Archive for the ‘medical devices’ Category

Here’s why you should never use decorative contact lenses—in graphic pictures

October 30th, 2019
Closeup image of man wearing scary contact lenses.

Enlarge (credit: Getty / Aurich Lawson)

Unless you’d like to keep the pirate look going, it’s best to avoid costume contact lenses this Halloween.

Like every October, health authorities and medical organizations want to remind you that the decorative, over-the-counter lenses are not only illegal, they’re also terrible for your eyes. And not telling tales. The lenses can cause infections, sores, scratches, vision-impairing scars, and even blindness. It’s easy to find eye-related horror stories from people who turned to black-market lenses to change the color, shape, or look of their eyes (some lenses even add logos to your eyeballs).

Just on Tuesday, USA Today reported the case of a Cleveland woman who got decorative lenses stuck to her eyeballs. The lenses were supposed to turn her brown eyes blue but instead made them swollen and red. She had to have them removed in an emergency room.

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Posted in black market, blindness, CDC, contact lenses, eye injuries, fda, halloween, infection, medical devices, science, vision | Comments (0)

FDA safety scandal: 50K hidden reports of heart device malfunctioning

May 21st, 2019
The Food and Drug Administration headquarters in White Oak, Md.

Enlarge / The Food and Drug Administration headquarters in White Oak, Md. (credit: Getty | Congressional Quarterly)

The Food and Drug Administration allowed the maker of a faulty implantable heart device to secretly log 50,000 malfunction incidents, according to a series of investigations by Kaiser Health News.

The device—the Sprint Fidelis, made by Medtronic—consists of a pair of wires and a defibrillator to jolt the heart into a regular rhythm. But doctors found that it was giving patients random, harmful zaps and sometimes failed during actual cardiac emergencies.

Medtronic recalled the device in 2007 but only after it was implanted in around 268,000 patients. Many of those patients have since faced the ghastly choice of learning to live with the faulty device or undergoing an invasive, risky—sometimes deadly—surgery to remove it. According to the KHN investigation, they’ve been making that choice without information from the 50,000 incident reports.

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Posted in fda, medical devices, regulation, safety, science | Comments (0)

Medtronic’s Implantable Defibrillators Vulnerable to Life-Threatening Hacks

March 22nd, 2019
The U.S. Department of Homeland Security Thursday issued an advisory warning people of severe vulnerabilities in over a dozen heart defibrillators that could allow attackers to fully hijack them remotely, potentially putting lives of millions of patients at risk. Cardioverter Defibrillator is a small surgically implanted device (in patients' chests) that gives a patient's heart an electric

Posted in cyber security, hacking medical devices, hacking news, Healthcare Cybersecurity, Medical Device Cybersecurity, medical devices, pacemaker, Pacemaker hacking, Vulnerability | Comments (0)

High-tech toilet seat monitors your heart as you sit on the can

February 19th, 2019

If developing heart disease scares the poo out of you, this new monitor may be just the thing.

Engineers at Rochester Institute of Technology have designed a high-tech toilet seat that effortlessly flushes out data on the state of your cardiovascular system. The tricked-out porcelain throne measures your blood pressure, blood oxygen level, and the volume of blood your heart pumps per beat (stroke volume)—taking readings every time you sit down to catch up on some reading of your own. The engineers, led by David Borkholder, recently published a prototype of the seat in the open-access journal JMIR mHealth and uHealth.

According to the inventors, the seat’s daily data dump could make patients and their doctors privy to early warning signs of heart failure, potentially helping to prevent further deterioration and avoid costly hospital stays. Moreover, the seat could ease in-home monitoring for heart patients, who often strain to consistently track their tickers with other, non-toilet-based monitors.

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Posted in BCG, blood, cardiovascular disease, ECG, Health, heart, heart failure, heart monitor, medical devices, oxygenation, science, sensors, toilet | Comments (0)

Scanners to be patched after government warns of vulnerabilities

August 9th, 2017

Siemens says that there’s no evidence its scanners have been compromised – but the patches will be ready by the end of the month

Posted in healthcare, IoT, medical devices, Security threats, Siemens, Vulnerability | Comments (0)

Independent labs to probe medical devices for security flaws

July 27th, 2017

Medical devices have been a focus of concern – but a network of independent labs will work with manufacturers and health providers to improve their security health

Posted in healthcare security, medical devices, Security threats, WHISTL Labs | Comments (0)

Independent labs to probe medical devices for security flaws

July 27th, 2017

Medical devices have been a focus of concern – but a network of independent labs will work with manufacturers and health providers to improve their security health

Posted in healthcare security, medical devices, Security threats, WHISTL Labs | Comments (0)

Your pacemaker could be put in the witness box against you

July 24th, 2017

What happens when a wearable or embedded medical device tells a different story to someone suspected of a crime?

Posted in Law & order, medical devices, Technologies | Comments (0)

Pacemakers patched against potentially lifethreatening hacks

January 12th, 2017

Potential exploits are ‘the fuel of nightmares’, say experts

Posted in DHS, fda, Law & order, medical devices, pacemakers, Security threats, St. Jude Medical, USFDA, Vulnerability | Comments (0)

Medical Devices Should Withstand Rigor, Expert Says

September 23rd, 2016

In a keynote at the Internet of Things Forum Dr. Kevin Fu said that medical devices should be subjected to rigor so patients can make clinically relevant decisions.

Posted in Archimedes Center for Medical Device Security, Dr. Kevin Fu, Health, Health Security, hospitals, Internet of things, IoT, Medical device security, medical devices, vulnerabilities | Comments (0)