Handwashing Antiseptics: The Product Selection Challenge

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.

Peck: Stepping back a little from the regulatory aspect of things and more toward the practical, in terms of judging a product, wouldn’t a staff know that a product is not quite right for them, even without the data if, after using it awhile, their hands are starting to get rough and scaly?

McCormick: When you look at the contents of the CDC’s hand hygiene guideline, it is very clear that the product you purchase for your facility should meet user acceptability criteria, and costs should not be the major component. I am very disappointed when I hear people say, “Well, I was told we had to buy such and such because that is what is on our contract.”

Peck: Isn’t it possible to make a cost case that by buying just the cheap products, you’re going to be spending more down the road to remedy the results, whereas the more expensive product might reduce future costs?

McCormick: It’s possible. But I’d say first of all, if staff doesn’t like it, they will not use it, and you will fall short in preventing infections. If they don’t use it and think they have to resort to using soap and water, we know from studies how miserably we have failed in encouraging optimal compliance with the use of soap and water. If done properly, handwashing can be effective, but we have not been successful in achieving optimal compliance.

Peck: Haven’t studies shown LTC staff handwashing compliance rates of as little as 20%?

McCormick: If you review compliance rate data over the past 25 to 30 years, you’ll see periods when compliance rates increase, but the increase wasn’t sustained, and that is the problem. Essentially you find a Hawthorne effect: Just the act of paying attention improves things for a while, but the effect wears off. If you could sustain a Hawthorne effect for an indefinite period of time, you would be in good shape, but we can’t seem to do it. We get busy doing other things, nobody champions the cause, and pretty soon, even though you had a nice boost in compliance, you slide back into noncompliance.

Peck: Would it help if LTC purchasers would buy products that are more acceptable to the staff, perhaps such that they would be more inclined to use them?

McCormick: Yes, I think it would, and I think success might also be predicated on the people who champion the cause-are they seen as highly credible, well liked, charismatic? If you can pick such people, you’ll do better.

Another aspect that is often overlooked is the powerful impact of a good role model. Physicians and nursing managers who are extremely vigilant about setting a good example and verbally setting the same expectation for all workers are often amazed at the “trickle-down” effect on compliance.

Peck: Is there another approach to compliance that perhaps might be used on a regular basis?

McCormick: One study recently looked at monitoring compliance at the patient level, giving patients the power and the license to say to the staff person, “Have you washed your hands or have you used alcohol gel?” Maryanne McGuckin of the University of Pennsylvania has done a number of studies in which patients were taught to ask healthcare providers to wash their hands. The results showed significant improvement in performance. One variation of one of these studies was to give patients a cute little fuzzy weeble-looking thing that had a tag on it that said, “Did you wash your hands?” You could give them to patients to stick on their gowns and, if they did not want to ask you verbally, they could just point to the little weeble. The results provided tangible evidence that you can empower patients.

Interestingly, Professor McGuckin found in subsequent studies that approximately only 30% of patients were willing to ask the physician the handwashing question, but they would readily ask the nurse at a rate of above 70%. And yet physicians are prime offenders. Also, this approach would not work in an ICU where you have patients who cannot be their own advocates. As a result of these findings, researchers are pursuing methods of automating audits of hand hygiene compliance. The results of these audits will provide good information about and improvement in compliance over time. Other research has shown that it is possible to achieve positive change by providing feedback to workers about their performance. Most workers want to do a good job and are willing to make the necessary changes when provided with accurate information on the need for improvement.

Peck: One thing that seems to get people’s attention these days is legal action. Do you know of any liability suits that have been brought in cases where failure to properly handwash led to a serious or fatal infection?

McCormick: I’m aware of a case in which two patients shared a room; one had a staph infection, and the other observed that the employees did not wash their hands well before they attended to him. Unfortunately, he developed a staph infection, too, and sued the provider. He won his case. Interestingly, the strain of staph that the second person had was different from that of the first patient, and it is possible that the source of infection for the second patient was his own skin flora. The jury did not consider that in their verdict. You just never know what a jury is going to do.

Peck: Staff these days are wearing gloves all the time to protect against HIV and other bloodborne pathogens, and sometimes think that by doing so, they’re covered and don’t have to worry about handwashing. Your comments on that?

McCormick: This is a common observation and a very vexing problem for most infection control practitioners. There are numerous studies showing that you cannot remove gloves without contaminating your hands. We tell staff, even though you throw the majority of the organisms away when you put the gloves in the wastebasket, you don’t throw them all away; some remain on your hands. If you put on a clean pair of gloves, these microorganisms are simply going to multiply on your skin while in the warm, moist confines of the glove. And if you peel off your gloves and rub your eyes or touch your nose, as people often do without thinking, you could inoculate your own eye or nose. Staphylococcus aureus is an organism that thrives in the nose. But this concept is a very hard sell.

The whole concept of hand sanitizing is a hard sell. You will find many people who are just as vigilant as they can be, but there are always the lackadaisical ones who will take their chances. Some individuals simply don’t believe that they may be responsible for transmission of infection to others because the time interval between transmission and evidence of disease can be lengthy; the causal relationship just isn’t obvious. Everything we’ve discussed-purchasing good quality products, establishing and enforcing strict hand sanitation regimens-has to be brought to bear to make sure that healthcare workers don’t take chances with patients and place them at increased risk of infections.

Because healthcare workers are required to do a lot of “wet work”-for example, bathing patients or frequent handwashing-skin irritation can be a real occupational risk. In fact, skin irritation has been identified as a major impediment to hand hygiene. The risk can be minimized significantly by routine use of hand lotions. We did a study in our hospital in which we identified workers with very irritated hands and required that they apply lotion at least four times per eight-hour shift. We then checked the condition of their hands every week. Very significant improvement was seen in the first week and was maintained throughout the month-long study.

The new CDC hand hygiene guideline emphasizes the need for the application of hand lotion to prevent skin irritation, and employers should provide these lotions. These products should be carefully selected to ensure compatibility with handwashing agents and gloves. Many of the lotions on the market for healthcare workers provide label information about compatibility with latex gloves and antimicrobial ingredients, such as chlorhexidine gluconate.

In sum, hand hygiene sounds like a rather simple concept and an easy procedure, but in reality good hand hygiene with optimal compliance is complex and requires continued vigilance by all healthcare workers to prevent cross-transmission of infectious agents between them and their patients.