New York: The problem is that the entire process is not evidence driven…these changes were not implemented because there is data indicating that infection in the cath lab is a problem. Even if we are able to generate data that hats, masks, etc., are of no utility, I doubt that the Joint Commission and administrators would change their views.
Chris White, New Orleans, Louisiana: Allen, while you may be correct, there is something wrong with that picture. I don’t remember going to a Joint Commission administrator for healthcare advice. Their job is to help facilities “be the best they can be”, after “we” show them what needs to be done. Without evidence, we’re left with Voodoo dolls.
Bonnie Weiner, Worchester, Mass.: Again, the Joint Commission doesn’t care so much what the policy is, just that we adhere to it. If we can get a meaningful group (SCAI, AHA?) to endorse a rational policy, they can support it and we can take it to our hospitals and systems. Unlike MOC, just saying “no more” here won’t work. I almost got my privileges suspended for not wearing a hat in the control room.
Mitch Krucoff, Raleigh, North Carolina: We have one hybrid lab with such rigor, otherwise cath and EP suites are an independent space. By the way, I always thought the argument for bouffants was that Andreas looked so incredibly dashing in one (Figure 1)!
David Cohen, Kansas City, Missouri: We do hybrid procedures only in our 2 hybrid labs, where we steadfastly observe OR sterility protocols. Including reciting the fire safety risk in every time out.
Jim Blankenship, Danville, Penn.: It is true that the Joint Commission’s response would likely be to say that they are just enforcing a hospital’s own rules. Our ID expert told me that our hospital adopted the surgical attire guidelines of the Association of periOperative RNs (AORN) that state all facial hair must be covered, including ears, sideburns, and nape of the neck.7 These guidelines have been contradicted in part by the recent statement from the American College of Surgeons pasted below (online August 4, 2016).8 The Board of Regents of the American College of Surgeons (ACS) approved this statement in July 2016:
“The tenets of the American College of Surgeons (ACS) include professionalism, excellence, inclusion, innovation, and introspection. Appropriate attire is a reflection of professionalism and facilitates establishing and maintaining a patient-physician rapport based on trust and respect. In addition, in so far as clean and properly worn attire may decrease the incidence of health care-associated infections, it also speaks to a desire and drive for excellence in clinical outcomes and a commitment to patient safety.
“The ACS guidelines for appropriate attire are based on professionalism, common sense, decorum, and the available evidence. They are as follows:
- Soiled scrubs and/or hats should be changed as soon as feasible and certainly prior to speaking with family members after a surgical procedure.
- Scrubs and hats worn during dirty or contaminated cases should be changed prior to subsequent cases even if not visibly soiled.
- Masks should not be worn dangling at any time.
- Operating room (OR) scrubs should not be worn in the hospital facility outside of the OR area without a clean lab coat or appropriate cover up over them.
- OR scrubs should not be worn at any time outside of the hospital perimeter.
- OR scrubs should be changed at least daily.
“During invasive procedures, the mouth, nose, and hair (skull and face) should be covered to avoid potential wound contamination. Large sideburns and ponytails should be covered or contained. There is no evidence that leaving ears, a limited amount of hair on the nape of the neck or a modest sideburn uncovered contributes to wound infections.
“Earrings and jewelry worn on the head or neck where they might fall into or contaminate the sterile field should all be removed or appropriately covered during procedures.
“The ACS encourages clean appropriate professional attire (not scrubs) to be worn during all patient encounters outside of the OR.
“The skullcap is symbolic of the surgical profession. The skullcap can be worn when close to the totality of hair is covered by it and only a limited amount of hair on the nape of the neck or a modest sideburn remains uncovered. Like OR scrubs, cloth skull caps should be cleaned and changed daily. Paper skullcaps should be disposed of daily and following every dirty or contaminated case.
“Religious beliefs regarding headwear should be respected without compromising patient safety.
“Many different health care providers (surgeons, anesthesiologists, CRNAs, laboratory technicians, aids, and so on) wear scrubs in the OR setting. The ACS strongly suggests that scrubs should not be worn outside the perimeter of the hospital by any health care provider. To facilitate enforcement of this guideline for OR personnel, the ACS suggests the adoption of distinctive, colored scrub suits for the operating room personnel.
“The ACS emphasizes patient quality and safety and prides itself on leading in an ever-changing and increasingly complex health care environment. As stewards of our profession, we must retain emphasis on key principles of our culture, including proper attire, since attention to such detail will help uphold the public perception of surgeons as highly trustworthy, attentive, professional, and compassionate.
