ASTM International Group approves guide for cleaning reusable medical devices

Oct. 11, 2019

ASTM International’s committee on medical and surgical materials and devices (F04) has approved the third in a series of standards that help evaluate effective cleaning procedures for medical devices. The new guide, which focuses on extraction of test soils to validate cleaning methods, will soon be published as F3321.

According to ASTM International member Ralph Basile, the guide is an important step in the process of validating cleaning instructions that healthcare workers perform to prepare a device for the next patient.

Device manufacturers, testing laboratories, and regulatory agencies will be the primary users of the new standards. Basile notes that healthcare facilities might also find the new standard helpful in understanding how manufacturers validate their cleaning instructions.

Basile notes that the committee is now developing a fourth standard in this series, aimed at detecting and quantifying cleaning markers for validating cleaning methods for reusable medical devices (WK63284). The previous two standards are F3208 and F3293.

ASTM welcomes participation in the development of its standards. Become a member at www.astm.org/JOIN. The next meeting of ASTM International medical and surgical materials and devices committee is Nov. 5-8, in Houston, TX.

ASTM has the release.

Image courtesy of Kat Velez, LeeSar Regional Service Center, Fort Myers, FL, HPN’s 2017 SPD of the Year
261278015 © Александр Лебедько | Dreamstime.com
Photo 45764679 © Antonio Guillem | Dreamstime.com