Dr. Scott Ellner, Vice Chairman of Surgery and the Director of Surgical Quality at Connecticut's
Saint Francis Hospital and Medical Center, states why antiseptic sterility is so very necessary.
Q: The FDA has recently recommended that manufacturers package preoper-
ative or pre-injection skin antiseptics in
single-use containers. How will this change
use of these products?
Dr. Ellner: I think the FDA’s guidance makes it clear that
this is an important patient care issue for manufacturers
to address. This is an important step for patient safety.
Currently, topical antiseptic products are packaged in either
single-use containers or multiple-use containers. Single use
containers will help to minimize the risk of infection and the
possibility of contamination with bacteria during use.
In most cases, these changes will not impact current practices. However, hospitals that frequently use multiple-use
containers will likely need to transition to single-use containers. There
are potential cost implications, but it is important to keep in mind that the
cost of one infection is high as well, so reducing the risk is imperative.
Q: How has the healthcare industry's perspective
on the topic of sterile antiseptic skin preparation
changed since the FDA hearing a year ago?
Dr. Ellner: Following last year’s FDA hearing, industry organizations,
such as the Association for Professionals in Infection Control and
Epidemiology (APIC) and the Society for Healthcare Epidemiology of
America (SHEA), voiced their support for the sterile manufacture of
skin antiseptics. APIC stated that it “believes all skin-preparation prod-
ucts should be manufactured to be sterile.” SHEA also stated in a letter
to the FDA that they “advocate for the use of sterile products consistent
with the use of aseptic technique during the procedure.”
While some manufacturers stated altering their manufacturing processes
to include sterilization would require considerable time and expense, there
are currently topical skin antiseptics available that are sterile.
Now that the FDA is asking manufacturers to voluntarily label their
products as sterile solutions or nonsterile solutions, it shows there is
increased interest in understanding the difference between sterile and
nonsterile options. It also appears that the industry is more educated on
the topic, which is leading to a change in the way professionals evaluate
products and view manufacturers.
Q: How do you expect that perspective to evolve now
that the FDA has issued new recommendations around
package labeling and single-use packaging?
Dr. Ellner: I think the healthcare industry will start to examine product
labels more carefully, paying closer attention to sterility lan-
guage, as they select appropriate products for their facilities.
These new recommendations could also influence changes to
preoperative standard protocols for many facilities. For exam-
ple, in our organization, we are now requiring our colorectal
patients to perform three days of chlorohexadine gluconate
(CHG) showers prior to surgery. In accordance with the new
FDA recommended guidelines, we would prefer our patients
to use skin antiseptics that have been sterilized for use.
Q: What, if any, misconceptions exist within the
Q: What are some of the potential consequences of
healthcare industry about antiseptic products?
Dr. Ellner: The biggest misconception, which is currently
being addressed, is that skin antiseptics are automatically
sterile because of the inherent antimicrobial activity of antiseptics. Some of
this is driven by products being labeled “sterile,” when it is really only the
outer packaging that has been sterilized. In most cases, the antiseptic inside
the package, arguably the most important component because it touches
patients’ skin, is not sterilized. Delivering the best patient outcomes starts
with ensuring the antiseptic product used around and on patients’ skin,
including the product and the packaging, is safe and non-contaminated.
Dr. Ellner: While virtually all antiseptic solutions can be subject to bacterial
contamination, terminally sterilized products are designed to help decrease
the risk of organisms finding their way to already compromised patients. It is
key for healthcare professionals to know whether a product is sterile or nonsterile so they can make informed decisions about the products they use.
Similarly, it’s important to remain informed about the types of active
ingredients used in antiseptics so that healthcare professionals do not use a
product on a patient who is allergic to it or is contraindicated for the type of
procedure being performed. Every healthcare professional needs to carefully
evaluate all product labels and risk factors before each procedure.
Q: How can these misconceptions be overcome?
Dr. Ellner: Greater awareness of these issues is the first step. The FDA’s
new recommendation that manufacturers label products as a “nonsterile
solution” or “sterile solution” is an important educational step. While
the FDA is helping to increase awareness about the issue of antiseptic
sterility, manufacturers need to ensure healthcare professionals understand the risks and consequences, as well as know the options that are
available to mitigate negative outcomes. More training and education in
these areas is needed to affect changes in standard procedures.
Dr. Scott Ellner
Vice Chairman of
Saint Francis Hospital