“This statement will be published October 2016 in the Bulletin of the American College of Surgeons.”
Bonnie Weiner, Worchester, Mass.: Since we don’t work in operating rooms, we should have our own standards (read the ACE standards). Even the argument for hybrid rooms is wearing a little thin as devices get smaller and smaller.
Dean Kereiakes, Cincinnati, Ohio: I thought you would find this amusing [below]. Very pertinent to recent discussions. Comes from a plastic surgery group at our hospital. The picture (Figure 2) is priceless! Dr. Michael Leadbetter, plastic surgeon in Cincinnati, a member of a group of prominent surgeons, wrote a note to the director of his hospital regarding the state of sterile technique needed in their hospital. Here’s their view:
“The Plastic Surgery Group was in receipt of your interoffice memorandum of July 19, 2016 in reference to operating room attire policy. We have to admit that we are somewhat concerned about the ridiculousness of this decision. Our group has over 150 years of cumulative operative experience wearing standard surgical caps in the operating room and to date have absolutely no indication that the use of a standard surgical cap has caused any type of wound infection in our patients. In review of the literature back to 1973, there are only two articles that even closely allude to the fact that hair is a problem in the operating room and as a matter of fact, in the neurosurgical literature, the majority of neurosurgeons never shave their patient’s head completely and leave the hair intact. You can certainly understand that if someone has hair that goes down to their shoulders that this can be a problem, but a standard haircut with a surgical cap and only hair exposed being at the posterior aspect of the neck, has never been a concern for our operative patients. We have done hair transplantation surgery for over 34 years, and never experienced any type of scalp infection, other than the occasional folliculitis due to regrowth of hair. Even bouffant hairstyle surgical caps do not completely cover hair that grows down the posterior part of the scalp onto the neck.
“With this in mind and every effort being made to abide by this questionable new policy, we are enclosing for your review the new recommended hairstyle for surgeons and new head protection designed for future standards (Figure 2). Please forward this to JCH [Joint Commission] examiners to make sure that they meet their OR Attire Policy Standards.
“Overreacting? No more so than the knee-jerk reaction by the committee concerning a policy that has very little evidence-based support in the literature …The Concerned Plastic Surgery Group”
The Bottom Line
The Joint Commission and AORN make the rules and increasing adherence to sterile OR technique in the cath appears the norm. SCAI and other organizations can step forward to put common sense and evidence-based medicine to work, but for the time being, the “be sterile” rule applies as it does in the OR, as much as we may not like it.
- Kern M. Do I need to wear a hat and mask in the cath lab? Cath Lab Digest. 2009 Mar; 17(3). Available online at www.cathlabdigest.com/articles/Do-I-Need-Wear-a-Hat-and-Mask-Cath-Lab. Accessed September 7, 2016.
- Email discussion group. Cath Lab Digest. 2002 Dec; 10(12). Available online at www.cathlabdigest.com/articles/Email-Discussion-Group-5. Accessed September 7, 2016.
- Baddour LM, Bettmann MA, Bolger AF, et al. Nonvalvular cardiovascular device-related infections. Circulation. 2003; 108(16): 2015-2031.
- Chambers CE, Eisenhauer MD, McNicol LB, et al; Members of the Catheterization Lab Performance Standards Committee for the Society for Cardiovascular Angiography and Interventions. Infection control guidelines for the cardiac catheterization laboratory: society guidelines revisited. Catheter Cardiovasc Interv. 2006; 67(1): 78-86.
- Bashore TM, Balter S, Barac A, Byrne JG, Cavendish JJ, Chambers CE, et al; ACCF Task Force Members. 2012 American College of Cardiology Foundation/Society for Cardiovascular Angiography and Interventions expert consensus document on cardiac catheterization laboratory standards update: A report of the American College of Cardiology Foundation Task Force on Expert Consensus documents developed in collaboration with the Society of Thoracic Surgeons and Society for Vascular Medicine. J Am Coll Cardiol. 2012; 59; 2221-2305.
- Naidu SS, Rao SV, Blankenship J, Cavendish JJ, Farah T, Moussa I, et al. Clinical expert consensus statement on best practices in the cardiac catheterization laboratory: Society for Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2012 Sep 1; 80(3): 456-464.
- RP summary: recommended practices for surgical attire. AORN Journal. 2012 Jan; 95(1): 141-142. Available online at http://www.aornjournal.org/article/S0001-2092(11)01092-1/abstract. Accessed September 7, 2016.
