Your recent HPN Daily Update included a press release from Medline about Gunter Kampf’s study "Efficacy of ethanol-based hand foams using clinically relevant amounts: a cross-over controlled study among healthy volunteers." This study has several germane limitations in its design that may cause confusion in interpreting the conclusions of the study.

Based on the information contained in the press release, this study appears to be flawed in several key areas. The author establishes an arbitrary rub-in time of 30 seconds to justify testing a small volume of product. He then selects a European method (EN1500) that samples only the fingertips of human subjects and differs greatly from product application and use per U.S. guidelines and FDA proposed efficacy criteria¹. The U.S. Centers for Disease Control and Prevention (CDC) has identified hand hygiene products with 62% alcohol content as meeting the requirements for an effective hand sanitizer in healthcare settings. Also, the FDA has utilized expert panels and reviewed submitted data to verify that products containing 60-95% ethanol are effective when properly formulated. The European standard does not apply in the U.S.² STERIS stands behind the clinical performance of Alcare Plus Antiseptic Handrub with Emollients, Alcare Foamed Antiseptic Handrub, and Soft ‘N Sure Foamed Antiseptic Handrub based on the results obtained by studies conducted within the FDA proposed testing methodology.

Furthermore, this study incorrectly implies that foamed alcohol sanitizers differ significantly from alcohol gel or liquid sanitizers for rub-in characteristics. The amount of gel, liquid or foam products will have very similar rub-in times based on a liquid volume amount. Both gel and foam sanitizers "break" (become more liquid) once friction is applied during application and inherently 2.5 grams of foam (approximately a golf ball size) and 2.4 mL of gel will rub-in within similar time frames.

The author does accurately state that "real life in a practical setting" must be considered. In doing so, one must recognize that there is greater variation and potential impact based on hand size (i.e. surface area), skin condition, and room humidity, than the dosage form of a sanitizer (foam vs. gel or liquid). To note, the finger tip method outlined by this study does not account for these variations in the way the FDA proposed methods address this issue. The STERIS foam sanitizers allow users to adjust the dispensed quantity to adapt for these variations. Interestingly, the study’s author fails to address the U.S. preference for foam sanitizers. STERIS recognizes that when healthcare workers have a product they like, they will use it. If the goal in hospitals is good hand hygiene practices and compliance that results in infection prevention, this is no small point.

Healthcare personnel typically rub in these products "on-the-go"; one of the major advantages for this product category is not being tied to a sink. The suggestion that 1.6 grams of just water will provide the same efficacy as the same quantity of 62% ethanol foam sanitizer is an incredulous statement in light of overwhelming evidence to the contrary. This statement implies that hand hygiene practices should go back to the sink. While STERIS fully supports the use of soap and water as a critical component of an effective hand hygiene program, the use of wash products take longer to wash, rinse and dry than is needed for foam alcohols products to rub in. This seems illogical if the author’s primary concern is time needed for hand hygiene events.

It is important that proper context and U.S. standards as defined by the FDA and CDC are applied when studies are presented that seem to make blanket statements about important infection prevention products being widely used in U.S. hospitals today.

References

1. Food and Drug Administration. Topical antimicrobial drug products for over-the-counter human use; tentative final monograph for health care antiseptic drug products-proposed rule. Federal Register, Parts 333 and 369, Vol 59, No 116, June 17, 1994; pp. 31402-31452.

2.CEN (European Committee for Standarization) EN 1500. Chemical disinfectants and antiseptics-hygenic handrub: test method and requirements (phase 2, step 2. Brussels:CEN, 1997.