Press Release: November 2006
Contact: Steve Ebben
248-551-2667
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).
In healthcare, many medical tubing connection devices are utilized to deliver medication, gases, and enteral feedings. These devices frequently have similar and often identical connectors, despite the variety of intended clinical applications (i.e., epidural, intravenous, enteral, etc.) The multitude of similar connectors in a busy healthcare environment presents a real risk of inadvertent misconnection, with potentially lethal consequences.
On March 26 and 27, 2007, the BTUC presented its risk assessment results to the FDA and Medsun participants at the MedSun Representatives Conference in Church Falls, Virginia.
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.
Per Izabella Gieras, BTUC’s Director of Technology Management, “We are pleased to have been chosen to help the FDA and Medsun address this national patient safety topic. We believe that our work will increase the awareness of misconnections and provide an innovative approach to address them in a healthcare 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, improving the patient safety.”
The next steps are to work with MedSun on distributing the project results industry-wide. These actions will form the foundation for creating safe device designs; first by developing institutional programs and regulatory standards that prevent tubing and catheter misconnections.
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.
