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.

Case Medical Issued Patent on Wash Monitoring Device

Case Medical was issued U.S. Patent 9,885,664 for Case Soil, a wash monitoring system that represents the organic soils and bioburden found on surgical instruments that need to be cleaned and prepared for their next use at health care facilities.

“When included as part of the cleaning process, the Case Soil indicator provides sterile processing departments an accurate proxy for the cleanliness and safety of the entire load. It may be used for daily monitoring of cleaning effectiveness in automated washers and ultrasonic machines,” according to a news release.

“Case Soil provides a consistent, reproducible, ‘go, no-go’ method to visually check the performance of automated washers and ultrasonic cleaners as well as the process parameters of multi-enzymatic cleaners and detergents for reprocessing surgical devices” Case Medical CEO Marcia Frieze said. “This process is easy to use, and easy to monitor as failures are instantly recognizable.”

The indicator contains a mixture of sterile blood components, proteins, fat and carbohydrates typically found on surfaces of used medical devices, dried onto a stainless-steel coupon to simulate bioburden. The coupon – with a defined area for inspection – is placed within a hinged stainless-steel holder, representative of a surgical tray.

“Existing wash monitors primarily monitor protein residuals or the effectiveness of alkaline cleaners. However, few, of the currently available indicators monitor pH neutral enzymatic cleaners and the presence of the substrates that they were intended to remove,” according to the news release. “Health care acquired infections have been linked to dirty surgical tools, a major cause of disease transmission from

patient to patient. FDA, AAMI and the CDC issued alerts for better infection prevention methods and monitoring for the well-being of patients, staff and the community at large. The medical device industry has previously used test soils that simulate residues commonly found on surgical devices for validation. However, those commonly used in health care facilities are typically composed of blood only or contain no blood products, rather synthetic materials on a plastic substrate. These are not truly representative of the soils or materials they are supposed to simulate.”



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