Entries in Medical Devices (4)


Can Your Insulin Pump Be Hacked?

iStockphoto/Thinkstock(LONDON) -- Technology security experts have sent out a warning about the potential vulnerability of sensitive equipment -- not computers, but medical devices such as insulin pumps.

A researcher from McAfee, the global tech security company, was able to hack into an insulin pump and cause the device to dispense all 300 units of insulin it contained, according to BBC News.

The wireless signals used to communicate with the pump could compromise the security of the device, researcher Barnaby Jack said.

“We can influence any pump within a 300-foot range,” Jack told the BBC. “We can make that pump dispense its entire 300 unit reservoir of insulin and we can do that without requiring its ID number.”

A single dose of that much insulin can be fatal.

Jack wasn’t the first person to hack into an insulin pump.  In 2011, a diabetic experimenting with his own equipment identified security vulnerabilities that could leave these machines open to someone remotely controlling their readings.  He presented his findings at a computer security conference later that year.

Other devices that use wireless signals to monitor patient’s medical conditions include pacemakers and defibrillators, which are also vulnerable to attack.

While the potential dangers are very real, other experts say the devices are very safe overall.

“There is no silver bullet, it’s not that these problems are easy to address,” he said. “But there is technology available to reduce these risks significantly,” Kevin Fu, associate professor of computer science at the University of Massachusetts at Amherst, told the BBC.

Dr. Tadayoshi Kohno wrote about the security of these devices in a 2010 edition of the New England Journal of Medicine.  At that time, he stressed to ABC News that the risk to patients is very low.

“I would have no qualms about getting one of the devices on the market now if I needed them,” Kohno said. “I think it’s preparing for the unexpected [that matters]....The last thing we want is, in five or 10 years, to think, ‘Oops we should have thought about security.’”

Outside of experiments, there have been no known incidents of medical device hacking, and doctors say using this type of equipment can life-saving.

“Manufacturers have to make them to an extremely high level of liability.  They are critical to life,” said Dr. David Lubarsky, professor and chief of the University of Miami Health System.  “Diabetes is infinitely more dangerous than the possibility of a hacker deciding to target your insulin pump.”

Copyright 2012 ABC News Radio


Medical Device Recalls Reveal Cracks in Regulatory Procedures, Researchers Say

Photo Courtesy - Getty Images(CLEVELAND) -- The approval process for medical devices has been the topic of growing scrutiny. Monday, a study published in the Archives of Internal Medicine suggests most medical devices recalled for life-threatening or very serious hazards were cleared by the Food and Drug Administration through an expedited review process called 510(k), or were considered so "low risk" they were exempt from review entirely.

"In my view, the regulatory system is failing," said Dr. Steven Nissen, a co-author of the study and chairman of cardiovascular medicine at the Cleveland Clinic.

Nissen and colleagues examined the number of medical device recalls from 2005 to 2009 and determined which regulatory pathway they had taken -- 510(k) or the more rigorous premarket approval process. Of 113 recalls of devices determined by the FDA to cause serious health problems or death, 80 were cleared through 510(k), and eight were exempt from FDA regulation.

"Some 80 percent or so of devices being recalled were actually never fully clinically tested in people," Nissen said.

It's unclear from Nissen's study how many devices approved through the standard PMA pathway have been recalled.

If a device is shown to be substantially similar to one already on the market, the 510(k) pathway allows its makers to bypass the PMA pathway's rigorous preclinical testing and inspections.

For implantable devices, like an artificial hip or an artificial heart valve, a recall means an operation.

"If you want to take back a heart valve you have to sit down with a patient and say, look, we have two very different, bad choices here. We can wait until your device fails, or we can go in and do an operation and put a new device in," Nissen said. "Those are very difficult choices."

Copyright 2011 ABC News Radio


FDA to Improve Premarket Review of Medical Devices

Photo Courtesy - Getty Images(SILVER SPRING, Md.) -- The U.S. Food and Drug Administration announced plans Wednesday to improve the most common path to market for medical devices. The agency revealed its plan consisting of 25 actions to implement during 2011.

Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health (CDRH), hopes these new actions will result in "a smarter medical device program that supports innovation, keeps jobs here at home and brings important, safe and effective technologies to patients quickly."

Key measures of the plan include establishing a new Center Science Council of senior FDA experts who will ensure timely and consistent decision making based on science, new guidance that will increase the efficiency of the premarket review process, and a recommendation of a suitable time for submission of clinical data for premarket review.

Copyright 2011 ABC News Radio


Report Calls FDA Monitoring 'Problematic'

Photo Courtesy - Getty Images(NEW YORK) -- A new report suggests that the Food and Drug Administration (FDA) is not doing an adequate job of monitoring the safety of medical devices, according to HealthDay.

"The agency often misses problematic devices," said lead author Shannon Brownlee, an instructor at the Dartmouth Institute for Health Policy and Clinical Practice.

Brownlee joined New York-based investigative journalist Jeanne Lenzer in an article that focused on the FDA's approval and follow-up monitoring of a device that prevents or reduces seizures in patients with epilepsy.

The article claimed that the FDA did not require the manufacturer of the Vague Nerve Stimulator (VNS) to report the cause of death in patients using the device.

According to the report, over 900 deaths have been reported by the FDA in patients who had the device implanted in the 13 years it has been on the market. 

Copyright 2010 ABC News Radio

ABC News Radio