Medical Devices Could Be Sabotaged By Terrorists, Says Intertech Expert; Manufacturers Need to Boost Security.

NORWOOD, Mass. -- Hundreds of hospital patients could be seriously injured by a terrorist or criminal who systematically sabotages medical devices, says David A. Vogel, president of Intertech Engineering Associates.

"A terrorist or a madman could access software-driven medical devices and injure many people and perhaps kill some victims. Medical device manufacturers have been somewhat carefree about publishing master passwords for devices or shipping all devices with the same master password," says Vogel, whose firm tests medical devices and develops the software and electronics in them.

A terrorist or miscreant could become trained as a biomedical technician and alter tens or even hundreds of devices in a hospital, Vogel says. With access to the devices and passwords, the individual could sabotage equipment like X-ray machines, defibrillators and intravenous line pumps. Even worse, it could take a long time to recognize the problem, and determine how many devices are altered.

He might alter the calibrations on an IV pump so that it would overdose a patient with a drug, or sabotage a defibrillator so that it wouldn't produce enough energy to restart the victim's heart, Vogel says.

Medical device manufacturers need to do more to secure their products, he adds. The first step is for manufacturers to become aware of the problem and start building in security features.

Vogel is recognized as a top expert in medical-device design, software safety/risk management and FDA compliance. He holds a Ph.D. in bioengineering from the University of Michigan, and an SB from MIT.

Intertech, in Norwood, Mass., uses a painstaking software risk-management process in medical device projects to avoid rework and dangerous failures. Web: www.inea.com.