Standardization News

ASTM International’s committee on medical and surgical materials and devices (F04) is developing two standards to help evaluate performance of brushes that clean medical devices. One is focused on brush parts that clean internal channels and the other is focused on brush parts that clean external surfaces Additional related standards may follow.

The committee welcomes anyone who wants to help create these standards.

“During clinical use, surgical instruments and other reusable medical devices sometimes become contaminated with infectious agents,” says ASTM International member Ralph J. Basile, vice president of regulatory affairs atHealthmark Industries Co. “Effectively cleaning devices is a key step in making them ready for use on the next patient.”

While brushes are often part of the protocol for medical-device cleaning, there are not standardized ways to evaluate brush performance. The proposed standards will fill this gap, helping a number of groups:

• cleaning-brush and medical-device manufacturers;
• brush users in healthcare facilities;
• medical device regulators; and,
• other standards organizations that write methods for medical device reprocessing.

The two work items are:

• WK53082: Guide for Characterizing Performance of Brushes Designed to Clean the Internal Channel of a Medical Device, and
• WK57049: Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surfaces of a Medical Device.

ASTM welcomes participation in the development of its standards. Become a member at www.astm.org/JOIN.

ASTM Committee F04 on Medical and Surgical Materials and Devices Next Meeting: May 9-12, 2017, May Committee Week, Toronto, Ontario, Canada 
Technical Contact: Ralph J. Basile, Healthmark Industries Co., Fraser, Mich., tel +1.248.238.8435  
ASTM Staff Contact: Kathleen Chalfin, tel +1.610.832.9717