Posts Tagged ‘medical devices’

Meet The Real-Life Bionic Woman

Tuesday, May 11th, 2010

Six years ago, Claudia Mitchell suffered injuries in a motorcycle accident that led to the loss of her left arm. In 2006, through the Rehabilitation Institute of Chicago, she became the first female recipient of a $3 million robotic arm controlled by her own nervous system.

The “myolectric” prosthetic limb receives movement information from electrodes connected to Claudia’s existing nerves, which were routed by surgeons into positions on her chest. When those electrodes receive electrical signals from the brain, movement in the arm is triggered.

Remarkably, the prosthetic can be controlled in a fairly natural manner, allowing Claudia to perform simple tasks much in the same way she would with a real arm. It’s one of the first cases of nerve-rerouting surgery to enable control of a prosthetic via electrodes, whereas prosthetics in the past were controlled by muscle movement in the neighboring limbs.

Connected Glucose Meter Scores Points For Kids

Wednesday, May 5th, 2010

For children and parents alike, growing up with diabetes can be a painful process, as monitoring blood-sugar levels is a daily requirement to ensure good health. Glucose meters still depend on a fresh blood sample which means pricking a child’s finger several times a day, a procedure that Bayer hopes to liven up with a new device being marketed to parents with tech-savvy kids.

The device is called “Didget,” and it’s a blood glucose meter that connects to the Nintendo DS — the popular internet-connected portable gaming system. When connected to a DS, the Didget transmits information about how regularly its owner has performed a blood sugar test, and DS games with Didget compatibility reward the player with special unlocks and online leaderboard points.

While it remains to be seen how the glucose meter will ensure the security of potentially sensitive patient health data when connected to a WiFi network device such as the DS, Bayer hopes its new gadget will provide incentive to kids living with diabetes. As reported in the New York Times, Dr. Phyllis Speiser of Cohen Children’s Medical Center of New York agrees that “any device, any technology that will encourage children to do what they need to do is a good development.”

New Bluetooth Coming To Your Wristwatch

Monday, May 3rd, 2010

While Bluetooth can currently be found in just about every mobile handset and earpiece on the market, the wireless standard is about to receive a low-energy makeover that will give greater connectivity to even the smallest devices.

The new Bluetooth could pop up anywhere because if its low power usage. For example, a standard-sized wristwatch could alert its wearer to incoming calls and text messages, whereas previous Bluetooth watches have been cumbersome in size and required a frequent charge. Small medical devices such as glucose monitors could also incorporate the standard, making them cheaper and easier to integrate than with existing proprietary options.

Executive Michael Foley anticipates that the interface will open up connectivity for a wide variety of items that were previously too small for wireless connection. “It’s going to enable an entirely new market for Bluetooth and allow it to be used in a category of products that Bluetooth just couldn’t be used in before.”

Medical Device Malfunction Case Continues

Wednesday, April 28th, 2010

pic3-46We previously posted about Guidant LLC’s $300 million plea agreement–the result of multiple FDA investigations surrounding mechanical failures in Guidant’s Implantable Cardioverter-Defibrillators (ICDs).

Hoewver, as described in yesterday’s New York Times, a federal judge has rejected the plea arrangement.

According to The Times,

Donovan W. Frank of United States District Court said the provisions of the agreement were “not in the best interest of justice and do not serve the public’s interest because they do not adequately address Guidant’s history and the criminal conduct at issue.” [...]

Judge Frank said that prosecutors should have sought probation for Guidant and its parent, Boston Scientific. Probation would have required the companies to take certain steps, like helping to rebuild public confidence in the safety of heart devices, in addition to paying a fine.

The judge also outlined other provisions that might be suitable in a new plea deal, including charitable activities by Guidant to improve heart device safety and improve medical care among minority patients.

Microsoft Researcher Recommends Password Tattoos for Pacemakers

Tuesday, April 27th, 2010

pic1-46Many implanted medical devices such as pacemakers and auto-defibrillators are now equipped with wireless capabilities, giving doctors remote access for patient monitoring and troubleshooting. However, as Mocana CEO adrian Turner described on CNBC, there is growing concern about the security of these devices and their vulnerability to hackers, who could intentionally cause life-threatening malfunctions or steal patient information. So what is the best method for securing these lifesaving devices?

One option is password protection, yet obvious questions arise. Where would these passwords be stored? Could they be easily compromised? And of course, if a patient were unconscious and in need of emergency treatment, they would be unable to provide this information. That is, unless the password were tattooed somewhere on the patient’s body.

