This standard guide will describe methods for characterizing of the cleaning efficacy of brushes designed to clean the internal channels of medical devices. The methods utilize a force tester to mechanically actuate a brush forth and back within a channel. In the first method, the force required for the forth and back motion within the channel will be measured at an established speed. The next method utilizes the same force tester and protocol (forth and back motion), the brush will be actuated in a presoiled lumen and the amount of soil removed will be measured.
Purpose of Test Method: Brushes designed to clean during decontamination procedures play an important role in the effective reprocessing of clinically used medical devices. This standard guide will provide objective, quantifiable and reproducible methods for evaluating the cleaning characteristics of a brush in a test that simulates the cleaning challenge of a defined target area(s) of a medical device. This will also make possible the comparison of one brush design to another. Who Would Use this Method and What Problem Does It Solve: Manufacturers of cleaning brushes will be able to evaluate and document the cleaning performance of their brushes for the target area(s) of medical device(s) and evaluate modification to design and construction that might improve performance. This information can also be shared with the users of the brushes (medical device reprocessors) to help them evaluate the performance of commercially available brushes. There does not currently exist a standard method for characterizing the cleaning efficacy of brushes designed to clean inside of channels. While ASTM and other standards groups have methods to characterize brushes designed for other purposes (i.e., paint), such methods are not employed to evaluate brushes for cleaning medical devices. The lack of such methods is gap in the validation of brushes designed to clean medical devices. This proposed standard guide will help to close this gap.
Keywordsreuse, reusable medical device, cleanliness testing, cleaning brush,
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
Draft Under Development