Press Release: December 2006

Contact: Steve Ebben
248-551-2667
steve.ebben@beaumontservices.com

FDA Hires Beaumont Technology Usability Center For Patient Safety Project

The Beaumont Technology Usability Center is assisting the U.S. Food and Drug Administration in a national patient safety initiative to prevent tubing and catheter misconnection errors in pediatric intensive care units. The project, a part of the Medical Product Safety Network – or MedSun – program, is expected to conclude in April 2007.

“In the health care industry, many medical tubing connection devices are utilized to deliver medication, gases, and nutrition,” says Izabella Gieras, BTUC’s director of technology management. “These devices frequently have similar or even identical connectors, despite their different clinical applications (e.g., epidural, intravenous, intestinal, etc.). The similarity of these connectors in a busy health care environment presents a real risk of misconnection errors, with potentially lethal consequences. BTUC is pleased to have the opportunity to serve the FDA in this important patient safety initiative.”

About The Beaumont Technology Usability Center
BTUC’s mission is to advance excellence in healthcare by improving medical technology and its use. The Center provides medical device and equipment manufacturers with product development services that improve patient safety, minimize the cost of product development and shorten the time-to-market. The BTUC is a multidisciplinary team of health care experts affiliated with Beaumont Hospitals. Beaumont is comprised of two hospitals - including a 1,061-bed tertiary care, teaching, research and referral center in Royal Oak, MI and a 254-bed acute care community teaching hospital in Troy, MI. Beaumont also includes six community-based medical centers, rehabilitation, primary and specialty care clinics, four nursing centers, home care and hospice.

About Medsun
MedSun (the Medical Product Safety Network) is a project under the direction of the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA). It is designed to collect data on adverse events and situations indicating the potential for harm involving medical devices. The objective of the MedSun pilot program is to determine if the MedSun system proves useful in helping CDRH obtain better data on problems with medical devices from the clinical community.