Medical Device Link.

NEWS TRENDS

An FDA project that’s examining tubing misconnection problems could push manufacturers to change their product designs. The patient safety initiative involving the Medical Product Safety Network (MedSun) and a team of healthcare experts is looking at how to prevent tubing and catheter errors in pediatric intensive-care units.

“Many connectors look very similar,” notes Izabella Gieras, director of technology management at the Beaumont Technology Usability Center (Royal Oak, MI). “And there’s potential for misconnecting something that’s infusing medication with something that’s infusing air or formula. The results could be adverse.”

Gieras thinks the project could identify errors and lead to physical design changes.

It’s possible that the program’s findings could mean manufacturers would have to modify the design of certain types of medical devices. “The risk assessment will identify potential misconnection errors. Therefore, the focus on administrative controls such as education and policy changes could lead to physical design changes,” says Gieras. “The design of the devices susceptible to misconnections should incorporate some type of forcing function” that prevents clinicians from connecting devices that should not fit together.

The Beaumont center began working on the MedSun project last November. The center’s team is composed of human factors and clinical engineers and clinical staff. The team developed a risk assessment process to classify and evaluate the connectors and the severity of all possible misconnections in the pediatric ICU.

The project is scheduled to end in April.