Press Release: April 2007
Contact: Steve Ebben248-551-2667
steve.ebben@beaumontservices.com
Beaumont's Usability Center Provides Results To FDA
In November 2006, the Food & Drug Administration (FDA) sought the expertise of the Beaumont Technology Usability Center (BTUC) to evaluate potential tubing and catheter misconnection errors in Pediatric Intensive Care Units (PICU).
On March 26 and 27, 2007, BTUC presented its risk assessment results to the FDA and Medsun participants at the MedSun Representatives Conference in Church Falls, Va.
Over the past few months, the BTUC team, composed of clinical and human factors engineers and two clinical nurse specialists, worked on developing a risk assessment tool to identify and classify the different types of potential misconnections in the PICU. The results highlight the areas with most adverse consequences to the patient.
“We are pleased to have been chosen to help the FDA and Medsun address this national patient safety topic,” says Izabella Gieras, BTUC’s Director of Technology Management. “We believe that our work will increase the awareness of misconnections and provide an innovative approach to address them in a health care environment.”
The regulatory bodies call for testing new device purchases for performance, safety and usability. Lisa Lau, BTUC’s Human Factors Engineer, recommends that hospitals "conduct usability tests in conjunction with their risk assessment to mitigate misconnection risks and improve patient safety.”
The next step is to work with MedSun on distributing the project results industry-wide. The ideal outcome is for hospitals to develop programs that prevent tubing and catheter misconnections and eventually for industry misconnections standards to be created.
About The Beaumont Technology Usability Center
BTUC’s mission is to advance excellence in health care by improving medical technology and its use. The Center, based at Beaumont Hospital, 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. For more information, see www.beaumontusability.com.
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 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 the CDRH obtain better data on problems with medical devices from the clinical community.
