There's good news and bad news about surgical preps. The good news? Fierce market competition continues to bring new and improved products that focus on user convenience and patient safety (see "A Sampling of What's New in Patient Preps" on page 38). The bad news is that the sheer number of choices - and company claims and counterclaims - can make even veteran administrators throw up their hands. What's more, there's still no clear regulatory guideline to help you make more informed decisions. Here's an update.
The Monograph makes glacial progress
The U.S. Food and Drug Administration still has not addressed a decade-long regulatory vacuum. In 1994, the FDA published its Tentative Final Monograph (TFM) for Healthcare Antiseptics. Intended as a framework for future FDA regulation of patient preps and other antiseptic products, the document has languished for 10 years. In 2003, the FDA collected public comment and industry data regarding products not covered in the TFM. Although the industry expected a Final Monograph for Healthcare Antiseptics to be issued this year, indications are that it won't be released until 2005, according to officials.
"This is one of our division's top three priorities," says Michelle Jackson, PhD, a microbiologist for the FDA's Over-the-Counter Drugs Division. "When it's finalized, it'll be a very big document; a Final Monograph must address everything. We're backlogged on the data, and it doesn't appear that we'll finalize it in 2004."
In the TFM, the FDA recognized that alcohol and iodine products as safe and effective as active ingredients for preps. The TFM notes that virtually all other active ingredients are unproven. However, even products containing alcohol or iodine should be tested both in vivo and in vitro to prove the efficacy of their specific formulations. Companies selling products containing active ingredients other than alcohol or iodine should have both in vivo and in vitro data generated by an FDA-audited laboratory to show safety and efficacy.
The TFM also advanced a plan for regulating the claims companies could make about preps. The catch is that until it is finalized, compliance with the TFM is voluntary and some products currently have a good bit of leeway regarding product claims.
"When the monograph is finalized, all manufacturers will be on an even plane," says Mardi Bentzen of 3M, the maker of DuraPrep Surgical Solution. "We would all have to do the same tests and report data in the same way. Product users can expect the same [safety and efficacy] data from everyone."
In anticipation of the Final Monograph, most but not all manufacturers have brought their products into compliance with the TFM. "As a potential patient, it's scary to think I could be prepped with one of those solutions that don't adhere to safety standards across the board," says Liz Hutson, prep product manager for Cardinal Health, the maker of Prevail FX.
Use what we have
For now, manufacturers say users can look to the TFM for some guidance when selecting products. They also have some loose guidance from the CDC.
Here are some suggestions for using the limited available guidance from the FDA and CDC to find the prep product right for your OR.
- Find out if the product has a New Drug Approval (NDA). This is the most rigorous of the FDA testing, and products with an NDA have proved safety and efficacy and adhere to strict labeling guidelines.
- See if the active ingredient is alcohol (60 percent to 95 percent in an aqueous solution), iodine tincture or topical solution, isopropyl alcohol (70 percent to 91.3 percent) or povidone-iodine (5 percent to 10 percent). The FDA considers these established to be proven safe and effective and does not require NDAs for them. All other active ingredients should be proven safe and effective first, however.
- If the product doesn't have an NDA, find out if the maker has voluntarily complied with testing guidelines in the TFM on Healthcare Antiseptics. Request information on testing methodology and test results. The TFM says:
'' the product should be tested both in vivo and in vitro;
'' the test should be done on an abdomen (dry) site and a groin (moist) site; and
'' within 30 seconds of application, the product should reduce bacteria by 1 log10 per square centimeter on the dry site. Ten minutes after application, the test should show a reduction of bacteria of 2 log10 per square centimeter on the abdomen, and 3 log10 per square centimeter on the groin. Bacteria reduction (from baseline) should last for six hours.
"The TFM guidelines are stringent, restrictive and exhaustive. They set the bar very high for the performance of an antiseptic," says Bill Brandmeyer of Medi-Flex, Inc., the maker of ChloraPrep. "I'm looking to the final document to keep the bar high so the market has the highest level of skin antisepsis possible."
Meanwhile the CDC's "Guideline for Prevention of Surgical Site Infection," published in 1999 may also provide a certain degree of help. The Guidelines state:
- Alcohol is highly effective against bacteria, fungi and viruses, but spores can be resistant, and alcohol is highly flammable.
- Chlorhexidine gluconate and iodine-based products both have a broad spectrum of activity, but of the two, chlorhexidine is probably slightly more effective, has better residual activity and is not inactivated by blood or serum proteins. The CDC does not comment on other active ingredients.
The CDC now strongly recommends that patients be required to bathe or shower with an antiseptic agent at least one night before surgery. It doesn't comment on which antiseptic to use. An article in April's American Journal of Infection Control sheds some light on the CDC's recommended two-step approach to patient prepping. The article asserts that when patients shower or bathe with an antiseptic before the day of surgery, more bacteria are killed quickly by pre-op prepping, and the reduction of bacteria can last for days.