FDA, Cardinal Health Assess Scope of Potential Contamination Risk

Dr. Jeffrey E. Shuren MD, JD, Director - CDRH Offices: Office of the Center Director, released the following statement on Thursday (January 16, 2020): “On Jan. 11 and again on Jan. 15, 2020, medical device manufacturer Cardinal Health alerted its customers to...

U.S Health System Uses Medtronic Stealth Autoguide Cranial Robotic Guidance Platform

Phoenix Children’s Hospital is the first-ever health system in the U.S. to receive and deploy the newly FDA-cleared Medtronic Stealth Autoguide platform.

Cook Medical TriForce Peripheral Crossing Set Now Available

Cook Medical’s TriForce® Peripheral Crossing Set is now commercially available. As of January 2020, these products are available to physicians in the United States to support procedures to treat patients with vascular obstructions.

PENTAX Medical Launches IMAGINA Endoscopy System in U.S.

IMAGINA offers practitioners a modern user interface and unique endoscope design to provide excellent visualization, improve the operator experience and positively influence long-term patient care costs.

New ASTM International Guide Supports Proper Medical Device Cleaning


ASTM International’s committee on medical and surgical materials and devices (F04) approved a new guide that seeks to improve the cleaning of medical devices. The standard provides methods for simulated soiling of reusable medical devices for the purpose of improving cleaning instructions.

The guide (F3293) offers methods for how to identify clinically relevant areas of the device to soil, time allowed for the soil to dry, and other procedures.

“This provides guidance on applying test soils to medical devices to simulate clinical use,” says ASTM International member Ralph Basile, vice president of marketing and regulatory affairs, Healthmark Industries Co.

Basile noted that the guide includes information on the design of the device, material composition, and other challenges to cleaning the device, particularly in worst-case scenarios.

Medical device manufacturers, testing labs, and regulatory agencies will be the primary users of this standard. Healthcare facilities might also find it helpful to better understand how manufacturers validate their cleaning instructions.

To purchase standards, contact ASTM International customer relations (tel +1.877.909.ASTM;

For more news in this sector, visit ASTM Standards for Healthcare Services, Products, and Technology.




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