Archive for August, 2010

04.08.2010 blog, news No Comments

FDA Medical Device Regs Updated

Medtronic, Stryker, J&J Face New U.S. Rules for Medical Device Approvals
By David Olmos and Sophia Yan – Aug 3, 2010 9:01 PM PT

Medical device makers Medtronic Inc., Johnson & Johnson and Stryker Corp. face new safety rules under a revamped program laid out by U.S. regulators that may help speed approval of products from condoms to CT scanners.

The Food and Drug Administration released the proposed new requirements for the so-called 510(k) program that covers products similar to previously approved devices, or about 90 percent of products cleared for sale.

Medical device companies say the 510(k) process is rife with delays and inconsistent requirements, while consumer advocates say patients are at risk because of inadequate safety rules. The new proposals address both issues, giving device makers a more predictable process while insisting they provide more safety data, said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. read more

02.08.2010 blog, HITECH MU No Comments

LifeMed ID Smart Cards Enhance “Meaningful Use”

Life Med ID is the leading Smart Card USA provider for securing patient ID and access to electronic medical records.  The system is the latest technology that can help hospitals and integrated medical groups to meet the new HITECH act “meaningful use” guidelines.  The system is a web based system that integrated to other EMR systems to aggregate the patient’s medical records into a single holistic medical record system.

Current implementations of the system have yielded patient benefits in faster registration at the admit station for the hospitals and clinics.  Patient wait times have decreased from 18 minutes to 3 minutes, a significant improvement in initial encounters and satisfaction.  Life Med also has self-service kiosks that can be deployed in the lobby of facilities that can read the smart cards, and help patients with encounter forms and registration.  Patients can also login to view their own medical information with a web browser.  In emergencies, EMT personell can have satellite connected smart card readers to view critical patient medical information. read more