Do I Need to Wear a Hat and Mask in the Cath Lab?
How sterile does the cardiac catheterization laboratory have to be? In the initial years of catheterization at The Cleveland Clinic, Mason Sones was seen performing the procedure in a sterile gown and glove with a sterile mosquito clip at his side in case he wanted a cigarette. Although this may be an exaggeration, the general catheterization procedure is considered a “clean” procedure performed outside of an operating room. With the evolution of the interventional field, the cath lab now needs operating room (OR) sterility for the complex and device-related procedures such as atrial septal defect (ASD) closure devices, implantable peripheral stents, and pacemakers and automated implantable cardioverter defibrillators (AICDs).
Are the data to support instituting a complete 24-hour/7-day-a-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. Here’s a case in point. Mr. Cary Lunsford, from Presbyterian Intercommunity Hospital in Whittier, California, wrote, “We recently had a Joint Commission inspection in our lab. We passed, except that one of our techs who was setting the patient up (as we have done for the last 27 years in this laboratory) was wearing only a hat, mask and sterile gloves. We got dinged by the Joint Commission inspector, who said that this is a sterile procedure and needs full sterile gown when getting the patient ready for the doctor. The Joint Commission reviewer was an expert in surgery and considered this to be a sterile procedure, rather than a clean one.” Mr. Lunsford continued that he knows certain areas of the country and some individuals in particular that do not even wear a hat or mask during the procedure. What is the right thing to do in our labs today?
To clarify the question, I asked some of my cath lab director colleagues across the country and in Europe about their sterile preparation practices. I received some very interesting and informative responses (see Table 1 and responses below). Of the 32 labs informally surveyed, most always wear hat, mask and sterile gloves (no gown) to prep the patient and back table. Less frequently reported was the use of hat, mask, gloves and sterile gown to prepare both patient and back table. Finally, it was rare that full scrub suits, hat, mask, gloves and gown were always required and the cath room was considered a completely sterile environment exactly like the OR. However, we recognize that a completely sterile environment at all times fails to address the realities of working in the cardiac cath lab.
How frequently does infection occur after cardiac cath?
The rate of infections in the cardiac cath lab ranges between 0.1% and 0.6%.1 Devices related to an increased potential for infections include an intra-aortic balloon pump, intravascular stents, atrial and ventricular septal defect and arterial closure devices, pacemakers and leads, and any other implantable hardware such as the TandemHeart support systems or other long-term large diameter catheters.
What do the guidelines tell us?
In 2006, the Society for Cardiac Angiography & Interventions (SCAI) published infection control guidelines for the cardiac catheterization laboratory.2 Dr. Charles Chambers and his colleagues on the writing committee made several important recommendations consistent with what most cath labs do today. Historically, the original cath procedures in the 1970s often involved cut-downs (brachial artery) and it was therefore considered an operation requiring complete sterile technique like an OR. The cardiac catheterization laboratory has evolved, but remains a complex environment in which implantable devices, femoral artery puncture closure devices and other such equipment must be used in a secure sterile fashion for obvious reasons.
The SCAI infection control guidelines revision of 2006 indicated that for patient preparation, aseptic technique includes 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 not necessary with regard to sheath removal and vascular closure devices except for special precautions in diabetic patients after a vascular closure device placement. For prolonged cath lab procedures, before vascular closure device (VCD) insertion, the lab should consider new puncture site cleaning, new sterile gloves, and new drapes prior to device insertion. When VCD sutures are involved, the exteriorized ends should be cut very low. Antibiotic cream can be applied to the puncture site.
What about hand washing and double gloves?
From the SCAI guidelines, among the most important sterile precautions we can perform in the cath lab (and in fact anywhere) is good hand washing. Operator-specific recommendations include hand washing in a two-step mechanism: first, for 2-3 minutes, wash with water and a chlorhexidine-based product; the next step is waterless alcohol-based scrub for 2-3 minutes with a good bactericidal. Double gloving has been considered and recommended since the integrity of some gloves, especially in the thumb and index finger areas, are known to be associated with micropunctures. The use of double gloves is optional but may be recommended to reduce reverse contamination.
What does OSHA and the Joint Commission tell us?
The Occupational Safety and Health Administration (OSHA) does not specify cath lab behavior. It does address safety in the cath lab workplace for protection against blood-borne pathogens. (See the OSHA revision of the Blood-borne Pathogens Standard, Needle Stick Safety and Prevention Act 29 CFR 1910.1030, which clarifies the need for safer needle devices and keeping a log of injuries from contaminated sharps.) From OSHA’s view of 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. During the procedure, the use of cap mask, eye protection, sterile gown and gloves for insertion of catheters and guide wires, especially for wire and catheter exchanges [my suggestion], is strongly recommended for protection of both patient and operators. Shoe covers are not required solely to prevent a surgical site infection, but are recommended to reduce contamination of other areas of the health care facility.
