Aug 04, 2015

A proposed ASTM International standard will help develop “test soils” that validate cleaning methods for reusable medical devices. This will help companies that make endoscopes, clamps, suction tubes, arthroscopic shavers and other devices, as well as companies that provide cleaning systems for those products.

Reusable medical devices are often exposed to biological materials such as blood, tissue, fecal matter, bile, lipids and other soils. Device manufacturers provide cleaning instructions for professionals who reprocess a device after use. The standard will describe formulations to make test soils that help ensure cleanliness of these reusable products.

Manufacturers will use the standard to design and test cleaning strategies for products. Companies that make cleaning systems, such as sonication baths, will use the standard to test the effectiveness of their products against various test soils. Also, third-party reprocessors will use the standard to validate their cleaning procedures.

“Having a consensus document detailing suitable soils for this testing can help industry better comply with regulatory requirements and provide reprocessors with more effective cleaning protocols,” says ASTM member Stephen Spiegelberg, president, Cambridge Polymer Group.

The proposed standard stems from discussions following an ASTM workshop on medical device cleanliness in 2010.

The task group developing the standard (WK50782, Practice for Standard Test Soils for Validation of Cleaning Methods for Reusable Medical Devices) welcomes interested parties to participate. In addition, representatives from industry, academia and regulatory agencies are encouraged to attend a November 2016 workshop in Orlando, Florida. Abstracts are welcome from speakers with expertise in these areas:

• Composition and characterization of clinically relevant soils;
• Composition and characterization of test soils that can simulate clinical soiling;
• Design and test effectiveness of cleaning procedures; and
• International standards, both voluntary and regulatory, related to validation of cleaning procedures.

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

For more news in this sector, visit www.astm.org/sn-medical.

ASTM Committee F04 on Medical and Surgical Materials and Devices Next Meeting: Nov. 17-20, 2015, November Committee Week, Tampa, Fla.
Media Inquiries: Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org
Technical Contact: Stephen Spiegelberg, Cambridge Polymer Group, Boston, Mass, tel +1.617.629.4400 ext. 12; stephen.spiegelberg@campoly.com 
ASTM Staff Contact: Pat Picariello, tel +1.610.832.9720; ppicariello@astm.org

Release #9885