October 10, 2008

New system helps coordinate response to product recalls

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Neil Powe, M.D., M.P.H., M.B.A.

New system helps coordinate response to product recalls

Vanderbilt Medical Center has adopted the Risk and Safety Management Alert System (RASMAS) to oversee its recall management process.

The RASMAS system offers its users a Web-based forum to communicate with one another about who performs which task during the critical period after a product recall is launched.

From drugs and medical supplies to ground beef and tomatoes, product recalls impacting VMC are common. So far this year VMC has dealt with more than 1,400 recalls, and from June 2006 through June 2008 the Medical Center had to address a total of 5,913 product recalls.

“With RASMAS we are reducing the number of 'left hand knowing what the right hand is doing' type of issues during our recalls,” said Amie Hollis, program coordinator of the RASMAS Recall System in the Center for Clinical Improvement.

“During a recall there are participants identified in the organization who have specific tasks. There is a defined timeline for these participants to act. All of the participants leave notes in the web-based system saying what actions they have taken and who they have spoken with regarding a particular recall. Thanks to RASMAS we have all the names, who talked to whom, what actions were taken, and this information is all in one place.”

Most significant for VMC are recall items such as prescription medications, medical devices, human tissue products and other medical products. But other, more common, items can also pose a challenge.

“The big, publicly known cases are the food recalls due to E. coli and salmonella,” Hollis said. “Also, lead paint recalls, related to children's toys, and product adulteration recalls such as toothpaste with diethylene glycol instead of glycerin are good examples of recalls with massive volume.

“In each instance with these recalls we were potentially affected and were able to locate, remove, and replace all products because we have real-time recall notification with RASMAS, and we have in place a large network of over 150 Vanderbilt employees ready to tackle these issues as they arise.”

The RASMAS system allows a large organization such as VMC to increase patient safety by enabling it to rapidly learn about product safety alerts, receive improved reliability of information about these alerts, and follow a managed process which provides structure to an effective product recall.

“In addition to its recall alert function, RASMAS offers a component to the product recall process that no other service offers, and that's closure, or a loop back,” said Diane Moat, J.D., clinical risk manager in the Office of Risk and Insurance Management.

“RASMAS helps to identify people throughout the organization who have tasks in specific areas they are responsible for. So when the recall alerts are made there is a timeframe to respond to get a product off the shelves, complete the documentation, and close that loop.”