Not-for-profit plugs hole in recall system

By Jack Beaudoin
12:00 AM

Richard Fiddleman of Mitretek Systems is astounded that the nation's medical device recall and alert system has been ignored by policy-makers and healthcare IT vendors alike.

Two patients died and several hundred more were sickened in 2001 when contaminated bronchoscopes were used at Johns Hopkins Hospital. While much of the blame was laid at the feet of the manufacturer, the case also showed that the manual recall process used by hospitals across the country was defective as well. A manufacturer's letter to JHH was sent to the loading dock, where it was left unopened.

"The recall system is totally paper-based in hospitals and exists only on the FDA Web sites," Fiddleman notes. The problem is that the FDA sends out about 5,000 notices annually, some of them up to 60 pages in length - which often end up on a secretary's desk. Add to it inconsistent terminology, formatting and a shotgun approach to recipients, and the system was clearly in need of change.

Enter Mitretek Systems, a 501c(3) not-for-profit company that was spun out from the MITRE Corporation in the 1996. After creating a medical device database for the Indian Health Service to deal with the Y2K threat, Mitretek staff realized there was no real system for alerting critical hospital personnel about product flaws and failures.

The company began to develop RASMAS - it stands for Risk and Safety Management Alert System - in 2001. When it showed a prototype to Johns Hopkins, healthcare officials "were very excited with what we were doing," Fiddleman remembers, and asked to be a test site.

After applying a rapid development approach, Mitretek began showing a finished version of RASMAS at conferences in 2003.

"We realized our perception was correct," Fiddleman said. "It was a serious problem that (commercial) vendors weren't interested in."

RASMAS works by capturing alerts from various sources including the FDA, Consumer Product Safety Commission and subscriber submitted manufacturer notices, downloading data as it is obtained. After creating a raw alert record, the data is formatted into an XML record that is double-checked with human review to ensure that all cells are populated properly and the duplicate data is removed. Finally, the structured release is sent to designated recipients at RASMAS client hospitals.

The Web-based system then monitors activity that should follow the alert - if the alert isn't opened, activated and assigned to a hospital employee, the system elevates the alert to a supervisor, all the way up the chain of command. The system also creates an audit trail of past alerts and actions taken.

JHH is one of four sites now using RASMAS, which has been officially endorsed by the American Hospital Association. Officials there say labor hours dedicated to handling alerts has dropped by 80 percent since deploying the system.

But patient safety concerns will trump ROI as a reason to subscribe to the system. William Schaffner, MD, chief of preventive medicine at Vanderbilt University in Nashville and a consultant with the Tennessee Department of Health said in an interview last year that that FDA recall procedures "were neither efficient nor effective" in the bronchoscope case."

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