The Suit Magazine

All technology, no matter how well designed, has a failure rate. But when medical technology breaks down, the results can be fatal. Although the FDA subjects any new medical technology to a review process before it can be marketed, amazingly enough, there is no defined procedure for monitoring the equipment's performance once it has been placed on the market.

“When there's a medical malpractice lawsuit, people think that everybody's named as a defendant, but actually, often the medical device servicer and the medical device manufacturer are not among those named,” said David Darnel, founder of MedProductsLaw Inc. Darnel began his career as a hospital biomedical engineer in 1979 (Certified Clinical Engineer) and later transitioned to the legal side of medical technology. “Occasionally lawsuits would arise in the hospital, and I would be called as the hospital's engineer, as a fact witness,” he added. “... I was able to see how different lawyers operated and I said, 'You know, I can do that.'”

Even when a medical device operates perfectly, human error can result in patient injury or even death. In recent years hospitals have emphasized buying and deploying technology over hiring more medical staff as a money saving strategy. “If the standard of care medically, let's say, is to do carbon dioxide monitoring on this category of patient, the old approach is to hire people to do blood gas testing,” Darnel said. “The new approach reduces the need for clinical FTEs [full time equivalents] and instead, hooks up a continuous or sampling monitoring device.”

Bringing in more and more technology to handle medical needs also increases the risk of either product failure or human error in handling that technology. For example, multiple monitoring devices, each using different alarms might be missed or misinterpreted, leading hospital staff to ignore a critical warning.

Darnel believes  that the best way to cope with medical technology failure is to take precautions to keep it from happening in the first place. “There's a safety theory that says that an injury doesn't happen but for the alignment of several problems. It's called the Swiss cheese model of error, where an error doesn't pass through unless all the different factors line up,” Darnel said. “So you can achieve a safer healthcare process if you're involved in the design, acquisition and the training of the devices, rather than reacting after the fact to change procedures.” Recently, Darnel became the Director of Biomedical Engineering at the new Orange Regional Medical Center in New York.


For more information, please visit: www.medproductslaw.com

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