Cath Lab Digest

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?