One Way to Reduce Medical Errors

Originally Published MDDI March 2003

EDITOR'S PAGE

Medical technology is no panacea, but it can play a much greater role in reducing medical errors than it does today.

Last month in this space, we commented on the important role of failure analysis in the medical device industry. Our topic was inspired by the extensive news coverage of the space shuttle disaster. 

This month, a very different sort of tragedy has been in the news. Due to a simple human error, surgeons at Duke University Medical Center transplanted an incompatible set of heart and lungs into a 17-year-old patient, Jesica Santillan. Because the organs were of a different blood type, Jesica's body rejected them. A second transplant failed. 

In contrast to the space shuttle disaster, this tragedy occurred in spite of technology, not because of it. As one of the heads of the medical center noted, the event demonstrated both the strengths and weaknesses of the U.S. healthcare system. Jesica "came to Duke to benefit from a surgical procedure that requires technology at least as complicated as that needed to send a human to the moon and back," said Chancellor Ralph Snyderman, MD. "The surgical procedure was performed with technical excellence second to none." The failure of the surgery, he concluded, was due not to technology, but to "human errors and an insufficient backup system."

Though technology was not responsible for this terrible error, we wonder whether technology could avert this type of incident in the future. Perhaps not. Technology is not a cure for human fallibility. But at the same time, it is clear that technology will play a crucial role in reducing medical errors. The opportunities for the device industry to contribute are enormous. 

The new FDA commissioner, Mark McClellan, has made it clear that reduction of medical errors will be an agency priority. Speaking at a New York conference sponsored by UBS Warburg last February 4, he described several pending agency efforts in this direction. To supplement existing MedWatch and similar programs, FDA will hire 50 to 70 new people for postmarket surveillance. 

In addition, McClellan wants to establish a single 800 number for consumers and professionals to call in adverse events to FDA, and to have an "automatic reporting system" via computers. Rather than spend resources for new computers and software, the system would rely on existing health information systems at hospital networks and insurance companies. These systems would be adapted to automatically alert FDA whenever an adverse report was entered. Pilot projects at CDER and CDRH are already under way.

McClellan put a particular emphasis on bar coding. Although he spoke of it only in the context of drugs and biologics, it's clear that as medical devices increasingly interact with drugs and hospital systems, bar coding will become ever more important. 

Though much of the current focus is on drugs, bar codes are also being used to increase the safety of medical devices used to administer those drugs. Last September, B. Braun Medical Inc. introduced an IV infusion system designed to do just that. Its aim is to ensure that the correct patient received the correct dose of the correct drug from an authorized clinician. To do this, the firm has relied on bar codes to virtually eliminate the need to program IV pumps by hand—a major source of preventable drug errors.

Radio-frequency identification (RFID) systems could likewise reduce errors. While RFID systems can perform like bar codes, they can also offer critical tools for device tracking. Just as RFID-equipped wristbands can identify patients, so devices bearing battery-free RFID tags can be traced from their arrival at a facility through use on a patient. The data provided to hospital information systems by such devices could also strengthen reporting of adverse incidents. To date, the most serious limitation to RFID has been cost. However, a low-cost generation of tags is likely in the near future.

Technology will not soon replace the human role in healthcare. But it will play an increasingly important part in enhancing the human touch, and, sometimes, in correcting it.

The Editors

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