- American College of Surgeons. Statement on Operating Room Attire. 2016 Aug 4. Available online at https://www.facs.org/about-acs/statements/87-surgical-attire. Accessed September 7, 2016.
Bachert A. AORN, ACS spar on head coverings in the OR. The skullcap: should it stay or should it go? The Gupta Guide. MedPage Today. 2016 Aug 6. Available online at http://www.medpagetoday.com/HospitalBasedMedicine/GeneralHospitalPractice/59872?xid=nl_mpt_DHE_2016-08-27&eun=g335619d0r&pos=3. Accessed Sept. 7, 2016.
Association of periOperative Registered Nurses. 3 Steps for Achieving Safe Attire. Periop Insider: 2016 articles. Available online at https://www.aorn.org/about-aorn/aorn-newsroom/periop-insider-newsletter/2016/2016-articles/3-steps-for-achieving-safe-attire. Accessed Sept. 7, 2016.
Disclosure: Dr. Kern reports he is a consultant and speaker for St. Jude Medical and Philips Volcano, and a consultant for Opsens, ACIST Medical, Heartflow, and Merit Medical.
I enjoyed commenting on cath lab attire in 2016, but I was surprised by the American College of Surgeons (ACS) statement on OR attire. This is fascinating in that it is seems more like a fraternity handbook on proper behavior than a medical society statement. What an embarrassment to release this document without any supporting data. I don’t know if there even is any data available (a quick Google search reveals guidelines and theories, but I couldn’t quickly find an actual study on operating room attire and infection).
Since there is no data, the ACS statement is more of a “cultural” statement. They are up front about their message. The reasons provided for proper attire start with “maintaining a patient-physician rapport based on trust and respect.” The closest they come to infection control is “properly worn attire may decrease the incidence of health care-associated infections.” For some reason, they are then quick to point out that “There is no evidence that leaving ears, a limited amount of hair on the nape of the neck or a modest sideburn uncovered contributes to wound infections.” But they also say large sideburns should be covered…so it is contradictory. Most likely, one of the writers thinks modest sideburns is a cool look.
The document focuses more on statements like “The skullcap is symbolic of the surgical profession.” To me, this is like saying, “We senior members of this club think surgeons should look and dress a certain way, so if you want to be in our club, wear a skullcap.” Further down in the document, it gets more absurd. “Operating room (OR) scrubs should not be worn in the hospital facility outside of the OR area without a clean lab coat or appropriate cover up over them.” Why? This rule certainly does not have an infection rationale behind it. A dirty white coat is not any less of an infection barrier to the underlying scrubs then a clean white coat. Rather, it’s just a clubby “look” they are going for in this document.
I get it. I am always teaching my trainees and young faculty not to walk around with coffee stains on their white coat. I tell them “It’s just not a good look…you’re a grown-up now,” but I wouldn’t make coffee stains a reason to take formal action against a doctor. Same thing with “OR scrubs should not be worn at any time outside of the hospital perimeter.” Well, that is just plain absurd. I would understand if they said “Hospital scrubs should not be stolen” or “Stolen hospital scrubs should be returned for washing before wearing in surgery” but they seem to want anyone wearing scrubs outside the hospital to receive a citation. This document is just an embarrassing example of surgical arrogance.
This is an emotional issue. Most interventional cardiology procedures, especially PCI, are not open surgery and we do not believe we have an infection problem. But there are definitely some interventional cardiologists who share the ACS view that an invasive cardiologist should “look” a certain way, i.e., all interventional cardiologists should dress like they dress. This, however, is just a mild form of prejudice and should be recognized as such.
On the other hand, I can tell Jim (Blankenship, past SCAI president) is not terribly enthusiastic about dragging SCAI into this. I can see how the optics of this can go sideways….i.e., “Well…is there a downside to hats and masks?” “Even if there is a really small chance of preventing an infection, shouldn’t everyone do it?”
So, it would seem one way to approach this problem would be a study powered for futility, i.e., if we can’t find an infection difference in 5000 or so procedures, then any difference is too small to be meaningful. Can we do this quickly through the NCDR database? Suppose we capture “Are hats and masks actually worn in your cath labs” and then capture any infection outcomes. It’s not randomized, but it’s not expensive and very doable. Any thoughts?
Paul Teirstein, MD
Scripps Clinic, La Jolla, California