What did the cath lab directors say about their lab’s sterile techniques?
This topic engendered the prevailing skepticism about hats and masks and the resignation to regulators’ dictates about hats, masks and gowns.
Here’s just a few of the comments. One interventionalist from Illinois wrote that “I am not convinced that mask and gowns really make a great difference to the patient [during prep]. I believe that there are no specific guidelines on this. Those that are based on expert consensus may or may not have data sufficient to support it and it is unlikely any one can do such a study. However in my lab, I wear hat, mask, gown, and gloves as a barrier of protection for myself.”
Another lab director from the same state said, “The Department of Public Health decides how the labs will be set up and it makes little difference what the data is based on and more on their preconceived notions.”
Another director indicated, “In this day and age of evidence-based rather than opinion-based guidelines, I would like anyone to cite the data that wearing a surgical mask improves the outcome of diagnostic coronary procedure. Since we have always done it this way, it seems a flimsy excuse to incorporate this mandate into guideline. One could make cogent argument to use a mask for implanted devices, but it is hard to imagine that operator breathing somehow compromises the safety of diagnostic angiography. If so, then perhaps we should all wear masks and hats for phlebotomy.”
From Europe: “After doing 50,000 cases, including several 100 atrial shunt closure device implantations, without mask or hat, and with our preparing technique using only gloves and everybody else walking into the lab in street clothes and shoes, we had one nosocomial infection in a patient with a simple coronary angiogram. We since have reverted to wearing a mask but no hats with the idea to protect the physician probably more than the patient. The masks are worn quite leisurely, to say the least. At least the chin is covered in most cases.” Another European practice relates that “it is not necessary to wear hat and mask. Techs mask for procedures most of the time.”
One well-known interventionalist from the southern U.S. said, “It is not a routine over the past 20 years for technologists, nurses and doctors to wear hats and mask for percutaneous procedures. We do it for structural heart disease cases and any open cut down procedures. The fact that we dip every stent in ‘Tabasco’ sauce probably helps. EP procedures are not performed in the cath lab. Their rules are different for their laboratories, where everyone wears protective garb.”
In Texas, we are told “…in our hospital, Joint Commission guidelines are interpreted. Our technologists wear hat and mask for prep, but not for every case. Device implants, both peripheral and structural, are used with complete sterile technique. The Joint Commission does not rule on sterile preparations. It allows the hospitals to interpret based on the reviewer at the time, which results in major variations within a center based upon the venue reviewed and also between centers.”
Another interventionalist indicated that “no one is allowed in our cath room without cap, mask, scrubs, shoe covers and lead. For all procedures, we wear caps, mask and gowns from beginning to end. The SCAI physician papers are best document I know of currently extant on the issue. Hospital infection control officers try mildly to move the cath labs to an OR-type environment, particularly now that there are heart rooms, vascular rooms and EP rooms all contiguously aligned. So far, [these officers] have not reached us.”
One writer adds, “It has been my experience that low incidence of infection related to cath procedures has served as a license to many practitioners to become sloppy and tolerate uncontrolled activity in their laboratories. While surveying cath labs as part of the SCAI program, I found doctors giving lip service to infection control, but not enforcing rudimentary control such as mask, sterile gowns or even scrubbing. Even though our locals affirm and enforce, they still have to remind staff not to eat in the control room just outside the labs. Occasional reminders of things like that help promote a consciousness of our overall rules [for patient safety].”
From Washington, D.C.: “We have done about 18,000 patients in a year in the cath lab, not including EP studies. We have had no known infections related to cath or PCI. We do not use cap, mask, nor shoe covers, and never have. We do not use sterile gown to prep. We feel strongly that in the absence of an open wound, there is no need for them. The Joint Commission needs to learn from successful centers like ours what is needed, what is safe and what is recommended. I know they are prone to like cap and mask. OSHA has an issue with the mask as it relates to possible risk of blood product contamination in someone’s mouth, eyes, nostrils, etc. For reasons I do not understand, [some regulators] speak all the time about the need for OR sterile technique in cath labs.”
My final word on this subject is that while we may not know the answer, it is important to be cognizant of transmission of infection, both to and from the patient. When in doubt, be fully sterile. I recommend prep for routine cases in hat, mask and sterile gloves. If you think you might touch the back table because you’re 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. I hope the dialog from our cath lab colleagues helps us decide which practice we should adopt and when to change.