Efficacy of Hand Hygiene Products is Subject of New ASTM Antimicrobial Standard

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Professional hand hygiene products are subjected to vigorous testing prior to being marketed and introduced for use in a healthcare setting. Now, a new ASTM International standard approved by Committee E35 on Pesticides, Antimicrobials and Alternative Control Agents describes the use of pigskin as an alternative to human hands in testing the efficacy of hand hygiene products in combating contamination.

ASTM E2897, Guide for Evaluation of the Effectiveness of Hand Hygiene Topical Antimicrobial Products Using Ex Vivo Porcine Skin, was developed by Subcommittee E35.15 on Antimicrobial Agents.

While testing hygiene products on human hands can be done, tests involving human volunteers can be expensive and are limited in the types of pathogens that can be used. According to Peter Karanja, a research and development scientist, STERIS Corp. and an E35 member, ASTM E2897 overcomes such limitations and offers the benefit of being applicable to a wide variety of hand-washing conditions.

“ASTM E2897 will permit testing of pathogens that may be encountered in a healthcare environment but would not be tested on human subjects,” says Karanja. “It also permits testing of conditions that cannot be simulated in a test tube while offering less expensive and higher throughput screening hand hygiene products.”

In addition to ASTM E2897, E35.15 is developing a related proposed standard, ASTM WK36911, Guide for Measuring the Inactivation of Persistent Activity of Topical Antimicrobial Products Using Ex Vivo Porcine Skin. This proposed guide will demonstrate the compatibility of topical antimicrobial products and the ability to maintain persistent activity exhibited by products used in a healthcare setting. Like ASTM E2897, ASTM WK36911 uses pigskin as a surrogate for human skin.

All interested parties are invited to participate in the development of E35.15 standards. For more information on becoming an ASTM member, visit www.astm.org/JOIN.

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