To the Editor: We are very concerned about a number of inaccurate and misleading statements made about 3M? DuraPrep? Surgical Solution and other products in the June 2001 article entitled "5 Products for Better Prepping."

In regards to DuraPrep solution:

• You list the glass ampoule as a "built-in disadvantage." The glass ampoule is an advantage. It was selected for patient and healthcare worker safety because it is a barrier to ethylene oxide (EO), the most common method of sterilization for medical devices. Exposure of iodophors to EO results in the creation of 2-iodoethanol (ethylene iodohydrin), a toxic substance with a risk of acute toxicity. Most plastics are not a barrier to EO.
• You state that the water insoluble DuraPrep film is a "disadvantage" because it "traps free iodine and prevents it from killing bacteria" and because it must "be removed with a 3M lotion." Both statements are completely untrue. Studies done by independent, FDA-audited laboratories on healthy volunteers show that bacteria contacting the film are killed for at least 12 hours and that low bacterial counts are maintained under transparent dressings for up to 3 days. Both sets of studies prove that the iodine remains active and is not "trapped" in the film. In part because of this fact, 3M recommends that the iodophor film be left on at the conclusion of the procedure and be allowed to gradually wear away. If the clinician wants to remove the film for aesthetic purposes, our packaging clearly states that either isopropyl alcohol on a gauze sponge or 3M Remover Lotion can be used. Your article also failed to mention two other major advantages: it resists removal by blood and irrigating solutions and enhances drape adhesion.
• The FDA warning letter you mentioned was issued over six years ago and 3M has since addressed the FDA's concerns. Regarding the efficacy of DuraPrep solution, tests performed with over 100 different microbes, including antibiotic resistant microbes, have shown greater than 99% bacterial kill. Studies have shown that our product exceeds FDA log reduction requirements at specified time points for both dry and moist sites. DuraPrep solution is a true one-step solution requiring only one coat and no scrubbing of the site. Clinical studies published in peer-reviewed journals have favorably compared it to traditional surgical scrub products.

Regarding other inaccurate and misleading statements:

• A water-soluble surgical solution is not a requirement for release of bacteria-killing free iodine.
• Prior to US introduction, Chlora-Prep One-Step? solution has been in use in Canada only. It is not currently available in Europe although other chlorhexidine/alcohol combinations are in common use.
• Persist? prep swab is an alcohol-iodophor combination product and is brown, not bright green.
• Techni-Care? Surgical Scrub is one of several alcohol-free antimicrobial products. In addition, it's our understanding that the published proven kill time of 30 seconds is based entirely on in-vitro testing performed on only five microbes. The FDA does not support claims based only on in-vitro data.
• One of the sources quoted in the article claims virucidal action for his product. The FDA does not support such claims for topical antiseptic products.

Finally, the article failed to discuss an important safety point pertaining to all alcohol-containing surgical prepping products. These products are flammable and require caution for safe use. Alcohol-containing surgical solutions should not be allowed to pool and must be dry prior to draping or use of cautery or other potential ignition sources. Users should follow all manufacturer instructions to ensure proper and safe usage.

We feel it is our obligation to call to your attention these corrections to provide your readers with accurate information on this important category of products.

-Mardi Bentzen, Market Manager, 3M Health Care