Two new ASTM International standards help describe methods for characterizing the performance of brush parts that clean medical devices. The new standards (one available as F3275 and one soon to be published as F3276) were developed by ASTM International’s committee on medical and surgical materials and devices (F04). According to committee member Ralph Basile, the standards describe how programmable force testers – configurable motorized test stands used for tension and compression testing applications – are used to eliminate the human element in testing. This allows for reproducibility within and among labs and for a variety of brush parts.
“Brushes play a critical role in cleaning used medical devices,” says Basile, vice president of marketing and regulatory affairs, Healthmark Industries. “Brushes help dislodge and remove organic and other soils deposited on instruments, flexible endoscopes, and other devices during patient procedures. Before these standards were developed, there had not been published consensus standards for characterizing and evaluating the performance of such brushes.”
Brush manufacturers will be able to use the standards to compare the performance of different brush part designs, while makers of medical devices will be able to describe and define brush designs that are effective at cleaning their devices.
In addition, the standards could help regulators review cleaning instructions submitted by device manufacturers. Also, healthcare professionals will have more and better information, allowing them to compare one commercially available brush to another.
The medical and surgical materials and devices committee plans on developing more medical brush standards and all are invited to participate. Become a member at www.astm.org/JOIN. The next meeting of the committee is May 14-17 in Denver, CO, USA.