This unconventional solution has been proposed by a Microsoft researcher as a way to guarantee access to implantable devices in case of emergency. Using invisible ink that could be exposed under ultra-violet light, the tattooed passwords would be nearly undetectable under normal conditions. According to the researcher’s proposal, patients would have the option of “user-chosen” phrases, random character strings or hieroglyphic-like designs for their permanent identifiers. Whether many of those wearing implanted devices would actually be willing to get tattooed remains to be seen.

Mocana a Sponsor of Software Design for Medical Devices Conference

Monday, April 19th, 2010

pic8-44Mocana is a sponsor of the 13th Software Design for Medical Devices conference taking place in San Diego, CA May 24 – 26.

With presentations from medical technology industry leaders and experts, including representatives from the FDA, this year’s conference will address a range of topics aimed at regulatory compliance and design quality, including best practices to:

- Manage compliance with the amended Medical Device Directive

- Organize your structure and process to address new regulatory requirements

- Achieving shorter development cycles without sacrificing compliance and quality

- Plan a process where SQA works closely with stakeholders in the early stages of project development

- Integrate human factors engineering into medical devices to make them safe, effective and efficient to use

Medical Device Malfunctions Cost Company Millions

Monday, April 12th, 2010

pic1-43The Implantable Cardioverter-Defibrillator (ICD) has become a go-to device for patients recovering from congestive heart failure, arrhythmia and related cardiovascular impairments. Implanted beneath the skin in a surgical procedure, the ICD monitors and occasionally corrects abnormal heart behavior.

Due to malfunctions in a number of their models, Guidant LLC–a leading manufacturer of ICD’s–began issuing recalls on some of its devices back in 2005. And now, after a series of investigations by the FDA, Guidant is facing nearly $300 million in fines due to their improper reporting of these malfunctions.

The corporation has been officially charged with withholding information from the FDA and making materially false statements about its products, and its plea agreement with the U.S. Department of Justice is still under review.

In addition to these charges by the FDA, several class action lawsuits have sprung up on behalf of individuals affected by malfunctioning devices, which were still being marketed at the time of recall.

Smart Pills Tell When They’re Taken

Monday, April 12th, 2010

pic2-43According to recent PopSci article, researchers at The University of Florida have created a prototype pill that, when ingested, transmits data to medical personnel.

The prototype pills are standard white, with an antenna that is printed onto the surface…with silver nanoparticles. The capsule also contains a tiny microchip…. When the pill is taken, the microchip beams a signal to an external receiver…which in turn transmits a signal to a phone or computer that informs doctors or loved ones that the pill has been consumed. There is no battery on board the pill because it is powered by tiny bursts of low-voltage charge transmitted from the external device.

The antenna breaks down when introduced to the body’s natural processes, and the microchip passes safely through the digestive tract.

The development could end up a major healthcare breakthrough since, as reported by PopSci, mismanagement of prescription medications is responsible for over 200,000 patient deaths every year.

Conference Highlights the Latest in Medical IT

Monday, April 12th, 2010

pic3-43From electronic medical records systems to wireless patient monitoring devices, a wide range of new healthcare technologies and IT systems were on display at this year’s Healthcare Information and Management Systems Society conference in Atlanta. And with over $20 billion in Federal healthcare IT stimulus money soon-to-come, healthcare providers at the conference were ready to move ahead with the latest innovations in healthcare IT.

However, according to a recent InformationWeek article, these developments could be happening too quickly:

The $20 billion-plus healthcare IT stimulus program has more hospitals and doctors than ever planning to implement e-medical record and other health IT systems. But CIOs report they’re finding it hard to recruit IT talent, especially those with the skills to work on EMRs and physician order entry systems.

New Wireless Standard for Medical Devices

Monday, April 12th, 2010

pic4-43The ZigBee Alliance has announced the public availability of ZigBee Health Care, a new version of the ZigBee wireless standard that is intended specifically for medical devices.

According to the ZigBee Alliance,

ZigBee Health Care provides a global standard for interoperable wireless devices enabling secure and reliable monitoring and management of noncritical, low-acuity healthcare services targeted at chronic disease. It promotes aging independence, overall health, wellness and fitness by providing more information about one’s state of health.

Designed for use in homes, fitness centers, retirement communities, nursing homes and a variety of medical care facilities. It also supports the needs of a diverse and global ecosystem of consumers, service providers, care providers, payers, product manufacturers and policymakers.

Included in the standard are specifications for extended battery life, wireless range and output power, as well as customizable security features for access control and key generation.