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Handwashing Antiseptics: The Product Selection Challenge

December 1, 2004
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Interview with Rita McCormick, RN, CIC, Senior Infection Control Practitioner, University of Wisconsin Hospital & Clinics Authority
INTERVIEW WITH RITA MCCORMICK, RN, CIC, SENIOR INFECTION CONTROL PRACTITIONER, UNIVERSITY OF WISCONSIN HOSPITAL & CLINICS AUTHORITY Handwashing antiseptics: The product selection challenge The vagaries of the U.S. Food and Drug Administration (FDA) review processes are usually something best left to the experts. They are so technical, detailed, and drawn out as to be comprehensible to only the most dedicated intelligence. For those with day jobs, there is only one reason to pay them any attention: They govern the safety and usefulness of our foods and medicines. All of which is to say that when it comes to those hand sanitizers so important to facility infection control, some FDA action is afoot that is worth following because it could have an important bearing on selection of those products. Recently Rita McCormick, RN, CIC-a University of Wisconsin infection control practitioner who has been a committee member for the development of a number of the Centers for Disease Control and Prevention (CDC) infection prevention guidelines, and who has been keenly interested in product selection in the area of healthcare infection reduction-described the situation and its long-term care implications to Richard L. Peck, editor-in-chief of Nursing Homes/Long Term Care Management.

Peck: Would you briefly describe the FDA's recent actions concerning hand sanitizers and other antiseptic products?

McCormick: Last year the FDA reopened what is called the Tentative Final Monograph, or TFM, process for healthcare antiseptic drug products. The TFM process sets the criteria for ruling which ingredients are safe and effective, which require further testing, and what manufacturers can say about their products in their labeling. Reopening the TFM for these products ended a nine-year hiatus, but the process is still under way with a somewhat distant end in sight-finalization quite possibly in June. Finalization of the TFM will give these criteria the weight of law. Until then, however, there is no federal regulation of these products. For long-term care facilities and others, that means "buyer beware."

Peck: What are the factors buyers should be looking for in a handwashing product being marketed to them?

McCormick: The ideal is to find the criteria the manufacturers have used to put a label claim on their product. That means, typically, that they have done the studies that the TFM requires to substantiate the claim. For example, because alcohol is one of the ingredients that is generally regarded as safe and effective, everybody who brought a product to market whose major ingredient was alcohol simply slapped on a label so indicating. The problem is that when you look at the other ingredients manufacturers might put into the product to diminish hand irritation or some other added benefit, it is up to you, as a customer, to determine whether it works. For example, if the manufacturer puts in an emollient that keeps the hand supple and soft, but the emollient is incompatible with another common ingredient, say chlorhexidine gluconate, you might not be getting the antimicrobial efficacy you presumed you were buying. If the manufacturer has no data on this one way or the other, then you are buying blindly. You're saying, "Well, I guess it's OK."

It's always a good idea to ask the sales representative or other company contact for the technical data associated with the product that support their label claims. Most good manufacturers should be able to provide this information without difficulty.

Peck: Can you just write to the manufacturer, "Please send your supporting data on your product?"

McCormick: They should be able to respond to that. It depends upon the manufacturer. There are very large companies that value their reputation, and you know they've jumped through all kinds of hoops and have depth of resources to meet sound criteria. Then there are the fly-by-night operations that, to grab a quick buck, put in some emollients and maybe a little glycerine and sell this untested product cheaper than anyone else.

The really big problem is that when a TFM has been tentative for as long as this one has, nobody wants to police all the label claims, so it is not surprising that the FDA hasn't put a lot of effort in this direction all this time. There are products out there that, if they had to prove efficacy, might not be able to come up with the data. There has been no watchdog for this.

This situation has been very discouraging for reputable companies that attempt to do the right thing and then are outsold by those that have not done any of the research and development but are willing to make a variety of claims. Some companies, for instance, have made claims of persistence, or residual antimicrobial effect, for their alcohol hand hygiene products, although it is well known that alcohol has no persistence. When one asks for an explanation, the typical response is that the persistent effect is from an ingredient that is inactive. It stands to reason that one can't label an ingredient as inactive but then claim that the same ingredient is responsible for extended activity.

Peck: In terms of getting some understanding of what sorts of information on criteria that the TFM offers, how does one get access? Is it on the FDA Web site?

McCormick: The TFM is so old that it's not on the FDA Web site anymore. If you go to the site, it will say that the TFM is not available online but is obtainable from an address that they provide. But I have tried to order older items a couple of times through the FDA Web site and have had limited success.