Tim Lozier, marketing manager at Farmingdale, NY-based EtQ, says his company has developed an FDA-compliance software solution that is Web-based but with offline capability. Modules include change management, calibration and maintenance, corrective and preventive actions, and employee training. In the case of adverse events, Lozier says, the software filters out the most critical events first.

The importance of monitoring lab equipment has led Raritan, NJ-based Ortho Clinical Diagnostics to develop a 24/7 remote monitoring system for its own product lines, says Susan Kadri, vice president of transfusion medicine, worldwide. Using a broadband Internet connection, data exchanged is securely encrypted via a VPN. "We know when something will go wrong, then schedule maintenance time," she says.

Reducing errors to ensure patient safety is as much a part of giving blood as it is prescribing and administering standard medications. A major trend today, says Lori Giannetta, director of operations for Trumbull, CT-based Korchek Technologies, is the use of bar codes on blood bags and patient wristbands. With and increasing number of procedures moving to the point of care, Giannetta says her company has developed both a wired and wireless hand-held device for use at the bedside before a transfusion begins. Not only does the device match the patient with the blood product, but it also documents any and all adverse events. "But we are taking it one step further," she says. "The scanning also allows vital signs to be captured at the bedside."

Advancing automation

by Richard R. Rogoski