New Standard Supports Cleaning Protocols for Reusable Medical Devices

In 2013, the Centers for Disease Control and Prevention alerted FDA about a potential association between multi-drug resistant bacteria and duodenoscopes, and FDA's investigation showed that infections were occurring despite confirmation that the users were following proper manufacturer cleaning and disinfection or sterilization instructions.

ASTM plans to publish a new standard to help the medical industry create and select materials using to test the cleanliness of reusable medical equipment.

This has been a concern of federal and health care authorities for years, especially with a type of medical equipment called a duodenoscope. These are flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum). They are used in some 500,000 procedures annually in the United States to diagnose and treat problems in the pancreas and bile ducts, but if they are not thoroughly cleaned and disinfected, contamination can occur.

In 2013, the Centers for Disease Control and Prevention alerted FDA about a potential association between multi-drug resistant bacteria and duodenoscopes, and FDA's investigation showed that infections were occurring despite confirmation that the users were following proper manufacturer cleaning and disinfection or sterilization instructions. So the agency worked with federal partners, manufacturers, and other stakeholders to better understand the critical factors contributing to bacterial infections associated with duodenoscopes and began monitoring the situation.

ASTM's F04 committee on medical and surgical devices is developing the F3208 standard, Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices. The standard will provide formulas for preparing "test soils" that resemble blood, feces, and other biological material to simulate contamination in reusable medical devices, such as pumps and endoscopes, so cleaning methods can be tested.

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